(22 days)
The BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML device studies. Instead, it describes a 510(k) submission for a medical device (BiomarC Tissue Marker) based on substantial equivalence to a predicate device.
For medical devices, particularly non-software devices, the "acceptance criteria" are often met through demonstration of substantial equivalence by showing similar technological characteristics and performance to a legally marketed predicate device. The "study" in this context refers to bench testing to demonstrate this substantial equivalence, rather than a clinical trial with specific performance metrics like sensitivity, specificity, etc.
Here's a breakdown of the information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (BiomarC Tissue Marker K001807) regarding technological characteristics, safety, and effectiveness. | "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." |
Note: The actual specific criteria for "safety and effectiveness" during bench testing are not detailed in this summary. For a hardware device like this, these would typically involve biocompatibility, mechanical integrity, visibility under various imaging modalities, etc., all compared to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. "Bench testing" is mentioned, which typically involves laboratory tests on the device itself or test materials, not human or patient data in the sense of a clinical test set.
- Data Provenance: Not applicable for bench testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. The "ground truth" for a physical device like this in a 510(k) submission focused on substantial equivalence comes from engineering specifications and performance evaluations against established standards or the predicate device's known performance, not expert consensus on data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for studies involving human interpretation or assessments, such as imaging studies where a consensus ground truth is established.
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
- Not applicable. This is a physical tissue marker, not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm. Bench testing evaluates its physical properties and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this substantial equivalence argument would be the established performance and safety profile of the predicate device, as well as engineering and material specifications relevant to the device's function (e.g., visibility on imaging, biocompatibility). It is established through bench testing.
8. The sample size for the training set
- Not applicable. There is no AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML algorithm or training set.
Summary of the Study Mentioned:
The "study" described is bench testing. This testing was aimed at demonstrating that the BiomarC Tissue Marker's technological characteristics, safety, and effectiveness are substantially equivalent to a legally marketed predicate device (BiomarC Tissue Marker K001807). The specific details of this bench testing (e.g., methods, parameters, exact outcomes) are not provided in this summary but would have been part of the full 510(k) submission. The FDA reviewed this submission and determined the device to be substantially equivalent, allowing it to proceed to market.
{0}------------------------------------------------
AUG 2 1 2003
ATTACHMENT 4 KU32347 (V.10F2 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 |
July 28, 2003 Submitted:
Device Name
| Trade Name: | BiomarC® Tissue Marker |
|---|---|
| Classification Name: | Implantable Staple, 21 CFR 878.4750 |
| Common/Usual Name: | Tissue Marker |
| Predicate Device |
BiomarC Tissue Marker (K001807)
Indication for Use
BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. B BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
{1}------------------------------------------------
510(k) SUMMARY (CONTINUED) (432349 (f. 2 xF2)
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2003
Mr. Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K032347
Trade/Device Name: BiomarC Tissue Marker Regulation Number: 21 CFR 878.4750, 878.4300 Regulation Name: Implantable staple, implantable clip Regulatory Class: II Product Code: GDW, NEU Dated: July 28, 2003 Received: July 30, 2003
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 - Mr. Robert W. Johnson
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.
Much A. Milliken
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}------------------------------------------------
ATTACHMENT 2
Indications for Use Statement
(432747 510(k) Number (if known) _
BiomarC Tissue Marker Device Name
Indications for Use
The BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over the Counter Use (Per 21 CFR 801.109) (Division Sign-Ofr) Division of General, Restorative
and Neurological Device
-10(k) Number _
2347
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.