Fiducial Marker

K211590 · Carbon Medical Technologies, Inc. · IYE · Jun 10, 2021 · Radiology

Device Facts

• Record ID: K211590
• Device Name: Fiducial Marker
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 10, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

Device Story

Device is a sterile, single-use, implantable fiducial marker; consists of pyrolytic carbon-coated zirconium oxide marker within a lyophilized glucan gel carrier. Implanted into body tissue to serve as a reference point for radiotherapy and SBRT. Visible across multiple imaging modalities: kV X-ray, CT, CBCT, mammography, ultrasound, and MRI. Used by clinicians to localize targets for radiation therapy; enables accurate radiation delivery by providing a stable reference frame. Benefits patient by facilitating precise target localization, potentially sparing surrounding healthy tissue during radiation treatment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, visibility, MR safety/compatibility, and sterilization/packaging/shelf-life evaluations.

Technological Characteristics

Pyrolytic carbon-coated zirconium oxide marker in lyophilized glucan gel carrier. Sterile, pyrogen-free, single-patient use. Visible on kV X-ray, CT, CBCT, mammography, ultrasound, and MRI. No electronic components or software.

Indications for Use

Indicated for patients requiring implantation of fiducial markers for visualization and reference frame establishment during stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

Regulatory Classification

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.

Predicate Devices

• BiomarC Fiducial Marker (K110772)
• Preloaded Tissue Marker (K100994)

Submission Summary (Full Text)

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June 10, 2021

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Carbon Medical Technologies Inc. % Mr. Eric Furlich Director - R&D and Regulatory Affairs 1290 Hammond Road ST. PAUL MN 55110

Re: K211590

Trade/Device Name: [Trade Name] Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: May 20, 2021 Received: May 24, 2021

Dear Mr. 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/cfpmp/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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. 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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# Indications for Use

510(k) Number (if known) K211590

Device Name [Trade Name] Fiducial Marker

Indications for Use (Describe)

The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) SUMMARY - K211590

## Submitter's Name, Address and Date of Submission

Eric Furlich Director - R&D and Regulatory Affairs Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110 Phone: [phone] Fax: [phone]

Submitted:

### Device Name

| Trade Name: | [Trade Name] Fiducial Marker |
|----------------------|---------------------------------------------------|
| Common Name: | Fiducial Marker |
| Classification Name: | Medical charged-particle radiation therapy system |
| | 21 CFR 892.5050 |
| Product Code: | IYE |

## Predicate Device

BiomarC Fiducial Marker (K110772) Preloaded Tissue Marker (K100994)

### Indication for Use

The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

### Device Description

The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).

### 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, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices.