K Number

Device Name

CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES

Manufacturer

THERMOMEDICS INC.

Date Cleared

2013-10-07

(112 days)

Product Code

FLL CLI

Regulation Number

880.2910

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113159

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on standard infrared technology for temperature measurement.

Therapeutic

No
A therapeutic device is used for treating or alleviating a medical condition. This device is an infrared thermometer intended for measuring body temperature, which is a diagnostic function, not a therapeutic one.

Diagnostic

No.
The device measures body temperature, which is a physiological parameter, but it does not diagnose a medical condition or disease itself. It may be used as an aid in diagnosis, but its primary function is measurement, not diagnosis. The "intended use" section specifies "measurement of human body temperature," not diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "infrared thermometer" and utilizes "infrared technology to measure infrared energy emitted from the skin surface," indicating it is a hardware device with a sensor.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The Caregiver Professional Clinical Thermometer measures human body temperature from the surface of the skin using infrared technology. It does not analyze any specimens taken from the body.
Intended Use: The intended use is to measure body temperature, which is a physiological measurement taken directly from the body, not an analysis of a biological sample.

Therefore, based on the provided information, this device falls under the category of a clinical thermometer, which is a medical device but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

all ages

Intended User / Care Setting

medical professionals or by consumers in a home environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113159

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.

Summary

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: +886-2-6625-8188 #6134 Fax: +886-2-6625-0868 Email: paul@taidoc.com.tw
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: 858 779 1060 Fax: 305 433 5129 E-mail: gohara@thermomedics.com

1. 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.

Page 1 of 3

D. Panel: General Hospital (80)
1. Intended Use:

1. 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

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

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

1. 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
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.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

B1. Indications for Use

Indications for Use

510(k) Number: K131771

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

Indications for Use:

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)________________________________________________________________________________________________________________________________________________________________________

Page I of ____________________________________________________________________________________________________________________________________________________________________