(31 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical probe and power generator, with no mention of intelligent algorithms or data processing.
Yes
The device is described as "coagulat[ing] a volume of tissue," which is a therapeutic action. Additionally, the predicate devices are ablation systems, indicating a therapeutic purpose.
No
The device is described as an ablation probe intended for the coagulation of soft tissue, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "needle-like device" and includes accessories, indicating it is a physical hardware device, not software only.
Based on the provided information, the VivaTip™ Microwave Ablation Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- VivaTip Function: The VivaTip™ Microwave Ablation Probe is a device that is inserted directly into soft tissue to coagulate it using microwave energy. It is a therapeutic device used for treatment, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device used for a therapeutic procedure (tissue ablation), not for analyzing a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The VivaTip Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Product codes
GEI
Device Description
The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
- 3 2003
510(k) Summary
General Information
K032702 (pg 1 of 1)
| Classification | Class II |
|---|---|
| Trade Name | VivaTipTM Microwave Ablation Probe and Accessories |
| Submitter | Vivant Medical, Inc. |
| 1916-A Old Middlefield Way | |
| Mountain View, CA 94043 | |
| (650) 694-2900 | |
| Contact | Steven Kim |
| Vice President of Research and Development |
Intended Use
The VivaTip Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Predicate Devices
| VivaWave™ Microwave Ablation System | K011676 |
|---|---|
| Tri-Loop™ Microwave Ablation Probe | K032047 |
Device Description
The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.
Materials
All patient contact materials used in the manufacture of the VivaTip™ Microwave Ablation Probe are suitable for this use and have been used in numerous previously cleared products.
Summary of Substantial Equivalence
The VivaTip™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Vivant Medical believes the VivaTip™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
OCT - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Kim Vice President of Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043
Re: K032702
Trade/Device Name: VivaTip™ Microwave Ablation Probe and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 29, 2003 Received: September 3, 2003
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.
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 - Mr. Stephen Kim
Enclosure
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) 594-4659. 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,
Mark A. Millman
elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
This application KO32702
VivaTip™ Microwave Ablation Probe and Accessories
The VivaTip™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use __
(Per 21 CFR 801.109) (Optional Format 1-2-96)
for Mark N Millman
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K032702
Confidential