BIOMARC FIDUCIAL MARKER

K132708 · Carbon Medical Technologies, Inc. · NEU · Dec 20, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132708
• Device Name: BIOMARC FIDUCIAL MARKER
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.

Device Story

BiomarC Fiducial Marker is a sterile, pyrogen-free, single-patient-use, carbon/metallic composite marker. It serves as a radiopaque implant to mark soft tissue sites for subsequent surgical localization. The marker is visible on standard radiographs and MRI. It is delivered to the target site using a preloaded delivery system or other compatible, commercially available delivery devices. The device is used by clinicians in a clinical setting to facilitate surgical planning and guidance by providing a permanent or semi-permanent reference point within the patient's anatomy.

Clinical Evidence

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

Technological Characteristics

Carbon/metallic composite marker; sterile; pyrogen-free; radiopaque; MRI compatible; single-patient use; delivered via preloaded or compatible delivery systems.

Indications for Use

Indicated for radiographic marking of soft tissue in patients requiring future surgical procedures.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• BiomarC Tissue Marker (K063193)
• EchoTip® Ultra Fiducial Needle (K111895)

Submission Summary (Full Text)

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## 510(k) SUMMARY

# DEC 2 0 2013

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

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

Phone: [phone] Fax: [phone]

Submitted: August 28, 2013

#### Device Name

| Trade Name: | BiomarC Fiducial Marker |
|----------------------|-----------------------------------------|
| Common Name: | Tissue Marker |
| Classification Name: | Implantable Clip (21 CFR 878.4300, NEU) |

## Predicate Devices

BiomarC Tissue Marker (K063193) EchoTip® Ultra Fiducial Needle (K111895)

### Indication for Use

The BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.

#### 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 delivery devices 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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

Public Health Service

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

Carbon Medical Technologies Incorporated Mr. Andrew J. Adams Director, Regulatory Affairs & Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110-5876

December 20, 2013

Re: K132708

Trade/Device Name: BiomarC Fiducial Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: November 15, 2013 Received: November 18, 2013

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 (21 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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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" (21CFR 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/ReportalProblem/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.

For

Sincerely vours.

Radiological Health

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

Enclosure

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

Indications for Use

510(k) Number (if known) K132708

. .. ... .. .. .. .. .. .. ..

#### Device Name BiomarC Fiducial Marker

Indications for Use (Describe)

The Biomac Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.

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

2 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)