BiomarC Fiducial Marker

K191797 · Carbon Medical Technologies · IYE · Jul 29, 2019 · Radiology

Device Facts

• Record ID: K191797
• Device Name: BiomarC Fiducial Marker
• Applicant: Carbon Medical Technologies
• Product Code: IYE · Radiology
• Decision Date: Jul 29, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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 Story

BiomarC Fiducial Marker is a sterile, single-use, carbon/metallic composite marker; implanted into body tissue to serve as a reference frame for stereotactic radiosurgery and radiotherapy target localization. Device provides visibility on standard radiographs, ultrasound, and MRI. Delivered via preloaded delivery system or compatible needles. Used by clinicians in clinical settings to improve target localization accuracy during radiation therapy planning and delivery. Benefits include enhanced visualization of treatment targets, facilitating precise radiation delivery.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility, visibility, MR safety/compatibility, and sterilization/packaging/shelf-life validation.

Technological Characteristics

Carbon/metallic composite discrete marker. Sterile, pyrogen-free, single-patient use. Compatible with standard radiographs, ultrasound, and MRI. Delivered via preloaded system or compatible needles.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy target localization via implanted markers for visualization.

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)
• BiomarC Fiducial Marker (K132064)
• BiomarC Fiducial Marker (K132708)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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# 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

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.

#### 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.