The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population.

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).

Device Description

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text.

The provided document is a 510(k) summary for a Digital Clinical Thermometer Model V901US. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a novel device's efficacy through extensive clinical trials. Therefore, the "study" described herein is primarily a series of verification and validation (V&V) activities focused on changes from the predicate device, rather than a clinical study in the traditional sense involving human subjects for performance evaluation.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Acceptance Criteria	Reported Device Performance (Results of Verification)
Battery change from CR1225(3V) to LR41(1.5V)	The Unit should go into the factory mode and operating mode and function as expected.	PASS. Traceable to V901US Design Verification Tests 1 thru 28.
Backlight change from three color to no backlight	Verify by observation that unit does not have backlight.	PASS. Traceable to V901US Design Verification Test 11.
Indication icon for < 32°C changed from "L" to "Lo"	Verify by observation that the "Lo" indicator comes up for temperature below 32.0°C or 90°F.	PASS. Traceable to V901US Design Verification Test 12.
Indication icon for > 42.9°C changed from "H" to "Hi"	Verify by observation that the "Hi" indicator comes up for temperature above 42.9°C or 109.9°F.	PASS. Traceable to V901US Design Verification Test 12.
Measurement time changed from 8 seconds to 10 seconds	The average measurement time shall be less than 10 seconds.	PASS. Traceable to V901US Design Verification Test 1.
Number of beeps after measurement changed from 5 to 10	Verify by observation that the number of beeps after a measurement is complete is 10.	Pass. Traceable to V901US Design Verification Tests 2 and 26.
Fever alert point changed from 38.3°C/100.9°F to 37.8°C/100.0°F	Verify by observation that the number of beeps for fever is activated.	PASS. Traceable to V901US Design Verification Test 26.
Power down time changed from 90s to 10min	Verify that Auto power turns the unit off in 10 ± 1 minutes when no action is taken.	Pass. Traceable to V901US Design Verification Test 3.
Addition of password-triggered Factory mode (replaces un-triggered mode)	1. Verify that the unit goes into the factory mode. 2. The product should have the following accuracy in water-bath mode: • ±0.2 °F 98.0°F-102.0°F • ±0.3°F 96.4°F-97.9°F, 102.1°F-106.0°F• ±0.5 °F <96.4°F or >106°F	PASS. Traceable to V901US Design Verification Tests 1 thru 28.

Study Details (Verification & Validation Activities)

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

Sample Size: The document does not explicitly state the sample size (number of devices) used for each specific test. However, the tests are described as "VerificationActivity," implying laboratory testing of device units. For the accuracy testing (part of the Factory Mode validation), it refers to "the product," which could imply a representative sample.
Data Provenance: The tests were conducted by Amperor Electronics (SZ) Co., Ltd. in Shenzhen, Guangdong, P.R. China, where the device is manufactured. The tests are in-vitro simulations (water-bath), not human clinical data. The studies are prospective as they are conducted as part of the design verification for the new device model.

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 ground truth for these engineering verification tests is established by calibrated laboratory equipment (e.g., precise temperature references, timers, power measurement devices), not by clinical experts.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective engineering measurements and observations (e.g., checking if a beep sounds, if an icon displays correctly, or if a temperature is within a specified range). There is no "adjudication" in the sense of reconciling differing expert opinions.

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

No, this was not done. This device is a simple clinical thermometer, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI performance in image-based diagnostics with human interpretation, which is not relevant here.

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

Not explicitly applicable in the AI sense. The "algorithm" here is the device's
firmware for temperature measurement, display, and alerts. All cited tests (e.g., accuracy in water-bath, timing, display of icons, beeping) are effectively "standalone" tests of the device's automated functions without human interpretation of a complex output. The "human-in-the-loop" would be the user reading the temperature, but the tests verify the accuracy of the reading produced by the device itself.

7. The Type of Ground Truth Used

The ground truth for these verification tests is physical measurement against calibrated standards. For example, for temperature accuracy, the ground truth is the precisely controlled temperature of a water-bath (simulated environment). For timing, it's a calibrated timer. For display, it's direct observation of the device's screen.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning product that requires a "training set." The firmware of the thermometer is developed using traditional software engineering methods, not by training on data.

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

Not applicable. As there is no training set, there is no ground truth needed for it. The functionality of the device is based on physical principles of temperature measurement and programmed logic, not learned patterns from data.

Summary of the "Study" Context:

This document describes a regulatory submission for a minor modification of an existing medical device (clinical thermometer). The "study" here refers to the design verification and validation activities performed to ensure that the changes introduced (e.g., battery type, display icons, measurement time, power-down time) do not negatively impact the device's safety or effectiveness and that the new functionalities meet their specified requirements. It is an engineering validation process, not a clinical trial or AI model validation. The "acceptance criteria" are the predefined performance thresholds for these engineering tests.

Summary

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Digital Clinical Thermometer Model V901US

KII2116

510(K) SUMMARY

OCT 4 2011

AS REQUIRED BY SECTION 21 CFR 807.92(c)

Amperor Electronics (SZ) Co., Ltd. Digital Clinical Thermometer Model V901US

1. SUBMITTED BY, CONTACT PERSON AND DATE OF THIS SUMMARY:

A. Company Name: Amperor Electronics (SZ) Co., Ltd.

Address: 8, Sarpotau Building, Ku-Su Village, Shi-Shian Town, Baoan County,

Shenzhen, Guang dong P.R. China

B. Contact Person

Amperor Electronics : Steel Chen, Director, Safety and Regulatory Kaz USA, Inc: Raj Kasbekar, Global Vice-President, Regulatory Affairs

C. Date of Preparation of this Summary: September 12, 2011

2. DEVICE NAME:

Table 1: Device Names

	Device
Proprietary Name	V901US
Common/Usual Name	Digital Clinical Thermometer
Classification Name	Clinical electronic thermometer

3. DEVICE CLASSIFICATION:

Digital Clinical Thermometer V901US (21CFR 880.2910, Product Code FLL) has been classified under section 510 of the Act as Class II (Clinical Electronic Thermometer).

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4. INTENDED USE / INDICATIONS FOR USE:

5. SUBSTANIAL EQUIVALENCE:

The digital thermometer model V901US is substantially equivalent to the predicate device V9XX (K082266) made by Amperor electronics (SZ) Co., Ltd., for the following reasons:

1. It has the same intended use/indication for use as the predicate.
1. It has the same operating principle and technological characteristics as the predicate.
1. The digital thermometer model V901US has some minor changes from the predicate device that include speed of temperature determination and display, change in battery type, display graphics, audible beep intensity and power down time. These changes have been verified and validated ( as part of performance testing) and are included as part of this submission. A summary of these verification and validation activities is attached. These changes raise no new issues of safety and effectiveness.

The changes (minor) to the new device include:

1. The speed of temperature determination and display has increased.
1. Change in battery type from CR1225(3V) to LR41(1.5V).
1. The power down time has been changed from 90s to 10min.
1. The intensity of the three color backlight is reduced.
1. The indication icon for less than 32C has been changed from "L" to"Lo".
1. The indication icon for more than 42.9C has been changed from "H" to"Hi".

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1. "Valid complete" beeps have been changed from 5 Beeps to 10 Beeps.
1. Fever alert point has been changed from 38.3C to 37.8C.
1. Changed the appearance of housing.

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Digital Clinical Thermometer Model V901US

Design Control Activities Summary
Device Modification	Change in Risk	VerificationActivity	AcceptanceCriteria	Results ofVerification

Device Related Changes
Changes to device hardware, software or sensors.
		Changes to device hardware.
Battery change fromtype:CR1225(unrechargeable)3Vtotype:LR41(unrechargeable)1.5V	No change in riskprofile	The verificationactivity for thechange in batteryincludesconfirmation thatthe unit can gointo the operatingmode and factorymode and carryout its normalfunctions. Startthe unit and holdthe start buttonfor 3 seconds. Theunit should enterthe factory mode.Take a fewreadings in thismode. Shut theunit off and startit again. This willput the unit in theoperating mode.Take a fewreadings in thismode.	The Unit shouldgo into thefactory mode andoperating modeand function asexpected.	PASS. Traceable toV901US DesignVerification Tests1 thru 28.
Backlight change from threecolor: green,orange and red todo not have backlight.	No change in riskprofile	Start the unit.Ensure that theunit does not havebacklight innormal andelevatedtemperature	Verify byobservation thatunit does nothave backlight.	PASS. Traceable toV901US DesignVerification Test11.
The indication icon for less than32°C has beenchanged from "L" to"Lo"	No change in riskprofile	For the normaloperating mode,the software shallsignal the userwith no language-specific wordsother than Err, HIand Lo. Thesemessages arewidelyunderstood andhave precedentfor successfulacceptance inotherinternationallydistributedproducts.	Verify byobservation thatthe "Lo" indicatorcomes up fortemperaturebelow 32.0°C or90°F	PASS. Traceable toV901US DesignVerification Test12.
The indication icon for morethan 42.9°C has been changedfrom "H" to"Hi"	No change in riskprofile	For the normaloperating mode,the software shallsignal the userwith no language-specific wordsother than Err, HIand Lo.Thesemessages arewidelyunderstood andhave precedentfor successfulacceptance inotherinternationallydistributedproducts.	Verify byobservation thatthe "Hi" indicatorcomes up fortemperatureabove 42.9°C or109.9°F	PASS. Traceable toV901US DesignVerification Test12.
Changes to device software.
Measurement time change from8 seconds to 10 seconds.	No change in riskprofile	Start the unit.Take a readingusing a simulatedwaterbath. Recordthe time requiredto take a reading.The average timeshall be less than10 seconds.	The averagemeasurementtime shall be lessthan 10 seconds.	PASS. Traceable toV901US DesignVerification Test 1.
The amount of beeps after ameasurement is complete haschanged from 5 beeps to 10beeps.	No change in riskprofile	Start the unit.Take a readingusing a simulatedwater-bath. Verifythat the numberof beeps toindicate end of ameasurement is10.	Verify byobservation thatthe number ofbeeps after ameasurement iscomplete is 10.	Pass. Traceable toV901US DesignVerification Tests2 and 26.
The Fever alert point has beenchanged from 38.3°C/100.9 to37.8°C/100.0.	No change in riskprofile	Start the unit. Setthe water bathtemperature toabove 100 deg F.Take a reading inthe water-bath.Verify that thefever alert beepssound.	Verify byobservation thatthe number ofbeeps for fever isactivated.	PASS. Traceable toV901US DesignVerification Test26.
The power down time has beenchanged from 90s to 10min.	No change in riskprofile	Start the unit.Keep it in the onstate for over 10minutes.Software controlunit should turnsitself offautomatically ifthere is no actiontaken for 10minutes (± 1minute).	Verify that Autopower turns theunit off in 10 ± 1minutes when noaction is taken.	Pass. Traceable toV901US DesignVerification Test 3.
A separate Factory mode wasadded that can be triggeredonly by inputting a password.	In the olderversion, thefactory mode wastriggered withoutany user input.This was changedsuch that a userhas tointentionally putin a password toenable the factorymode. This wasdone to reducethe risk related toany inaccuratemeasurementsduring normalclinical use. This	1. After startingthe unit, press andhold the ONswitch (powerkey) for morethan 3 seconds.The signal "- - -"will appear. Thenkey in a right onedigit password, bypressing the sameON switch, whichwill put the unitinto the factorymode.2. Verify accuracyof the product in awater bath.	1. Verify that theunit goes into thefactory mode.2.The productshould have thefollowingaccuracy in water-bath mode:±0.2 °F 98.0°F-102.0°F±0.3°F 96.4°F-97.9°F,102.1°F-106.0°F±0.5 °F <96.4°For >106°F	PASS. Traceable toV901US DesignVerification Tests1 thru 28.
profile of thethermometer byeliminating anyinaccuratetemperaturemeasurements.

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Digital Clinical Thermometer Model V901US

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Digital Clinical Thermometer Model V901US

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Digital Clinical Thermometer Model V901US

Changes to device sensors.
NONE
Manufacturing Process Changes
NONE
Vendor Changes
NONE
Material Changes in Outer Casing of Device
There was no change to any patient contacting material. The probe cover is the only part that comes in contact with the patient or end user. Biocompatibility Testing for the probe cover was addressed in 510(K) K082266 of predicate device.
Labeling Changes

Changes done may have been to clarify or further elaborate existing language only. Legal entity and format only.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.

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

Amperor Electronics (SZ) Company, Limited % Mr. Raj Kasbekar Regulatory Affairs Kaz Incorporated 250 Turnpike Road Southborough, Massachusetts 01772

OCT - 4 2011

Re: K112116

Trade/Device Name: Digital Clinical Thermometer Model V901US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 13, 2011 Received: September 14, 2011

Dear Mr. Kasbekar:

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. Kasbekar

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 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.

Susan Quon

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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Digital Clinical Thermometer Model V901US

Intended Use/Indications for Use Statement

510(k) Number (if known): K | 1 2 \ 1 2 \ 1 2 \ (b

Digital Clinical Thermometer Model V901US Device Name:

Intended Use/Indications For Use:

The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. This thermometer is intended for the adult and pediatric population.

The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive or Instant mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature ), or standard mode (actual determination of temperature).

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _ _ _ _ _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Ch 9/30/4

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

510(k) Number: K112116

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Date: 2010-10-14 Revision: 1.1

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.