HIVOX EAR THERMOMETER, TS SERIES

K020471 · Hivox Biotek, Inc. · FLL · May 2, 2002 · General Hospital

Device Facts

• Record ID: K020471
• Device Name: HIVOX EAR THERMOMETER, TS SERIES
• Applicant: Hivox Biotek, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The AVITA TS0/TS1 Infrared Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature, through the opening of auditory canal, by consumers in the home.

Device Story

Hand-held, reusable infrared ear thermometer; measures tympanic temperature via radiation emitted from ear canal. Device uses infrared thermopile sensor to detect thermal radiation; converts input to digital temperature reading. Intended for home use by consumers. Provides non-invasive temperature monitoring; assists in tracking body temperature for health management.

Clinical Evidence

Bench testing only. Device conforms to ASTM E1965-98, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Infrared ear thermometer; utilizes infrared thermopile sensor. Hand-held form factor. Complies with ASTM E1965-98, IEC 60601-1, and IEC 60601-1-2. Reusable, non-sterile.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature via the tympanic membrane for individuals of all ages in a home setting.

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

• Braun ThermoScan IRT 3020 One Seconds Ear Thermometer (K983295)
• K-Jump Health Co., Ltd.'s Infrared Ear Thermometer, Model KI-8120 (K984551)

Submission Summary (Full Text)

{0}------------------------------------------------

## MAY 022002

KO20471

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the .equirements 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 TS0/TS1 Infrared Ear Thermometer |
| | | Models TS-001,TS-002,TS-003 and TS-101,TS-102,TS-103 |
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | 1. Braun ThermoScan IRT 3020 One Seconds Ear Thermometer (K983295) |
| | | 2. K-Jump Health Co., Ltd.'s Infrared Ear Thermometer, |
| | | Model KI-8120 (K984551) |
| 5.0 | Device Description: | AVITA TS0/TS1 Infrared Ear Thermometer is a hand-held, non-sterile, |
| | | reusable clinical thermometer intended for the determination of human |
| | | temperature by radiation emitted via the human ear (Tympanic Temperature). |
| 6.0 | Intended Use: | The AVITA TS0/TS1 Infrared Ear Thermometer is intended for the |
| | | intermittent measurement and monitoring of human body temperature, through |
| | | the opening of auditory canal, by consumers in the home. |
| 7.0 | Performance<br>Summary: | In terms of operating specification, Safety & EMC requirements, the device<br>conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and<br>IEC 60601-1-2 requirements. |

#### 8. Conclusions:

The AVITA TS0/TS1 Infrared Ear Thermometer have the same intended use and similar technological characteristics as the Braun ThermoScan IRT 3020 One Seconds Ear Thermometer (K983295) and

* Jump Health Co., Ltd.'s Infrared Ear Thermometer, Model KI-8120 (K984551). Moreover, bench ( > . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVTA TS0/TS1 Infrared Ear Thermometer, Models TS-001,TS-002,TS-003 and 1S-101,TS-102,TS-102,TS-103 is substantially equivalent to the predicate devices.

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 0 2 2002

Mr. Ke-Min Jen Official Correspondent Hivox Biotek, Incorporated 12 F, No. 156, Chien Kuo North Road Taipei. CHINA ( TAIWAN )

Re: K020471

Trade/Device Name: HIVOX Cover-Free Ear Thermometer TS-510 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer ( IR Ear ) Regulatory Class: II Product Code: FLL Dated: February 6, 2002 Received: February 12, 2002

Dear Mr. Jen:

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.

{2}------------------------------------------------

#### Page 2 - Mr. Ke-Min Jen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

{3}------------------------------------------------

1411. Duruse 10 : I bar

### HIVOX BIOTEK II

12F, No. 156, Scc. 1 Chien Kuo N. Rd., Taipei 104, Taiwan, ROC FAX: [phone] TEL: [phone] E-MAIL: [e-mail]

---

Page

### 510 (K) NUMBER ( IF KNOW ): _ K020471

DEVICE NAME: _________________________________________________________________________________________________________________________________________________________________ INDICATIONS FOR USE:

The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 1

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use

OR

Over-The-Counter-Use √

( Per 21 CFR 801.109 )

( **Optional Format 1-2-96** )

Laluna Cassevitz

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4021 . Con Number _________________________________________________________________________________________________________________________________________________________________

J-