The 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 home and professional use.

Device Description

FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the FORA ComfortScan Ear Thermometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Expanded Intended Use: To include home and professional settings.	Met: The device demonstrated safety and effectiveness for both home and professional use in lab and clinical accuracy reports.
Performance Equivalency to Predicate Device: Maintain the same performance characteristics as the predicate device (FORA ComfortScan Ear Thermometer, model TD-1261).	Met: The device exhibited the same performance characteristics as the predicate device, supported by lab and clinical accuracy reports.
Safety and Effectiveness: Demonstrate safety and effectiveness for the modified indications.	Met: Software verification and validation, along with risk analysis tests for user population changes, confirmed the performance, safety, and effectiveness.

Study Details:

The provided text describes a 510(k) summary for a modified medical device. The primary objective of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the FORA ComfortScan Ear Thermometer, model TD-1261 (K081445).

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

The document states: "The performance of the FORA ComfortScan Ear Thermometer in the lab and clinical accuracy report demonstrated that the meter is safe and effective for home and professional use."
Sample Size: The specific sample size for the test set (clinical accuracy report) is not provided in the given text.
Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, considering it's a 510(k) submission to the FDA, the clinical data would typically adhere to recognized standards for clinical accuracy.

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

This information is not provided in the document. The text refers to "clinical accuracy report" but does not detail the methodology for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set

The adjudication method is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable to this device. The FORA ComfortScan Ear Thermometer is a standalone device for measuring body temperature and does not involve human readers for interpretation, nor does it incorporate AI assistance for human readers.

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

Yes, this is a standalone performance study from the perspective of how the device operates. The thermometer itself provides the temperature reading directly, without human interpretation for the measurement output. The "clinical accuracy report" would assess the device's ability to accurately measure temperature on its own.

7. The Type of Ground Truth Used

While not explicitly stated, for a clinical thermometer, the ground truth for accuracy studies typically involves simultaneous measurements using a highly accurate reference thermometer (often a rectal thermometer or a standardized probe in a controlled environment) or comparison to other clinically accepted temperature measurement methods. The document mentions "lab and clinical accuracy report," which implies comparison against a reliable standard.

8. The Sample Size for the Training Set

This information is not provided in the document. The device uses infrared technology, which traditionally relies on established physics principles and calibration rather than a machine learning "training set" in the conventional AI sense. The "training set" concept is not relevant here for device function.

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

This question is not applicable as there is no mention or indication of a "training set" in the context of machine learning for this device. The device's operation is based on physical principles of infrared detection. Its accuracy would be established through calibration and validation against known temperature standards.

Summary

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Section 11. 510(k) Summary

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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: K120712

1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
  Correspondence: Pinjung Chen Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0868 Email: pinjung.chen@taidoc.com.tw

Date of submission: March 6th, 2012

1. Device name:
  Proprietary name: FORA ComfortScan Ear Thermometer

Regulatory information:

Regulation section: 21 CFR 880.2910 A.
Classification: Class II B.
FLL, Clinical electronic thermometer C. Product Code:
General Hospital (80) Panel: D.

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1. Intended Use:
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The 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 home and professional use.

4. Device Description:

Substantial Equivalence Information:

A. Predicate device name:

FORA ComfortScan Ear Thermometer, model TD-1261

Predicate K number: K081445 B.

C. Comparison with predicate:

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

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

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The modifications:

The intended use is expanded to for home and professional use. .
Labeling changes due to the modified indications. ■
1. Test Principle:

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

1. Performance Characteristics:
  FORA ComfortScan Ear Thermometer has the same performance characteristics as the predicate device.

The performance of the FORA ComfortScan Ear Thermometer in the lab and clinical accuracy report demonstrated that the meter is safe and effective for home and professional use.

Software verification and validation, and risk analysis tests specific to user population change confirmed that the performance, safety and effectiveness of the FORA ComfortScan Ear Thermometer are equivalent to the predicate device.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Pinjung Chen Regulatory Affairs Specialist Taidoc Technology Corporation 6F, No 127 Wugong 2nd Road Wugu District New Taipei County China 248

JUN - 6 2012

Re: K120712

Trade/Device Name: FORA ComfortScan Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 6, 2012 Received: March 8, 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 (OS) 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/ucm 115809.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 yours,

for Seale
St. Luke's

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

Indications for Use:

The 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 home and professional use.

Prescription Use _ (21 CFR Part 801 Subpart D) And/Or Over the Counter Use _ X (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)

Rell C. 6/6/12

Division Sign-Off Office of Device Evaluation (ODE) K120712 510(k)_

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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.