ENDOTINE RIBBON

K050611 · Coapt Systems, Inc. · GAM · Apr 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050611
• Device Name: ENDOTINE RIBBON
• Applicant: Coapt Systems, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Apr 6, 2005
• 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 subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

Device Story

The ENDOTINE Ribbon™ is a bioabsorbable surgical implant designed for soft tissue fixation in midface suspension surgery. The device consists of a fixation platform pre-loaded on an insertion tool. During surgery, the physician uses the tool to place the implant, which secures the cheek subdermis in an elevated position. The device is intended for use by surgeons in a clinical or operating room setting. By providing a stable fixation platform, the device assists in maintaining the elevated position of the cheek tissue, potentially improving surgical outcomes in midface suspension procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bioabsorbable surgical implant; pre-loaded on an insertion tool; sterilized as a single unit. The device functions as a soft tissue fixation platform.

Indications for Use

Indicated for patients undergoing subperiosteal midface suspension surgery requiring fixation of the cheek subdermis in an elevated position.

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 Midface™ ST 4.5 Device (K032698)

Submission Summary (Full Text)

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

Coapt Systems, Inc.

#### 2002 APR 6

#### 510(k) SUMMARY 10.0

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™. 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 Ruedy 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 8, 2005

### DEVICE TRADE OR PROPRIETARY NAME ENDOTINE Ribbon™

# DEVICE COMMON OR CLASSIFICATION NAME

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

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

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

| Name of Predicate Device | Name of Manufacturer | 510(K) or PMA Number |
|------------------------------------|----------------------|----------------------|
| ENDOTINE Midface™<br>ST 4.5 Device | Coapt Systems, Inc | K032698 |

# 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 subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

# 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 Modified Ribbon™. The Modified 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 unmodified predicate device, the ENDOTINE Midface™ ST 4.5 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.

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

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans.

2005 APR 6

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050611

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 8, 2005 Received: March 10, 2005

Dear Ms. Ruedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined 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 encroom's regions and the Medical Device Amendments, or to conimeres processified in accordance with the provisions of the Federal Food. Drug. de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Act, that do movice, subject to the general controls provisions of the Act. The r our may, merere, mains of the Act include requirements for annual registration. Iisting of general controls provisions were mactice, 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 elassified (overal controls. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obac or vents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial cquivalence determination does not mean Flease of advised that I Dri 3 installed on our device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any rederal statutes and regulations sincluding, but not limited to: registration and listing (21 comply with an the Act 31equirements, n.e., good manufacturing practice requirements as set CFR Part 807), idocing (21 CFR Part 807), good manat 820); and if applicable, the clectronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Linda Ruedy

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your of substantial equivalence of your device to a legally premarket notineatem " mesults 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 If you don't specific as not any and [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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

L. Misiura, C.Petrat, Ph.D.

Miriam C. Provost, Ph.D. 42-Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Kosobil Special 510(k) Premarket Notification ENDOTINE Ribbon™

# STATEMENT OF INDICATIONS FOR USE

Not yet assigned 510(k) Number (if known): ENDOTINE Ribbon™ Device Name:

Indications For Use:

The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

Prescription Use __

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


5 orative

los 06 11

. . . 014