COAPT SYSTMES ENDOTINE DEVICE

K014153 · Coapt Systems, Inc. · HWC · Mar 15, 2002 · Orthopedic

Device Facts

• Record ID: K014153
• Device Name: COAPT SYSTMES ENDOTINE DEVICE
• Applicant: Coapt Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

Device Story

Endotine Device is a bioabsorbable fixation implant for browplasty procedures; fabricated from L-PLA. Device features a post for insertion into cranial bone and barbs on the face for direct sub-dermis fixation without sutures. Used by surgeons in clinical settings; inserted using specialized installation instruments including a stepped drill. Eliminates need for suture-based fixation used in predicate devices. Provides mechanical stability for tissue during healing; benefits patient by simplifying surgical technique and reducing reliance on traditional suturing methods.

Clinical Evidence

No clinical data. Evidence consists of in-vitro bench testing comparing shear strength to the predicate device and animal testing to confirm functional adequacy and tissue-device interface performance.

Technological Characteristics

Bioabsorbable fixation device fabricated from L-PLA. Features a post for cranial bone insertion and barbs for sub-dermis fixation. Includes dedicated installation instruments (stepped drill, tray). Non-electronic, mechanical device.

Indications for Use

Indicated for patients undergoing browplasty surgery requiring fixation of the sub-dermis to the cranial bone.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Bionx Endobrow Screw

Submission Summary (Full Text)

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# AR 1 5 2002

#### 510(K) SUMMARY

#### 1. SUBMITTER:

Coapt Systems, Inc 261 Hamilton Avenue Suite 413 Palo Alto, CA 94301 Telephone: [phone]

Contact: Jude Paganelli, Vice President Operations Date Prepared: December 10, 2001

#### 2. DEVICE:

Endotine Device Classification Name: Bioabsorbable Fixation Device Trade Name: Coapt Systems Endotine Device

#### 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Endotine Device was the Bionx Endobrow Screw marketed by Bionx Implants, Blue Bell, PA

#### 4. DEVICE DESCRIPTION:

The Endotine Device is a device fabricated from L-PLA that is intended for use in browplasty procedures. The device is molded with a post that is inserted directly into the cranial bone. A series of barbs along its face provides a feature that allows for the direct fixation the sub-dermis without the use of suture. The device is inserted into the bone with the use of an installation instrument. Additional instruments include a stepped drill and sterilization tray.

### 5. INTENDED USE:

The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

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## 6. COMPARISON OF CHARACTERISTICS:

The Endotine Device is fabricated from L-PLA, while the Bionx Endobrow Screw is fabricated from L/DL-PLA. The Endotine device design provides direct fixation to the sub-dermis. The Bionx Endobrow Screw provides fixation to the device through the use of suture that is affixed to the sub-dermis.

The indications for use of the two devices are identical.

#### 7. PERFORMANCE DATA:

The following performance data was provided in support of the substantial equivalence determination:

- 1. Bench Testing: Comparison of the shear strength of the Endotine Device In-Vitro compared to the predicate device.
- 2. Animal Testing: The testing demonstrated the acceptability of the Endotine Device and confirmed that the device functions adequately to meet its intended use.
- 3. Tissue Interface: Comparison of the device to tissue interface of the Endotine Device to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its head turned to the left, and the eagle's body is formed by three human profiles facing the same direction.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Ms. Jude Paganelli Coapt Systems Inc. 261 Hamilton Avenue Suite 413 Palo Alto, CA 94301

Re: K014153

Trade/Device Name: Endotine Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 10, 2001 Received: December 18, 2001

Dear Ms. Paganelli:

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 for associated in the 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 - Ms. Jude Paganelli

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,

R. Mark A. Mellem

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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### INDICATIONS FOR USE

The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

for Muke n Wilkerson
Division Signer

(Division Sign-ﻟﺖ Division of General Restorative and Neurological Devices K014153

510(k) Number:***_***