A ViTA Agil IT101 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature , orally, rectally and under the arm, by consumers in the home.

AviTA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either rapid mode (4-seconds orally, 6-seconds rectally and under the arm -- Predicative Temperature), or standard mode(actual determination of temperature),

Device Description

AVITA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer and is designed to instantly take the body temperature orally, rectally or under the arm. With its rapidity and precisemenss, Agil IT101 gives a temperature reading in merely 4 seconds orally and 6 seconds rectally and under the arm respectively.

AI/ML Overview

The provided 510(k) summary for the AVITA Agil IT101 Instant Digital Thermometer indicates that the device was evaluated based on compliance with established standards, but it does not include a detailed study proving the device meets specific acceptance criteria for accuracy and precision in the way typically expected for AI/ML-driven devices or more complex medical instruments.

Instead, the performance summary highlights conformity to general medical device standards.

Here's an attempt to extract and present the requested information based solely on the provided text, noting where information is missing for a detailed AI/ML-type study.

Acceptance Criteria and Reported Device Performance

The submission states conformity to various standards as its performance summary, implying these standards contain the acceptance criteria for a digital thermometer. Specific numerical performance criteria (e.g., accuracy range, precision) are not detailed in the provided text.

Acceptance Criterion (Implied by Compliance)	Reported Device Performance
Conforms to ASTM E1112-98	Conforms
Conforms to PrEN 12470-3	Conforms
Conforms to IEC 60601-1	Conforms
Conforms to IEC 60601-1-2	Conforms
Rapid mode measurement time (Oral)	4 seconds
Rapid mode measurement time (Rectal/Under arm)	6 seconds

Note: The specific numerical tolerance for temperature accuracy as per these standards (e.g., ±0.1°C) is not provided in the summary. The acceptance criteria are implicitly met by "conforms to" the standards.

Study Details

The submission mentions "bench testing contained in this submission and clinical testing supplied" but does not provide details about these studies. Therefore, most of the requested information regarding the study design is not available in the provided text.

Sample size used for the test set and the data provenance:
- Test Set Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a simple digital thermometer, ground truth typically refers to a reference thermometer reading rather than expert interpretation of images or other complex data.
Adjudication method for the test set:
- Not applicable/Not specified. Ground truth establishment for a thermometer's accuracy usually involves comparing readings to a highly accurate reference standard, not a consensus among experts, unless the "clinical testing" involved something more complex, which is not described.
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:
- Not applicable. This is not an AI/ML device subject to MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone device in the sense that it provides a temperature reading, but it does not employ an algorithm that would typically be evaluated in the context of AI/ML or image interpretation. Its "algorithm" is likely the predictive logic for rapid mode temperature.
The type of ground truth used:
- Likely involved a comparison to a highly accurate reference thermometer in a controlled environment, as is standard for thermometer validation, but explicitly not stated in the document.
The sample size for the training set:
- Not applicable. This device does not use machine learning algorithms that require a "training set" in the conventional sense. The "predictive" aspect likely comes from engineering and calibration based on known physiological temperature curves, not data-driven machine learning.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for machine learning.

Conclusion based on provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant medical device standards (ASTM, PrEN, IEC) for safety and electromagnetic compatibility. It mentions "bench testing" and "clinical testing" but does not detail the specific methodologies, sample sizes, or ground truth establishment processes for these tests in a way that would answer the requested questions for a typical AI/ML device study. For a digital thermometer, the "study" demonstrating performance would primarily involve calibration and accuracy tests against a known standard under various conditions defined by the cited standards.

Summary

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SEP 1 0 2001

510(K) SUMMARY

K 012136

his summary of 510(k) safety and effectiveness information is being submitted in.accordance with the requirements of SMDA and 21 CFR §807.92

1.0	Submitter's Name:	AVITA International Corp
	Address:	9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan, R.O.C.
	Phone:	001-886-2-85121568
	Fax:	001-886-2-85121347
	Contact:	Mr. Geo Lin, General Manager
2.0 Device Name:		AVITA Agil IT101 Instant Digital Thermometer
3.0	Classification:	Class II
4.0 Predicate Device:		Microlife IT2CA1 Digital 4-Sec. Predicative Thermometer (K990168)
5.0 Device Description:		AVITA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile,reusable clinical thermometer and is designed to instantly take the bodytemperature orally, rectally or under the arm. With its rapidity andprecisemenss, Agil IT101 gives a temperature reading in merely 4 seconds orallyand 6 seconds rectally and under the arm respectively.
6.0	Intended Use:	The AVITA Agil IT101 Instant Digital Thermometer is intended for theintermittent measurement and monitoring of human body temperature, in eitherRapid mode (4-seconds orally, 6-seconds rectally and under the arm --Predicative Temperature), or standard mode(actual determination oftemperature), orally, rectally and under the arm , by consumers in the home.
7.0	PerformanceSummary:	In terms of operating specification, Safety & EMC requirements, the deviceconforms to applicable standards included ASTM E1112-98, PrEN 12470-3,IEC 60601-1 and IEC 60601-1-2 requirements.

8. Conclusions:

he AVITA Agil 1T101 Instant Digital Thermometer have the same intended use and similar technological characteristics as the Microlife IT2CA1 Digital 4-Sec. Predicative Thermometer (K990168). Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVTA Agil 1T101 Instant Digital Thermometer, is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its wings and head. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2001

AViTA International Corporation Mr. Allen Reich Harvest Consulting Corporation 900 North Switzer Canyon Drive, #142 Flaggstaff, Arizona 86001

Re: K012136

Trade/Device Name: AViTA Agil IT101 Instant Digital Thermometer Regulation Number: 880.2910 Regulation Name: Thermometer, Electronicthermometer, Predictive Thermometer Regulatory Class: II Product Codc: FLL Dated: September 10, 2001 Received: July 9, 2001

Dear Mr. Reich:

This letter corrects our substantially equivalent letter of September 10, 2001 regarding the trade name.

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). 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 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. Reich

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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NUMBER (IF KNOWN): 510 (k)

DEVICE NAME: AViTA Agil IT101 Instant Digital Thermometer AVITA International Corp.

INDICATIONS FOR USE:

A ViTA Agil IT101 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature , orally, rectally and under the arm, by consumers in the home.

The device is to used and installed by people exception of handicapped persons and children.

The device is to used in the ENVIRONMENT of room temperature & normal environment condition.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter(Optional Format)	V
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(Division Sign-Off)
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K012136

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.