ENCIRCLE LOCALIZATION DEVICE

K022286 · Vivant Medical, Inc. · KNW · Oct 11, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022286
• Device Name: ENCIRCLE LOCALIZATION DEVICE
• Applicant: Vivant Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.

Device Story

The enCircle™ Localization Device is a disposable instrument used to mark non-palpable breast lesions for surgical excision. It consists of a curved localization element and a needle cannula delivery system. The device is operated by a clinician in a clinical setting. By placing the localization element at the site of the lesion, the device provides a physical marker that guides the surgeon during the excision procedure, potentially improving the accuracy of lesion removal.

Clinical Evidence

Bench testing only. In-vitro testing compared the performance of the enCircle™ Localization Device against the previously cleared Vivant Breast Lesion Localization Device, demonstrating equivalent performance and improved consistency of deployment.

Technological Characteristics

Disposable instrument comprising a curved localization element and a needle cannula delivery system. Materials are biocompatible and have been used in previously cleared products. No electronic or software components.

Indications for Use

Indicated for the localization of non-palpable breast lesions to facilitate surgical excision.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Breast Lesion Localization Device - Vivant Medical, Inc. (K003439)
• Bovie Hand Control - Sybron Corporation (K790187)

Submission Summary (Full Text)

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OCT 11 2002

K022286

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# 510(k) Summary

General Information

| Classification | Class II |
|----------------|-----------------------------------------------------------------------------------------------|
| Trade Name | enCircle™ Localization Device |
| Submitter | Vivant Medical, Inc.<br>1916-A Old Middlefield Way<br>Mountain View, CA 94043<br>650-694-2900 |
| Contact | Steven Kim<br>Director, Research & Development |

## Intended Use

The enCircle™ Localization Device is intended for localization of non-palpable breast lesions.

### Predicate Devices

| Breast Lesion Localization Device - Vivant Medical, Inc. | K003439 |
|----------------------------------------------------------|---------|
| Bovie Hand Control - Sybron Corporation | K790187 |

### Device Description

The enCircle™ Localization Device is a disposable instrument consisting of a curved localization element and a needle cannula delivery system. The device is used to localize non-palpable breast lesions to facilitate surgical excision of the lesions.

### Materials

All materials used in the manufacture of the enCircle™ Localization Device are suitable for this use and have been used in numerous previously cleared products.

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# Testing

In-Vitro testing, comparing the performance of the enCircle™ Localization Device versus the previously cleared Vivant Breast Lesion Localization Device, revealed equivalent performance with improved consistency of deployment.

# Summary of Substantial Equivalence

The enCircle™ Localization Device is equivalent to the original device from Vivant Medical as well as the RF Electrosurgical predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Vivant Medical believes the enCircle™ Localization Device is substantially equivalent to existing legally marketed devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

# OCT 11 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Kim Director, Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, CA 94043

Re: K022286

Trade/Device Name: enCircle™ Localization Device Regulation Number: 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: KNW Dated: July 12, 2002 Received: July 15, 2002

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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

. . . . . . . . . . . .

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:

| 510(k) Number (if known): | This application |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Device Name: | enCircle™ Localization Device |
| Indications for Use: | The enCircle™ Localization Device is<br>intended for localization of non-palpable<br>breast lesions. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| 510(k) Number | K022286 |
|---------------|---------|
|---------------|---------|