(35 days)
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No
The summary describes a system for monitoring tissue temperature using standard electronic and thermocouple technology. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The device's intended use is to monitor tissue temperatures, not to treat a disease or condition.
No
The device is described as a system intended to "monitor tissue temperatures during clinical procedures requiring temperature feedback," indicating a monitoring function rather than a diagnostic one. It provides temperature measurements, which are physiological parameters, but does not state that it is used to identify diseases or conditions.
No
The device description explicitly states it consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM), which are hardware components.
Based on the provided information, the VivaTherm™ Temperature Measurement System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor tissue temperatures during clinical procedures requiring temperature feedback." This describes a device used in vivo (within the body) to measure a physiological parameter (temperature).
- Device Description: The system consists of an electronic monitor and temperature probes. This aligns with devices used for direct measurement within the body or on the surface.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. The VivaTherm™ system does not involve the analysis of specimens outside the body.
Therefore, the VivaTherm™ Temperature Measurement System is a medical device used for in vivo temperature monitoring, not an IVD.
No.
The provided clearance letter does not contain any mention of a Predetermined Change Control Plan (PCCP) or language indicating that the device is authorized under such a plan. PCCPs are specifically called out in clearance documents when applicable.
Intended Use / Indications for Use
The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.
Product codes
FLL, BWX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing of the VivaTherm™ Temperature Measurement System confirmed similar performance as compared to a predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.
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JUN 2 3 2003 510(k) Summary
Image /page/0/Picture/1 description: The image shows the text "K031556 Page 1 of 2". The text appears to be handwritten. The first line is a code or identifier, and the second line indicates that this is page 1 of a 2-page document.
General Information
| Classification | Class II |
|---|---|
| Trade Name | VivaTherm™ Temperature Measurement System |
| Submitter | Vivant Medical, Inc. |
| 1916-A Old Middlefield Way | |
| Mountain View, CA 94043 | |
| 650-694-2900 | |
| Contact | Steven Kim |
| 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.
1
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three lines forming the body and head, and two curved lines representing the arms or hands.
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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 |
| System | |
| Indications for Use: | The VivaTherm™ Temperature |
| Measurement System is intended to | |
| monitor tissue temperatures during | |
| clinical procedures requiring temperature | |
| 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