(24 days)
Not Found
No
The summary describes a microwave ablation system and its components, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for "coagulation of soft tissue," which is a medical procedure used to treat disease or injury.
No
The device is described as a microwave ablation system intended for coagulation of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system consists of a microwave power generator and a disposable probe, which are hardware components.
Based on the provided information, the VivaWave™ Microwave Ablation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for coagulation of soft tissue." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system that delivers microwave energy to tissue for coagulation. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
Therefore, the VivaWave™ Microwave Ablation System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.
Product codes
GEI
Device Description
The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.
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): 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
510(k) Summary
FEB 2 4 2005
| General Information | K050223 |
|---|---|
| Classification | Class II |
| Trade Name | Coaxial Introducer |
| Submitter | Vivant Medical, Inc. |
| 1916-A Old Middlefield Way | |
| Mountain View, CA 94043 | |
| (650) 694-2900 | |
| Contact | Kristine Foss |
| Vice President, Regulatory, Quality and Clinical |
Intended Use
The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.
Predicate Devices
VivaWave™ Microwave Ablation System
Device Description
The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.
Materials
All patient contact materials used in the manufacture of the Coaxial Introducer are suitable for this use and have been used in numerous previously cleared products.
Summary of Substantial Equivalence
The VivaWave Microwave Ablation System with the addition of the Coaxial Introducer 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 Coaxial Introducer is substantially equivalent to existing legally marketed devices.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
FEB 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristine Foss Vice President, Regulatory, Quality and Clinical Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043
Re: K050223
Trade/Device Name: Coaxial Introducer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 28, 2005 Received: February 9, 2005
Dear Ms. Foss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure to regars the Medical Device Amendments, or to commerce phor to may 20, 1970, accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costicule Hot (110) that the device, subject to the general controls provisions of the Act. The r out may, mercerere, manel at the Act include requirements for annual registration, listing of general controlo provisive, 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 rr your device is elabilition (overal controls. Existing major regulations affecting your device can may be subject to back added to begulations, 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 r 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rendrun radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Kristine Foss
This letter will allow you to begin marketing your device as described in your Section 510(k) The lotel watification. The FDA finding of substantial equivalence of your device to a legally premated 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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):
This application
050223
Device Name:
Coaxial Introducer
Indications for Use:
The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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 of General, Restorative, and Neurological Devices
510(k) Number K050223