DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9

K041516 · Vega Technologies, Inc. · FLL · Sep 8, 2004 · General Hospital

Device Facts

• Record ID: K041516
• Device Name: DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
• Applicant: Vega Technologies, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital Thermometer, models MT-XX8 and MT-XX9 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

Digital thermometer (models MT-XX8, MT-XX9) measures human body temperature; uses thermistor sensor; signal processed by hard-wired ASIC (Application Specific Integrated Circuit) rather than programmable control; displays temperature on LCD; includes buzzer for audible alerts; powered by 1.5V DC battery; features automatic low-battery detection. Used in clinical or home settings for oral, axillary, or rectal temperature monitoring. Provides digital readout to assist healthcare providers or patients in assessing body temperature.

Clinical Evidence

Bench testing only. Device performance verified against ASTM E1112-98 standard and EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements.

Technological Characteristics

Thermistor-based temperature sensor; hard-wired ASIC for signal calculation; LCD display; buzzer; 1.5V DC battery power; low-battery detection circuit. Complies with ASTM E1112-98, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.

Indications for Use

Indicated for the measurement of 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

• Mesure model ST8631 (K021048)

Submission Summary (Full Text)

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VEGA TECHNOLOGIES, INC.

# 510(K) SUMMARY

# SEP = 8 2004

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

The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

1. Submitter's Identifications: Establishment: EStablishment:
DONGGUAN DALANG VIGOR ELECTRONICS MFY. Yang Wu District, Da Lang Town, Dong Guan City Guang Dong Prov., CHINA Registration Number: 9616843 Operations: Manufacturer Status: Active

- Date Of Registration Status: 2004
Owner/Operator: VEGA TECHNOLOGIES, INC. 11F-13, 100 Chang-Chun Rd., Taipei CHINA (Taiwan) 104. Owner/Operator Number: 9036509

Contact: Mr. Joseph Lu VEGA TECHNOLOGIES, INC. VEGA TEOHNOEOOLES, II. Taipei, CHINA (TAIWAN) 104 Phone: [phone] Fax: [phone]

- 2. Name of the Device: Name on the Device: MT-XX8 and MT-XX8 and MT-XX9.
- 3. Information of the 510(k) Cleared Device (Predicate Device): ST8631 (K021048).

### 4. Device Description:

:

·

The Digital Thermometers, models MT-XX8 and MT-XX9, are the electronic themometers by i he Digital Themistor as the temperature sensor. The signal of sensor is calculated and displayed using a thermistor as the temperature sonton: The organs of on is considered the hard-wire by an ASIC (Application Openile 10)
control instead of programmable control. Basically MT-XX8 and MT-XX9 have the same control firstead on programmable control and on the different measuring range caused by some small different design in IC circuit.

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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 MT-XX8 and MT-XX9, it was designed and verified according to the US standard ASTM E1112-98.

#### 5. Intended Use:

The Digital Thermometer, models MT-XX8 and MT-XX9 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 Thermometer, models MT-XX8 and MT-XX9 are substantially equivalent to the Mesure model ST861 (K021048).

- 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 VEGE Digital thermometer, including MT-XX8 and MT-XX9, have the same intended use and technological characteristics as the cleared device of Mesure model ST8631 (K021048). Moreover, verification and validation 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

Mr. Joseph Lu General Manager Vega Technologies, Incorporated 11F-13, 100, Chang-Chun Road, Taipei CHINA (TAIWAN) 104

Re: K041516

Trade/Device Name: Digital Thermometer/ Models MT-XX8 and MT-XX9 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 21, 2004 Received: August 27, 2004

Dear Mr. Lu:

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 approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Nr.), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device a may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lu

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements nical that I DA nas made statutes and regulations administered by other Federal agencies. or the rice of arry - with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice alled instills (21 CF refr in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as better 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) This lottor wification. The FDA finding of substantial equivalence of your device to a premaired 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), If you desire specific at a work of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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,

Chiu Lin, Ph.D.

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): | K041516 |
| Device Name: | Digital Thermometer / Models MT-XX8 and MT-XX9. |
| Indications For Use: | The Digital Thermometer, models MT-XX8 and MT-XX9 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. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | OR |
| | Over-The-Counter Use √<br>(21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number: | K041516 |
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