(35 days)
The VivaTherm™ Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.
The VivaTherm™ Temperature Measurement System consists of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-ProbeTM).
The provided document, K031556 for the VivaTherm™ Temperature Measurement System, mentions "Bench testing of the VivaTherm™ Temperature Measurement System confirmed similar performance as compared to a predicate device." However, it does not provide specific acceptance criteria, reported device performance metrics in a table, or detailed information about a study to prove these criteria were met.
Therefore, many of the requested sections cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in the document. The document only mentions "confirmed similar performance as compared to a predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable, as no expert-based ground truth establishment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no expert-based adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is a direct temperature measurement system, not an AI-assisted diagnostic tool for human readers.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The document states "Bench testing... confirmed similar performance as compared to a predicate device." This implies a standalone (device only) test, but no specific metrics or study details are provided beyond this general statement. No "algorithm only" study is discussed as this is a hardware device for direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For a temperature measurement device, the "ground truth" would likely be a highly accurate reference thermometer or controlled temperature environment. The document only refers to comparison with a predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a temperature measurement device, not an AI/ML model that requires a training set in that context.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
Summary of Available Information:
- Acceptance Criteria: Not explicitly stated. Implied to be "similar performance" to a predicate device.
- Study Description: "Bench testing...confirmed similar performance as compared to a predicate device." No details provided.
- Device Type: VivaTherm™ Temperature Measurement System, consisting of a multi-channel electronic temperature monitor (T-Box™) and single-use thermocouple-based temperature probes (T-Probe™).
- Intended Use: 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).
The provided text focuses on the substantial equivalence argument based on general performance similarity and device characteristics (indications for use, basic function, materials, manufacturing), rather than detailed performance study results against specific acceptance criteria.
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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 WayMountain View, CA 94043650-694-2900 |
| Contact | Steven KimVice 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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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 MeasurementSystem |
| Indications for Use: | The VivaTherm™ TemperatureMeasurement System is intended tomonitor tissue temperatures duringclinical procedures requiring temperaturefeedback. |
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
§ 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.