The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Device Description

BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength.

BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism.

AI/ML Overview

This document describes the BiomarC Fiducial Marker, a device intended for use in stereotactic radiosurgery and radiotherapy target localization. The submission is a 510(k) premarket notification, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies. As such, the information provided focuses on demonstrating equivalence rather than a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device with specific performance metrics beyond what is provided in the substantial equivalence comparison.

Here's an analysis of the provided text in the context of your questions:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the BiomarC Fiducial Marker's performance. Instead, it aims to demonstrate substantial equivalence to predicate devices by comparing their characteristics and showing that the proposed device is just as safe and effective. The "reported device performance" is inferred through this comparison and the various safety and biocompatibility tests.

The closest we get to "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" for the proposed device (BiomarC Fiducial Marker) is that it meets or matches these characteristics.

Characteristic	Acceptance Criteria (Predicate Devices' Characteristics)	Reported Device Performance (BiomarC Fiducial Marker)
Indications for Use	The BiomarC Tissue Marker (K063193) is indicated for radiographic marking of soft tissue. The Fiducial Markers (K071614) are intended for stereotactic radiosurgery and radiotherapy target localization.	The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. (This expands on K063193's use and aligns with K071614)
Material	K063193: Pyrolytic carbon coated zirconium oxide; K071614: Gold	Pyrolytic carbon coated zirconium oxide
Use	Single use (Both K063193 and K071614)	Single use
Sterility	Sterilized by EO with an SAL of 1x10-6 (Both K063193 and K071614)	Sterilized by EO with an SAL of 1x10-6
Pyrogens	Pyrogen free (K063193); Unknown (K071614)	Pyrogen free
Biocompatibility	Cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone/tissue), haemocompatibility tests demonstrating non-toxicity, non-sensitizing, non-irritating, non-mutagenic, non-hemolytic per ISO 10993 series (similar for both predicates)	Cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone), and haemocompatibility tests demonstrating non-toxic, non-sensitizing, non-irritating, non-mutagenic, and non-hemolytic per ISO 10993 series
Visualization	K063193: Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT), ultrasound, and MRI; K071614: Visible on EPID, film, kV and CR.	Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT), ultrasound, and magnetic resonance imaging (MRI)
Device Body Contact Category	Implant device, tissue/bone, permanent (Both K063193 and K071614)	Implant device, tissue/bone, permanent

Summary of the "Study" Proving Equivalence:

The "study" described is a comparison to predicate devices and performance testing (primarily biocompatibility and visualization demonstrations), rather than a clinical trial with specific performance endpoints. The core argument is:

The BiomarC Fiducial Marker is identical to the BiomarC Tissue Marker (K063193) except for its expanded indications for use.
The expanded indications are consistent with those of another predicate, the Fiducial Markers (K071614).
Biocompatibility and performance testing confirms that the BiomarC Fiducial Marker is substantially equivalent to the Fiducial Markers for the expanded indications for use. (This is the key claim for approval).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. A 510(k) submission based on substantial equivalence to existing devices often relies on the established safety and performance of those predicates and standardized lab testing (e.g., ISO 10993 for biocompatibility) rather than new clinical trials with patient test sets.

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)

This information is not provided. Given the nature of the submission (demonstrating equivalence through material properties and standard tests), there wouldn't typically be a "test set" with expert adjudicated ground truth in the way one would for diagnostic AI devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. There is no mention of a clinical "test set" requiring adjudication in the document.

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

This information is not applicable. The device is a physical fiducial marker, not an AI or imaging diagnostic software, so MRMC studies or AI assistance metrics are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical fiducial marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device is primarily based on:

Standardized testing methods: Such as ISO 10993 series for biocompatibility, which has established protocols for determining safety.
Physical properties: Demonstrating visibility on various imaging modalities (x-ray, CT, MRI, ultrasound).
Predicate device characteristics: The established safety and effectiveness of the legally marketed predicate devices (K071614 and K063193) serve as the "ground truth" for what constitutes acceptable performance and safety for this type of device.

There is no mention of expert consensus, pathology, or outcomes data being used directly for this specific 510(k) submission as a new ground truth.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are likely informed by prior experience with K063193 and general medical device engineering knowledge.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as point 8.

Summary

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510(k) Summary 5

5. 510(k) Summary

.APR 2 8 2011

Andrew Adams Director - Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110

Phone: 651-653-8512 Fax: 651-407-1975

Submitted: March 17, 2011

Device Name

Trade Name: BiomarC Fiducial Marker Accelerator, Linear, Medical, 21 CFR 892.5050 Classification Name: Common/Usual Name: Tissue Marker

Predicate Devices

Fiducial Markers (K071614) BiomarC Tissue Marker (K063193)

Indication for Use

The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Device Description

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Technological Characteristics and Performance

BiomarC Fiducial Marker is identical to BiomarC Tissue Marker (K063193) except the indications for use have been expanded in accordance with Fiducial Markers (K071614). Biocompatibility and performance testing confirms that the BiomarC Fiducial Marker is substantially equivalent to the Fiducial Markers for the expanded indications for use (Table 5).

Characteristic	Proposed Device	Predicate Device	Predicate Device
Trade name	BiomarC FiducialMarker	Fiducial Markers	BiomarC Tissue Marker
510(k) number	K110772	K071614	K063193
510(k) holder	Carbon MedicalTechnologies, Inc.	Civco Medical Solutions	Carbon MedicalTechnologies, Inc
Indications for use	The BiomarC FiducialMarkers are intended tobe implanted into thebody to accuratelyvisualize and constitutethe reference frame forstereotactic radiosurgeryand radiotherapy targetlocalization.	The Fiducial Markersare intended to beimplanted into the bodyto accurately visualizeand constitute thereference frame forstereotactic radiosurgeryand radiotherapy targetlocalization.Specifically, they can beused in intracranialdiseases as gliomas,neuromas,meningiomas,astroctyomas,arteriovenousmalformations, andmetastatic carinomas.Additionally, they canbe used in the body fortreating hepatic,pancreatic,retroperitoneal,paraspinal, skeletal,prostatic and breasttumors.	The BiomarC TissueMarker is indicated foruse to radiographicallymark soft tissue during asurgical procedure of forfuture surgicalprocedures.
Use	Single use	Single use	Single use
Sterility	Sterilized by EO with anSAL of 1x106	Sterilized by EO with anSAL of 1x106	Sterilized by EO with anSAL of 1x106
Pyrogens	Pyrogen free	Unknown	Pyrogen free
Marker material	Pyrolytic carbon coatedzirconium oxide	Gold	Pyrolytic carbon coatedzirconium oxide
Device body contactcategory	Implant device,tissue/bone, permanent	Implant device,tissue/bone, permanent	Implant device, tissue,permanent

BiomarC Fiducial Marker Premarket Notification 510(k) 5-2

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(Table 5) (continued)
-----------------------	--	--	--	--

Safety	Biocompatibility testing for:	Biocompatibility testing for:	Biocompatibility testing for:
	cytotoxicity,sensitization,intracutaneousreactivity,systemic toxicity,genotoxicity,implantation (muscleand bone), andhaemocompatibility	cytotoxicity,sensitization,irritation,systemic toxicity,implantation, andhemolysis	cytotoxicity,sensitization,intracutaneousreactivity,systemic toxicity,genotoxicity,implantation (muscle),and haemocompatibility
	has demonstrated thatthe BiomarC FiducialMarker is:	has demonstrated thatthe Fiducial Marker is:	has demonstrated thatthe BiomarC TissueMarker is:
	non-toxic (cyto andsystemic),non-sensitizing,non-irritating(intracutaneous andimplantation),non-mutagenic, andnon-hemolytic	non-cytotoxic,non-sensitizing,non-irritating,non-reacting implanted,and non-hemolytic	non-toxic (cyto andsystemic),non-sensitizing,non-irritating(intracutaneous andimplantation),non-mutagenic, andnon-hemolytic
	per testing in accordancewith the ISO 10993series.	per testing in accordancewith ISO 10993.	per testing in accordancewith the ISO 10993series.
Visualization	Visible on standardradiographs (x-ray,mammography,fluoroscopy, kV, andCT), ultrasound, andmagnetic resonanceimaging (MRI)	Visible on EPID, film,kV and CR.	Visible on standardradiographs (x-ray,mammography,fluoroscopy, kV, andCT), ultrasound, andmagnetic resonanceimaging (MRI)

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Andrew J. Adams Director-Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road SAINT PAUL MN 55110-5867

APR 2 8 2011

Re: K110772

Trade/Device Name: BiomarC Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 17, 2011 Received: March 21, 2011

Dear Mr. Adams:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 me (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

K110772 510(k) Number (if known): __

Device Name: BiomarC Fiducial Marker

Indications for Use:

The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Patel

(Division Sign-Off)

SIOK

adiningica Office 31 10

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

BiomarC Fiducial Marker Premarket Notification 510(k) 4-1

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.