TEMPORALSCANNER THERMOMETER, SENSORTOUCH

K011291 · Exergen Corp. · FLL · Jul 12, 2001 · General Hospital

Device Facts

• Record ID: K011291
• Device Name: TEMPORALSCANNER THERMOMETER, SENSORTOUCH
• Applicant: Exergen Corp.
• Product Code: FLL · General Hospital
• Decision Date: Jul 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

Device Story

The TemporalScanner is a handheld, battery-operated infrared thermometer used to measure skin temperature over the temporal artery. It operates by measuring natural thermal infrared radiation emitted from the skin surface. The device uses a thermopile infrared sensor and a thermistor to measure ambient temperature. These inputs are amplified, conditioned, and processed by an internal microprocessor using a patented 'Arterial Heat Balance' (AHB) algorithm to calculate and display body temperature. The device is intended for use by clinicians or consumers. The healthcare provider or user sweeps the sensor across the forehead to capture the peak temperature. The output is a digital temperature reading on an LCD screen. This measurement provides a non-invasive alternative to traditional methods, potentially benefiting patients by offering a quick, comfortable, and accurate temperature assessment.

Clinical Evidence

Clinical evidence includes a prospective study of 304 infants younger than 1 year comparing TA, tympanic, and rectal thermometry. Results showed TA thermometry had a sensitivity of 0.66 for detecting rectal fever (≥38°C) compared to 0.49 for tympanic thermometry (p<0.001). TA thermometry was better tolerated than rectal thermometry (p=0.007).

Technological Characteristics

Thermopile infrared sensor; thermistor for ambient temperature compensation; microprocessor-based signal conditioning; LCD display; battery-operated (9V); impact-resistant casing; conforms to ASTM E1965-98, EN 60601-1 (safety), and EN 60601-1-2 (EMC).

Indications for Use

Indicated for intermittent measurement of human body temperature in people of all ages.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Exergen Surface Temperature Scanner (K873010)
• Braun Thermoscan IRT 3020/3520 (K983295)

Submission Summary (Full Text)

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

JUL 12 2001

X011291

# 510(k) Summary

Submitter's Name: Exergen Corporation

Address: 51 Water Street
Watertown, MA 02172

Phone: [phone]
[phone]

Fax: [phone]

Contact: Gerald A. Clay

Date of Summary: April 27,2001

Trade Name: TemporalScanner Thermometer, formerly known as SensorTouch

Classification: Thermometer, Clinical, Electronic
Product Code: FLL
Regulation No. 880.2910
Class: II
Panel: 80 (General Hospital)

Predicate Device(s): Exergen Surface Temperature Scanner (K 873010) (Exergen Predicate)
Braun Thermoscan IRT 3020/3520 (K983295)(Braun Predicate)

Device Description: The TemporalScanner is a hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery.

Intended Use: The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

# Technological

Characteristics: The TemporalScanner Thermometer and the predicate devices are all used to measure the temperature of a human by means of a thermopile

Questions? Contact FDA/CDRH/OCE/DID at CDRH@[e-mail] or 301-796-8118

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infrared sensor transducer coupled with electronic signal amplification, conditioning, and display unit.

The Exergen Predicate employed solid-state electronic signal amplification which is technology similar to the electronic surface mount technology used by the TemporalScanner Thermometer and the Braun Predicate. The Braun Predicate's signal conditioning consists of making mathematical adjustments to display the familiar oral range. Similarly, the TemporalScanner Thermometer's signal conditioning consists of making mathematical adjustments to the temperature measured at the skin surface over the temporal artery to display the familiar rectal range. All display units are solid-state displays, with the Exergen Predicate using an LED display while the TemporalScanner Thermometer and the Braun Predicate employ an LCD display.

All of the devices meet ASTM E1965-98 Standard for Infrared Thermometers for Intermittent Determination of Patient Temperature, to the extent that this standard applies to them.

The primary difference between the TemporalScanner Thermometer and the Braun Predicate is that the Braun Predicate measures the temperature of the auditory canal and mathematically converts and displays a familiar oral temperature, while the TemporalScanner measures surface skin temperature over the temporal artery and mathematically converts and displays a familiar rectal temperature.

Summary of non-clinical Performance Testing:

| Performance test | | Results |
| --- | --- | --- |
| Accuracy tests | | Pass |
| (b)(4) | | Pass |
| (b)(4) | | Pass |
| (b)(4) | | Pass |
| (b)(4) | | Pass |
| (b)(4) | | Pass |
| EMC tests | | Pass |
| (b)(4) | | Pass |
| (b)(4) | | Pass |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

**Conclusion:**

Since performance testing confirms conformance to the same standard as both predicate devices, we conclude the device is substantially equivalent to those devices.

Questions? Contact FDA/CDRH/OCE/DID at CDRH@[e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015
DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service

JUL 12 2001

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Exergen Corporation
C/O Mr. William Hare
Associate
Fish and Richardson, PC
601 13th Street, NW
Washington, DC 20005

Re: K011291
Trade/Device Name: TemporalScanner Thermometer, SensorTouch
Regulation Number: 880.2910
Regulatory Class: II
Product Code: FLL
Dated: April 27, 2001
Received: April 27, 2001

Dear Mr. Hare:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Page 2 - Mr. Hare

action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

510(k) Number (if known): K011291
Device Name: TemporalScanner Thermometer

Indications For Use: The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109)
OR
90428.W11


(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
General Hospital Devices
Number K011291

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015
DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service

JUL 12 2001

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Exergen Corporation
C/O Mr. William Hare
Associate
Fish and Richardson, PC
601 13th Street, NW
Washington, DC 20005

Re: K011291
Trade/Device Name: TemporalScanner Thermometer, SensorTouch
Regulation Number: 880.2910
Regulatory Class: II
Product Code: FLL
Dated: April 27, 2001
Received: April 27, 2001

Dear Mr. Hare:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Page 2 - Mr. Hare

action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

510(k) Number (if known): K011291
Device Name: TemporalScanner Thermometer

Indications For Use: The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109)
OR
90428.W11


(Division Sign-Off)
Division of Dental, Infection Control,
General Hospital Devices
Number K011291

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

5-1

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration

From: Reviewer(s) - Name(s) William M. Burdick Memorandum

Subject: 510(k) Number K011291

To: The Record - It is my recommendation that the subject 510(k) Notification:

☐ Refused to accept.
☐ Requires additional information (other than refuse to accept).
☐ Is substantially equivalent to marketed devices.
☐ NOT substantially equivalent to marketed devices.

De Novo Classification Candidate?
☐ YES ☐ NO

☐ Other (e.g., exempt by regulation, not a device, duplicate, etc.)

Is this device subject to Postmarket Surveillance?
☐ YES ☐ NO

Is this device subject to the Tracking Regulation?
☐ YES ☐ NO

Was clinical data necessary to support the review of this 510(k)?
☐ YES ☐ NO

Is this a prescription device?
☐ YES ☐ NO

Was this 510(k) reviewed by a Third Party?
☐ YES ☐ NO

Special 510(k)?
☐ YES ☐ NO

Abbreviated 510(k)? Please fill out form on H Drive 510k/boilers
☐ YES ☐ NO

This 510(k) contains:

Truthful and Accurate Statement ☐ Requested ☑ Enclosed
(required for originals received 3-14-95 and after)

☑ A 510(k) summary OR ☐ A 510(k) statement

☐ The required certification and summary for class III devices N/A
☑ The indication for use form (required for originals received 1-1-96 and after)

Material of Biological Origin ☐ YES ☑ NO

The submitter requests under 21 CFR 807.95 (doesn’t apply for SEs):

☐ No Confidentiality ☐ Confidentiality for 90 days ☐ Continued Confidentiality exceeding 90 days

Predicate Product Code with class:

Additional Product Code(s) with panel (optional):

80 FLL, Class II

880-29102 Electronic Thermometer (Infrared)

Review: Patricia Cucente (Branch Code) 7/12/01 (Date)

Final Review: Susan Punn (Division Director) 7/10/01 (Date)

Revised: 8/17/99

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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510(k) "Substantial Equivalence" Decision-Making Process (Detailed)
* 510(k) Submissions Compare New Devices to Marketed Devices. FDA Requests Additional Information if the Relationship Between Marketed and "Predicate" (Pre-Amendment) Reclassified Post-Amendments) Devices is Unclear.
** This Decision is Normally Based on Descriptive Information Alone, But Limited To Information is Sometimes Required.
*** Data May Be the 510(k), Other 510(k)s, The Center's Classification Files, or the Literature.

Questions? Contact FDA/CDRH/OCEANS at [e-mail] or 801-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# "SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K011291

Reviewer: William M. Burdick

Division/Branch: DDIGD/GHDB

Device Name: Exergen TemporalScanner Infrared Thermometer

Product To Which Compared (510(K) Number If Known): Please refer to 3L of attached "510(k) REVIEW".

| | YES | NO | |
| --- | --- | --- | --- |
| 1. Is Product A Device | X | | If NO = Stop |
| 2. Is Device Subject To 510(k)? | X | | If NO = Stop |
| 3. Same Indication Statement? | X | | If YES = Go To 5 |
| 4. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness? | | | If YES = Stop NE |
| 5. Same Technological Characteristics? | | X | If YES = Go To 7 |
| 6. Could The New Characteristics Affect Safety Or Effectiveness? | | X | If YES = Go To 8 |
| 7. Descriptive Characteristics Precise Enough? | | X | If NO = Go To 10
If YES = Stop SE |
| 8. New Types Of Safety Or Effectiveness Questions? | | | If YES = Stop NE |
| 9. Accepted Scientific Methods Exist? | | | If NO = Stop NE |
| 10. Performance Data Available? | X | | If NO = Request Data |
| 11. Data Demonstrate Equivalence? | X | | Final Decision: SE |

(Continued on Next Page.)

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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1. Intended Use: Please refer to #2 of attached "510(k) REVIEW".
2. Device Description: Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if necessary) to support the statement. Is the device life-supporting or life sustaining? Is the device implanted (short-term or long-term)? Does the device design use software? Is the device sterile? Is the device for single use? Is the device for home use or prescription use? Does the device contain drug or biological product as a component? Is this device a kit? Provide a summary about the devices design, materials, physical properties and toxicology profile if important.

Please refer to #1 of attached "510(k) REVIEW".

## EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED

1. Explain why not a device: N/A
2. Explain why not subject to 510(k): N/A
3. How does the new indication differ from the predicate device's indication: N/A
4. Explain why there is or is not a new effect or safety or effectiveness issue: N/A
5. Describe the new technological characteristics: Please refer to 3N of attached "510(k) REVIEW".
6. Explain how new characteristics could or could not affect safety or effectiveness: The new characteristics are design, component, and software changes which are characteristics of legally marketed predicate devices.
7. Explain how descriptive characteristics are not precise enough: Clinical testing was necessary to assure that the thermometer would provide accurate measurements over the range of possible body temperatures for all patient ages from neonatal to geriatric.
8. Explain new types of safety or effectiveness questions raised or why the questions are not new: N/A
9. Explain why existing scientific methods can not be used: N/A
10. Explain what performance data is needed: N/A
11. Explain how the performance data demonstrates that the device is or is not substantially equivalent: The clinical results supported the clinical accuracy of the thermometer.

## ATTACH ADDITIONAL SUPPORTING INFORMATION

Please refer to the attached "510(k) REVIEW".

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Page 1 of 510(k) review

# MEMO TO THE RECORD
## 510 (K) REVIEW

K011291

DATE: July 6, 2001
FROM: William M. Burdick
DIVISION: DDIGD/GHDB
COMPANY NAME: Exergen Corporation
DEVICE NAME: Exergen TemporalScanner Infrared Thermometer

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION-MAKING DOCUMENTATION

## NARRATIVE DEVICE DESCRIPTION

1. SUMMARY DESCRIPTION OF THE DEVICE UNDER REVIEW:

This submission is for a hand-held, battery-operated, infrared forehead thermometer designed to measure the temperature of the surface of the skin over the temporal artery. This device, as with all infrared thermometers, measures the infrared radiation emitted by the patient and converts the measurement to a temperature according to the Stefan-Boltzman Law. IR sensing is based on thermopile instead of pyroelectric technology for this device. The structure of the sensor is based on conventional semiconductor technology and includes a housing in which a layer of material is covered with a thermocouple film. When the thermocouple film is struck by infrared radiation, the temperature of the thermocouple film changes. Voltages are generated that are indicative of the amount of infrared radiation received and the ambient temperature as measured by a thermistor. These outputs are amplified and conditioned, and the resulting signals are sent to a microprocessor within the unit. In the microprocessor, algorithms are used to convert the amplified and conditioned signals to a body temperature measurement. For additional technical information, please refer to ATTACHMENT A.

Clinical testing was performed in order to assure the accuracy of the subject thermometer. The clinical test results appeared to be satisfactory (please refer to consult memorandum from Dr. Joy Samuels-Reid). Dr. Samuels-Reid stated that, "The sponsor will need to provide explicit instructions for placement of the device during temperature taking." It appears that the sponsor has provided adequate instructions in the Directions for Use (DFU).

Bench test data was not provided in this submission, but the sponsor did claim conformance to the FDA consensus standard for infrared thermometers. ASTM E 1965-98.

2. INTENDED USE:

This device is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages.

DEVICE DESCRIPTION:

A. Life-supporting or life-sustaining: No
B. Implant (short-term or long-term): No

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Page 2 of 510(k) review

C. Is the device sterile? No
If yes, is sterility information provided? No

D. Is the device for single use? No

E. Is the device for prescription use? No

F. Is the device for home use or portable? Yes
Whether the answer is yes or no, is adequate environmental testing, including EMC, performed for the intended environment, and are results provided, including test protocols, data, and a summary? Yes

G. Does the device contain drug or biological product as a component? No

H. Is this device a kit? No

I. Software-driven: Yes
Estimated level of concern: (Major, Moderate, Minor)? Moderate
Has the firm provided a hazard analysis, software requirements and design information, adequate test plans/protocols with appropriate data and test reports, documentation of the software development process including quality assurance activities, configuration management plan, and verification activities and summaries, commensurate with the level of concern, as discussed in the Reviewer Guidance for Computer Controlled Medical Devices? Yes
Software version: N/A

J. Electrically Operated: Yes (battery-operated)
If yes, are AAMI or IEC leakage currents met and is the test protocol, data, and results provided? Yes, EN 60601-1

K. Applicable standards to which conformance has been demonstrated (e.g., IEC, ANSI, ASTM, etc.):

- ASTM E 1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

- EN 60601-1:1990 - Medical Electrical Equipment Part 1: General Requirements for Safety.

- EN 606011-1-2:1993 - Medical Electrical Equipment Part 1: General Requirements for Safety; 2. Collateral standard: Electromagnetic Compatibility - Requirements and Tests.

- EN 55011 - EMC.

L. Device(s) to which equivalence is claimed, manufacturer, and 510(k) number or preamendment status:

Thermoscan Clinical Electronic Thermometer, Model IRT 3020/3520 (K983295), mfred. by Braun.

M. Submission provides comparative specifications? Yes
comparative in vitro data? No
performance data? No
animal testing? No
clinical testing? Yes
biocompatibility testing? No

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Page 3 of 510(k) review

N. Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if necessary) to support the statement. Provide a summary about the devices design, materials, physical properties and toxicology profile if important.

Please refer to ATTACHMENT B for a comparison of the relative similarities and differences between the two devices.

No new issues of safety or effectiveness exist for this device.

O. Does the submission include a summary of safety and effectiveness information upon which an equivalence determination is based? Yes

P. RECOMMENDATION:

I believe that this device is equivalent to: 80 FLL

Classification should be based on:

880.2910 - Clinical Electronic Thermometer (Infrared Thermometer)

Class: II

William M. Burdick
Biomedical Engineer

- Attachments: ATTACHMENT A - Technical Specifications
ATTACHMENT B - SE Comparison

cc.: K011291
Burdick/CHRON

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4014 Released by CDRH on 08-25-2015

ATT A2A MIE M1

Substantial Equivalence Table

| Item | Exergen TemporalScanner Thermometer (TemporalScanner)† | Exergen Surface Temperature Scanner K873010 (Dermatemp) (Exergen Predicate) | Braun Thermoscan IRT 3020/3520 Thermometer K983295 (Braun Predicate) |
| --- | --- | --- | --- |
| Intended Use | The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages. | The Surface Temperature Scanner is intended for the intermittent determination of surface temperature anywhere on the skin surface of a patient | The Braun predicate is intended for the intermittent measurement and monitoring of human body temperature in the home for use on people of all ages. |
| Where used | Skin surface of the forehead | Anywhere on the skin surface | Skin surface of the auditory canal |
| Technology Used | Arterial Heat Balance | Arterial Heat Balance | Arterial Heat Balance‡ |
| Performance Specifications: | | | |
| Measurement range (max accuracy) | 60 °F to 107.6 °F (15.5 °C to 42 °C) | 96 °F to 102 °F (35 °C to 39 °C) | 68 °F to 108 °F (20 °C to 42.2 °C) |
| Total range (min accuracy) | 60 °F to 107.6 °F (15.5 °C to 42 °C) | 60 °F to 110 °F (15 °C to 43 °C) | 68 °F to 108 °F (20 °C to 42.2 °C) |
| Accuracy (max) | +/- 0.4 °F (0.2 °C) | +/- 0.2 °F (0.1 °C) | +/- 0.4 °F (0.2 °C) |
| Operating Ambient Range: | | | |
| Temperature | 60 to 104 °F (15.5 to 40 °C) | 65 °F to 95 °F (18 °C to 35 °C) | 50 °F to 104 °F |
| Humidity | Per ASTM 1965-98, up to 95% noncondensing | Per ASTM 1965-98, up to 95% noncondensing | Per ASTM 1965-98, up to 95% noncondensing |
| Display resolution | 0.1 °F or °C | 0.1 °F or °C | 0.1 °F or °C |
| Temperature scales | degrees F or C (factory selectable) | degrees F or C (user selectable) | degrees F or C (user selectable) |
| Storage: | | | |
| Temperature | -4° to 122 °F (-20 to 50 °C) | -4° to 122 °F (-20 to 50 °C) | -4° to 122 °F (-20° to 50 °C) |
| | | | |

† Formerly the SensorTouch
‡ Patented by Exergen and licensed to Braun Thermoscan

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| humidity (max) | up to 95% noncondensing | up to 95% noncondensing | 95% noncondensing |
| --- | --- | --- | --- |
| Electromagnetic
compatible | Yes per EN 60601-1-2 | Yes per EN 60601-1-2 | Yes per EN 60601-1-2 |
| Item | SensorTouch and
Exergen TemporalScanner
Thermometer | Exergen
Surface Temperature Scanner
K873010 | Braun Thermoscan IRT
3020/3520 Thermometer
K983295 |
| | (TemporalScanner)* | (Exergen Predicate) | (Braun Predicate) |
| Display modes | Displayed temperature is the actual
temperature of the temple artery plus
a mathematical adjustment to
approximate the familiar rectal range | Displayed temperature is the actual
temperature of the surface of the skin
at the point of measurement. | Displayed temperature is the actual
ear temperature plus a mathematical
adjustment to approximate the familiar
oral range |
| | | | |
| Power source | 9 volt Alkaline | 9 volt Alkaline | 2 lithium batteries CR/2032/DL 2032 |
| display | LCD | LED | LCD |
| IR transducer | Thermopile | Thermopile | Thermopile |
| | | | |
| Indicators | | | |
| Battery low warning | yes, audible and visual | yes, audible | yes |
| User error | Yes | no | yes |
| Instrument
Malfunction | Yes | no | yes |
| | | | |
| Disposable covers | not required | not required | yes |
| | | | |
| Case material | 5x4 | 5x4(5x4) | unknown |
| memory function | No | no | yes |
| Auto off | Yes | yes | yes |
| | | | |
| Standards met | ASTM E1965-98 | ASTM E1965-98 | ASTM E1965-98 |
| UL listed | Yes | no | yes |
| CE mark | Yes | Yes | yes |
| | | | |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Discussion of Table

## Similarities:

1. Same intended use demonstrates equivalence.
2. All units meet the same standard; therefore, the three devices should perform the same.
3. All units are battery operated.
4. All units use solid-state displays, minimizing battery drain.
5. All units have warning displays, such as battery low.
6. All units are CE marked, showing an independent third party assessment of the safety of the devices.
7. The SensorTouch, (renamed TheTemporalScanner), and the Thermoscan are UL listed, another independent third party assessment of the safety of the devices.
8. Consumer Report evaluation on the SensorTouch and the Thermoscan shows an independent third party assessment of the performance of the two devices.

## Differences:


Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

ATTACHMENT A

# Product Specifications

| Clinical Accuracy | Meets ASTM E1965-98 and MDD 93142/EEC standards for electronic and radiation thermometers to the extent applicable to thermometers which measure the surface of the skin over the temporal artery. |
| --- | --- |
| Regulatory Approvals | CE Mark to -0197, TUV, Declaration of Conformity-ISO 9003/08.94, NIST certifiable traceable calibrations. |
| EMI/ RFI Protection | Error message displayed |
| Calibration Protection | Error message displayed |
| Temperature Range | 15.5 to 42°C (60 to 107.5°F) |
| Operating Environment | 15.5 to 40°C (60 to 104°F) |
| Resolution | 0.1°C or °F |
| Response Time | Approximately 0.004 seconds |
| Time Displayed on Screen | 30 seconds before automatic shutdown |
| Battery Life | Approximately 7,500 readings |
| Size | 7.0 in x 1.75 in x 1.25 in(17.8 cm x 4.45 cm x 3.18 cm) |
| Weight | 4.16 oz (120 grams) incl batt |
| Display Type | High contrast LCD |
| Construction Method | Impact resistant casing, Hermetically sealed sensing system |
| Warranty | 1 Year |
| Laboratory Error: | +/- 4°F (+/- 0.2°C) |
| Storage Range: | -4°F - 122°F (-20°C-50°C) |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{20}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Date: June 12, 2001

From: Joy H. Samuels-Reid, M.D., Medical Officer, CDRH/DDIGD

To: William M. Burdick, Biomedical Engineer, CDRH/ ODE/DDIGD/GHDB

Device: Exergen Temporal Scanner Infrared Thermometer -K011291

Sponsor: Exergen Corporation

Re: Clinical Trials


The supporting data, taken together, provide adequate documentation for the temporal artery thermometer as an adjunct in assessing temperature. The sponsor will need to provide explicit instructions for placement of the device during temperature taking. It will be necessary to specify site or technique differences due to age.

Joy H. Samuels-Reid, M.D.

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{21}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# DEPARTMENT OF HEALTH AND HUMAN SERVICES

## MEMORANDUM

Food and Drug Administration
Office of Device Evaluation
9200 Corporate Avenue
Rockville, MD 20850

## REQUEST FOR CONSULTING REVIEW

**Date:** June 4, 2001

**From:** William M. Burdick, Biomedical Engineer, CDRH/ODE/DDIGD/GHDB (HFZ-480)

**To:** Joy Samuels-Reid, M.D., Medical Officer, CDRH/ODE/DDIGD (HFZ-480)

**PMA/IDE/510(k)#:** K011291

**Device Name:** Exergen TemporalScanner Infrared Thermometer

**Sponsor Name:** Exergen Corporation

## REASON FOR REQUEST

☑ New Submission[ ] Response to Deficiency Letter
☐ Protocol Change[ ] Design Change
☐ New Material(s)[ ] Labeling
☐ Indication(s)
☐ Other: _________________________

## TYPE OF REVIEW REQUESTED

☐ Engineering[ ] Materials
☐ Sterility[ ] Toxicology
☑ Clinical[ ] Statistical
☐ Labeling[ ] Regulatory Status Determination
☐ Jurisdiction Determination
☐ Other: _________________________

## COMMENTS: Joy,

I need an assessment from you that their clinical trials are okay for this thermometer. Sorry I didn't get it to you, sooner. Please be aware that this is a **forehead IR thermometer**. Their site of placement of the thermometer IR sensor must be stated in a very specific manner. Any questions, I will be in on Wednesday.

Bill

Please Respond By: July 11, 2001

Signature of Requester: William M. Burdick

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Screening Checklist

## For all Premarket Notification 510(k) Submissions

3-30-01

| Device Name: *Temperals cannel Thermometer* K 011291 | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Submitter (Company): *Exergen Corp.* | | | | | | |
| Items which should be included
(circle missing & needed information) | S P E C I A L | | A B B R E V I A T E D | | T R A D I T I O N A L | |
| | YES | NO | YES | NO | YES | NO |
| 1. Cover Letter clearly identifies Submission as:
a) “Special 510(k): Device Modification”
b) “Abbreviated 510(k)”
c) Traditional 510(k) | GO TO #2,3 | | GO TO #2,4,5 | | ☑ GO TO #2,5 | |
| | | | | | | |
| 2. GENERAL INFORMATION: REQUIRED IN ALL 510(K) SUBMISSIONS
☑ IF ITEM IS NEEDED | | | | | | |
| Financial Certification or Disclosure Statement for 510(k)s with a Clinical Study 807.87(i) including forms 3454 and/or 3455 | NA | | YES | | NO | |
| | SPECIALS | | ABBREVIATED | | TRADITIONAL | |
| | YES | NO | YES | NO | YES | NO |
| a) trade name, classification name, establishment registration number, device class | | | | | ☑ | |
| b) OR a statement that the device is not yet classified | FDA-may be a classification request; see coordinator | | | | | |
| c) identification of legally marketed equivalent device | NA | | | | ☑ | |
| d) compliance with Section 514 - performance standards | NA | | | | ☑ | |
| e) address of manufacturer | | | | | ☑ | |
| f) Truthful and Accurate Statement | | | | | ☑ | |
| g) Indications for Use enclosure | | | | | ☑ | |
| h) SMDA Summary or Statement (FOR ALL DEVICE CLASSES) | | | | | ☑ | |
| i) Class III Certification & Summary (FOR ALL CLASS III DEVICES) | | | | | | |
| j) Description of device (or modification) including diagrams, engineering drawings, photographs, service manuals | | | | | ☑ | |
| k) Proposed Labeling: | | | | | ☑ | |
| i) package labeling (user info) | | | | | ☑ | |
| ii) statement of intended use | | | | | ☑ | |
| iii) advertisements or promotional materials | | | | | | |
| i) MRI compatibility (if claimed) | | | | | | |
| l) Comparison Information (similarities and differences) to named legally marketed equivalent device (table preferred) should include: | | | | | ☑ | |
| i) Labeling | | | | | ☑ | |
| ii) intended use | | | | | ☑ | |
| iii) physical characteristics | | | | | | |
| iv) anatomical sites of use | | | | | | |
| v) performance (bench, animal, clinical) testing | NA | | | | | |
| vi) safety characteristics | NA | | | | | |
| m) If kit, kit certification | | | | | | |
| 3. "SPECIALS" - ONLY FOR MODIFICATIONS TO MANUFACTURER'S OWN CLASS II, III OR RESERVED CLASS I DEVICE | | | | | | |
| a) Name & 510(k) number of legally marketed (unmodified) predicate device | | | * If no - STOP not a special | | | |
| b) STATEMENT - INTENDED USE AND INDICATIONS FOR USE OF MODIFIED DEVICE AS DESCRIBED IN ITS | | | | | | |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| LABELING HAVE NOT CHANGED* | | | | |
| --- | --- | --- | --- | --- |
| c) STATEMENT - FUNDAMENTAL SCIENTIFIC TECHNOLOGY OF THE MODIFIED DEVICE HAS NOT CHANGED* | | | | *If no - STOP not a special |
| d) Design Control Activities Summary | | | | |
| i) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis | | | | |
| ii) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied | | | | |
| iii) A declaration of conformity with design controls. The declaration of conformity should include: | | | | |
| 1) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met | | | | |
| 2) A statement signed by the individual responsible, that manufacturing facility is in conformance with design control procedure Requirements as specified in 21 CFR 820.30 and the records are available for review. | | | | |
| | SPECIALS | | ABBREVIATED | | TRADITIONAL | | ✓ IF ITEM IS NEEDED AND IS MISSING |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | YES | NO | YES | NO | YES | NO | |
| 4. ABBREVIATED 510(K): SPECIAL CONTROLS/CONFORMANCE TO RECOGNIZED STANDARDS - PLEASE FILL OUT THE STANDARDS ABBREVIATED FORM ON THE H DRIVE | | | | | | | |
| a) For a submission, which relies on a guidance document and/or special control(s), a summary report that describes how the guidance and/or special control(s) was used to address the risks associated with the particular device type | | | | | | | |
| b) If a manufacturer elects to use an alternate approach to address a particular risk, sufficient detail should be provided to justify that approach. | | | | | | | |
| c) For a submission, which relies on a recognized standard, a declaration of conformity to the standard. The declaration should include the following: | | | | | | | |
| i) An identification of the applicable recognized consensus standards that were met | | | | | | | |
| ii) A specification, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations noted below | | | | | | | |
| iii) An identification, for each consensus standard, of | | | | | | | |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118
Page 2

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| any way(s) in which the standard may have been adapted for application to the device under review, e.g., an identification of an alternative series of tests that were performed | | | |
| --- | --- | --- | --- |
| iv) An identification, for each consensus standard, of any requirements that were not applicable to the device | | | |
| v) A specification of any deviations from each applicable standard that were applied | | | |
| vi) A specification of the differences that may exist, if any, between the tested device and the device to be marketed and a justification of the test results in these areas of difference | | | |
| vii) Name/address of test laboratory/certification body involved in determining the conformance of the device with applicable consensus standards and a reference to any accreditations for those organizations | | | |
| d) Data/information to address issues not covered by guidance documents, special controls, and/or recognized standards | | | |
| 5. Additional Considerations: (may be covered by Design Controls) | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| a) Biocompatibility data for all patient-contacting materials, OR certification of identical material/formulation: | | | | | | | |
| i) component & material | | | | | | | |
| ii) identify patient-contacting materials | | | | | | | |
| iii) biocompatibility of final sterilized product | | | | | | | |
| b) Sterilization and expiration dating information: | | | | | | | |
| i) sterilization method | | | | | | | |
| ii) SAL | | | | | | | |
| iii) packaging | | | | | | | |
| iv) specify pyrogen free | | | | | | | |
| v) ETO residues | | | | | | | |
| vi) radiation dose | | | | | | | |
| c) Software validation & verification: | | | | | | | |
| i) hazard analysis | | | | | | | |
| ii) level of concern | | | | | | | |
| iii) development documentation | | | | | | | |
| iv) certification | | | | | | | |

Items shaded under "NO" are necessary for that type of submission. Circled items and items with checks in the "Needed &amp; Missing" column must be submitted before acceptance of the document.

Passed Screening ☑ Yes ☐ No
Date: MAY - 2 2001

Reviewer: William M. Burdick
Concurrence by Review Branch: 6/4/01

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Internal Administrative Form

| | | |
| --- | --- | --- |
| | YES | NO |
| 1. Did the firm request expedited review? | | ☑ |
| 2. Did we grant expedited review? | | ☑ |
| 3. Have you verified that the Document is labeled Class III for GMP purposes? | | ☑ |
| 4. If, not, has POS been notified? | | ☑ |
| 5. Is the product a device? | ☑ | ☑ |
| 6. Is the device exempt from 510(k) by regulation or policy? | ☑ | ☑ |
| 7. Is the device subject to review by CDRH? | | ☑ |
| 8. Are you aware that this device has been the subject of a previous NSE decision? | | ☑ |
| 9. If yes, does this new 510(k) address the NSE issue(s), (e.g., performance data)? | | ☑ |
| 10. Are you aware of the submitter being the subject of an integrity investigation? | | ☑ |
| 11. If, yes, consult the ODE Integrity Officer. | | ☑ |
| 12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book Memo #I91-2 and Federal Register 90N0332, September 10, 1991. | | ☑ |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{26}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

April 30, 2001

Food and Drug Administration
Center for Devices and
Radiological Health
Office of Device Evaluation
Document Mail Center (HFZ-401)
9200 Corporate Blvd.
Rockville, Maryland 20850

EXERGEN CORP.
C/O FISH AND RICHARDSON, PC
601 13TH STREET, NW
WASHINGTON, DC 20005
ATTN: WILLIAM HARE

510(k) Number: K011291
Received: 27-APR-2001
Product: TEMPORALSCANNER
THERMOMETER,
SENSORTOUCH

The Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), has received the Premarket Notification you submitted in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Act) for the above referenced product. We have assigned your submission a unique 510(k) number that is cited above. Please refer prominently to this 510(k) number in any future correspondence that relates to this submission. We will notify you when the processing of your premarket notification has been completed or if any additional information is required. YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA ALLOWING YOU TO DO SO.

On January 1, 1996, FDA began requiring that all 510(k) submitters provide on a separate page and clearly marked "Indication For Use" the indication for use of their device. If you have not included this information on a separate page in your submission, please complete the attached and amend your 510(k) as soon as possible. Also if you have not included your 510(k) Summary or 510(k) Statement, or your Truthful and Accurate Statement, please do so as soon as possible. There may be other regulations or requirements affecting your device such as Postmarket Surveillance (Section 522(a)(1) of the Act) and the Device Tracking regulation (21 CFR Part 821). Please contact the Division of Small Manufacturers Assistance (DSMA) at the telephone or web site below for more information.

Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the Document Mail Center will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations, we cannot accept telefaxed material as part of your official premarket notification submission, unless specifically requested of you by an FDA official. Any telefaxed material must be followed by a hard copy to the Document Mail Center (HFZ-401).

You should be familiar with the manual entitled, "Premarket Notification 510(k) Regulatory Requirements for Medical Devices" available from DSMA. If you have other procedural or policy questions, or want information on how to check on the status of your submission (after 90 days from the receipt date), please contact DSMA at [phone] or its toll-free number [phone], or at their Internet address http://www.fda.gov/cdrh/dsmamain.html or me at [phone].

Sincerely yours,

Marjorie Shulman
Consumer Safety Officer
Premarket Notification Staff
Office of Device Evaluation

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{27}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015
DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service

MAY 4 2001

Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850

Ms. Jill B. Deal
Fish &amp; Richardson P.C.
601 Thirteenth Street, NW
Washington, DC 20005

Re: Sensor Touch Temporal Thermometer

Dear Ms. Deal:

Thank you for your March 14 correspondence responding to our February 21 letter. We acknowledge that you plan to submit a premarket notification [510(k)] for the modified Sensor Touch Temporal Thermometer, and that when you do so, you will submit labeling complying with the terms in our April 3 letter.

We appreciate your cooperation in this matter. If you have any questions regarding the submission of your 510(k), you may contact Ms. Patricia Cricenti, Chief, General Hospital Devices Branch, Office of Device Evaluation at 301.443.8879. If you have any questions regarding this letter, please do not hesitate to call me at 301.594.4618.

Sincerely yours,

Leslie E. Dorsey
Consumer Safety Officer
General Hospital Devices Branch
Division of Enforcement II
Office of Compliance
Center for Devices and Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

cc:
- HFA-224
- HFZ-330
- HFZ-333
- HFZ-480(PCricenti)

Draft: LEDorsey/5-3-01 3505-4-01
Final: JWMilto:5/4/01

OC Track #86724
Disk #32, Exergen 3 Ltr

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{29}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
14 Released by CDRH on 08-28-20 Service

Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850

FEB 21 2001

Ms. Jill B. Deal
Fish &amp; Richardson P.C.
601 Thirteenth Street, NW
Washington, DC 20005

Re: Sensor Touch Temporal Thermometer

Dear Ms. Deal:

This correspondence is in reference to your August 2, 2000 letter. While you have satisfactorily addressed our labeling concerns regarding the Sensor Touch Temporal Thermometer, the b)(4) which was not discussed in our July 31, 2000 telephone conversation, still remains unaddressed. Please refer to our April 3, 2000 letter, item #5 (enclosed) for further explanation of our concerns with the b)(4) as stated in this letter.

In addition to the above, the medical device listing regulations (21 CFR Part 807) (enclosed) require certain establishments to list their devices with the FDA and to maintain a historical file of labels, labeling, and promotional material for those devices. Paragraph 807.31(e) of the regulations requires the owner or operator of establishments upon request, to provide FDA with information on these files.

In order to confirm your labeling modifications, we request that you provide us with a

Please provide a response within fifteen (15) working days of receipt of this letter to me at the letterhead address. The response should include both the materials mentioned above and a statement informing us when you plan on submitting your new 510(k).

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Page 2 - Ms. Jill B. Deal

If you have any questions regarding the submission of a new 510(k), you may contact Ms. Patricia Cricenti, Chief, General Hospital Devices Branch, Office of Device Evaluation at 301.443.8879. If you have any questions regarding this letter, please do not hesitate to call me at 301.594.4618.

Sincerely yours,

Leslie E. Dorsey
Consumer Safety Officer
General Hospital Devices Branch
Division of Enforcement II
Office of Compliance
Center for Devices and Radiological Health

Enclosures

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

cc:
- HFA-224
- HFR-NE250
- HFZ-330
- HFZ-333
- HFZ-480(PCricenti)

Draft: LEDorsey/2-15-01 9453-21-01
Reviewed: CBNiebauer/2-15-01
Final: JWMilto:2/21/01

OC Track #84275
Disk #32, Exergen 2 Ltr

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{32}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# FISH &amp; RICHARDSON P.C.

601 Thirteenth Street N.W.
Washington, DC 20005

Telephone
202 783-5070

Facsimile
202 783-2331

Web Site
www.fr.com


**BY HAND DELIVERY**

April 27, 2001

510(k) Document Mail Center (HFZ-401)
Room 42ON
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

BOSTON
DALLAS
DELAWARE
NEW YORK
SAN DIEGO
SILICON VALLEY
TWIN CITIES
WASHINGTON, DC

Re: Exergen TemporalScanner Infrared Thermometer (formerly, SensorTouch)
Section 510(k) Premarket Notification (Traditional)

Dear Sir or Madam:

We attach as Exhibits A-C to this letter correspondence from staff in the CDRH
Office of Compliance that relates to an infrared temporal thermometer manufactured
by our client, Exergen Corporation (Exergen). The SensorTouch Temporal
Thermometer (SensorTouch) was formerly distributed by Phillips Electronics North
America (Phillips), which owns the SensorTouch trademark. The commercial
agreement between Phillips and Exergen ended on February 19, 2000. Under the
circumstances, Exergen decided that, in the future, the former SensorTouch
manufactured by Exergen should be sold under another name, specifically, the
TemporalScanner thermometer (TemporalScanner).

As you will see, in a letter from Steven E. Budabin, M.S., Consumer Officer, Office
of Compliance, CDRH attached as Exhibit A, Mr. Budabin did not take issue with
the then-SensorTouch’s legal status as a cleared device under section 510(k) of the
Federal Food, Drug and Cosmetic Act. Rather, his concerns focused primarily on




Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{33}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

FISH &amp; RICHARDSON P.C.

510(k) Document Mail Center (HFZ-401)
April 27, 2001
Page 2

(b)(4) The April 3 Letter is attached as Exhibit C to this letter.

We believe that a new 510(k) premarket notification is not required because the TemporalScanner is merely an update to the original, cleared version of the SensorTouch device, the Exergen Surface Temperature Scanner (Dermatemp) (K873010)(Exergen Predicate) to include technologically current components. Nevertheless, in accordance with Ms. Dorsey’s request, Fish &amp; Richardson is submitting a “catch-up” 510(k) pre-market notification on behalf of Exergen.

The TemporalScanner is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages. As explained in greater detail in the attached premarket notification, the TemporalScanner is substantially equivalent to the Exergen Predicate and the Braun Thermoscan IRT 3020/3520 Thermometer (Braun Predicate) (K983295) because they have the same intended use and the same technological characteristics.

As you will see, Item 5 of the February 26 Letter posed three questions. Information responding to all of these questions can be found in Part 8 of this 510(k). Information relating to the (b)(4) can be found at page 8-3; information relating to substitution of (b)(4) used in the Exergen Predicate can be found at page 8-4 and information relating to (b)(4) of the TemporalScanner from the Exergen Predicate can be found at page 8-2.

We understand from conversations with a reviewer that clinical data is required for all 510(k) premarket notifications for infrared thermometers. This data can be found at Part 11, beginning at page 9-30. The requisite certification regarding financial interests can be found at Part 12. With respect to (b)(4), these can be found at Part 9, beginning at page 9-3.

We are aware that on April 19, 2001, CDRH issued its Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers (Guidance). Labeling materials for the device appear at Part 4, including draft directions for use. Final labeling materials have not been prepared. When labeling materials have been agreed with FDA, Exergen will consult the Guidance in preparing the final version of the labeling materials.

We trust that the information contained in the attached premarket notification will be sufficient to enable FDA to find the TemporalScanner substantially equivalent to the predicate device for the listed intended use and indications. Please direct any additional questions or requests for information to me or to William Hare of this office or to me at 202-783-5070.

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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FISH &amp; RICHARDSON P.C.

510(k) Document Mail Center (HFZ-401)
April 27, 2001
Page 3

We also request that FDA notify the company of a finding of substantial equivalence by sending a facsimile to me at Fish &amp; Richardson at 202-783 2331.

Very truly yours,
Jill B. Deal

cc: Leslie Dorsey (without attachments)
40053493.doc

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{35}

UPPA

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES-4114 Released by CDRH on 08-25-2015

Records processed under FORM 4114

Public Health Service

Food and Drug Administration

2088 Gahhar Road

Rockville MD 20850

# CERTIFIED MAIL RETURN RECEIPT REQUESTED

Letter Exhibit A

Mr. Patrick J. Dinley
President
Philips Electronics North America Corporation
P.O. Box 120015
Stamford, Connecticut 06912-0015

Re: Sensor Touch Thermometer, K873010

Dear Mr. Dinley:

The Food and Drug Administration (FDA) has reviewed promotional materials for the Sensor Touch Temporal Thermometer (Sensor Touch). This product is manufactured by Exergen Corporation (Exergen), distributed by Philips Electronics North America (Philips) and is a device as defined within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The Sensor Touch has been cleared under section 510(k) of the Act and is intended to measure the body temperature of patients by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

We have reviewed a Philips press release titled, Philips Introduces a Revolutionary, Non-Invasive Way To Take Temperature, dated January 10, 1999, which makes claims for the Sensor Touch that have not been cleared by the agency. Specifically, the press release states that the Sensor Touch can measure core body temperatures.

Such a claim represents a major modification in the intended use of the device as described under 21 CFR 807.81(a)(3)(ii) and requires the submission of a new 510(k) prior to marketing the Sensor Touch with that claim.

Continued promotion of the Sensor Touch for claims of measuring core body temperature causes your device to be misbranded and adulterated under sections 502(o) and 501(f)(B) of the Act, respectively.

We have also reviewed additional promotional materials that make claims for the Sensor Touch which have not been supported with data. The materials reviewed include: a Philips brochure titled, Philips Sensor Touch, Non-Invasive, Gentle, Easy, and Fast, Accurate (brochure dated 12/98-5K); an article titled, Philips Unveils Sensor Touch from HFN dated January 18, 1999; and the press release.

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{36}

Page 2 - Ms. Patrick Dinkes
Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Statements made in these promotional materials which have not been supported to the agency with data include the following:


Please submit a prompt response to this office in writing regarding Philips plans for corrective action and for removing the misleading information from the marketplace. You may submit your response to me at the letterhead address.

Sincerely yours,

Steven E. Budabin, M.S.
Consumer Safety Officer
Promotion and Advertising
Policy Staff
Office of Compliance
Center for Devices and
Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{37}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850

FEB 21 2001

Ms. Jill B. Deal
Fish &amp; Richardson P.C.
601 Thirteenth Street, NW
Washington, DC 20005

RECEIVED
FEB 26 2001
FISH &amp; RICHARDSON, P.C.

Letter Exhibit B

Re: Sensor Touch Temporal Thermometer

Dear Ms. Deal:

This correspondence is in reference to your August 2, 2000 letter. While you have satisfactorily addressed our labeling concerns regarding the Sensor Touch Temporal Thermometer, the (b)(4) which was not discussed in our July 31, 2000 telephone conversation, still remains unaddressed. Please refer to our April 3, 2000 letter, item #5 (enclosed) for further explanation of our concerns with the (b)(4) as stated in this letter.


In addition to the above, the medical device listing regulations (21 CFR Part 807) (enclosed) require certain establishments to list their devices with the FDA and to maintain a historical file of labels, labeling, and promotional material for those devices. Paragraph 807.31(e) of the regulations requires the owner or operator of establishments upon request, to provide FDA with information on these files.

In order to confirm your labeling modifications, we request that you provide us with a (b)(4)

Please provide a response within fifteen (15) working days of receipt of this letter to me at the letterhead address. The response should include both the materials mentioned above and a statement informing us when you plan on submitting your new 510(k).

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{38}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Page 2 - Ms. Jill B. Deal

If you have any questions regarding the submission of a new 510(k), you may contact Ms. Patricia Cricenti, Chief, General Hospital Devices Branch, Office of Device Evaluation at 301.443.8879. If you have any questions regarding this letter, please do not hesitate to call me at 301.594.4618.

Sincerely yours,

Leslie E. Dorsey
Consumer Safety Officer
General Hospital Devices Branch
Division of Enforcement II
Office of Compliance
Center for Devices and Radiological Health

Enclosures

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{39}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

Food and Drug Administration
Rockville MD 20857

APR 3 2006

Letter Exhibit C

Mr. Howard M. Holstein
Hogan &amp; Hartson
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004-1109

Dear Mr. Holstein:

We acknowledge receipt of your July 14, 1999 response to our April 13, 1999 correspondence to Mr. Patrick J. Dinley of Philips Electronics North America Corporation. We apologize for our delay in responding. Below I have outlined our concerns and followed them with our comments to your response to these concerns:


Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Page 2 - Mr. Howard M. Holstein

It appears, that given the history of communication between Philips Electronics and the FDA regarding the Sensor Touch, 514


new labeling claims. Please provide a response within 15 days of receipt of this letter stating when you plan on submitting your new 510(k). If you choose to not submit a new 510(k), provide us with the specific steps you have taken to correct the noted labeling violations for which you have not adequately responded to. Include in your response information on what is being done with the labeling that is currently in distribution.

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

Page 3 - Mr. Howard M. Holstein

If you have any questions, please do not hesitate to contact me at 301.594.4618, ext. 115.

Sincerely yours,

Leslie E. Dorsey
Consumer Safety Officer
General Hospital Devices Branch
Division of Enforcement II
Office of Compliance
Center for Devices and Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{42}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

cc:
- HFA-224
- HFZ-330
- HFZ-333
- HFZ-480 (HTrinh)

Draft: LEDorsey/3-30-00 4-3-00
Review: MSheldon for CBNiebauer/3-31-00
Final: JMIlto: 4/3/00

OC Track #80864
Disk #32, Philips.ltr

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{43}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Table of Contents to Section 510(k) Premarket Notification of the TemporalScanner Thermometer by Exergen Corporation

| Section | Title | Page |
| --- | --- | --- |
| | | |
| | | |
| 1 | FDA Cover Sheet | 1-1 |
| | | |
| 2 | Truthful and Accurate Statement | 2-1 |
| | | |
| 3 | Performance Standards | 3-1 |
| | | |
| 4 | Labeling | 4-1 |
| | Proposed TemporalScanner DFU | 4-2 |
| | Draft Device Labels for TemporalScanner Thermometer | 4-13 |
| | Exergen Predicate Device Labeling | 4-16 |
| | Braun Predicate Device Labeling | |
| | | |
| 5 | Statement of Indications for Use | 5-1 |
| | | |
| 6 | Substantial Equivalence Table | 6-1 |
| | Table | 6-2 |
| | Discussion of SE Table | 6-3 |
| | | |
| 7 | Summary | 7-1 |
| | | |
| 8 | Description | 8-1 |
| | Operational Block Diagram of Typical IR Thermometer | 8-6 |
| | Temporal Scanner Pictures | 8-7 |
| | Exergen Predicate Pictures | 8-12 |
| | Braun Predicate Pictures | 8-20 |
| | Flowchart for Algorithm | 8-24 |
| | | |
| 9 | Performance Data | 9-1 |
| | Performance Data for Product Acceptance | 9-2 |
| | Phillips Declaration of Conformity to Directive 93/42/EEC | 9-6 |
| | EMC Testing Conducted By Phillips | 9-9 |
| | Safety Testing Conducted on Behalf of Exergen | 9-11 |
| | ☑ Testing Conducted By Exergen | 9-15 |
| | Consumer Reports Testing | 9-18 |
| | Results of Clinical Trials in the ☑ | 9-20 |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{44}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| | Reports of Clinical Trials in | 9-24 |
| --- | --- | --- |
| | Summary | 9-25 |
| | Clinical Study No. 1 | 9-30 |
| | Clinical Study No. 2 | 9-37 |
| | Clinical Study No. 3 | 9-87 |
| | Clinical Study No. 4 | 9-99 |
| | Clinical Study No. 5 | 9-101 |
| | | |
| 10 | Biocompatibility Data | 10-1 |
| | | |
| 11 | Software | 11-1 |
| | | |
| 12 | Clinical Trial Financial Certification | 12-1 |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{45}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Table of Contents to Section 510(k) Premarket Notification of the TemporalScanner Thermometer by Exergen Corporation

| Section | Title | Page |
| --- | --- | --- |
| | | |
| | | |
| 1 | FDA Cover Sheet | 1-1 |
| | | |
| 2 | Truthful and Accurate Statement | 2-1 |
| | | |
| 3 | Performance Standards | 3-1 |
| | | |
| 4 | Labeling | 4-1 |
| | Proposed TemporalScanner DFU | 4-2 |
| | Draft Device Labels for TemporalScanner Thermometer | 4-15 |
| | Exergen Predicate Device Labeling | 4-18 |
| | Braun Predicate Device Labeling | 4-38 |
| | | |
| 5 | Statement of Indications for Use | 5-1 |
| | | |
| 6 | Substantial Equivalence Table | 6-1 |
| | Table | 6-2 |
| | Discussion of SE Table | 6-3 |
| | | |
| 7 | Summary | 7-1 |
| | | |
| 8 | Description | 8-1 |
| | Operational Block Diagram of Typical IR Thermometer | 8-6 |
| | Temporal Scanner Pictures | 8-7 |
| | Exergen Predicate Pictures | 8-12 |
| | Braun Predicate Pictures | 8-20 |
| | Flowchart for Algorithm | 8-24 |
| | | |
| 9 | Performance Data | 9-1 |
| | Performance Data for Product Acceptance | 9-2 |
| | Phillips Declaration of Conformity to Directive 93/42/EEC | 9-6 |
| | ☑ Testing Conducted By Phillips | 9-9 |
| | Safety Testing Conducted on Behalf of Exergen | 9-11 |
| | ☑ Testing Conducted By Exergen | 9-15 |
| | Consumer Reports Testing | 9-18 |
| | Results of Clinical Trials in the ☑ | 9-20 |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{46}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| | Reports of Clinical Trials in | 9-24 |
| --- | --- | --- |
| | Summary | 9-25 |
| | Clinical Study No. 1 | 9-30 |
| | Clinical Study No. 2 | 9-37 |
| | Clinical Study No. 3 | 9-87 |
| | Clinical Study No. 4 | 9-99 |
| | Clinical Study No. 5 | 9-101 |
| | | |
| 10 | Biocompatibility Data | 10-1 |
| | | |
| 11 | Software | 11-1 |
| | | |
| 12 | Clinical Trial Financial Certification | 12-1 |

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{47}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Section 1
## FDA Cover Sheet

Cover Sheet from HHS Publication FDA 95-4158
page 1 - 1 of 5
Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118
42

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| CDRH SUBMISSION COVER SHEET | | | | |
| --- | --- | --- | --- | --- |
| Date of Submission: | | FDA Document Number: | | |
| Section A | Type of Submission | | | |
| PMA | PMA Supplement | PDP | 510(k) | Meeting |
| ☐ Original submission | ☐ Regular | ☐ Presubmission summary | ☐ Original submission: | ☐ Pre-IDE meeting |
| ☐ Modular submission | ☐ Special | ☐ Original PDP | ☐ Traditional | ☐ Pre-PMA meeting |
| ☐ Amendment | ☐ Panel Track | ☐ Notice of intent to start clinical trials | ☐ Special | ☐ Pre-PDP meeting |
| ☐ Report | ☐ 30-day Supplement | ☐ Intention to submit Notice of Completion | ☐ Abbreviated | ☐ 180-day meeting |
| ☐ Report Amendment | ☐ 30-day Notice | ☐ Notice of Completion | ☑ Additional information: | ☐ Other (specify): |
| | ☐ 135-day Supplement | ☐ Amendment to PDP | ☐ Traditional | |
| | ☐ Real-time Review | ☐ Report | ☐ Special | |
| | ☐ Amendment to PMA Supplement | | ☐ Abbreviated | |
| IDE | Humanitarian Device Exemption | Class II Exemption | Evaluation of Automatic Class III Designation | Other Submission |
| ☐ Original submission | ☐ Original submission | ☐ Additional information | ☐ Original submission | Describe submission: |
| ☐ Amendment | ☐ Additional information | | | |
| ☐ Supplement | ☐ Repart | | | |
| Section B Applicant or Sponsor | | | | |
| Company / Institution name: Exergen Corporation | | Establishment registration number: 1221195 | | |
| Division name (if applicable): | | Phone number (include area code): [phone] | | |
| Street address: 51 Water Street | | FAX number (include area code): [phone] | | |
| City: Watertown | | State / Province: MA 02172 | | Country: USA |
| Contact name: Gerald A. Clay | | | | |
| Contact title: Director, Regulatory Affairs | | Contact e-mail address: [e-mail] | | |
| Section C Submission correspondent (if different from above) | | | | |
| Company / Institution name: Fish & Richardson, PC | | Establishment registration number: NA | | |
| Division name (if applicable): | | Phone number (include area code): [phone] | | |
| Street address: 601 13th Street, NW | | FAX number (include area code): [phone] | | |
| City: Washington | | State / Province: DC | | Country: USA 20005 |
| Contact name: William Hare (Associate) or Jill B. Deal (Partner) | | | | |
| Contact title: | | Contact e-mail address: [e-mail] [e-mail] | | |

Version 2.0

FINAL DRAFT — May 8, 1998

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{49}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| **Section D1** | **Reason for Submission — PMA, PDP, or HDE** | |
| --- | --- | --- |
| ☐ New device
☐ Withdrawal
☐ Additional or expanded indications
☐ Licensing agreement

☐ Process change
☐ Manufacturing
☐ Sterilization
☐ Packaging
☐ Other (specify below)

☐ Response to FDA correspondence:
☐ Request for applicant hold
☐ Request for removal of applicant hold
☐ Request for extension
☐ Request to remove or add manufacturing site

☐ Other reason (specify): | ☐ Change in design, component, or specification:
☐ Software
☐ Color Additive
☐ Material
☐ Specifications
☐ Other (specify below)

☐ Labeling change:
☐ Indications
☐ Instructions
☐ Performance Characteristics

☐ Shelf life
☐ Trade name
☐ Other (specify below) | ☐ Location change:
☐ Manufacturer
☐ Sterilizer
☐ Packager
☐ Distributor

☐ Report submission:
☐ Annual or periodic
☐ Post-approval study
☐ Adverse reaction
☐ Device defect
☐ Amendment

☐ Change in ownership
☐ Change in correspondent |
| **Section D2****Reason for Submission — IDE** | | |
| ☐ New device
☐ Addition of institution
☐ Expansion / extension of study
☐ IRB certification
☐ Request hearing
☐ Request waiver
☐ Termination of study
☐ Withdrawal of application
☐ Unanticipated adverse effect
☐ Notification of emergency use
☐ Compassionate use request
☐ Treatment IDE
☐ Continuing availability request

☐ Other reason (specify): | ☐ Change in:
☐ Correspondent
☐ Design
☐ Informed consent
☐ Manufacturer
☐ Manufacturing process
☐ Protocol – feasibility
☐ Protocol – other
☐ Sponsor

☐ Report submission:
☐ Current investigator
☐ Annual progress
☐ Site waiver limit reached
☐ Final | ☐ Response to FDA letter concerning:
☐ Conditional approval
☐ Deemed approved
☐ Deficient final report
☐ Deficient progress report
☐ Deficient investigator report
☐ Disapproval
☐ Request extension of time to respond to FDA
☐ Request meeting |
| **Section D3****Reason for Submission — 510(k)** | | |
| ☐ New device
☐ Additional or expanded indications
☑ Other reason (specify): | ☐ Change in technology
☐ Change in design | ☐ Change in materials
☐ Change in manufacturing process |
| Requested by FDA. See letter from Leslie Dorsey, Consumer Safety Officer, General Hospital Services Branch. Division of Enforcement II, Office of Compliance, CDRH, FDA to Jill B. Deal, Fish & Richardson, P.C., dated Feb, 21, 2001. (Exhibit B to cover letter) | | |

Version 2.0

FINAL DRAFT — May 8, 1998

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| Section E Additional Information on 510(k) Submissions | | | | | |
| --- | --- | --- | --- | --- | --- |
| Product codes of devices to which substantial equivalence is claimed: | | | | Summary of, or statement concerning, safety and effectiveness data:
☐ 510(k) summary attached
☐ 510(k) statement | |
| 1880FLL | 2 | 3 | 4 | | |
| 5 | 6 | 7 | 8 | | |
| Information on devices to which substantial equivalence is claimed: | | | | | |
| 510(k) Number | Trade or proprietary or model name | | | Manufacturer | |
| 1 K873010 | 1 Surface Temperature Scanner | | | Exergen Corporation | |
| 2 K983295 | 2 Thermoscan JRT 30201/3520 | | | 2 Braun Thermoscan | |
| 3 | 3 | | | 3 | |
| 4 | 4 | | | 4 | |
| 5 | 5 | | | 5 | |
| 6 | 6 | | | 6 | |
| Section F Product Information — Applicable to All Applications | | | | | |
| Common or usual name or classification name: | | | | | |
| Trade or proprietary or model name | | | | Model number | |
| 1 TemporalScanner Thermometer, SensorTouch | | | | 1 not known at this time | |
| 2 | | | | 2 | |
| 3 | | | | 3 | |
| 4 | | | | 4 | |
| 5 | | | | 5 | |
| FDA document numbers of all prior related submissions (regardless of outcome): | | | | | |
| 1 | 2 | 3 | 4 | 5 | 6 |
| 7 | 8 | 9 | 10 | 11 | 12 |
| Data included in submission: ☐ Laboratory testing ☐ Animal trials ☐ Human trials | | | | | |
| Section G Product Classification — Applicable to All Applications | | | | | |
| Product code: 80FL | C.F.R. Section: 880.2910 | | | Device class: ☑ Class I ☐ Class II ☐ Class III ☐ Unclassified | |
| Classification panel: General Hospital & Personal Use Device | | | | | |
| Indications (from labeling): The TemporalScanner Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature of subjects of all ages | | | | | |

Version 2.0

FINAL DRAFT — May 8, 1998

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{51}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

| Note: Submission of this information does not affect the need to submit a 2891 or 2891a Device Establishment Registration form. | | | FDA Document Number: | |
| --- | --- | --- | --- | --- |
| Section H Manufacturing / Packaging / Sterilization Sites Relating to a Submission | | | | |
| ☑ Original
☐ Add
☐ Delete | FDA establishment registration number: | | ☑ Manufacturer
☐ Contract sterilizer
☐ Contract manufacturer
☐ Repackager / relabeler | |
| Company / Institution name:
Exergen Corporation | | | Establishment registration number:
1221195 | |
| Division name (if applicable): | | | Phone number (include area code):
[phone] | |
| Street address:
51 Water St. | | | FAX number (include area code):
[phone] | |
| City:
Watertown | | State / Province:
MA 02172 | | Country:
USA |
| Contact name:
Gerald A. Clay | | | | |
| Contact title:
Director, Regulatory Affairs | | | Contact e-mail address:
[e-mail] | |
| ☐ Original
☐ Add
☐ Delete | FDA establishment registration number: | | ☐ Manufacturer
☐ Contract sterilizer
☐ Contract manufacturer
☐ Repackager / relabeler | |
| Company / Institution name: | | | Establishment registration number: | |
| Division name (if applicable): | | | Phone number (include area code):
( ) | |
| Street address: | | | FAX number (include area code):
( ) | |
| City: | | State / Province: | | Country: |
| Contact name: | | | | |
| Contact title: | | | Contact e-mail address: | |
| ☐ Original
☐ Add
☐ Delete | FDA establishment registration number: | | ☐ Manufacturer
☐ Contract sterilizer
☐ Contract manufacturer
☐ Repackager / relabeler | |
| Company / Institution name: | | | Establishment registration number: | |
| Division name (if applicable): | | | Phone number (include area code):
( ) | |
| Street address: | | | FAX number (include area code):
( ) | |
| City: | | State / Province: | | Country: |
| Contact name: | | | | |
| Contact title: | | | Contact e-mail address: | |

Version 2.0

FINAL DRAFT — May 8, 1998

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

{52}

Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# Section 2
## Truthful and Accurate Statement

Questions? Contact FDA/CDRH/OCE/DID at [e-mail] or 301-796-8118

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Records processed under FOIA Request # 2015-4114 Released by CDRH on 08-25-2015

# PREMARKET NOTIFICATION
## TRUTHFUL A…