CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES

K131771 · Thermomedics, Inc. · FLL · Oct 7, 2013 · General Hospital

Device Facts

• Record ID: K131771
• Device Name: CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
• Applicant: Thermomedics, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Oct 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Caregiver professional Clinical Thermometer is an infrared thermometer intended for the measurement of human body temperature in people of all ages without contact to the body and may be used by medical professionals or by consumers in a home environment.

Device Story

The Caregiver Professional Clinical Thermometer (Model PRO-TF300) is a non-contact infrared thermometer. It detects infrared energy emitted from the surface of human skin; converts this radiation into a digital temperature value. Used by medical professionals or consumers in clinical or home settings. The device provides a temperature reading on a display, assisting users in monitoring body temperature for clinical decision-making. Benefits include non-invasive, hygienic temperature measurement without physical contact.

Clinical Evidence

Bench testing only. The device was validated according to ASTM E1965-98 standards, including laboratory accuracy, clinical accuracy (clinical bias and repeatability), storage stability, shock resistance, and cleaning procedure testing. Safety and electromagnetic compatibility (EMC) were evaluated per IEC 60601-1 and IEC 60601-1-2, respectively.

Technological Characteristics

Non-contact infrared thermometer. Sensing principle: infrared radiation detection. Standards: ASTM E1965-98 (accuracy/performance), IEC 60601-1 (safety), IEC 60601-1-2 (EMC). Features include digital display, memory storage, and user interface. Battery-powered.

Indications for Use

Indicated for measurement of human body temperature in all ages, including infants, children, and adults. Suitable for use by medical professionals in clinical settings or by consumers in home environments. No specific contraindications listed.

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

• U-RIGHT TD-1240 Thermometer (K113159)

Submission Summary (Full Text)

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ОСТ 0 7 2013

## B2. 510(k) Summary

### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is:

- l. Submitter Information: Application Correspondence: Contact Person: Paul Liu Address: 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan Phone: [phone] #6134 Fax: [phone] Email: [e-mail]
Date of submission: June 10, 2013

Applicant: Company Name: Thermomedics Inc. Contact Person: Gary J O'Hara Address: 18310 Calle La Serra Rancho Santa Fe, CA 92091 Phone: [phone] Fax: [phone] E-mail: [e-mail]

- 2. Device name:
·

Proprietary name: Caregiver Professional Clinical Thermometer Model no: PRO-TF Series (Model PRO-TF300) Regulatory information:

Regulation section: 21 CFR 880.2910 A.

- B. Classification: Class II
- Product Code: FLL, Clinical electronic thermometer C.

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- D. Panel: General Hospital (80)
- 3. Intended Use:

Caregiver professional Clinical Thermometer is an infrared thermometer intended for the measurement of human body temperature in people of all ages without contact to the body and may be used by medical professionals or by consumers in a home environment.

- 4. Device Description:
Caregiver Professional Clinical Thermometer (Model PRO-TF300) is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

Substantial Equivalence Information:

- Predicate device name: A. U-RIGHT TD-1240 Thermometer
- B. Predicate K number: K113159
- C. Comparison with predicate:

Caregiver Professional Clinical Thermometer (Model PRO-TF300) has the following similarities to the predicate device:

- same operating principle, 그
- same fundamental scientific technology,
- 베 incorporate the same basic circuit design,
- 문 incorporate the same materials,
- 그 same shelf life
- manufactured by the same process 1

The modifications encompass:

- displayed temperature range 그

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- memory storage capacity
- modification in the physical appearance
- 글 a modification in the user interface
- 트 labeling change due to the modifications
- 5. Test Principle:

The thermometer measures temperature by reading infrared radiation emitting from the skin and converts it into a temperature value.

- 6. Performance Characteristics:
Caregiver Professional Clinical Thermometer (Model PRO-TF300) was validated by the tests according to ASTM E1965-98.

A brief description for each test was given in this section. Table 1 lists items of tests related standard complied and format of data presentation.

| Item | Standard complied | Data presentation | Attachment |
|-------------------------------------|-------------------|-----------------------------------------|------------|
| Laboratory accuracy | ASTM E1965-98 | Measurement error | A3.1 |
| Clinical accuracy | ASTM E1965-98 | Clinical bias<br>Clinical repeatability | A3.2 |
| Storage stability | ASTM E1965-98 | Measurement error | A3.3 |
| Shock | ASTM E1965-98 | Measurement error | A3.4 |
| Cleaning procedure | ASTM E1965-98 | Measurement error | A3.5 |
| Safety | IEC 60601-1 | Evaluated by SGS | A3.6 |
| Electromagnetic compatibility (EMC) | IEC 60601-1-2 | Evaluated by SGS | A3.7 |

Table 1. Summary of test

# 7. Conclusion:

Based on the information provided in this submission, the Caregiver Professional Clinical Thermometer (Model PRO-TF300) is substantially equivalent to the predicate U-RIGHT TD-1240 Thermometer.

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Public Health Service

Food and Drue Administration 0903 New Hampshire Avenue Document Control Center - WObb-G Iver Spring, MD 20993-0002

#### October 7, 2013

Thermomedics, Incorporated Mr. Paul Liu 6F, NO. 127, Wugong 2nd Road, Wugu District New Taipei City TAIWAN 24888

Re: K131771

Trade/Device Name: Caregiver Professional Clinical Thermometer, PRO-TF Series (Model PRO-TF300) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL Dated: September 6, 2013 Received: September 9, 2013

Dear Mr. Liu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Liu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office. of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary's Runner-S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# B1. Indications for Use

## Indications for Use

510(k) Number: K131771

Caregiver Professional Clinical Thermometer, PRO-TF Series (Model PRO-TF300)

Indications for Use:

Caregiver professional Clinical Thermometer is an infrared thermometer intended for the measurement of human body temperature in people of all ages without contact to the body and may be used by medical professionals or by consumers in a home environment.

And/Or Over the Counter Use __ X ____________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saijad H. Sye

Division Sign-Off Office of Device Evaluation (ODE) 510(k)________________________________________________________________________________________________________________________________________________________________________

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