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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it a 510(k) summary for the BiomarC Tissue Marker, which focuses on establishing substantial equivalence to a predicate device through technological characteristics and bench testing.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Technological Characteristics: Equivalent to predicate device (BiomarC K042296, Promex K023450)	"The technological characteristics are equivalent to the predicate device."
Safety: Tested to be safe	"Bench testing has demonstrated that the device is safe..."
Effectiveness: Tested to be effective	"Bench testing has demonstrated... effective..."
Performance: Substantially equivalent to predicate device	"...its performance is substantially equivalent to the predicate device."
Radiographic Visibility: Clearly visible on standard radiographs	"clearly visible on standard radiographs..."
MRI Compatibility: Clearly visible on MRI	"...as well as Magnetic Resonance Imaging (MRI)..."
Ultrasound Visibility: Clearly visible on ultrasound	"...and ultrasound."
Sterility: Device is sterile	"BiomarC is a sterile..."
Nonpyrogenicity: Device is nonpyrogenic	"...nonpyrogenic..."
Single Use: Device is for single use	"...single use tissue marker..."
Composition: Nonabsorbable pyrolytic carbon coated zirconium oxide marker	Description of material provided.

Missing from the text: Specific quantitative or qualitative metrics for what constitutes "equivalent," "safe," "effective," or "substantially equivalent." For instance, there are no reported signal-to-noise ratios for visibility, specific biocompatibility test results, or detailed performance benchmarks. The statement relies on an overarching claim of equivalence to predicates.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes "bench testing" but does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). Bench testing typically involves laboratory-based assessments of materials and functional properties, rather than human subject data sets that would have provenance details.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable/Not mentioned. The document refers to "bench testing," which does not typically involve human expert ground truth establishment in the way clinical studies or image-based AI evaluations would. The assessment revolves around engineering and material properties, compared to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable/Not mentioned. Similar to point 3, bench testing does not involve adjudication methods like 2+1 or 3+1 typically used for clinical trial data or image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document focuses on bench testing and substantial equivalence to a predicate device based on technological characteristics. It does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

Not applicable. The BiomarC Tissue Marker is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's inherent function is what is being assessed.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the bench testing would likely be based on engineering specifications, material science standards, and established performance characteristics of the predicate devices. For example, "radiographic visibility" would be determined by whether the marker appears clearly on an X-ray image according to defined imaging parameters, or "sterility" confirmed by adherence to established sterilization validation protocols. It is not an "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The Sample Size for the Training Set:

Not applicable. As the BiomarC Tissue Marker is a physical device and not an AI/ML algorithm, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this device.

Summary of What the Document Provides:

The document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on:

Comparison of technological characteristics to predicate devices.
"Bench testing" to demonstrate safety, effectiveness, and performance equivalency.
Basic functional descriptions (visibility on imaging modalities, sterility, nonpyrogenicity).

What is Lacking for an AI/Software Device Evaluation:

The provided text is entirely unsuitable for answering these questions in the context of an AI or software device. It illustrates a different type of medical device submission (a physical implantable marker) where the criteria for evaluation, "ground truth," and study types are fundamentally different from those applicable to AI/ML devices. Therefore, most of the requested fields are "Not applicable" or "Not mentioned" because they pertain to AI/ML specific evaluations.

Summary

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063193/51

ATTACHMENT 5

510(K) SUMMARY

Submitter's Name, Address and Date of Submission

NOV 2 1 2006

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

October 18, 2006 Submitted:

Device Name

Trade Name:	BiomarC® Tissue Marker
Classification Name:	Implantable Staple, 21 CFR 878.4750Implantable Clip, 21 CFR 878.4300

Tissue Marker Common/Usual Name:

Predicate Device

BiomarC Tissue Marker (K042296) Promex Biopsy Site Tissue Marker Device (K023450)

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

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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.

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Public Health Service

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carbon Medical Tecnologies, Inc. % Mr. Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110-5867

Re: K063193

Trade/Device Name: BiomarC Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulation Class: II Product Code: NEU Dated: October 30, 2006 Received: November 1, 2006

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.

NOV 2 1 2006

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

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Page 2 - Mr. Robert W. Johnson

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.

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

for Pete O
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063193

Indications for Use

510(k) Number (if known): K063193

Device Name: BiomarC Tissue Marker

Indications for Use:

The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 2

510(k) Number L063193

Regulation Number and Section

§ 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.