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 Description

The V-Mark Breast Biopsy Site Marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in commercially available biopsy probes. The V-Mark Breast Biopsy Site Marker marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The V-Mark contains a titanium component for permanent radiographic visibility. 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.

AI/ML Overview

The acceptance criteria and study details for the InterV brand V-Mark® Breast Biopsy Site Marker with Titanium Anchor are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a special 510(k) where the primary change is the removal of a contrast agent from the polymer while retaining a titanium component for radiographic visibility. The acceptance criteria are implicitly tied to the performance of the original predicate device (Medical Device Technologies, Inc. InterV brand V-Mark Breast Biopsy Site Marker, K051421). The key performance aspects are related to the marker's visibility and deployment.

Acceptance Criteria (Implied from Predicate/Original Design Specifications)	Reported Device Performance (Modified Device)
Visibility under MRI and ultrasound for at least 6 weeks (from intended use statement)	Not explicitly re-evaluated and reported in detail for the modified device, but since the core mechanism for visibility (titanium) remains and the change is in the resorbable polymer, it's implied to meet this. The filing states "The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer."
Permanent visibility by fluoroscopy (from intended use statement)	"The titanium component of the device provides for permanent radiographic visibility." This directly addresses and meets the criterion.
Wire retention in the polymer (without contrast, equivalent to polymer with contrast)	"Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast." This explicitly meets the criterion.
Deployment through the delivery system (meeting original design specifications)	"Finished product testing of the device without contrast, including deployment through the delivery system, met the original design specifications." This explicitly meets the criterion.
Overall device performance (substantially equivalent to the original product and meets the same finished product specifications for performance)	"Removal of contrast agent from the polymer did not affect device performance." and "The V-Mark Breast Biopsy Site Marker... is substantially equivalent to the original product and meets the same finished product specifications for performance." This overarching claim indicates all original criteria are met.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study with patients. The performance data seems to be derived from engineering/bench testing. The document mentions "Finished product testing of the device without contrast, including deployment through the delivery system."
Data Provenance: The data appears to be from internal laboratory/bench testing ("All testing was performed post sterilization"). No country of origin is specified for the data itself, but the manufacturer is based in Gainesville, Florida, USA. The testing is retrospective in the sense that it's comparing a modified device to a previously approved one, but the specific tests performed on the modified device would be prospective for that particular modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This was not a human-in-the-loop study requiring ground truth established by experts. The evaluation focused on material properties and mechanical performance.

4. Adjudication method for the test set:

Not applicable. There was no need for adjudication for this type of performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is not an algorithm; it is a physical medical device. The "standalone" performance here refers to the device's physical and material properties, which were tested without human-in-the-loop performance in a clinical scenario for this submission.

7. The type of ground truth used:

The "ground truth" for the performance evaluation appears to be the original design specifications and the established performance of the predicate device (K051421). For example, "Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast" implies the predicate device's wire retention served as the benchmark. Similarly, meeting "original design specifications" for deployment implies those specifications served as the ground truth.

8. The sample size for the training set:

Not applicable. This submission concerns a modification to an existing physical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned or implied.

Summary

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

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 withTitanium Anchor
Common Name:	Biopsy Site Marker
Classification Name:	Implantable staple (per 21 CFR section 878.4750)
510(k) Owner's andManufacturer's Name:	Medical Device Technologies3600 SW 47th AvenueGainesville, FL 32608Tel: 352-338-0440Fax: 352-338-0662
Corresponding Official:	Kristine LiberackiManager Regulatory Affairs and Quality Assurance3600 SW 47th AvenueGainesville, FL 32608(800) 338-0440 ext 350Fax: 352-338-0662
Predicate Device(s):	Medical Device Technologies, Inc. InterV brand V-MarkBreast Biopsy Site Marker, K051421.
Device Description:	The V-Mark Breast Biopsy Site Marker is made of aresorbable copolymer, a polyester derivative of lactic andglycolic acids. Polylactic/polyglycolic acid copolymersdegrade and resorb in vivo by hydrolysis into lactic andglycolic acids, which are then metabolized by the body. Thesite markers are deployed through an applicator that fits incommercially available biopsy probes. The V-Mark BreastBiopsy Site Marker marks the site of biopsy tissue sample,and is visible for up to 6 weeks by x-ray, ultrasound andMRI. The body then metabolizes the marker over time. TheV-Mark contains a titanium component for permanentradiographic visibility
Intended Use:	The intended use is identical to the predicate device. TheInterV brand V-Mark Breast Biopsy Site Marker withTitanium Anchor is intended to mark tissue during apercutaneous breast biopsy procedure, be visible under MRI

4- l

CONFIDENTIAL

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

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

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.

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

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.

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

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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

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

Kos 3518

December, 2005

TAB 3

INDICATIONS FOR USE

510(k) Number: -

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

Indications for Use.

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.

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.