COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

K023922 · Coapt Systems, Inc. · HWC · Dec 20, 2002 · Orthopedic

Device Facts

• Record ID: K023922
• Device Name: COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
• Applicant: Coapt Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Special
• 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

The ENDOTINE system is a bioabsorbable implant designed for browplasty surgery. It functions as a bone fixation fastener to secure the sub-dermis to the cranial bone. The system includes the bioabsorbable implant, a stainless steel step drill-bit, a drill handle, an installation instrument, and a sterilization tray. It is used by surgeons in a clinical setting to provide mechanical fixation during brow lift procedures. The device is intended to hold tissue in place while healing occurs, after which the implant is absorbed by the body.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technological, and performance characteristics.

Technological Characteristics

Bioabsorbable implant; stainless steel step drill-bit; mechanical bone fixation fastener; intended for surgical use; sterilization tray included.

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

• Coapt Systems ENDOTINE Device (K014153)

Submission Summary (Full Text)

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KO23922

# Summary of Safety and Effectiveness

### Trade Name:

Coapt Systems ENDOTINE Device TM

#### Manufacturer Information:

Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Phone: [phone] (Daniel Jacobs, MD) Site Registration number: 3003644133 e-mail: [e-mail]

## Contact:

Shellev Trimm 1152 Navarro Street Santa Rosa, CA 95401 Phone: [phone] FAX: [phone] e-mail: [e-mail]

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Establishment Registration Number: 3003644133

#### FDA Device Classification:

| Standard Product Nomenclature: | Smooth or Threaded Metallic Bone Fixation Fastener |
|--------------------------------|----------------------------------------------------|
| Product Code: | HWC |
| CFR Number: | 888.3040 |
| Risk Class: | Class II |
| Classification Panel: | General Restorative & Neurological Devices |

#### Intended Use and Indication for Use:

The ENDOTINE device intended use and indication for use will remain unchanged.

The ENDOTINE device will continue to be intended for use in browplasty surgery.

The ENDOTINE device will continue to be labeled with the indication for use of:

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.

.age 17

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K023922 page 24

## Product Description:

The ENDOTINE system includes the bioabsorbable ENDOTINE Implant, a stainless steel step drill-bit intended to be used in conjunction with the drill handle, and the ENDOTINE installation instrument and a sterilization tray.

### Substantial Equivalence:

Establishment of equivalence is based on similarities of intended use, fundamental scientific technology, labeling, design, dimensional specification, performance specification, ergonomics of the patient-user interface, packaging and expiration dates, and sterilization. Based on the criteria set forth in 21 CFR 807.87 and under the New 510(k) Paradigm, it is the belief of Coapt Systems that the ENDOTINE device cleared to market in K014153 and the proposed ENDOTINE device are substantially equivalent in all aspects expect material.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized human profiles incorporated into the design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coapt Systems, Inc. c/o Ms. Shelley Trimm RCO Consulting 1152 Navarro Street Santa Rosa, California 95401

#### Re: K023922

Trade/Device Name: Coapt Systems 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: November 22, 2002 Received: November 25, 2002

Dear Ms. Trimm:

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. Iisting 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 (OS) 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. Shelley Trimm

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]. 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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CONFIDENTIAL

# STATEMENT FOR INDICATIONS FOR USE

Page 1 of 1

510(k) Number: 14044153

Device Name: Coapt Systems ENDOTINE Device

Indication 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

NO

or

Over-the-Counter Use

Yes

(Division Sign-Off)

510(k) Number:

sion Sign-Oil) Givision of General, Restorative and Neurological Devices

Number K023922