AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES

K092958 · Avita Corporation · FLL · Dec 2, 2009 · General Hospital

Device Facts

• Record ID: K092958
• Device Name: AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
• Applicant: Avita Corporation
• Product Code: FLL · General Hospital
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AViTA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.

Device Story

Hand-held, battery-operated, non-sterile, reusable infrared thermometer; measures natural thermal infrared radiation emitted from ear tympanic (TS2x/TS3x series) or temporal artery over forehead (TS3x series only). Used by patients or caregivers in home environment for intermittent temperature monitoring. Device detects thermal radiation, converts to temperature reading, and displays result to user. Facilitates clinical decision-making regarding fever management and patient health status.

Clinical Evidence

Bench testing only. Device conforms to ASTM E1965-98(2003) for performance specifications and IEC 60601-1/IEC 60601-1-2 for safety and electromagnetic compatibility.

Technological Characteristics

Hand-held, battery-operated infrared thermometer. Sensing principle: detection of natural thermal infrared radiation. Standards: ASTM E1965-98(2003), IEC 60601-1, IEC 60601-1-2. Non-sterile, reusable.

Indications for Use

Indicated for intermittent measurement of human body temperature in people of all ages in home settings.

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

• AViTA TS8/TS9 series Scanéo IR Ear/Forehead Thermometer (K031503)

Submission Summary (Full Text)

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510(K) SUMMARY

DEC - 2 2009

1492958

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

# 1. Submitter's Name: AViTA Corporation

9F , No. 78 , SEC. 1 , Kwang-Fu Rd., San-Chung, Taipei Address: County., Taiwan , 241 Phone: [phone] Fax: [phone] i Contact: Mr. Nelson Lin / R&D Manager

#### 2. Device Name :

| Trade Name: | AVITA Scanéo IR Thermometer |
|---------------------|-----------------------------------|
| | Model no.: TS2x/TS3x series |
| Common Name: | IR Thermometer |
| Classification name | thermometer, electronic, clinical |

- The AViTA Scanéo IR Thermometer (Model no. 3. DEVICE CLASS TS2x/TS3x series) has been classified as Regulatory Class: II Panel: 80 Product Code: FLL Regulation Number: 21CFR 880.2910
#### 4. Predicate Device:

The predicate device is the AViTA TS8/TS9 series Scanéo IR Ear/Forehead Thermometer (K031503) marketed by AVITA CORPORATION.

#### 5. Intended Use: The AViTA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature by people of all ages in the home.

## 6. Device Description: The AViTA Scanéo TS2x/TS3x series IR Thermometer is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature.

#### The AVITA TS2x series IR Ear Thermometer measures

Product: AVITA Scanéo IR Thermometer (Model no. TS2x/TS3x series) Page 1 of 2 Section 4 - 510(k) Summarv RFV TRI

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human body temperature natural thermal emitted from the ear tympanic.

The AViTA TS3x series IR Ear / Forehead Thermometer can measure human body temperature in 2 ways:

(1) The temporal artery over forehead.

(2) Tympanic temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.

### 7. Performance Summary:

In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements. /

#### Conclusions: 8.

The AVITA Scanéo IR Thermometer (Model no. TS2x/TS3x series) has the same intended use and similar technological characteristics as the AVITA TS8/TS9 series Scanéo IR Ear/Forehead Thermometer (K031503) marketed by AVITA CORPORATION. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The AVTA Scanéo IR Thermometer (Model no. TS2x/TS3x series) is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, which is a common emblem associated with health and medical services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AVITA Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001

DEC - 2 2009

Re: K092958

Trade/Device Name: AViTA Sanéo IR Thermometer, Model no .: TS2x/TS3x Series A ViTA Corporation Regulation Number: 21CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 29, 2009 Received: November 2, 2009

Dear Ms. Reich:

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 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susa Runner

Susan Runner, D.D.S., M.A. Acting Division 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): K092958

Device Name: AViTA Sanéo IR Thermometer, Model no .: TS2x/TS3x series AViTA Corporation

Indications For Use:

The AVITA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages in the home.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

. V Over-The-Counter Use (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)

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510(k) Number: k092958

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