(26 days)
Not Found
No
The summary describes a hardware device for microwave ablation and does not mention any software features related to AI or ML.
Yes
The VivaRing™ Microwave Ablation Probe is intended for the "coagulation of soft tissue," which is a medical procedure used to treat diseases or injuries, thereby aligning with the definition of a therapeutic device.
No
Explanation: The device is intended for the "coagulation of soft tissue," which is a treatment or therapeutic function, not a diagnostic one. It is used to ablate tissue, not to identify or characterize disease.
No
The device description clearly outlines physical components like a probe, antenna, cannula, handle mechanism, and a saline-cooled shaft, indicating it is a hardware device.
Based on the provided information, the VivaRing™ Microwave Ablation Probe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a probe that delivers microwave energy to tissue for coagulation. This is an interventional device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. The VivaRing™ Microwave Ablation Probe is a therapeutic device used to treat tissue directly within the body.
N/A
Intended Use / Indications for Use
The VivaRing™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VivaRing M Microwave Ablation Probe consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR - 2 2004
510(k) Summary 6040279
General Information
| Classification | Class II |
|---|---|
| Trade Name | VivaRingTM 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 VivaRing™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Predicate Devices
| LoopTM Microwave Ablation Probe | K023311 |
|---|---|
| VivaTipTM Microwave Ablation Probe | K032702 |
Device Description
The VivaRing M Microwave Ablation Probe consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.
Materials
All patient contact materials used in the manufacture of the VivaRing™ Microwave Ablation Probe are suitable for this use and have been used in numerous previously cleared products.
Summary of Substantial Equivalence
The VivaRing™ 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 VivaRing™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.
Image /page/0/Picture/14 description: The image is completely black, lacking any discernible features or content. It appears to be a solid, dark rectangle with no visible details, textures, or variations in shading. The absence of any elements makes it impossible to determine the subject or context of the image. The image is a uniform, featureless void.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2004
Mr. Steven Kim Vice President of Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043
Re: K040279
Trade/Device Name: VivaRing™ 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: February 4, 2004 Received: February 5, 2004
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & now reviewed your been wined 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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos mat have been 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 r ou may, merce 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 (sec above) into either class II (Special Controls) or class III (PMA), it If your de roo 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, IDA 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 or any I 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 Or A rut our of 19 meeting (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. Steven Kim
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to cegm maing of substantial equivalence of your device to a legally prematicate 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 If you desire specific advice for Jour a01) 594-4659. Also, please note the regulation entitled, Coniact the Office of Computers as (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Miriam C. Provost
(6 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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: | VivaRing ™ Microwave Ablation Probe and Accessories |
| Indications For Use: | The VivaRing™ Microwave Ablation Probe is intended for |
| coagulation of soft tissue. Not for use in cardiac | |
| procedures. |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) (Division bigand Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________