INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

K051421 · Medical Device Technologies, Inc. · NEU · Aug 30, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051421
• Device Name: INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
• Applicant: Medical Device Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Aug 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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

V-Mark breast biopsy site marker consists of resorbable 75/25% poly(D,L-lactide-co-glycolide) copolymer and titanium anchor; deployed via handheld applicator through biopsy probes or coaxial needles (e.g., Mammotome, Pro-Mag, Bio-Pince, V-Core). Copolymer contains USP grade contrast agent for radiopacity; provides visibility under MRI and ultrasound for at least 6 weeks; copolymer resorbs in vivo via hydrolysis. Titanium anchor provides permanent radiographic visibility for long-term site identification. Used by clinicians in clinical settings to mark biopsy sites; aids in follow-up imaging and clinical decision-making regarding subsequent treatment or monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 75/25% poly(D,L-lactide-co-glycolide) copolymer with USP grade contrast agent and titanium anchor. Sensing principle: Radiopaque/echogenic/MRI-visible marker. Form factor: Implantable marker deployed via handheld applicator. Sterilization: Not specified.

Indications for Use

Indicated for marking tissue during percutaneous breast biopsy procedures in patients requiring post-biopsy site localization via MRI, ultrasound, or 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

• Biopsy Sciences Biopsy Site Marker (K023694)

Submission Summary (Full Text)

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Medical Device Technologies, Inc. Traditional 510(k) Pradition of Breast Biopsy Site Marker

AUG 0 6 2005

Ko5/421

Page 1 of 2

May, 2005

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# PREMARKET NOTIFICATION [510(K)] SUMMARY

#### October, 2004

| Trade Name: | InterV brand V-Mark Breast Biopsy Site Marker with<br>Titanium Anchor |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biopsy site markers |
| Classification Name: | Implantable stable (per 21 CFR section 878.4750) |
| Manufacturer's Name: | Medical Device Technologies, Inc.<br>3600 SW 47th Avenue<br>Gainesville, FL 32608 |
| Corresponding Official: | Kristine Liberacki<br>Manager Regulatory Affairs and Quality Assurance<br>3600 SW 47th Avenue<br>Gainesville, FL 32608<br>Phone: [phone] ext 350<br>Fax: [phone] |
| Predicate Device(s): | Biopsy Sciences Biopsy Site Marker, K023694. |
| Device Description: | The V-Mark biopsy site marker is made of two components;<br>a resorbable copolymer, a polyester derivative of lactic and<br>glycolic acids, and a titanium anchor.<br>Polylactic/polyglycolic acid copolymers degrade and resorb<br><i>in vivo</i> by hydrolysis into lactic and glycolic acids, which are<br>then metabolized by the body. The titanium anchor provides<br>a permanent component to the marker of the biopsy site. The<br>site markers are deployed through an applicator that fits<br>commercially available biopsy probes or coaxial needles<br>including the J&J Ethicon Mammotome 11 gauge biopsy<br>probe, the Pro-Mag Coaxial Introducer with Blunt Obturator,<br>the Bio-Pince Co-axial Introducer with Blunt Obturator, and<br>the Medical Device Technologies V-Core Co-axial<br>Introducer.<br><br>The V-Mark device marks the site of biopsy tissue sample,<br>and is visible for up to 6 weeks by x-ray, ultrasound and<br>MRI. The body then metabolizes the copolymer portion of<br>the marker over time. The titanium anchor provides<br>permanent radiographic visibility. |

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### CONFIDENTIAL

This document and the information contained herein may not be reproduced, used or disclosed t and the information oomafrom Medical Device Technologies, Inc.

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K05742f

Medical Device Technologies, Inc. Traditional 510(k) V-Mark Breast Biopsy Site Marker

May, 2005
Page 2 of 2

Intended Use:

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.

Technological Characteristics:

InterV brand V-Mark Breast Biopsy Site Markers are made of 75/25% poly(D,L-lactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity, plus a titanium anchor that provides permanent radiopacity for marking the site of the breast biopsy. The markers are deployed into the biopsy needle tract using hand held instruments that are compatible with commercially available biopsy probes or coaxial needles.

CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from Medical Device Technologies, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized design of three overlapping lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 3 0 2005

Ms. Kristine Liberacki Manager Regulatory Affairs and Quality Assurance Medical Device Technologies, Inc. 3600 Southwest 47th Avenue Gainesville, Florida 32608

Re: K051421

Trade/Device Name: Inter V® brand V-Mark™ Breast Biopsy Site Marker with Titanium Anchor

Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: August 5, 2005 Received: August 12, 2005

Dear Ms. Liberacki:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energe, 1976, the enactment date of the Medical Device Amendments, or to conimeres prior to may 20, 2018 since with the provisions of the Federal Food, Drug, de Hoos that have econ require approval of a premarket approval application (PMA). and Cosmetic Fee (110) was the device, subject to the general controls provisions of the Act. The r ou may, merelove, mains 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 may or babyeet to bases were as 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 r reaso or as 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 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. Kristine Liberacki

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins ictier will anow you to oegin maing of substantial equivalence of your device to a legally prematication: 110 PDF intents sification 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 spocitie acries in [phone]. Also, please note the regulation entitled, Colliact the Office of Compullier as (21 t m =1 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Barbara Buellup
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medical Device Technologies, Inc. Traditional 510(k) Traditional 3 10(!!)
V-Mark Breast Biopsy Site Marker

K05142/

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# INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

Device Name: InterV® brand V-Mark™ Breast Biopsy Site Marker with Titanium Anchor

Indications for Use:

The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is
t be visible The InterV brand V-Mark Dreast Diopsy one breast biopsy procedure, be visible by intended to mark tissue during a perculancous broad copy f
under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

× Prescription Use (per 21 CFR 801 Subpart D) or

Over-The-Counter Use (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE)

Barbara Bruch for MXM
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
**Division of General. Restorative,**
**and Neurological Devices**

3-510(k) Number Koslu21

CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed.
This document and the information of any Madicol Dovice Tochnologies Inc t and the Information contained for simmed for the Technologies, Inc.