VIVATHERM THEMPERATURE MEASUREMENT SYSTEM

K031556 · Vivant Medical, Inc. · FLL · Jun 23, 2003 · General Hospital

Device Facts

• Record ID: K031556
• Device Name: VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
• Applicant: Vivant Medical, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jun 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.

Device Story

VivaTherm™ Temperature Measurement System monitors tissue temperatures during clinical procedures. System comprises multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-Probe™). Device provides real-time temperature feedback to clinicians during procedures. Used in clinical settings to assist in monitoring thermal conditions; output allows clinicians to track tissue temperature, facilitating informed clinical decision-making during thermal-based interventions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-Probe™). Materials are biocompatible and previously cleared in other devices.

Indications for Use

Indicated for monitoring tissue temperatures during clinical procedures requiring temperature feedback in patients undergoing such procedures.

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

• Luxtron Multichannel 2000 Fluoroptic Thermometer (K841105)
• Endocare Electronic Thermometer System (K961365)
• URI Therm-X Model TX-100 Multichannel Thermocouple Thermometry System (K843381)

Submission Summary (Full Text)

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# JUN 2 3 2003 510(k) Summary

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# General Information

| Classification | Class II |
|----------------|-----------------------------------------------------------------------------------------------|
| Trade Name | VivaTherm™ Temperature Measurement System |
| Submitter | Vivant Medical, Inc.<br>1916-A Old Middlefield Way<br>Mountain View, CA 94043<br>650-694-2900 |
| Contact | Steven Kim<br>Vice President, Research & Development |

## Intended Use

The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.

#### Predicate Devices

| Luxtron Multichannel 2000 Fluoroptic Thermometer | K841105 |
|-----------------------------------------------------------------------|---------|
| Endocare Electronic Thermometer System | K961365 |
| URI Therm-X Model TX-100 Multichannel Thermocouple Thermometry System | K843381 |

## Device Description

The VivaTherm™ Temperature Measurement System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM).

#### Materials

All materials used in the manufacture of the VivaTherm™ Temperature Measurement System are suitable for this use and have been used in numerous previously cleared products.

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# Testing

Bench testing of the VivaTherm™ Temperature Measurement System confirmed similar performance as compared to a predicate device.

# Summary of Substantial Equivalence

. . . . .

The VivaTherm™ Temperature Measurement System is equivalent to the predicate The indications for use, basic overall function, methods of devices. manufacturing, and materials used are substantially equivalent to existing legally marketed devices.

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Public Health Service

JUN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Kim Vice President, Research & Development Vivant Medical, Incorporated 1916-A Old Middlefield Way Mountain View, California 94043

Re: K031556

Trade/Device Name: VivaTherm™ Temperature Measurement System Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL, BWX Dated: May 16, 2003 Received: May 21, 203

Dear Mr. Kim:

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. Kim

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]. 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 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.

Susan Runge

Susan Runner, DDS, MA Interim 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): | This application |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VivaTherm™ Temperature Measurement<br>System |
| Indications for Use: | The VivaTherm™ Temperature<br>Measurement System is intended to<br>monitor tissue temperatures during<br>clinical procedures requiring temperature<br>feedback. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR (Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format(Division Sign-Off)

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

510(k) Number: K031556