(90 days)
Not Found
No
The description focuses on the physical components and function of a biopsy site marker, with no mention of AI or ML for image analysis, diagnosis, or any other purpose.
No.
The device is used to mark a biopsy site, which is a diagnostic procedure, not a therapeutic one. The description explicitly states its purpose is to "mark tissue during a percutaneous breast biopsy procedure."
No
The device is a marker intended to mark tissue after a breast biopsy, not to diagnose a condition.
No
The device description clearly states it is made of physical components (resorbable copolymer and a titanium anchor) and is deployed through an applicator, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The V-Mark Breast Biopsy Site Marker is a device that is implanted into the body during a biopsy procedure. Its purpose is to mark the location of the biopsy site within the body for future imaging and reference.
- Intended Use: The intended use clearly states it's for marking tissue during a percutaneous breast biopsy procedure and being visible within the body using various imaging modalities.
The device is used in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, ultrasound, MRI, fluoroscopy
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 with
Titanium 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 Avenue
Gainesville, FL 32608 |
| Corresponding Official: | Kristine Liberacki
Manager Regulatory Affairs and Quality Assurance
3600 SW 47th Avenue
Gainesville, FL 32608
Phone: (800) 338-0440 ext 350
Fax: (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 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. |
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.
1
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.
2
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.
3
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
4
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.