BIOMARC PRELOADED TISSUE MARKER DEVICE

K042296 · Carbon Medical Technologies, Inc. · NEU · Sep 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042296
• Device Name: BIOMARC PRELOADED TISSUE MARKER DEVICE
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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

Device Story

BiomarC Preloaded Tissue Marker Device is a sterile, single-use delivery system for implantable tissue markers. Marker consists of non-absorbable pyrolytic carbon-coated zirconium oxide. Device is used during open, percutaneous, or endoscopic surgical procedures to mark specific soft tissue locations. Marker is visible on standard radiographs, MRI, and ultrasound. Delivery system utilizes an obturator or delivery gel to place the marker. Healthcare providers use the marker to identify surgical sites for future reference or follow-up procedures. Benefit includes precise localization of tissue sites for diagnostic or therapeutic monitoring.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-absorbable pyrolytic carbon-coated zirconium oxide marker. Delivery system includes obturator or delivery gel. Sterile, single-use, nonpyrogenic. Visible via radiography, MRI, and ultrasound.

Indications for Use

Indicated for radiographic marking of soft tissue at surgical sites 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

• Promex Biopsy Site Tissue Marker Device (K023450)
• BiomarC Tissue Marker (K032347)

Submission Summary (Full Text)

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## 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 |

August 25, 2004 Submitted:

### Device Name

| Trade Name: | BiomarC® Preloaded Tissue Marker Device |
|----------------------|--------------------------------------------------------------------------|
| Classification Name: | Implantable Staple, 21 CFR 878.4750<br>Implantable Clip, 21 CFR 878.4300 |
| Common/Usual Name: | Tissue Marker |

### Predicate Device

Promex Biopsy Site Tissue Marker Device (k)023450 BiomarC Tissue Marker (k) 032347

#### Indication for Use

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

### Device Description

The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.

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## 510(k) SUMMARY (CONTINUED)

# 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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Public Health Service

SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042296

Ro42270
Trade/Device Name: BiomarC® Preloaded Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, GDW Dated: August 24, 2004 Received: August 24, 2004

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegains and the Medical Device Amendments, or to commerce prior to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costicule Act (71ct) that to not required to the general controls provisions of the Act. The I ou may, dicroro, maries are a Act include requirements for annual registration, listing of general controls provisions of as tice, 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 If your device is enastined (600 a00 royals. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may ou round in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Dris issum that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I cochar statutes and regenanents, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements);
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT and 007); ideoining (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinn 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) This letter with anow you to begin maing of substantial equivalence of your device to a legally prematication. The PDF interessification 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 If you desire spocific acrievier J at [phone]. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Miriam C. Provost

to 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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K042296

# Indications for Use Statement

510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name

BiomarC® Preloaded Tissue Marker Device

Indications for Use

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

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K042296