(35 days)
No
The summary describes a physical device (ablation probe) and a generator that delivers microwave energy. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as being for "coagulation of soft tissue" and uses microwave energy to heat and ablate tissue, which is a destructive process, not a therapeutic one in the sense of restoring health or normal function.
No
The device is described as an ablation probe intended for the coagulation of soft tissue, indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like probes, cannulas, and a handle mechanism, indicating it is a hardware device.
Based on the provided information, the Tri-Loop™ Microwave Ablation Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue." This is a therapeutic procedure performed in vivo (within the body) to treat tissue.
- Device Description: The device is a probe designed to deliver microwave energy directly to tissue for heating and coagulation. This is an interventional device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside 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. This device is used to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Product codes
GEI
Device Description
The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
AUG - 6 2003
510(k) Summary
General Information
page 1 of 1
Classification Class II
Trade Name
Submitter
Tri-Loop™ Microwave Ablation Probe
Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, CA 94043
(650) 694-2900
Steven Kim Contact Vice President of Research and Development
Intended Use
The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Predicate Device
Vivant Medical Loop™ Microwave Ablation Probe
Device Description
The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.
Materials
All patient contact materials used in the manufacture of the Tri-Loop™ Microwave Ablation Probe are suitable for this use and have been used in numerous previously cleared products.
Summary of Substantial Equivalence
The Tri-Loop™ 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 Tri-Loop™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized symbol that resembles three overlapping waves or stripes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2003
Mr. Steven Kim Vice President of Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043
Re: K032047
Trade/Device Name: Tri-Loop™ Microwave Ablation Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 1, 2003 Received: July 7, 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.
2
Page 2 - Mr. Steven Kim
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,
Miriam C. Provost
for 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
3
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
KO32047 This application TRI-Loop " Hickowave Ablation Prole
TRI-Loop " Hickowave Ablation Prolet Deviee name
Tri-Laser™ Microwave Able
The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
Barbara Bammuma for CMU
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K032047
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Ja
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)