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

The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BiomarC Fiducial Marker, an existing device that has undergone modifications. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data for acceptance criteria.

Therefore, the information required to fully answer the request, such as a detailed table of acceptance criteria with reported device performance, sample sizes for test and training sets, specifics on ground truth establishment involving expert consensus, MRMC study results, or standalone algorithm performance, is not present in this submission.

The document states that the "Technological Characteristics and Performance" of the modified device are "equivalent to the predicate devices." This implies that the device is not undergoing a new clinical validation study to establish novel performance metrics but rather confirming that its modified design does not negatively impact existing, previously proven performance.

Here's what can be extracted and inferred based on the provided document:

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

Based on the nature of a 510(k) for a modified device, the "acceptance criteria" appear to be related to demonstrating the continued equivalence of key characteristics and performance aspects to the predicate devices. The document states:

Acceptance Criteria Category (Inferred)	Reported Device Performance (as stated in the document)
Technological Characteristics	"The technological characteristics are equivalent to the predicate devices."
Biocompatibility	"A biocompatibility... adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices."
Visibility (Radiographs, Ultrasound, MRI)	"A visibility... adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices."
MR Safety / Compatibility	"A... MR safety / compatibility adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices."
Sterilization and Packaging / Shelf Life	"A... sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices."
Risk Management (FMEA)	"A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced." (Implies risks are acceptable/managed)

Notes:

The reported performance is a declaration of substantial equivalence, not quantitative metrics from a new clinical study.
The "study that proves the device meets the acceptance criteria" in this context refers to the evaluations performed for the 510(k) submission, confirming that the modifications do not alter the substantial equivalence for these key characteristics. These are likely internal testing activities rather than large-scale clinical trials.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. For a 510(k) of a modified device, the "test set" would primarily refer to engineering and bench testing rather than a clinical dataset.
Data Provenance: Not specified. Again, likely internal testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not describe the establishment of a "ground truth" using experts for a test set in the context of an AI-driven device or diagnostic study. This approval is for a physical medical device (fiducial marker), not an AI algorithm.

4. Adjudication method for the test set:

Not applicable, as there's no mention of a clinical test set requiring expert adjudication for ground truth.

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 approval is for a fiducial marker, not an AI-assisted diagnostic or assistive tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For a physical device like a fiducial marker, "ground truth" would relate to its physical properties and measurable performance characteristics (e.g., visibility, biocompatibility, MRI compatibility). The "ground truth" for the equivalence claim is the performance data of the predicate devices. The current submission confirms that the modified device's performance matches that established "ground truth" of the predicates.

8. The sample size for the training set:

Not applicable. There is no AI training set mentioned as this is not an AI device.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carbon Medical Technologies % Eric Furlich R & D Engineer 1290 Hammond Rd. ST. PAUL, MN 55110-5876

July 29, 2019

Re: K191797

Trade/Device Name: BiomarC Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, NEU Dated: July 2, 2019 Received: July 3, 2019

Dear Eric Furlich:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia Mills Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 1

(Exhibits are on the following pages)

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Special 510(k) – BiomarC Fiducial Marker

ATTACHMENT 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below.
510(k) Number (if known)

Device Name BiomarC Fiducial Marker

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

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ATTACHMENT 5

510(k) SUMMARY

Submitter's Name, Address and Date of Submission

Eric Furlich R&D Engineer Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110

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

July 2, 2019 Submitted:

Device Name

Trade Name:	BiomarC Fiducial Marker
Common Name:	Fiducial Marker
Classification Name:	Accelerator, Linear, Medical (21 CFR 892.5050, IYE)

Predicate Device

BiomarC Fiducial Marker (K110772) BiomarC Fiducial Marker (K132064) BiomarC Fiducial Marker (K132708)

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

Technological Characteristics and Performance

The technological characteristics are equivalent to the predicate devices. A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. A biocompatibility, visibility, MR safety / compatibility and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices.

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.