(62 days)
The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.
The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.
Here's a breakdown of what is and is not present in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.
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):
- Not applicable/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. No clinical test set requiring 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:
- Not applicable/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not present. This is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.
8. The sample size for the training set:
- Not applicable/Not present. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not present. See point 8.
Summary of available information regarding testing:
The device underwent:
- Functional and Safety Testing:
- Biocompatibility testing
- Electrical testing
- Mechanical testing
- Standards Adhered to:
- IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
- IEC 60601-1-2 (Likely electromagnetic compatibility)
- IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
- IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
- AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
- FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)
The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.
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DEC 0 4 2008
KO82962
Page 1 of 2
| Section 5 – 510(k) Summary | |
|---|---|
| Submitter: | TivaMed, Inc.450 Sheridan Ave.Palo, Alto, CA 94306Office: 650-321-3332Fax: 650-326-0114 |
| Contact Person: | Shelley TrimmRA & QS Consultant, Alquest, Inc.4410 El Camino Real, Ste 204Los Altos, Ca 94022Ph: 707.508.5527FAX: 650.559.1985Email: strimm@alquest.com |
| Date Prepared: | October 2, 2008 |
| Trade Name: | TivaMed Cooled RF System(Electrosurgical Unit and Accessories – Common Name) |
| Classification: | Class II21 CFR 878.4400: Device, Electrosurgical, Cutting andCoagulation and Accessories |
| Product Code: | GEI |
| Predicate Device(s): | The subject device is equivalent to the following devices:Thermage ThermaCool™ System, K000944 (cleared7/19/2000); andThermage ThermaCool™ System K013639 (cleared1/29/2002). |
| Device Description: | TivaMed Cooled RF System uses radiofrequency (RF)energy to selectively heat a given volume of tissuebeneath the surface, while cryogen is delivered to theinside of the treatment tip to cool and protect the surfacetissue. |
| Intended Use: | The TivaMed Cooled RF System is indicated for use ingeneral surgical procedures for electrocoagulation andhemostasis |
TivaMed, Inc.
CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System
TivaMed, Inc.
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Page 2 of 2
| Functional andSafety Testing: | To verify the device design met its functional andperformance requirements, representative samples of thedevice underwent biocompatibility, electrical, andmechanical testing in accordance with IEC 60601-1,Medical Electrical Equipment - General Requirements forSafety; IEC 60601-1-2, IEC 60601-1-4, Medical ElectricalEquipment - General Requirements for Safety -Programmable Electrical Medical Systems; IEC 60601-2-2 Medical Electrical Equipment - Particular Requirementsfor the Safety of High Frequency Surgical Equipment;AAMI/ANSI/ISO 11135-1:2007 Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements fordevelopment, validation and routine control of asterilization process for medical devices; ISO 10993-1,Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing; Federal Register, Volume 43, No.122, 1978; FDA "ETO, ECH, and EG ProposedMaximum Residue Limits and Maximum Limits ofExposure". |
|---|---|
| Conclusion: | TivaMed, Inc., considers the TivaMed Cooled RF Systemto be equivalent to the predicate device listed above. Thisconclusion is based upon the devices' similarities inprinciples of operation, technology, materials, andindications for use. |
TivaMed, Inc.
CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System
TivaMed, Inc.
-で
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC. 0 4 2008
TivaMed. Inc. % Ms. Shelley Trimm Alquest. Inc. 4410 El Camino Real. Suite 204 Los Altos, California 94022
Re: K082962
Trade/Device Name: TivaMed Cooled RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 2, 2008 Received: October 3, 2008
Dear Ms. Trimm:
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. Iisting 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.
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.
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Page 2 - Ms. Shelley Trimm
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
Device Name: TivaMed Cooled RF System
The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Prescription Use X (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nest R. Odell forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
TivaMed, Inc.
CONFIDENTIAL
PreMarket Notification for the TivaMed RF Cooled System
TivaMed, Inc.
CONFIDENTIAL
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.