(136 days)
J&J Ethicon MicroMark, Inrad UltraClip Tissue Marker, SenoRx Gel Mark Biopsy Site Marker, Vivant Medical Biopsy Marker System
Here are the K/DEN numbers for the Reference Device(s) in a comma-separated list exactly as they appear in the text:
Not Found
No
The document describes a physical biopsy site marker and its material properties and deployment mechanism. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a biopsy site marker used to mark tissue and provide visibility for imaging, not to treat a disease or condition.
No
This device is a biopsy site marker, intended to mark tissue at the site of a biopsy for subsequent visibility. It does not diagnose any condition itself; rather, it aids in the localization of a previous procedure.
No
The device description clearly details a physical implantable marker made of a resorbable copolymer and potentially stainless steel, deployed via a hand-held applicator. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bio-MARK device is a physical marker implanted into tissue during a biopsy procedure. Its purpose is to mark the location of the biopsy site for future imaging and follow-up. It does not analyze a sample in vitro to provide diagnostic information.
- Intended Use: The intended use clearly states the device is for "marking tissue during a percutaneous breast biopsy procedure" and being "visible under MRI, ultrasound and x-ray." This is a procedural aid, not a diagnostic test.
Therefore, the Bio-MARK Biopsy Site Marker falls under the category of a surgical or procedural device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.
The Bio-MARK Permanent Biopsy Site Marker 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
NEU
Device Description
The Bio-MARK 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 the J&J Ethicon Mammotome 11 gauge biopsy probe. The Bio-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 marker over time. The Bio-MARK is sold in two styles: the Resorbable Bio-MARK is made of the copolymer only, the Permanent Bio-MARK is identical with the addition of a stainless steel component for permanent radiographic visibility.
Technological Characteristics: Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, ultrasound, x-ray, 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)
J&J Ethicon MicroMark, Inrad UltraClip Tissue Marker, SenoRx Gel Mark Biopsy Site Marker, Vivant Medical Biopsy Marker System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Biopsy Sciences, LLC Traditional 510(k) Bio-MARK Biopsy Site Marker
023694 (p.1 of 2)
TAB 4
MAR 1 7 2003
PREMARKET NOTIFICATION [510(K)] SUMMARY
October, 2002
| Trade Name: | Bio-MARK Resorbable Biopsy Site Marker
Bio-MARK Permanent Biopsy Site Marker |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biopsy site marker |
| Classification Name: | Instrument, biopsy (per 21 CFR section 878.4750) |
| Manufacturer's Name: | Biopsy Sciences, LLC
6340 North Pinnacle Ridge Drive
Tucson, AZ 85718 |
| Corresponding Official: | Sharon Rockwell
Vice-President RA/QA
5582 Chalon Road
Yorba Linda, CA 92886
Phone: (714) 695-9269
Fax: (714) 779-0406 |
| Predicate Device(s): | J&J Ethicon MicroMark, Inrad UltraClip Tissue Marker,
SenoRx Gel Mark Biopsy Site Marker, and Vivant Medical
Biopsy Marker System |
| Device Description: | The Bio-MARK 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 the J&J Ethicon
Mammotome 11 gauge biopsy probe. The Bio-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 marker over time. The Bio-MARK is sold in
two styles: the Resorbable Bio-MARK is made of the
copolymer only, the Permanent Bio-MARK is identical with
the addition of a stainless steel component for permanent
radiographic visibility. |
1
Biopsy Sciences, LLC Traditional 510(k) Bio-MARK Biopsy Site Marker
OA3694 (f.2 of 2)
The Bio-MARK Resorbable Biopsy Site Marker is intended Intended Use: mark tissue during a percutaneous breast biopsy to procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.
The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by x-ray.
- Technological Characteristics: Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2003
Ms. Sharon Rockwell Vice President RA/QA Biopsy Sciences, LLC 5582 Chalon Road Yorba Linda, California 92886
Re: K023694
Trade Name: Bio-Mark Resorbable and Permanent Biopsy Site Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: January 22, 2003 Received: January 23, 2003
Dear Ms. Rockwell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Sharon Rockwell
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TAB 3
INDICATIONS FOR USE
X023694 510(k) Number:
Device Name: Bio-MARK Resorbable Biopsy Site Marker, and Bio-MARK Permanent Biopsy Site Marker
Indications for Use:
The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.
The Bio-MARK Permanent Biopsy Site Marker 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.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K623694
☑ Prescription Use
(per 21 CFR 801.109)
or
Over-The-Counter Use
Confidential: This document and the information contained herein may not be reproduced, used or disclosed without written permission from Biopsy Sciences, LLC.