BIOMARC FIDUCIAL MARKER

K132064 · Carbon Medical Technologies, Inc. · IYE · Feb 28, 2014 · Radiology

Device Facts

• Record ID: K132064
• Device Name: BIOMARC FIDUCIAL MARKER
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Traditional
• 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 stereotactiv radiosurgery and radiotherapy target localization.

Device Story

BiomarC Fiducial Marker is a sterile, single-patient-use, carbon/metallic composite marker. Implanted into body tissue to serve as a radiopaque and MRI-visible reference point. Used by clinicians during stereotactic radiosurgery and radiotherapy planning. Markers are delivered via preloaded delivery system or compatible needles. Provides visual reference frame on standard radiographs and MRI scans to assist target localization. Benefits include improved accuracy in radiation therapy targeting.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, MR safety/compatibility, and sterilization/packaging validation.

Technological Characteristics

Carbon/metallic composite fiducial marker. Sterile, pyrogen-free, single-patient use. Visible on standard radiographs and MRI. Delivered via preloaded system or compatible needles.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy target localization; markers are implanted into the body to serve as a reference frame 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 Gold Fiducial Marker (K130678)

Submission Summary (Full Text)

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K132064
Page 1 of 1

## 510(k) SUMMARY

# Submitter's Name, Address and Date of Submission

FEB 2 8 2014

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

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

Submitted: July 2, 2013

#### 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 Gold Fiducial Marker (K130678)

### Indication for Use

The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactiv 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 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. MR safety / compatibility and sterifization and packaging / shelf life adoption evaluation confirmed that the modified device. BiomarC Fiducial Marker, was substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

February 28, 2014

Carbon Medical Technologies, Inc. % Mr. Andrew J. Adams Director, Regulatory Affairs & Quality Assurance 1290 Hammond Road SAINT PAUL MN 55110-5876

Re: K132064 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: February 20, 2014 Received: Feburary 21, 2014

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. 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Page 2 - Mr. Andrew Adams

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Archael D. DiHara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES .. Food and Drug Administration

# Indications for Use

510(k) Number (if known) K 132064

Device Name BiomarC Fiducial Marker

Indications for Use (Describe)

The BiomarC Fiducial Markers are intended into the body to accurately visualize and consitute 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)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Mechal D. O'Hara

FORM FDA 3881 (9/13)

PSC Publishing Screaces [phone] દા

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