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 biopsy site marker is made of two components; a resorbable copolymer, a polyester derivative of lactic and glycolic acids, and a titanium anchor. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The titanium anchor provides a permanent component to the marker of the biopsy site. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer. The V-Mark device 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 copolymer portion of the marker over time. The titanium anchor provides permanent radiographic visibility.

AI/ML Overview

The provided documents do not contain a detailed study demonstrating that the device meets specific acceptance criteria. The 510(k) submission is a "Premarket Notification" which indicates the device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence rather than proving performance against predefined acceptance criteria from a new clinical study.

However, based on the intended use and technological characteristics described, we can infer what the implicit performance characteristics are and how they were asserted rather than rigorously proven with a clinical study in this specific documentation.

Here's a breakdown based on the available text:

Inferred Acceptance Criteria and Reported Device Performance (Asserted)

Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance (Asserted in Device Description)
Visibility under X-ray/Fluoroscopy: Permanent visibility.	"The titanium anchor provides permanent radiographic visibility." (Device Description) "permanently visible by fluoroscopy." (Intended Use)
Visibility under Ultrasound: Visible for at least 6 weeks.	"visible for up to 6 weeks by x-ray, ultrasound and MRI." (Device Description) "be visible under MRI and ultrasound for at least 6 weeks" (Intended Use)
Visibility under MRI: Visible for at least 6 weeks.	"visible for up to 6 weeks by x-ray, ultrasound and MRI." (Device Description) "be visible under MRI and ultrasound for at least 6 weeks" (Intended Use)
Resorption of Copolymer: Degradation and resorption of the copolymer portion.	"Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body." (Device Description) "The body then metabolizes the copolymer portion of the marker over time." (Device Description)
Deployment: Deployable through commercially available biopsy probes/coaxial needles.	"The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer." (Device Description)

Study Information (Based on limitations of the provided document):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. The 510(k) summary provided appears to be a description of the device and its intended use, rather than a clinical study report with a test set. This type of submission would usually rely on bench testing and material characterization to support claims, and potentially existing predicate device data, rather than a new clinical "test set" in the context of human subjects.
- Data Provenance: Not specified. It's likely that any supporting data would have come from internal testing or literature reviews for the materials used, rather than a specific clinical study with a defined test set of patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. A clinical "ground truth" for a test set is not described or required for this type of 510(k) submission, which focuses on substantial equivalence of a physical implantable marker. The claims appear to be based on the known properties of the materials (resorbable polymers, titanium) and in vitro or ex vivo testing for visibility characteristics.
Adjudication method for the test set:
- Not applicable/Not specified.
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:
- Not applicable. This device is a physical biopsy site marker, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical biopsy site marker, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated as a "ground truth" for a clinical study. The claims regarding visibility and resorption are based on the known physical and chemical properties of the device materials (poly(D,L-lactide-co-glycolide) copolymer and titanium) and likely supported by in vitro or ex vivo laboratory testing. For example, radiopacity of materials can be characterized in a lab without human subjects.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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

TAB 4

PREMARKET NOTIFICATION [510(K)] SUMMARY

October, 2004

Trade Name:	InterV brand V-Mark Breast Biopsy Site Marker withTitanium Anchor
Common Name:	Biopsy site markers
Classification Name:	Implantable stable (per 21 CFR section 878.4750)
Manufacturer's Name:	Medical Device Technologies, Inc.3600 SW 47th AvenueGainesville, FL 32608
Corresponding Official:	Kristine LiberackiManager Regulatory Affairs and Quality Assurance3600 SW 47th AvenueGainesville, FL 32608Phone: (800) 338-0440 ext 350Fax: (352) 338-0662
Predicate Device(s):	Biopsy Sciences Biopsy Site Marker, K023694.
Device Description:	The V-Mark biopsy site marker is made of two components;a resorbable copolymer, a polyester derivative of lactic andglycolic acids, and a titanium anchor.Polylactic/polyglycolic acid copolymers degrade and resorbin vivo by hydrolysis into lactic and glycolic acids, which arethen metabolized by the body. The titanium anchor providesa permanent component to the marker of the biopsy site. Thesite markers are deployed through an applicator that fitscommercially available biopsy probes or coaxial needlesincluding the J&J Ethicon Mammotome 11 gauge biopsyprobe, the Pro-Mag Coaxial Introducer with Blunt Obturator,the Bio-Pince Co-axial Introducer with Blunt Obturator, andthe Medical Device Technologies V-Core Co-axialIntroducer.The V-Mark device 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 copolymer portion ofthe marker over time. The titanium anchor providespermanent radiographic visibility.

4-1

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 (240) 276-0115. 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 (800) 638-2041 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/

TAB 3

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.

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.