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

K053518 · Medical Device Technologies, Inc. · NEU · Jan 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053518
• Device Name: INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
• Applicant: Medical Device Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor 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

The V-Mark Breast Biopsy Site Marker is an implantable device used to mark biopsy sites in the breast. It consists of a resorbable 75/25% poly(D,L-lactide-co-glycolide) copolymer body and a titanium anchor. The device is deployed into the biopsy needle tract using a handheld applicator with a two-finger push control rod. It is compatible with various biopsy probes and coaxial needles. The marker provides temporary visibility (at least 6 weeks) under MRI and ultrasound, and permanent radiographic visibility via the titanium component. The resorbable polymer is metabolized by the body over time. The device is used by physicians in clinical settings during percutaneous breast biopsy procedures to facilitate long-term site identification for follow-up or surgical planning.

Clinical Evidence

Bench testing only. Performance testing included finished product evaluation of the modified device, specifically assessing deployment through the delivery system and wire retention in the polymer. Results demonstrated that the modified device met all original design specifications and performed equivalently to the predicate device containing the contrast agent.

Technological Characteristics

Materials: 75/25% poly(D,L-lactide-co-glycolide) copolymer and titanium anchor. Sensing/Actuation: Mechanical deployment via handheld applicator with two-finger push control rod. Form factor: Implantable marker. Connectivity: None. Sterilization: Not specified. Software: None.

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

• Medical Device Technologies, Inc. InterV brand V-Mark Breast Biopsy Site Marker (K051421)

Reference Devices

• J&J Ethicon Mammotome biopsy probe
• Pro-Mag Coaxial Introducer with Blunt Obturator
• Bio-Pince Co-axial Introducer with Blunt Obturator
• Medical Device Technologies V-Core Co-axial Introducer
• Suros Vacuum Assisted Biopsy System

Submission Summary (Full Text)

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

JAN 26 2006

jC053518

December, 2005

Page 1 of 2

# TAB 4

## PREMARKET NOTIFICATION [510(K)] SUMMARY

| Trade Name: | InterV brand V-Mark® Breast Biopsy Site Marker with<br>Titanium Anchor |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biopsy Site Marker |
| Classification Name: | Implantable staple (per 21 CFR section 878.4750) |
| 510(k) Owner's and<br>Manufacturer's Name: | Medical Device Technologies<br>3600 SW 47th Avenue<br>Gainesville, FL 32608<br>Tel: [phone]<br>Fax: [phone] |
| Corresponding Official: | Kristine Liberacki<br>Manager Regulatory Affairs and Quality Assurance<br>3600 SW 47th Avenue<br>Gainesville, FL 32608<br>[phone] ext 350<br>Fax: [phone] |
| Predicate Device(s): | Medical Device Technologies, Inc. InterV brand V-Mark<br>Breast Biopsy Site Marker, K051421. |
| Device Description: | The V-Mark Breast Biopsy Site Marker is made of a<br>resorbable copolymer, a polyester derivative of lactic and<br>glycolic acids. Polylactic/polyglycolic acid copolymers<br>degrade and resorb in vivo by hydrolysis into lactic and<br>glycolic acids, which are then metabolized by the body. The<br>site markers are deployed through an applicator that fits in<br>commercially available biopsy probes. The V-Mark Breast<br>Biopsy Site Marker 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 marker over time. The<br>V-Mark contains a titanium component for permanent<br>radiographic visibility |
| Intended Use: | The intended use is identical to the predicate device. The<br>InterV brand V-Mark Breast Biopsy Site Marker with<br>Titanium Anchor is intended to mark tissue during a<br>percutaneous breast biopsy procedure, be visible under MRI |

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

Technological

Non-Clinical

Kos 35/8

December, 2005

Page 2 of 2

and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy

Characteristics: The V-Mark Breast Biopsy Site Marker has been modified to remove the contrast agent that was incorporated into the polymer to provide radiopacity. The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer. V-Mark Breast Biopsy Site Markers are made of 75/25% poly(D,L-lactide-co-glycolide) copolymer. No other changes have been made to the formulation other than the elimination of the contrast agent

> The site 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. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, the Medical Device Technologies V-Core Co-axial Introducer, and the Suros Vacuum Assisted Biopsy System. For physicians who desire to perform biopsy under ultrasound guidance, a delivery system cannula with an echogenic tip is also available for multiple coaxial applications.

Performance Data: Removal of contrast agent from the polymer did not affect device performance. Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast. Finished product testing of the device without contrast, including deployment through the delivery system, met the original design specifications. All testing was performed post sterilization. The results support a determination that the modified device is substantially equivalent to the original product.

Conclusions: The V-Mark Breast Biopsy Site Marker, modified to eliminate the contrast agent from the original formulation, is substantially equivalent to the original product and meets the same finished product specifications for performance.

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 seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

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

Re: K053518

Trade/Device Name: InterV® 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: January 17, 2006 Received: January 20, 2006

Dear Ms. Liberacki:

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 - Ms. Liberacki

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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" (21 CFR 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/industry/support/index.html.

Sincerely yours,
Barbara Buchner
tos

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. Special 510(k) V-Mark Breast Biopsy Site Marker

Kos 3518

December, 2005

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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 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.

> Prescription Use (per 21 CFR 801 Subpart D)

ਾ

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

(PLEASE DO NOT WRITE BELOW THIS LINE)

Jarbare Buctup formon
**(Division Sign-Off)**

Division of General, Restoratives CDRH, Office of Device Evaluation (ODE) and Neurological Devices

510(k) Number K053518

3-1 CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from Medical Device Technologies, Inc.