(136 days)
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.
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.
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.
The Bio-MARK Biopsy Site Marker 510(k) submission (K023694) has limited detail regarding a formal study and acceptance criteria in the provided text. The document focuses on the device description, intended use, and substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and results.
However, based on the information provided, we can infer some "acceptance criteria" from the stated intended use and technological characteristics, and then identify what the filing states about the device meeting these:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Intended Use/Characteristics) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Resorbable Bio-MARK: | |
| Visible under MRI, ultrasound, and X-ray for at least 6 weeks. | "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." (Page 1) |
| Resorbs in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. | "Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body." (Page 1) |
| Composed of a resorbable copolymer (polyester derivative of lactic and glycolic acids). | "The Bio-MARK biopsy site marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids." (Page 1) |
| Permanent Bio-MARK: | |
| Visible under MRI and ultrasound for at least 6 weeks. | "The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue... and be visible under MRI and ultrasound for at least 6 weeks..." (Page 2) |
| Permanently visible by X-ray (fluoroscopy). | "...and be permanently visible by x-ray." (Page 2), and "...permanently visible by fluoroscopy." (Page 4) - using stainless steel component for permanent visibility. |
| Identical to Resorbable Bio-MARK with the addition of a stainless steel component for permanent radiographic visibility. | "the Permanent Bio-MARK is identical with the addition of a stainless steel component for permanent radiographic visibility." (Page 1) |
| Both models capable of being deployed through an applicator that fits in the J&J Ethicon Mammotome 11 gauge biopsy probe. | "The site markers are deployed through an applicator that fits in the J&J Ethicon Mammotome 11 gauge biopsy probe." (Page 1) |
| Both models made of 75/25% poly(D,L-lactide-co-glycolide) copolymer with USP grade contrast agent for radiopacity (except permanent component). | "Bio-MARK 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." (Page 2) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not explicitly state a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The document relies on describing the device's composition and intended function, asserting that it meets its intended use based on its design and similarity to predicate devices. This type of 510(k) submission typically does not include extensive clinical trial data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The provided document does not mention a test set with ground truth established by experts. No information on the number or qualifications of experts is available.
4. Adjudication Method for the Test Set:
No adjudication method is described, as no formal test set or clinical study requiring adjudication is detailed in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document does not describe any studies comparing human readers with or without AI assistance. The device is a physical biopsy site marker, not an AI software.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The Bio-MARK is a physical medical device, not an algorithm or AI. Therefore, a standalone algorithm performance study was not conducted or reported.
7. Type of Ground Truth Used:
No explicit "ground truth" as typically understood in AI/imaging studies is detailed. The assessment of the device's performance appears to be based on its material properties (resorbability, radiopacity due to contrast agent/stainless steel) and its intended mechanical function (deployment, visibility over time). This would likely have been verified through bench testing, material science testing, and potentially some in-vivo animal or limited human observational studies (though not detailed here) to confirm visibility and resorption characteristics.
8. Sample Size for the Training Set:
Not applicable. The Bio-MARK is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no training set for this device.
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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 MarkerBio-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, LLC6340 North Pinnacle Ridge DriveTucson, AZ 85718 |
| Corresponding Official: | Sharon RockwellVice-President RA/QA5582 Chalon RoadYorba Linda, CA 92886Phone: (714) 695-9269Fax: (714) 779-0406 |
| Predicate Device(s): | J&J Ethicon MicroMark, Inrad UltraClip Tissue Marker,SenoRx Gel Mark Biopsy Site Marker, and Vivant MedicalBiopsy Marker System |
| Device Description: | The Bio-MARK biopsy site marker is made of a resorbablecopolymer, a polyester derivative of lactic and glycolic acids.Polylactic/polyglycolic acid copolymers degrade and resorbin vivo by hydrolysis into lactic and glycolic acids, which arethen metabolized by the body. The site markers are deployedthrough an applicator that fits in the J&J EthiconMammotome 11 gauge biopsy probe. The Bio-MARK devicemarks the site of biopsy tissue sample, and is visible for up to6 weeks by x-ray, ultrasound and MRI. The body thenmetabolizes the marker over time. The Bio-MARK is sold intwo styles: the Resorbable Bio-MARK is made of thecopolymer only, the Permanent Bio-MARK is identical withthe addition of a stainless steel component for permanentradiographic visibility. |
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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.
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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.
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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
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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.
§ 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.