BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER

K023694 · Biopsy Sciences, LLC · NEU · Mar 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023694
• Device Name: BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
• Applicant: Biopsy Sciences, LLC
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks. The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

Device Story

Bio-MARK biopsy site markers are implantable devices used to mark tissue sites following percutaneous breast biopsy. The resorbable version consists of a 75/25% poly(D,L-lactide-co-glycolide) copolymer; the permanent version adds a stainless steel component for long-term radiographic visibility. Both incorporate a USP-grade contrast agent. Markers are delivered into the biopsy needle tract using a handheld applicator with a two-finger-push control rod, compatible with the J&J Ethicon Mammotome 11-gauge biopsy probe. The device provides a localized reference point for clinicians to identify the biopsy site during follow-up imaging (MRI, ultrasound, x-ray). The resorbable marker degrades via hydrolysis and is metabolized by the body, while the permanent marker remains visible via fluoroscopy. The device assists in clinical decision-making by ensuring accurate site localization for subsequent monitoring or surgical intervention.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 75/25% poly(D,L-lactide-co-glycolide) copolymer and USP grade contrast agent; permanent version includes stainless steel. Delivery: Handheld applicator with two-finger-push control rod. Compatibility: J&J Ethicon Mammotome 11-gauge biopsy probe. Imaging: Visible via MRI, ultrasound, and x-ray/fluoroscopy.

Indications for Use

Indicated for patients undergoing percutaneous breast biopsy procedures to mark the biopsy site for subsequent visualization via MRI, ultrasound, and x-ray/fluoroscopy.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• J&J Ethicon MicroMark
• Inrad UltraClip Tissue Marker
• SenoRx Gel Mark Biopsy Site Marker
• Vivant Medical Biopsy Marker System

Submission Summary (Full Text)

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Biopsy Sciences, LLC Traditional 510(k) Bio-MARK Biopsy Site Marker

023694 (p.1 of 2)

# TAB 4

MAR 1 7 2003

## PREMARKET NOTIFICATION [510(K)] SUMMARY

October, 2002

| Trade Name: | Bio-MARK Resorbable Biopsy Site Marker<br>Bio-MARK Permanent Biopsy Site Marker |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biopsy site marker |
| Classification Name: | Instrument, biopsy (per 21 CFR section 878.4750) |
| Manufacturer's Name: | Biopsy Sciences, LLC<br>6340 North Pinnacle Ridge Drive<br>Tucson, AZ 85718 |
| Corresponding Official: | Sharon Rockwell<br>Vice-President RA/QA<br>5582 Chalon Road<br>Yorba Linda, CA 92886<br>Phone: [phone]<br>Fax: [phone] |
| Predicate Device(s): | J&J Ethicon MicroMark, Inrad UltraClip Tissue Marker,<br>SenoRx Gel Mark Biopsy Site Marker, and Vivant Medical<br>Biopsy Marker System |
| Device Description: | The Bio-MARK biopsy site marker is made of a resorbable<br>copolymer, a polyester derivative of lactic and glycolic acids.<br>Polylactic/polyglycolic acid copolymers degrade and resorb<br>in vivo by hydrolysis into lactic and glycolic acids, which are<br>then metabolized by the body. The site markers are deployed<br>through an applicator that fits in the J&J Ethicon<br>Mammotome 11 gauge biopsy probe. The Bio-MARK device<br>marks the site of biopsy tissue sample, and is visible for up to<br>6 weeks by x-ray, ultrasound and MRI. The body then<br>metabolizes the marker over time. The Bio-MARK is sold in<br>two styles: the Resorbable Bio-MARK is made of the<br>copolymer only, the Permanent Bio-MARK is identical with<br>the addition of a stainless steel component for permanent<br>radiographic visibility. |

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Biopsy Sciences, LLC Traditional 510(k) Bio-MARK Biopsy Site Marker

OA3694 (f.2 of 2)

The Bio-MARK Resorbable Biopsy Site Marker is intended Intended Use: mark tissue during a percutaneous breast biopsy to procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.

> The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by x-ray.

- Technological Characteristics: Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker.

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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2003

Ms. Sharon Rockwell Vice President RA/QA Biopsy Sciences, LLC 5582 Chalon Road Yorba Linda, California 92886

Re: K023694

Trade Name: Bio-Mark Resorbable and Permanent Biopsy Site Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: January 22, 2003 Received: January 23, 2003

Dear Ms. Rockwell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Sharon Rockwell

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

for 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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## TAB 3

### INDICATIONS FOR USE

X023694 510(k) Number:

Device Name: Bio-MARK Resorbable Biopsy Site Marker, and Bio-MARK Permanent Biopsy Site Marker

#### Indications for Use:

The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.

The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

### (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K623694

☑ Prescription Use
(per 21 CFR 801.109)

or

Over-The-Counter Use

Confidential: This document and the information contained herein may not be reproduced, used or disclosed without written permission from Biopsy Sciences, LLC.