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.

AI/ML Overview

The enCircle™ Localization Device is intended for the localization of non-palpable breast lesions. The submission to the FDA focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a specific performance metric against acceptance criteria in a clinical study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative metrics or thresholds. The submission focuses on substantial equivalence to predicate devices.	In-vitro testing revealed equivalent performance with improved consistency of deployment compared to the previously cleared Vivant Breast Lesion Localization Device.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated. The "Testing" section mentions "In-Vitro testing." This suggests a laboratory-based evaluation of the device's physical and functional characteristics, potentially involving a certain number of device units or simulations.
Data Provenance: Not explicitly stated. The testing was "In-Vitro," meaning it was conducted in a controlled laboratory environment, not on human subjects. This type of testing typically wouldn't involve country of origin data or be classified as retrospective/prospective in a clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. As the testing was "In-Vitro" and focused on device performance characteristics rather than diagnostic accuracy, there was no need for expert ground truth establishment in the traditional sense of clinical image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical ground truth to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not conducted or mentioned. The submission relies on "In-Vitro testing" for performance comparison, not a study involving human readers or clinical cases.

6. Standalone Performance Study:

Yes, in spirit, but not as a typical clinical standalone study. The "In-Vitro testing" compared the "performance of the enCircle™ Localization Device" (algorithm only, if applicable to a physical device) against a predicate. However, it's not a standalone in the sense of an AI algorithm's diagnostic accuracy. It's a standalone evaluation of the physical device's function.

7. Type of Ground Truth Used:

Performance characteristics (likely engineering specifications or functional outcomes). For "In-Vitro testing," the "ground truth" would be defined by the expected functional parameters of the device (e.g., successful deployment, consistency of deployment, mechanical integrity, material properties), often against predetermined engineering specifications or the performance of a predicate device. This is distinct from clinical ground truth like pathology or expert consensus on patient data.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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.1916-A Old Middlefield WayMountain View, CA 94043650-694-2900
Contact	Steven KimDirector, 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

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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

510(k) Number (if known):	This application
Device Name:	enCircle™ Localization Device
Indications for Use:	The enCircle™ Localization Device isintended for localization of non-palpablebreast lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K022286
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Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.