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.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the FORA ComfortScan Ear Thermometer, model TD-1261A/B.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was validated by tests according to ASTM E1965-98 and met the requirements of prEN12470-5:2000 standards. While specific numerical acceptance criteria (e.g., maximum allowed error) are not explicitly stated in the provided text, the reported performance is that the device met the requirements of these standards for various tests. For the clinical accuracy test, the performance metrics reported are "Clinical bias" and "Clinical repeatability."

Item	Standard Complied	Acceptance Criteria (Implicit)	Reported Device Performance
Laboratory accuracy	ASTM E1965-98, prEN12470-5	Met requirements of the standards for measurement error	Met the requirements of the standards; measurement error assessed
Clinical accuracy	ASTM E1965-98, prEN12470-5	Met requirements of the standards for clinical bias & repeatability	Met the requirements of the standards; clinical bias and clinical repeatability assessed
Safety	IEC 60601-1	Met safety requirements	Evaluated by ETC (testing laboratory)
Electromagnetic compatibility (EMC)	IEC 60601-1-2	Met EMC requirements	Evaluated by ETC (testing laboratory)
Storage stability	ASTM E1965-98	Met requirements for measurement error after storage	Met the requirements of the standard; measurement error assessed
Cleaning procedure test	ASTM E1965-98, prEN 12470-5	Met requirements for measurement error after cleaning	Met the requirements of the standards; measurement error assessed
Shock test	ASTM E1965-98	Met requirements for measurement error after shock	Met the requirements of the standard; measurement error assessed
Displayed temperature	ASTM E1965-98	Met requirements for measurement error of displayed temperature	Met the requirements of the standard; measurement error assessed
Operating range	ASTM E1965-98, prEN12470-5	Met requirements for measurement error across operating range	Met the requirements of the standards; measurement error assessed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in either laboratory or clinical accuracy studies. It only mentions that the device was validated according to ASTM E1965-98 and prEN12470-5:2000. These standards typically outline requirements for sample sizes, but the specific numbers used in this particular study are not provided in the summary.

The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the 510(k) summary. Given that the device is a thermometer for measuring body temperature, the "ground truth" for clinical accuracy would typically involve a reference thermometer (e.g., a highly accurate hospital-grade rectal thermometer or a calibrated blackbody for laboratory testing), rather than expert interpretation of images or clinical findings that would require a panel of experts.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as medical imaging where multiple readers independently review cases and then reconcile their findings. For a device like an ear thermometer, which measures a physical quantity, this type of adjudication method is not applicable and therefore not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which assesses how human readers improve with AI assistance, is not applicable to a standalone medical device like an ear thermometer. This device directly measures temperature without human interpretation of complex data or AI assistance in diagnostic tasks. Therefore, no such study was done or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone (algorithm only) device in the sense that it provides a direct temperature reading without requiring a human-in-the-loop for interpretation or modification of its core function. The performance assessment described (laboratory and clinical accuracy) evaluates the device's standalone capability to measure temperature. So, yes, the described performance characteristics are a standalone assessment of the device.

7. The Type of Ground Truth Used

For "Laboratory accuracy" and "Clinical accuracy" tests, the ground truth would typically be established using:

Laboratory Accuracy: A highly accurate and calibrated reference thermometer or a blackbody temperature standard in a controlled laboratory setting.
Clinical Accuracy: A reference body temperature measurement obtained from a primary site (e.g., rectal, oral) using a highly accurate and calibrated clinical reference thermometer, often performed by qualified medical personnel.

The document implicitly refers to these by stating compliance with ASTM E1965-98 and prEN12470-5:2000, which define how such ground truth is established for thermometer testing.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI-based devices. As the FORA ComfortScan Ear Thermometer is an infrared sensor-based device that directly measures temperature and does not involve AI or machine learning algorithms that require a training phase, there is no training set in the conventional sense for this device.

9. How the Ground Truth for the Training Set Was Established

Since no training set is applicable for this device (as explained in point 8), the question of how its ground truth was established is not relevant.

Summary

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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

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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.

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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
Laboratoryaccuracy	ASTM E1965-98prEN12470-5	Measurement error	C.1
Clinical accuracy	ASTM E1965-98prEN12470-5	Clinical biasClinical repeatability	C.1
Safety	IEC 60601-1 ·	Evaluated by ETC	C.3
Electromagneticcompatibility(EMC)	IEC 60601-1-2	Evaluated by ETC	C.4
Storage stability	ASTM E1965-98	Measurement error	C.5
Cleaning proceduretest	ASTM E1965-98prEN 12470-5	Measurement error	C.6
Shock test	ASTM E1965-98	Measurement error	C.7
Displayedtemperature	ASTM E1965-98	Measurement error	C.8
Operating range	ASTM E1965-98prEN12470-5	Measurement error	C.9

Table 1. Summary of test

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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.

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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.

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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

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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

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.