BIOMARC GOLD TISSUE MARKER

K070436 · Carbon Medical Technologies, Inc. · NEU · Mar 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070436
• Device Name: BIOMARC GOLD TISSUE MARKER
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

BiomarC Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Device Story

Sterile, nonpyrogenic, single-use tissue marker; composed of 99.99% metallic gold. Device placed into soft tissue during open, percutaneous, or endoscopic procedures. Provides radiographic visibility on standard X-rays, MRI, and ultrasound. Used by surgeons to mark specific tissue locations for future identification or surgical intervention.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: 99.99% metallic gold. Form factor: Implantable tissue marker. Imaging compatibility: Radiographic, MRI, and ultrasound. Sterilization: Sterile.

Indications for Use

Indicated for radiographic marking of soft tissue during or for 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 (K0063193)
• RadioMed Soft Tissue Marker (K022346)

Submission Summary (Full Text)

{0}------------------------------------------------

K07 0436

1/2

ATTACHMENT 5

#### 510(K) SUMMARY

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

Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110

MAR 1 6 2007

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

February 12, 2007 Submitted:

## Device Name

| Trade Name: | BiomarC® Gold Tissue Marker |
|----------------------|-----------------------------------|
| Classification Name: | Implantable Clip, 21 CFR 878.4300 |
| Common/Usual Name: | Tissue Marker |

## Predicate Device

BiomarC Tissue Marker (K0063193) RadioMed Soft Tissue Marker (K022346)

# Indication for Use

BiomarC Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

# Device Description

BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.

{1}------------------------------------------------

K070436
2/2

# 510(k) SUMMARY (CONTINUED)

# Technological Characteristics and Performance

ג וי

The technological characteristics are equivalent to the predicate devices. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate devices.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three flowing ribbons extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carbon Medical Technologies, Inc. % Mr. Robert W. Johnson VP, Regulatory Affairs and Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110-5867

MAR 1 6 2007

Re: K070436

Trade/Device Name: BiomarC Gold Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 12, 2007 Received: February 15, 2007

Dear Mr. Johnson:

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.

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

{3}------------------------------------------------

Page 2 - Mr. Robert W. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Fof

Mark N. Muller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K070436

Indications for Use

510(k) Number (if known):

Device Name: BiomarC Gold Tissue Marker

Indications for Use:

The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Poth

(Division Sign-Of-Division of General, Restor attoca and Neurological Levices

510(k) Number

Page 1 of 2