(27 days)
The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.
The provided document does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria. It is a 510(k) summary for the BiomarC® Preloaded Tissue Marker Device, which primarily focuses on demonstrating substantial equivalence to a predicate device.
However, based on the limited information, here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics Equivalence | "The technological characteristics are equivalent to the predicate device." |
| Safety and Effectiveness | "Bench testing has demonstrated that the device is safe and effective..." |
| Substantial Equivalence to Predicate Device | "...and that its performance is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
- Not provided. The document states "Bench testing has demonstrated..." but does not specify the sample size, type of test set (e.g., human subjects, cadaveric, in-vitro materials), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The document refers to "Bench testing," which typically does not involve human experts establishing ground truth in the same way clinical studies or image-based diagnostic AI studies do.
4. Adjudication method for the test set
- Not applicable/Not provided. No adjudication method is mentioned, as the evaluation appears to be based on bench testing rather than expert-reviewed data.
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 is not an AI-powered diagnostic device. It is a physical medical device (tissue marker). Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical tissue marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Likely engineering specifications/performance metrics. Based on "Bench testing," the ground truth would typically be established by measurable engineering specifications (e.g., material compatibility, visibility under imaging modalities, marker retention, deployment force) that demonstrably align with the predicate device's performance. No specific type of ground truth beyond this is mentioned.
8. The sample size for the training set
- Not applicable/Not provided. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of the Study:
The document mentions "Bench testing" as the study conducted to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device. However, it provides no details about the methodology, specific tests performed, sample sizes, data, or results of this bench testing. The conclusion of these tests was that:
- The technological characteristics are equivalent to the predicate device.
- The device is safe and effective.
- Its performance is substantially equivalent to the predicate device.
The entire 510(k) submission hinges on demonstrating this "substantial equivalence" to a legally marketed predicate device (Promex Biopsy Site Tissue Marker Device K023450 and BiomarC Tissue Marker K032347) rather than meeting novel, predefined acceptance criteria through an extensive clinical trial.
{0}------------------------------------------------
K042296
1/2
510(K) SUMMARY
Submitter's Name, Address and Date of Submission
Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
| Phone: | 651-653-8512 |
|---|---|
| Fax: | 651-407-1975 |
August 25, 2004 Submitted:
Device Name
| Trade Name: | BiomarC® Preloaded Tissue Marker Device |
|---|---|
| Classification Name: | Implantable Staple, 21 CFR 878.4750Implantable Clip, 21 CFR 878.4300 |
| Common/Usual Name: | Tissue Marker |
Predicate Device
Promex Biopsy Site Tissue Marker Device (k)023450 BiomarC Tissue Marker (k) 032347
Indication for Use
BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.
{1}------------------------------------------------
KO42296
2/2
510(k) SUMMARY (CONTINUED)
Technological Characteristics and Performance
The technological characteristics are equivalent to the predicate device. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
{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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
Public Health Service
SEP 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc, 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K042296
Ro42270
Trade/Device Name: BiomarC® Preloaded Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, GDW Dated: August 24, 2004 Received: August 24, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 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 encrosure) to tegains and the Medical Device Amendments, or to commerce prior to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costicule Act (71ct) that to not required to the general controls provisions of the Act. The I ou may, dicroro, maries are a Act include requirements for annual registration, listing of general controls provisions of as tice, 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 If your device is enastined (600 a00 royals. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may ou round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Dris issum that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I cochar statutes and regenanents, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements);
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT and 007); ideoining (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Mr. Robert W. Johnson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maing of substantial equivalence of your device to a legally prematication. The PDF interessification 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 spocific acrievier J at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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
to 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}------------------------------------------------
Indications for Use Statement
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name
BiomarC® Preloaded Tissue Marker Device
Indications for Use
The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K042296
§ 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.