(62 days)
No
The summary describes a radiofrequency ablation system with a cooling mechanism. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML. The performance studies focus on electrical, mechanical, and biocompatibility testing, not algorithmic performance.
Yes
The device is indicated for "general surgical procedures for electrocoagulation and hemostasis," which are therapeutic interventions.
No
The device is indicated for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones. It uses RF energy to heat tissue and cool the surface, consistent with a therapeutic, not diagnostic, function.
No
The device description explicitly mentions using radiofrequency (RF) energy and cryogen delivery through a treatment tip, indicating the presence of hardware components beyond just software. The performance studies also include electrical and mechanical testing, further confirming it is not a software-only device.
Based on the provided information, the TivaMed Cooled RF System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details how the device uses RF energy to heat tissue and cryogen to cool the surface. This is a description of a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
Therefore, the TivaMed Cooled RF System is a surgical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To verify the device design met its functional and performance requirements, representative samples of the device underwent biocompatibility, electrical, and mechanical testing in accordance with IEC 60601-1, Medical Electrical Equipment - General Requirements for Safety; IEC 60601-1-2, IEC 60601-1-4, Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems; 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; FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure".
Key Metrics
Not Found
Predicate Device(s)
Thermage ThermaCool™ System, K000944; Thermage ThermaCool™ System K013639
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 0 4 2008
KO82962
Page 1 of 2
| Section 5 – 510(k) Summary | |
|---|---|
| Submitter: | TivaMed, Inc. |
| 450 Sheridan Ave. | |
| Palo, Alto, CA 94306 | |
| Office: 650-321-3332 | |
| Fax: 650-326-0114 | |
| Contact Person: | Shelley Trimm |
| RA & QS Consultant, Alquest, Inc. | |
| 4410 El Camino Real, Ste 204 | |
| Los Altos, Ca 94022 | |
| Ph: 707.508.5527 | |
| FAX: 650.559.1985 | |
| Email: strimm@alquest.com | |
| Date Prepared: | October 2, 2008 |
| Trade Name: | TivaMed Cooled RF System |
| (Electrosurgical Unit and Accessories – Common Name) | |
| Classification: | Class II |
| 21 CFR 878.4400: Device, Electrosurgical, Cutting and | |
| Coagulation and Accessories | |
| Product Code: | GEI |
| Predicate Device(s): | The subject device is equivalent to the following devices: |
| Thermage ThermaCool™ System, K000944 (cleared | |
| 7/19/2000); and | |
| Thermage ThermaCool™ System K013639 (cleared | |
| 1/29/2002). | |
| Device Description: | 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. | |
| Intended Use: | The TivaMed Cooled RF System is indicated for use in |
| general surgical procedures for electrocoagulation and | |
| hemostasis |
TivaMed, Inc.
CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System
TivaMed, Inc.
1
Page 2 of 2
| Functional and
Safety Testing: | To verify the device design met its functional and
performance requirements, representative samples of the
device underwent biocompatibility, electrical, and
mechanical testing in accordance with IEC 60601-1,
Medical Electrical Equipment - General Requirements for
Safety; IEC 60601-1-2, IEC 60601-1-4, Medical Electrical
Equipment - General Requirements for Safety -
Programmable Electrical Medical Systems; 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; FDA "ETO, ECH, and EG Proposed
Maximum Residue Limits and Maximum Limits of
Exposure". |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | TivaMed, Inc., considers the TivaMed Cooled RF System
to be equivalent to the predicate device listed above. This
conclusion is based upon the devices' similarities in
principles of operation, technology, materials, and
indications for use. |
TivaMed, Inc.
CONFIDENTIAL PreMarket Notification for the TivaMed RF Cooled System
TivaMed, Inc.
-で
2
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.
3
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
4
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