The 14G CORMARK™ Biopsy Site Identifier is composed of a bioresorbable collagen plug embedded with a titanium non-resorbable radiopaque marker or clip.

At the completion of a breast biopsy procedure, the marker is deployed into the biopsy cavity, using a stainless steel syringe-like applicator with 1 cm markings to aid in needle placement. The marker is intended to help relocate the biopsy site for any subsequent intervention or diagnosis. The collagen slowly absorbs and the titanium radiopaque marker is left behind as the permanent identifier of the biopsy site.

AI/ML Overview

The provided document is a 510(k) summary for the 14G CORMARK™ Biopsy Site Identifier, which seeks to establish substantial equivalence to a predicate device, the Caris™ Site Marker.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the 14G CORMARK™ Biopsy Site Identifier is substantially equivalent to the predicate device, Artemis Caris™ Site Marker. This means the acceptance criteria are implicitly that the new device performs at least as well as the predicate device and that any modifications do not raise new issues of safety or effectiveness.

Acceptance Criteria Category	Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (from text)
Intended Use	Same as predicate device (Caris™ Site Marker)	The 14G CORMARK™ Biopsy Site Identifier has the "same intended use" as the Caris™ Site Marker: "to mark the biopsy site during an open surgical or percutaneous breast biopsy procedure."
Principles of Operation	Same as predicate device	"The 14G CORMARK™ Biopsy Site Identifier... has the same... principles of operation... as the Artemis Caris™ Site Marker."
Materials	Same as predicate device	"The 14G CORMARK™ Biopsy Site Identifier... has the same... materials... as the Artemis Caris™ Site Marker." (Both are composed of a bioresorbable collagen plug embedded with a titanium radiopaque marker).
Technological Characteristics	Similar to predicate device, with minor modifications not impacting safety/effectiveness.	"The 14G CORMARK™ Biopsy Site Identifier... has the same... technological characteristics... as the Artemis Caris™ Site Marker." Minor modifications: a) change from Pebax to stainless steel syringe-like applicator, b) change in dimensions to accommodate 14G core needle biopsies.
Functionality	Similar to predicate device	"The 14G CORMARK™ Biopsy Site Identifier... is similar in... functionality as the predicate device."
Safety and Effectiveness	Modifications do not raise new issues of safety or effectiveness.	"The modifications are minor and do not raise any new issues of safety or effectiveness." "The device passed all design verification and validation tests conducted."

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

The document does not explicitly describe a separate test set size or data provenance (e.g., country of origin, retrospective/prospective) for proving acceptance criteria in a clinical study. The submission relies on demonstrating substantial equivalence through design verification and validation tests, and by comparing the characteristics of the new device to the predicate device.

The study referenced is not a clinical trial with a "test set" in the typical sense of patient data. It is a series of "design verification and validation tests" related to the design modifications.

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

This information is not provided in the document. As the submission relies on design verification and validation tests related to manufacturing and material properties rather than clinical outcomes on patients, the concept of "ground truth established by experts" in the context of clinical evaluation of performance is not applicable here.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As noted above, the submission does not detail a clinical study with an adjudicated "test set" in the context of human interpretation or diagnostic accuracy. The "tests conducted" are likely engineering and bench-top tests.

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

An MRMC comparative effectiveness study was not performed or reported in this document. The submission focuses on demonstrating substantial equivalence through design and material comparisons, and engineering tests. It does not evaluate human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not performed or reported. This device is a physical medical device (tissue marker and applicator), not an algorithm or software. Therefore, the concept of "algorithm only performance" does not apply.

7. Type of Ground Truth Used:

The "ground truth" for this submission would be defined by engineering specifications, material properties, and functional requirements established during the design process and verified through testing. For example, testing for proper deployment, bioresorption rates, radiopacity, and mechanical integrity would be compared against predefined specifications. The document states: "The device passed all design verification and validation tests conducted." This implies that the device met its pre-defined engineering and performance criteria, which serve as the "ground truth" for this type of submission.

8. Sample Size for the Training Set:

This information is not provided and is not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a "training set" of data.

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

This information is not provided and is not applicable for the same reasons as point 8.

Summary

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AUG 2 1 2003

510(k) Summary of Safety and EffectivenessK432217 (P. 1 of 2)
Date Prepared:	July 18, 2003
Submitted by:	Artemis Medical, Inc.21021 Corsair Blvd., Suite 100Hayward, CA 94545Contact: Allan L. Abati, Ph.D.VP Regulatory/Clinical Affairs and QAPhone: (510) 259-3150FAX: (510) 723-0617
Trade Name:	14G CORMARK™ Biopsy Site Identifier
Common Name:	Tissue Marker
Classification Name:	Implantable Clip or Staple21CFR 878.430021CFR 878.4750
Predicate Device:	Caris™ Site Marker

Intended Use:

The 14G CORMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.

Device Description

The 14G CORMARK™ Biopsy Site Identifier is composed of a bioresorbable collagen plug embedded with a titanium non-resorbable radiopaque marker or clip.

Technological Characteristics

The Artemis 14G CORMARK "" Biopsy Site Identifier has the same intended use, principles of operation, materials, and technological characteristics as the Artemis Caris™ Site Marker. Each of these devices is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site. Both devices consist of two portions: a bioresorbable collagen plug embedded with a radiopaque titanium permanent marker, and a syringe-like delivery system that can be directed to the biopsy site by the

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user or inserted through an appropriate percutaneous coaxial introducer for placement of the site marker in the desired location.

The only modifications from the predicate device are: a) a change from a Pebax syringelike applicator to a stainless steel syringe-like applicator with etched om markings, and b) a change in the dimensions of the syringe-like applicator, collagen plug and titanium wire to accommodate 14G core needle biopsy procedures, which by design produce smaller biopsy cavities.

Risk analysis activities relevant to the design modifications included a Hazard Analysis, a Failure Mode Effects Analysis and tests related to the design modifications. The device passed all design verification and validation tests conducted.

Summary

In summary, the 14G CORMARK™ Biopsy Site Identifier has the same indications for use, and is similar in design, materials, technological characteristics, and functionality as the predicate device. The modifications are minor and do not raise any new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Allan L. Abati, Ph.D. Vice President Regulatory/Clinical Affairs and Quality Assurance Artemis Medical, Inc. 21021 Corsair Boulevard, Suite 100 Hayward, California 94545

Re: K032217

Trade/Device Name: 14G corMARK™ Biopsy Site Identifier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, NEU Dated: July 18, 2003 Received: July 28, 2003

Dear Dr. Abati:

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 - Allan L. Abati, Ph.D.

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 vours.

for Mark N. Millhuser

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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INDICATION FOR USE STATEMENT

510(k) Number: K432217

Device Name:

14G CORMARK™ Biopsy Site Identifier

Indication for Use:

The 14G CORMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Mark McMahon

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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Artemis Medical, Inc

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.