COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER

K012955 · Bioform, Inc. · NEU · Oct 22, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012955
• Device Name: COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
• Applicant: Bioform, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Indications for Use

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

Device Story

Coaptite™ Tissue Marker is a sterile, nonpyrogenic, flexible, semi-solid, cohesive implant used as a single-use tissue marker. It consists of synthetic calcium hydroxylapatite beads suspended in an aqueous gel of sodium carboxymethylcellulose (NaCMC) and glycerin. The device is placed into soft tissue during open, percutaneous, or endoscopic surgical procedures. The radiopaque calcium hydroxylapatite beads allow for visualization of the surgical site via standard radiography, CT scan, MRI, and ultrasound. The device is MRI compatible due to the absence of ferrous materials. It serves to provide a permanent radiographic landmark for clinicians to identify specific tissue locations for future surgical or diagnostic interventions.

Clinical Evidence

Clinical evidence includes a study by Robert Mayer, M.D., with subjects followed for more than five years post-implant. Preclinical safety studies, including dog implant studies, were conducted under GLP guidelines. Results from in vivo testing (sensitization, short-term tissue reaction, systemic toxicity) identified the device as nonantigenic, a nonirritant, and nontoxic, with no long-term safety concerns observed over thirty-six months.

Technological Characteristics

Formulated from synthetic dense calcium hydroxylapatite (meeting ASTM-1185) and aqueous excipients (glycerin, sodium carboxymethylcellulose). Available in two particle size ranges: 75-125 microns (Coaptite™) and 25-45 microns (Coaptite™ FN). Non-ferrous, MRI compatible. Sterilized via in-house validated steam autoclave system using overkill methodology to 10^-6 SAL. Standalone implantable device.

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

Predicate Devices

• Durasphere Tissue Marker (K001807)
• Gel Mark Biopsy Site Marker (K000060)
• Auto Suture Site Marker staple (K983400)

Submission Summary (Full Text)

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

K012955

OCT 2 2 2001

510(k) Premarket Notification Submission Coaptite™ Tissue Marker

# 510(k) Summary of Safety and Effectiveness

| Trade Name: | Coaptite™ Tissue Marker and Coaptite™ FN Tissue<br>Marker |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Tissue Marker |
| Classification Name: | Implantable Tissue Marker |
| Official Contact: | Victor M. Bowers<br>Director Market Development<br>BioForm, Inc.<br>4133 Courtney Road<br>Franksville, WI 53126<br>Phone [phone]<br>Fax [phone] |

Date Prepared: 8-31-01

#### Intended Use

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

#### Product Description

Coaptite™ Tissue Marker is a sterile, nonpyrogenic, flexible, semi-solid, cohesive implant used as a single use tissue marker. The principle component of the Coaptite™ Tissue Marker is synthetic calcium hydroxylapatite, a radiopaque biomaterial with over twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology, and ophthalmology. The product is available in two particle size ranges to allow different needle sizes for percutaneous placement. Coaptite™ Tissue Marker (0008025-1 and 0008026-1) has a size range of 75-125 microns. Coaptite™ FN Tissue Marker (0008027-1 and 0008028-1) has a size range of 25-45 microns. The calcium hydroxylapatite beads are clearly visible on standard radiographs as well as CT scan, MRI, and ultrasound. The cohesive semi-solid, elastic nature of the Coaptite™ Tissue Marker is created by physical bonds formed with sodium carboxymethylcellulose (NaCMC). NaCMC has also been used safely as a biomaterial for over twenty years. Coaptite™ Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. There is no ferrous material used in the formulation for Coaptite™ Tissue Marker and therefore it is MRI compatible.

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

#### Substantial Equivalence

The following are predicate devices that are substantially equivalent to Coaptite™ Tissue Marker.

K001807 Durasphere Tissue Marker Carbon Medical Technologies 1290 Hammond Road St. Paul, MN 55110

K000060 Gel Mark Biopsy Site Marker SenoRx, Inc. 13766 Alton Parkway, Suite 144 Irvine, CA 92618

K983400 Auto Suture Site Marker staple United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856

Coaptite™ Tissue Marker is substantially equivalent to the Durasphere Tissue Marker (K001807) manufactured by Carbon Medical Technologies, Inc., St. Paul, MN., Gel Mark Biopsy Site Marker (K000060) manufactured by SenoRx Inc., Irvine, CA., and Auto Suture Site Marker staple (K983400) manufactured by United States Surgical Corporation, Norwalk, CT. The Federal Food and Drug Administration, following review of the 510(K) pre-marketing notifications submitted by each company, approved for manufacture and sale all three of the predicate Class II devices. The 510(K) Number for each product is provided above. All of these devices have the same indication for use as radiographis soft tissue marker.

## Biocompatibility Evaluations

Coaptite™ Tissue Marker is primarily formulated from synthetic dense calcium hydroxylapaptite meeting ASTM-1185, which has a proven record of excellent biocompatibility. The gel component of Coaptite™ Tissue Marker is an aqueous formulation of USP grade pharmaceutical grade excipients (glycerin and sodium carboxymethylcellulose). These excipients have extensive use in intramuscular injections such as Cortone®, Decadron®, Kenalog®, and Dalalone®. The battery of preclinical safety studies, dog implant studies, and clinical studies have shown that Coaptite™ Tissue Marker is biocompatible when injected into various submucosal or other tissues of animals. Subjects from the clinical study by Robert Mayer, M.D. are now more than five years out from implant placement with no long term concerns.

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

## Sterilization

Coaptite is sterilized using steam; processing is performed in-house using a validated autoclave system. Cycle parameters were validated using an overkill methodology to 10to SAL. Sterilization by the user is not required.

## Pre-Clinical Tests Performed

In vitro and in vivo tests were based on Tripartite and Biocompatibility guidelines and International Organization for Standardization ISO10993, Biological Evaluation of Medical Devices, using historically accepted test methods of biomedical materials or United States Pharmacopoeia references. These studies were conducted under GLP guidelines.

In vivo tests were performed to address sensitization, tissue reaction during short-term implantation, systemic reactions and long term safety issues. Results identified Coaptite™ Tissue Marker as nonantigenic, a nonirritant, and nontoxic with no concerns for long term safety issues based on thirty-six month data.

## Summary

In summary Coaptite™ Tissue Marker is substantialy equivalent to three predicate devices which all have the same indication for use. The components used in Coaptite™ Tissue Marker are biocompatible based on the history of their use in multiple medical devices as well as from pre-clinical and clincial experience. Coaptite™ Tissue Marker is equivalent in its application and is as safe as the predicate devices named above.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

OCT 22 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Victor M. Bowers Director of Market Development BioForm, Inc. 4133 Courtney Road, #10 Franksville, Wisconsin 53126

Re: K012955

Trade/Device Name: Coaptite™ Tissue Marker and Coaptite™ FN Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Codes: NEU, GDW Dated: August 31, 2001 Received: September 04, 2001

Dear Mr. Bowers:

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.

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

Page 2 - Mr. Victor M. Bowers

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sus-Well &

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

{5}------------------------------------------------

510(k) Premarket Notification Submission Coaptite™ Tissue Marker

## Kol2955 510(k) Number (if known):

Device Name: Coaptite™ Tissue Marker

#### Indications For Use:

Coaptite™ 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)

Sh
Division Sign Off

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

510(k) Number K012953

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)