BIOMARC TISSUE MARKER

K032347 · Carbon Medical Technologies, Inc. · GDW · Aug 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032347
• Device Name: BIOMARC TISSUE MARKER
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2

Intended Use

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

Device Story

BiomarC Tissue Marker is a sterile, nonpyrogenic, single-use implantable device. It consists of a nonabsorbable pyrolytic carbon-coated zirconium oxide marker. The device is placed into soft tissue during open, percutaneous, or endoscopic surgical procedures to serve as a radiographic landmark. It is visible on standard radiographs, MRI, and ultrasound. The marker is provided either alone or with a delivery gel. The device assists clinicians in identifying specific tissue locations for future surgical or diagnostic interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nonabsorbable pyrolytic carbon-coated zirconium oxide marker. Sterile, nonpyrogenic, single-use. Visible on X-ray, MRI, and ultrasound. Provided with or without delivery gel.

Indications for Use

Indicated for radiographic marking of soft tissue during or for future surgical procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

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

Predicate Devices

• BiomarC Tissue Marker (K001807)

Submission Summary (Full Text)

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AUG 2 1 2003

# ATTACHMENT 4 KU32347 (V.10F2 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

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

July 28, 2003 Submitted:

### Device Name

| Trade Name: | BiomarC® Tissue Marker |
|----------------------|-------------------------------------|
| Classification Name: | Implantable Staple, 21 CFR 878.4750 |
| Common/Usual Name: | Tissue Marker |
| Predicate Device | |

BiomarC Tissue Marker (K001807)

#### Indication for Use

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

#### Device Description

BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. B BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.

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# 510(k) SUMMARY (CONTINUED) (432349 (f. 2 xF2)

# Technological Characteristics and Performance

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

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

Re: K032347

Trade/Device Name: BiomarC Tissue Marker Regulation Number: 21 CFR 878.4750, 878.4300 Regulation Name: Implantable staple, implantable clip Regulatory Class: II Product Code: GDW, NEU Dated: July 28, 2003 Received: July 30, 2003

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.

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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/dsma/dsmamain.html

Sincerely yours.

Much A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 2

## Indications for Use Statement

(432747 510(k) Number (if known) _

BiomarC Tissue Marker Device Name

Indications for Use

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over the Counter Use (Per 21 CFR 801.109) (Division Sign-Ofr) Division of General, Restorative

and Neurological Device

-10(k) Number _

2347