MODIFICATION TO ENDOTINE RIBBON

K060828 · Coapt Systems, Inc. · GAM · Apr 19, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060828
• Device Name: MODIFICATION TO ENDOTINE RIBBON
• Applicant: Coapt Systems, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.

Device Story

ENDOTINE Ribbon™ is a bioabsorbable soft tissue fixation implant pre-loaded on an insertion tool. Used by surgeons during cosmetic procedures to elevate and fixate tissues in the temporal region, midface, lower face/jowl, and neck. The implant provides a fixation platform to secure tissue to deep temporal or mastoid fascia. The device is supplied sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bioabsorbable implant; pre-loaded on insertion tool; sterilized together. Class II device (Product Code: GAM).

Indications for Use

Indicated for elevation and fixation of tissues in the temporal region, midface, lower face/jowl, and neck during cosmetic procedures.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• ENDOTINE Ribbon™ (K051415)

Submission Summary (Full Text)

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Coapt Systems, Inc.

Special 510(k) Premarket Notification ENDOTINE Ribbon™

APR 1 ° 2006

K060828/2

#### 510(k) SUMMARY 10.0

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™ (Subject) . This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 8807.92 and pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990.

#### SPONSOR/APPLICANT NAME AND ADDRESS

Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: [phone] Facsimile: [phone]

#### CONTACT INFORMATION

Linda Ruedv Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: [phone] Facsimile: [phone] Email: [e-mail]

# DATE OF PREPARATION OF 510(K) SUMMARY

March 22, 2006

# DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Ribbon™

#### DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Absorbable Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM

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Coapt Systems, Inc.

2060828
2/2

### IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED

| Name of Predicate<br>Device | Name of Manufacturer | 510(k) or<br>PMA<br>Number |
|-----------------------------|----------------------|----------------------------|
| ENDOTINE Ribbon™ | Coapt Systems, Inc | K051415 |

### DEVICE DESCRIPTION

The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.

# INTENDED USE STATEMENT

The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.

# SUBSTANTIAL EQUIVALENCE

In review of the device description, predicate comparison and design control activities incorporated in this submission, no significant new issues of safety or effectiveness have been raised for the ENDOTINE Ribbon™ (Subject). The Subject Device meets all internal functional performance requirements.

Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The bird in the center is composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Coapt Systems, Inc. c/o Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, California 94303

Re: K060828

Trade/Device Name: ENDOTINE Ribbon™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 30. 2006 Received: March 31, 2006

Dear Ms. Ruedy:

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 cither 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

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#### Page 2 - Ms. Linda Ruedy

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. 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 vours.

'Qmee

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Coapt Systems, Inc.

Special 510(k) Premarket Notification ENDOTINE Ribbon™

# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Not yet assigned

ENDOTINE Ribbon™

Device Name:

Indications For Use:

The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic 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)

2m00

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

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510(k) Number_KCC 65 28