BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

K041331 · Biopsy Sciences, LLC · GDW · Jun 15, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041331
• Device Name: BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
• Applicant: Biopsy Sciences, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2

Intended Use

The Biopsy Sciences Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Device Story

Device consists of desiccated hydrogel marker deployed via hand-held applicator. Used during lung biopsy procedures performed via fine needle aspiration through coaxial needle. Upon removal of aspiration device, delivery system mates to coaxial needle; plunger deployment places marker into biopsy tract. Marker expands upon contact with fluids to fill tract. Provides visual confirmation of biopsy site during subsequent surgical resection. Benefits include improved accuracy in locating biopsy site for surgeons. Used in clinical settings by physicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Desiccated hydrogel (FocalSeal-L) marker; expands on fluid contact. Hand-held applicator delivery system. Mates to coaxial biopsy needles. Resorbable via hydrolysis.

Indications for Use

Indicated for marking biopsy locations in patients undergoing surgical resection of lung tissue to provide visualization of the biopsy site.

Regulatory Classification

Identification

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

Predicate Devices

• Biopsy Sciences Bio-MARK Biopsy Site Marker
• J&J Ethicon MicroMark
• SenoRx Gel Mark Biopsy Site Marker
• Artemis CoreMARK/MegaMARK Biopsy Site Identifier
• Vivant Medical Biopsy Marker System
• Medical Device Technologies Aspiration and Injection Needle

Submission Summary (Full Text)

{0}------------------------------------------------

K 041331 P/2

May, 2004

Biopsy Sciences, LLC Traditional 510(k) Lung Biopsy Site Marker

Trade Name:

JUN 1 5 2004

## 4

## PREMARKET NOTIFICATION [510(K)] SUMMARY

Biopsy Sciences Lung 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>3433 E. Fort Lowell Road<br>Suite 103<br>Tucson, AZ 85716 |
| 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 Biopsy Site Markers: | Biopsy Sciences Bio-MARK Biopsy Site Marker, J&J<br>Ethicon MicroMark, SenoRx Gel Mark Biopsy Site<br>Marker, and Artemis CoreMARK/MegaMARK Biopsy<br>Site Identifier. |
| Predicate Localization Devices: | Vivant Medical Biopsy Marker System, and Medical<br>Device Technologies Aspiration and Injection Needle |
| Device Description: | Biopsy Sciences Lung Biopsy Site Markers are made of<br>resorbable FocalSeal-L Surgical Sealant, an FDA<br>approved hydrogel used on the surgical site during lung<br>surgery. The FocalSeal-L hydrogel material degrades<br>in a manner similar to absorbable sutures, via<br>hydrolysis. The Site Markers mark the site of the<br>biopsy tissue sample, which provides accurate<br>visualization during surgical resection of the tumor.<br>Lung biopsy procedures are performed by fine needle<br>aspiration through a coaxial needle. When the fine<br>needle aspiration device is removed, the delivery<br>system is mated to the coaxial needle. The plunger of<br>the delivery system is depressed, which accurately |

places the Site Marker in the biopsy tract.

{1}------------------------------------------------

K04/331 l/h
May, 2004

Biopsy Sciences, LLC Traditional 510(k) Lung Biopsy Site Marker

Intended Use:

The Biopsy Sciences Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Technological Characteristics:

The Biopsy Sciences Lung Biopsy Sit Markers are made of desiccated hydrogel, which immediately expands on contact with fluids to fill the biopsy tract and accurately confirm the site of biopsy during surgical resection. The markers are deployed using a hand held applicator that mates to the coaxial needle used for the biopsy procedure.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2004

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

Re: K041331

Trade/Device Name: Lung Biopsy Site Marker Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: May 10, 2004 Received: May 19, 2004

Dear Ms. Rockwell:

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 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 Erth 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.

{3}------------------------------------------------

Page 2 - Ms. Sharon Rockwell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mails and of substantial equivalence of your device to a legally prematics notification: "The 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 If you desire specific acriously 31 [phone]. Also, please note the regulation entitled, Colliation of Orition of Compulation in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general informational 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

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

{4}------------------------------------------------

K04/331

## Indications for Use

510(k) Number (if known): K041331

Device Name: Lung Biopsy Site Marker

Indications For Use: The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

Division of General, Restorative, and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

**510(k) Number** K64/33/