ENDOTINE RIBBON

K051415 · Coapt Systems, Inc. · GAM · Jun 23, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051415
• Device Name: ENDOTINE RIBBON
• Applicant: Coapt Systems, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Traditional
• 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

The ENDOTINE Ribbon™ is a bioabsorbable implant used for soft tissue fixation during cosmetic procedures. The device consists of an insertion tool/cover and an implant featuring fixation tines attached to an anchoring leash. It is supplied sterile for single-use. During surgery, the device is used by a physician to elevate and secure tissues to the deep temporal fascia or mastoid fascia. The implant provides mechanical fixation to support tissue positioning. The device is intended for use in clinical settings by qualified surgeons. It benefits patients by providing a method for tissue suspension in facial rejuvenation procedures.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, including cadaver modeling and evaluations against USP Standards for absorbable surgical sutures, and surgeon feedback/observation.

Technological Characteristics

Bioabsorbable poly(glycolide/l-lactide) material. Device consists of an insertion tool/cover and an implant with fixation tines and an anchoring leash. Single-use, sterile. Design adheres to USP Standards for absorbable surgical sutures.

Indications for Use

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

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™ Device (K050611)
• PDS II Suture (N18331)
• Contour Necklift Threads (K050247)

Submission Summary (Full Text)

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JUN 2 3 2005

KOSI415,1/3

510(k) Premarket Notification ENDOTINE Ribbon™

#### 11 510(k) SUMMARY

#### 510(k) Summary 11.0

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™ Device. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 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

May 31, 2005

#### DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Ribbon™ Device

#### DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM

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KOS/4/5\$_{2/3}\$

Coapt Systems, Inc.

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

## 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 Ribbon™<br>Device | Coapt Systems, Inc | K050611 |
| PDS II Suture | Ethicon, Inc. | N18331 |
| Contour Necklift Threads | Surgical Specialties | K050247 |

#### DEVICE DESCRIPTION

The ENDOTINE Ribbon™ consists of an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.

#### 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 EQUIVLANCE COMPARISON

#### 1. Indications Summary

The "Indication Statement" for the ENDOTINE Ribbon™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices. The intended use statement for the ENDOTINE Ribbon™ is more specific than that of the PDS II Suture, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in face lift procedures. The differences between the ENDOTINE Ribbon™ and the predicate devices do not affect the safety and effectiveness of the ENDOTINE Ribbon™. The Contour Necklift Thread is intended to be used in a neck lift procedure.

#### 2. Technological Characteristics Summary

The ENDOTINE Ribbon™ is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Ribbon™. Further, the technological characteristics of the ENDOTINE Ribbon™ are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ENDOTINE Ribbon™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness.

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## 3. Performance Summary

The ENDOTINE Ribbon™ Device is safe and appropriate for the intended use due to the following:

- Its similarity to the predicate devices. .
- A design pathway that included extensive cadaver modeling and evaluations . which exceeded user specifications and USP Standards for absorbable surgical sutures.
- Feedback and user observation from several leading surgeons. .

The ENDOTINE Ribbon™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.

# SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the ENDOTINE Ribbon™ is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the ENDOTINE Ribbon™ Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/3/Picture/13 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 perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines forming its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2005

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

Re: K051415

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: May 31, 2005 Received: June 1, 2005

Dear Ms. Ruedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encreate) 75 the enactment date of the Medical Device Amendments, or to comments province to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have boon recuire approval of a premarket approval application (PMA). and Cosmetic Act (110-) that to nevice, subject to the general controls provisions of the Act. The r our may, therefore, manner of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 your device is classified dditional controls. Existing major regulations affecting your device it may be subject to saan additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oodo cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drivisation that your device complies with other requirements of the Act that I Drimas made a and regulations administered by other Federal agencies. You must or any 1 catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the 11th of 11th Part 801); good manufacturing practice requirements as set OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Linda Ruedy

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w yourse of substantial equivalence of your device to a legally premation nouried.com "Te 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 11 you desire specific acrepliance 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 other general mionmantial 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,

Miriam C. Provost, Ph.D.

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0514/5

Coapt Systems, Inc.

510(k) Premarket Notification ENDOTINE Ribbon™

#### STATEMENT OF INDICATIONS FOR USE 4

| 510(k) Number: | Not yet assigned |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ENDOTINE Ribbon™ |
| Indications for Use: | The ENDOTINE Ribbon™ is indicated for use in<br>elevation and fixation of tissues in the temporal region,<br>midface, lower face/jowl to the deep temporal fascia and<br>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)

Division of General Restorative

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