The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

Device Description

The Digital Clinical Thermometers, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) -- controlled circuit, which is considered the hard-wire control instead of programmable control. Basically WL-3305 and WL-3306 have the same intended use and operation function except for the different measuring range caused by some small different design in IC circuit.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, it was designed and verified according to the US standard ASTM E1112-98.

AI/ML Overview

Acceptance Criteria and Study Details for Innovatech Digital Clinical Thermometer

The Innovatech Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, was designed and verified according to the US standard ASTM E1112-98. The submission also states compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements. The primary basis of clearance is substantial equivalence to the predicate device, Actherm model ACT 2020 and ACT 2020+.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM E1112-98 Compliance	Designed and verified according to ASTM E1112-98.
EN 60601-1 Compliance	Compliance stated.
EN 60601-1-1 Compliance	Compliance stated.
EN 60601-1-2 Compliance	Compliance stated.
Substantial Equivalence to Predicate Device (Actherm ACT 2020/ACT 2020+)	Verification tests demonstrate the submitted models maintain the same safety and effectiveness as the cleared predicate device.

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

The document does not specify a sample size for a specific test set. The evaluation is primarily based on compliance with existing standards (ASTM E1112-98, EN 60601 series) and substantiating substantial equivalence to a predicate device.

The data provenance is not explicitly stated as retrospective or prospective clinical data. The document refers to "verification tests" and compliance with standards. Given the nature of a 510(k) for a clinical thermometer, these tests would typically involve laboratory validation, potentially including in-vitro or in-vivo performance testing against a reference standard in a controlled environment. No information on the country of origin of testing data is provided beyond the manufacturer's location in Taiwan.

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

This information is not provided in the document. The evaluation is based on compliance with established performance standards for clinical thermometers, which prescribe methods for determining accuracy and other performance characteristics. It does not appear to involve expert consensus for ground truth as would be common in diagnostic imaging or clinical decision support AI devices.

4. Adjudication Method for the Test Set

An adjudication method is not applicable and therefore not described in this document. The assessment relies on objective measurements against established technical standards for thermometer performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed as this is a standalone device (clinical thermometer) and not an AI-assisted diagnostic tool requiring human interpretation comparison.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone performance evaluation was done in the sense that the device's accuracy was verified against the requirements of ASTM E1112-98. This standard dictates the methods for determining the accuracy of electronic thermometers, and the device's performance was measured independently of human interpretation of the readings. The "verification tests" demonstrating "the same safety and effectiveness" as the predicate device are indicative of standalone performance assessment.

7. Type of Ground Truth Used

The ground truth for performance evaluation would be established by reference temperature standards as defined by ASTM E1112-98, which specifies the requirements for electronic thermometers for intermittent determination of patient temperature. This standard outlines procedures for testing accuracy against known, highly precise temperature sources.

8. Sample Size for the Training Set

This question is not applicable as the device is a hardware-based electronic clinical thermometer controlled by an ASIC (Application Specific IC) and does not involve AI or machine learning algorithms that require a training set. The "ASIC-controlled circuit" is described as "hard-wire control instead of programmable control."

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

This question is not applicable as the device does not employ machine learning or AI and therefore does not have a "training set."

Summary

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510(K) SUMMARY

DEC 1 3 2002

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Submitter's Identifications: Innovatech, Inc. 1F, No. 17, Lane 128, Sec. 1, Chung Shan Rd., Yungho City, Taipei County, Taiwan, R.O.C.

Contact: Ms. Tina Chang Product Manager

Date of Summary Preparation: October 15, 2002.

1. Name of the Device: Innovatech Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306.
1. Information of the 510(k) Cleared Device (Predicate Device): ACT 2020 and ACT 2020+ (K010238).
1. Device Description:

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5. Intended Use:

The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be used in the measurement of oral, axially and rectal temperature.

6. Comparison to the 510(k) Cleared Device (Predicate Device):

The Digital Clinical Thermometer, model BABY TEMP / WL-3305 is substantially equivalent to the Actherm model ACT 2020 (K010238), and the Well-life Digital Clinical Thermometer, model BABY TEMP(+) / WL-3306 is substantially equivalent to the Actherm model ACT 2020+ (K010238).

1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
  Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
1. Conclusions
  The Baby Temp series, including BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, have the same intended use and technological characteristics as the cleared device of Actherm model ACT 2020 and ACT 2020+. Moreover, verification tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovatech, Incorporated Mr. Tony C. S. Chang C/O Wincent Consultant Company Limited No. 5, Alley 5, Lane Cheng Hsing, Chung Ching Road, Pei Tun Dist., Taichung, TAIWAN R.O.C.

Re: K023500

Trade/Device Name: Digital Clinical Thermometer/Model: BABY TEMP/WL-3305 and BABY TEMP (+)/ WL-3306 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 15, 2002 Received: October 18, 2002

Dear Mr. Chang:

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. Chang

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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

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

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Indications for Use Statemen

Page 1 of 1

510(k) Number (if known):

Device Name:_ Digital Clinical Thermometer / Model: BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306.

Indications For Use :

Valtrex Cucerite

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

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

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.