IR FOREHEAD THERMOMETER, MODEL HV-T36

K032612 · Oriental Inspiration, Ltd. · FLL · Feb 19, 2004 · General Hospital

Device Facts

• Record ID: K032612
• Device Name: IR FOREHEAD THERMOMETER, MODEL HV-T36
• Applicant: Oriental Inspiration, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Feb 19, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all ages. The measured temperature correlates to axillary temperature.

Device Story

Electronic infrared digital forehead thermometer; scans forehead for arterial blood supply temperature. Displays results digitally and via voice output; range 35°C to 42.2°C (95°F to 108°F). Includes date/time display and memory storage for 30 measurement records. Used in home or clinical settings by patients or clinicians for intermittent temperature assessment. Provides non-invasive temperature monitoring; aids in fever detection and health assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance characteristics similar to the predicate device.

Technological Characteristics

Infrared sensor for forehead temperature measurement. Digital display with voice output. Memory capacity for 30 records. Battery-operated. Non-sterile, reusable. Class II device (Product Code FLL).

Indications for Use

Indicated for intermittent measurement and assessment of skin forehead temperature in humans of all ages. Correlates to axillary temperature. Over-the-counter use.

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

• FT101 Forehead Infrared Digital Thermometer (K020433)

Submission Summary (Full Text)

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# 510(k) Summary

As Required by 21 section 807.92 ( c )

Mansour Consulting LLC 1-Submitter Name:

- 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA
- (770) 777- 4146 3-Phone:
- (678) 623- 3765 4-Fax:

5-Contact Person: Jay Mansour

6-Date summary prepared: August 21*, 2003

- 7-Device Trade or Proprietary Name: IR FOREHEAD THERMOMETER, HV-T36
8-Device Common or usual name: Forehead Electronic Thermometer

- Clinical Electronic Thermometer 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device:

- FT101 Forehead Infrared Digital Thermometer, manufactured by IDT Technology . Limited and distributed in US by Oregon Scientific. 510k # K020433
## 11-Description of the Device:

This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF).

This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift.

HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.

## 12-Intended use of the device:

This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.

## 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

## 14-Summary comparing technological characteristics with other predicate device:

Image /page/0/Picture/22 description: The image shows an oval shape with the text "PAGE 10" written inside. The text is handwritten in a simple, slightly messy style. The oval shape is outlined in black, and the text is also in black.

K032612-

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Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.

| FDA file reference number | 510k # K020433 |
|--------------------------------------------------|------------------------|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three distinct head profiles, suggesting a focus on people and health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Oriental Inspiration Limited C/O Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharette, Georgia 30022

Re: K032612

Trade/Device Name: IR Forehead Thermometer, HV-T36 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 1, 2003 Received: December 4, 2003

Dear Mr. Mansour

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Mansour

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of 1

510(k) Number (if known): //326/2

Device Name: IR FOREHEAD THERMOMETER, HV-T36

Indications for Use:

This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all ages. The measured temperature correlates to axillary temperature

/ Over-the-Counter

Prescriptum

Clus-Ps

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

510(k) Number: K032622

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurence of CDRH, Office of Device Evaulation (ODL)

(Optional Format 3-10-98)

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