INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 by INNOCHIPS TECHNOLOGY CO., LTD.

Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Device Description

Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not contain a specific table of acceptance criteria for performance metrics (e.g., accuracy against a standard thermometer). Instead, it primarily focuses on comparing features and functionality to a predicate device and states that "Test results support the conclusion that actual device performance satisfies the design intent."

However, we can infer some key specifications and compare them to the predicate device, which implicitly serves as a benchmark for acceptability.

Feature	Acceptance Criteria (Implied by Predicate - K011059)	Reported Device Performance (InnoTherm ICT-100, ICT-200)
Measurement Temp Range	34.0 ~ 42.2 ℃ (93.2 ~ 108 °F)	32.0 ~ 43.0 ℃ (89.6 ~ 109.4 °F)
Ambient Range	10 ~ 40 ℃ (50 ~ 104 °F)	16.0 ~ 40.0 ℃ (93.2 ~ 108 °F)
Storage Range	-20 ~ 50 ℃ (-4 ~ 122 °F)	-10 ~ 41 ℃ (14 ~ 105.8 °F)
Display Type	LCD	LCD
Activation	Scan button	Scan button
Battery Type	CR2032 * 1 pcs	CR2032 * 1 pcs
Classification	thermometer, electronic, clinical (Class II), 21 CFR 880.2910	thermometer, electronic, clinical (Class II), 21 CFR 880.2910
Intended Population	Neonatal, pediatric, and adult population	Neonatal, pediatric, and adult population
Intended Use Setting	Auditory canal, used in the home setting	Auditory canal (no specific mention of home setting limitation)

Note: The reported device performance generally meets or slightly expands upon the predicate's ranges for temperature measurements. The "Ambient range" and "Storage range" show variations, but the document doesn't explicitly state these as "acceptance criteria" against which the new device was measured; rather, they are presented as comparative specifications. The overall conclusion is "substantially equivalent," implying these differences are acceptable.

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

The document states: "Testing was performed according to 'Harmonized Standard and ASTM'." It does not specify:

The exact sample size used for the test set.
The country of origin of the data.
Whether the study was retrospective or prospective.

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. For a clinical thermometer, ground truth would typically be established by comparison to a highly accurate reference thermometer, not necessarily by human experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, for a clinical thermometer, adjudication by experts for ground truth is not typically applicable.

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

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For a simple electronic thermometer, the objective is to measure temperature accurately, which is typically validated through direct comparison to a reference standard, not through reader studies.

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

Yes, a standalone performance evaluation was done. The document focuses on the device itself and its ability to measure temperature. The testing performed "according to 'Harmonized Standard and ASTM'" would assess the device's accuracy and performance independently.

7. The Type of Ground Truth Used

The document implies that testing was done against "Harmonized Standard and ASTM," which would mean the device's measurements were compared against established reference standards (e.g., highly accurate standard thermometers or controlled temperature environments) as defined by those standards. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is an infrared ear thermometer, a hardware device that directly measures a physical property (temperature). It does not use algorithms that require a "training set" in the context of machine learning or AI.

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

This information is not applicable as there is no "training set" for this type of device.

Summary

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K081788 pg 1 of 2

510(K) SUMMARY

[as required by 807.92(c)]

OEC 1 7 2008

1. Identification of the Device:
  -Proprietary-Trade Name: "Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)" INNOCHIPS TECHNOLOGY Co., Ltd. -Classification Name thermometer, electronic, clinical, Product Code: FLL -Common/Usual Name: Clinical Electronic Thermometer / Infrared Ear Thermometer
1. Equivalent legally marketed device:
  This product is similar in design and identical in function to the K011059 / INFARED EAR THERMOMETER, MODEL TH8 SERIES / RADIANT INNOVATION, INC.
1. Indications for Use (intended use):
  The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
1. Description of the device:
  Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.

Intended Use
Infrared Ear Thermometer(InnoTherm ICT-100, InnoTherm ICT-200)	RII INFRARED EARTHERMOMETER, MODELS TH8SERIES (K011059)
The device is an electronic clinicalthermometer using an infrared sensorto detect body temperature from theauditory canal in the neonatal,pediatric and adult population.	The device is an electronic clinicalthermometer using an infrared sensorto detect body temperature from theauditory canal in the neonatal,pediatric and adult population used inthe home setting.

1. Safety and Effectiveness, comparison to predicate device:

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202

Measurementtemp range	32.0 ~ 43.0 ℃(89.6 ~ 109.4 °F)	34.0 ~ 42.2 ℃(93.2 ~ 108 °F)
Ambient range	16.0 ~ 40.0 ℃(93.2 ~ 108 °F)	10 ~ 40 ℃(50 ~ 104 °F)
Storage range	-10 ~ 41 ℃(14 ~ 105.8 °F)	-20 ~ 50 ℃(-4 ~ 122 °F)
Display type	LCD	LCD
Activation	Scan button	Scan button
Battery type	CR2032 * 1 pcs	CR2032 * 1 pcs
Classification	thermometer, electronic, clinical(Class II), 21 CFR 880.2910	thermometer, electronic, clinical(Class II), 21 CFR 880.2910

6. Testing information and Conclusion

In all material respects, the "Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)" is substantially equivalent to RII INFRARED EAR THERMOMETER, MODELS TH8 SERIES (K011059) RADIANT INNOVATION, INC. Testing was performed according to 'Harmonized Standard and ASTM'. Test results support the conclusion that actual device performance satisfies the design intent.

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Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innochips Technology Company, Limited C/O Mr. Brandon Choi General Manager PATS Corporation 49 Candlewood Way Buena Park, California 90621

DEC 1 7 2008

Re: K081788

Trade/Device Name: Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 21, 2008 Received: November 21, 2008

Dear Mr. Choi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Choi

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clint S. Liz, Ph.D.

Chiu S. Lin, Ph. D Division 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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Indications for Use

510(k) Number (if known):

Device Name: Infrared Ear Thermometer (InnoTherm ICT-100, InnoTherm ICT-200)

Indications for use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Anten Om

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.