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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Coaxial Introducer," which is part of the VivaWave™ Microwave Ablation System. This submission is for market clearance through substantial equivalence to predicate devices, not for proving a new device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain any information about:

Acceptance criteria and reported device performance: This type of information is typically found in design validation or clinical study reports, which are not part of this 510(k) summary. The summary focuses on showing equivalence to existing devices.
Sample size used for the test set and data provenance: No test sets or clinical studies are mentioned.
Number of experts and their qualifications for ground truth: Not applicable here as no ground truth establishment is described.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device itself, not on human reader performance with or without AI.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
Type of ground truth used: No ground truth is established or discussed.
Sample size for the training set: Not applicable, as no training set for an algorithm is discussed.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence:

The 510(k) summary states that the Coaxial Introducer, as an accessory to the VivaWave™ Microwave Ablation System, is substantially equivalent to predicate devices. The basis for this claim is:

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." This is similar to the predicate device K011676.
Basic overall function: The Coaxial Introducer aids in the insertion of the microwave energy applicator.
Methods of manufacturing: Implied to be similar to existing devices.
Materials used: "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."

In conclusion, this 510(k) submission seeks market clearance based on substantial equivalence, not on the demonstration of specific acceptance criteria met through a performance study.

Summary

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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 WayMountain View, CA 94043
	(650) 694-2900
Contact	Kristine FossVice President, Regulatory, Quality and Clinical

Intended Use

Predicate Devices

VivaWave™ Microwave Ablation System

K011676

Device Description

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.

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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.

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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

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Indications for Use

510(k) Number (if known):

This application

050223

Device Name:

Coaxial Introducer

Indications for Use:

Prescription Use

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

Regulation Number and Section

§ 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.