DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306

K023500 · Innovatech, Inc. · FLL · Dec 13, 2002 · General Hospital

Device Facts

• Record ID: K023500
• Device Name: DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
• Applicant: Innovatech, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Battery-operated digital clinical thermometer; uses thermistor sensor to detect temperature; ASIC-controlled circuit processes signal; displays temperature on LCD; includes buzzer for audible alerts; detects low battery condition automatically. Used for oral, axillary, or rectal temperature measurement. Operated by clinicians or patients in home or clinical settings. Provides digital temperature readout to assist in clinical decision-making regarding patient health status.

Clinical Evidence

Bench testing only. Compliance verified against ASTM E1112-98, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 standards.

Technological Characteristics

Battery-operated (1.5V DC) electronic thermometer. Components: thermistor sensor, reference resistor, buzzer, ASIC-controlled circuit, LCD. Hard-wired control logic (non-programmable). Standards: ASTM E1112-98, EN 60601-1, EN 60601-1-1, EN 60601-1-2.

Indications for Use

Indicated for measuring human body temperature via oral, axillary, or rectal routes in patients of all ages.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• ACT 2020 and ACT 2020+ (K010238)

Submission Summary (Full Text)

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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: _______________________________________________________________________________________________________________________________________________

1. 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.

- 2. Name of the Device: Innovatech Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306.
- 3. Information of the 510(k) Cleared Device (Predicate Device): ACT 2020 and ACT 2020+ (K010238).
- 4. 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.

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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).

- 7. 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.

- 8. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 :

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.

Valtrex Cucerite

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

510(k) Number:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)