K Number

Device Name

FORA COMFORTSCAN EAR THERMOMETER

Manufacturer

FORA CARE INC.

Date Cleared

2012-06-15

(64 days)

Product Code

FLL CLI

Regulation Number

880.2910

Intended Use

FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

Device Description

FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

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

K081445

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on infrared technology and standard performance testing, with no mention of AI/ML algorithms or training/test data sets.

Therapeutic

No
The device is an ear thermometer used to detect body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.

Diagnostic

No.
Explanation: The device is an ear thermometer used to detect human body temperature. While temperature can be a symptom of illness, the device itself simply measures a physiological parameter and does not provide a diagnosis of a disease or condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "electronic thermometer using an infrared sensor" and "utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object." This indicates the device includes hardware components (infrared sensor, electronics) for measurement, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FORA ComfortScan Ear Thermometer is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this thermometer measures temperature from the ear canal and object surfaces. It does not analyze biological samples like blood, urine, or tissue.
The function is temperature measurement. The device's purpose is to measure temperature, which is a physiological parameter, not to diagnose a condition based on the analysis of a specimen.

Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

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

ear canal, human skin

Indicated Patient Age Range

people of all ages

Intended User / Care Setting

home

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)

The FORA ComfortScan Ear Thermometer was validated by the tests according to ASTM E1965-98 standard and met the requirements of prEN12470-5:2000 standard.

Laboratory accuracy: ASTM E1965-98, prEN12470-5 (Measurement error)
Clinical accuracy: ASTM E1965-98, prEN12470-5 (Clinical bias, Clinical repeatability)
Safety: IEC 60601-1 (Evaluated by ETC)
Electromagnetic compatibility (EMC): IEC 60601-1-2 (Evaluated by ETC)
Storage stability: ASTM E1965-98 (Measurement error)
Cleaning procedure test: ASTM E1965-98, prEN 12470-5 (Measurement error)
Shock test: ASTM E1965-98 (Measurement error)
Displayed temperature: ASTM E1965-98 (Measurement error)
Operating range: ASTM E1965-98, prEN12470-5 (Measurement error)

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.

K081445

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

K121118

JUN 1 5 2012

Section 11. 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: Pinjung Chen Address: 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan Phone: +886-2-6625-8188 #1176 Fax: +886-2-6625-0868
Email: pinjung.chen(@taidoc.com.tw

Date of submission: March 215t, 2012

Applicant: Company Name: FORA Care Inc. Contact Person: Sophia Wu Address: 810 Lawrence Drive, Suite104, Newbury Park, CA 91320 Phone: (805) 498-8188 Fax: (805) 498-7188 E-mail: sophiawu@foracare.com

1. Device name:
  Proprietary name: FORA ComfortScan Ear Thermometer, model TD-1261A/B Regulatory information:

A. Regulation section: 21 CFR 880.2910

Classification: B. Class II
C. Product Code: FLL, Clinical electronic thermometer
General Hospital (80) D. Panel:

11-page 1 of 3

3. Intended Use:

1. Device Description:
  FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

Substantial Equivalence Information:

A. Predicate device name:

FORA ComfortScan Ear Thermometer, model TD-1261A/B

B. Predicate K number: K081445

C. Comparison with predicate:

The FORA ComfortScan Ear Thermometer has the following similarities to the predicate device:

물 Same intended use.
Same operating principle. 1
Same functions and physical appearance.
Same fundamental scientific technology.
I Incorporate the same basic circuit design.
l Incorporate the same materials.
미 Same shelf life. .
Same user interface and software.
1 Packaged using the same materials.
. Manufactured by the same process.

The modifications:

510(k) applicant for the device is FORA Care Inc. ■
l Labeling changes due to the modifications.

5. Test Principle:

The thermometer measures temperature by reading infrared radiation emitting from the eardrum and surrounding tissues or the surface radiation of the object and converts it into a temperature value.

1. Performance Characteristics:
  The FORA ComfortScan Ear Thermometer was validated by the tests according to ASTM E1965-98 standard and met the requirements of prEN12470-5:2000 standard.

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	Appendix
Laboratory
accuracy	ASTM E1965-98
prEN12470-5	Measurement error	C.1
Clinical accuracy	ASTM E1965-98
prEN12470-5	Clinical bias
Clinical repeatability	C.1
Safety	IEC 60601-1 ·	Evaluated by ETC	C.3
Electromagnetic
compatibility
(EMC)	IEC 60601-1-2	Evaluated by ETC	C.4
Storage stability	ASTM E1965-98	Measurement error	C.5
Cleaning procedure
test	ASTM E1965-98
prEN 12470-5	Measurement error	C.6
Shock test	ASTM E1965-98	Measurement error	C.7
Displayed
temperature	ASTM E1965-98	Measurement error	C.8
Operating range	ASTM E1965-98
prEN12470-5	Measurement error	C.9

Table 1. Summary of test

7. Conclusion:

Based on the information provided in this submission, the FORA ComfortScan Ear Thermometer, model TD-1261AB, is substantially equivalent to the predicate FORA ComfortScan Ear Thermometer, model TD-1261AB.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 5 2012

FORA Care, Incorporated C/O Mr. Pinjung Chen Regulatory Affairs Specialist Taidoc Technology Corporation 6F, No.127, Wugong 2nd Road, Wugu District New Taipei City, Taiwan 24888

Re: K121118 .

Trade/Device Name: FORA ComfortScan Ear Thermometer, Model TD-1261A/B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 21, 2012 Received: April 12, 2012

Dear Mr. Chen:

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. Chen

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

S. Stuart Ryan

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Section 8. Indications for Use

Indications for Use

510(k) Number:

Device Name: FORA ComfortScan Ear Thermometer, model TD-1261A/B

Indications for Use:

Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for use in the home. It is also available to detect object's surface temperature including human skin.

Prescription Use _ (21 CFR Part 801 Subpart D)

Over the Counter Use __X And/Or -(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)

Division Sign-Off Office of Device Evaluation (ODE) 510(k) K12 m8

lül lli for RZC June 11, 2012
(Division Sign-Off) Page 1 of

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K121118 510(k) Number:

12 11 8

8- page 1 of 1