The ION HEALTH USB INSTA-SCAN 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 also available to detect object's surface temperature including human skin.

Device Description

The ION HEALTH USB INSTA-SCAN THERMOMETER is characterized by measuring human body temperature in the ear canal. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues when making a temperature measurement.

AI/ML Overview

This device, the ION HEALTH USB INSTA-SCAN THERMOMETER, is cleared under a 510(k) and demonstrates substantial equivalence to a predicate device, the FORA IR17 Ear Thermometer, model TD-1117 (K083299). Therefore, the study presented primarily focuses on establishing this substantial equivalence rather than independent performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the ION HEALTH USB INSTA-SCAN THERMOMETER. Instead, it relies on demonstrating substantial equivalence to a predicate device that has already met such criteria. The "reported device performance" is essentially that it matches the performance of the predicate.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as compared to Predicate)
Same performance characteristics as predicate device (FORA IR17 Ear Thermometer, TD-1117)	"ION HEALTH USB INSTA-SCAN THERMOMETER has the same performance characteristics as the predicate device."
System accuracy comparable to predicate device	"A comparison of system accuracy performance demonstrated that the ION HEALTH USB INSTA-SCAN THERMOMETER... and the currently marketed FORA IR17 Ear Thermometer... are substantially equivalent."
Performance, safety, and effectiveness equivalent to predicate device	"Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the ION HEALTH USB INSTA-SCAN THERMOMETER are equivalent to the predicate device."

2. Sample size used for the test set and the data provenance

The document does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the comparison study. It only states that a "comparison of system accuracy performance" was done.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study's focus is on comparing the new device to a predicate, not on generating novel ground truth through expert consensus.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an electronic thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting output. Therefore, an MRMC study and effects on human reader performance are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone electronic thermometer. The "study" described is a comparison of this device's performance against another standalone electronic thermometer (the predicate). The performance evaluated is the device's inherent measurement capabilities. So, in essence, the "study" assesses standalone performance by comparing it to another standalone device.

7. The type of ground truth used

The document does not explicitly state the "ground truth" used for the performance comparison. However, given it's a thermometer comparison, the implicit ground truth for accuracy studies of thermometers typically involves:

Reference thermometers or calibrated temperature sources: These would represent the "true" temperature against which both devices are measured.
Clinical measurements: In a clinical validation, the "true" body temperature might be established using gold-standard methods (e.g., rectal temperature, core body temperature) against which the ear thermometer readings are compared.

The document only states "system accuracy performance" was compared, implying such a reference method would have been used in the predicate's original clearance and presumably for this comparison too, even if not detailed here.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set." It's a sensor-based electronic device.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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Attachment B4. 510(k) Summary

......

AUG 15 2011

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's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondence: Teling Hsu Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: teling.hsu(@taidoc.com.tw

Date of submission: July 08, 2011

1. Device name:
  Proprietary name: ION HEALTH USB INSTA-SCAN THERMOMETER

Regulatory information:

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

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1. Intended Use:
  ﺎ

: 六

ION HEALTH USB INSTA-SCAN 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 also available to detect object's surface temperature including human skin.

1. Device Description:
  The ION HEALTH USB INSTA-SCAN THERMOMETER is characterized by measuring human body temperature in the ear canal. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues when making a temperature measurement.

Substantial Equivalence Information:

Predicate device name: A.

FORA IR17 Ear Thermometer, model TD-1117

Predicate K number: K083299 B.

C. Comparison with predicate:

The modified ION HEALTH USB INSTA-SCAN THERMOMETER has the following similarities to the predicate device:

l same operating principle,
same fundamental scientific technology, I
incorporate the same basic circuit design, ■
incorporate the same materials,
. same shelf life
packaged using the same materials, and .
제 manufactured by the same process.

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The modifications encompass:

added the USB data transmission ■
modification in the physical appearance ■
increased memory storage capacity ■
트 labeling change due to the modifications
1. Test Principle:

ーに、ショップ

The ear thermometer measures temperature by reading infrared radiation emitting from eardrum tissue. The small con-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts it into a temperature value. This kind of temperature from the eardrum has been found to be a clinically reliable indicator of body core temperature.

1. Performance Characteristics:
  ION HEALTH USB INSTA-SCAN THERMOMETER has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the ION HEALTH USB INSTA-SCAN THERMOMETER, iH08 and the currently marketed FORA IR17 Ear Thermometer, TD-1117 (cleared under K083299) are substantially equivalent.

Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the ION HEALTH USB INSTA-SCAN THERMOMETER are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the ION HEALTH USB INSTA-SCAN THERMOMETER is substantially equivalent to the predicate FORA IR17 Ear Thermometer, model TD-1117.

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

TaiDoc Technology Corporation Mr. Teling Hsu Regulatory Affairs Specialist 6F, No.127 Wugong 2nd Road Wugu District New Taipei City China (Taiwan) 24888

AUG 1 5 2011

Re: K111974

Trade/Device Name: ION Health USB Insta-Scan Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 2, 2011 Received: August 4, 2011

Dear Mr. Hsu:

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. Hsu

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 yours,

Anthony 20, 1922

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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Attachment B3. Indications for Use

Indications for Use

510(k) Number: K111974

Device Name: ION HEALTH USB INSTA-SCAN THERMOMETER

Indications for 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)

Division Sign-Off Office of Device Evaluation (ODE)

510(k)

8/17/11

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

B3-1 of 1 510(k) Number:

Page 1 of

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.