COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE

K032698 · Coapt Systems, Inc. · GAM · Oct 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032698
• Device Name: COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
• Applicant: Coapt Systems, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Oct 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

Device Story

The ENDOTINE Midface™-ST 4.5 is a sterile, single-use surgical implant system used in midface suspension procedures. The device consists of an insertion tool, a fixation platform with an anchoring leash, and an anchoring tack. During surgery, the device is used by a physician to secure and elevate the cheek subdermis. The bioabsorbable implant provides mechanical fixation to maintain the tissue in an elevated position post-operatively. The device is intended for use in a clinical or surgical setting. It benefits patients by providing a stable, absorbable means of tissue suspension during midface lift procedures.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing, including extensive cadaver modeling and evaluations, and surgeon feedback. Performance data met applicable standards and user specifications.

Technological Characteristics

Bioabsorbable implant system consisting of a fixation platform, anchoring leash, and anchoring tack. Materials are consistent with absorbable, implantable surgical devices. Supplied sterile for single use. Mechanical fixation principle.

Indications for Use

Indicated for patients undergoing subperiosteal midface suspension surgery to fixate 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 Forehead™ Device (K023992/K014153)
• PDS II Suture (N18331)
• Lactosorb® Panels (K974309)

Submission Summary (Full Text)

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10/23/03

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#### 11 510(k) SUMMARY

#### 11.0 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Midface™-ST 4.5 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 Mirchelles of 21
- 81000 of 1990.

# SPONSOR/APPLICANT NAME AND ADDRESS

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

# CONTACT INFORMATION

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

# DATE OF PREPARATION OF 510(K) SUMMARY

August 29, 2003

# DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Midface™-ST 4.5 Device

# DEVICE COMMON OR CLASSIFICATION NAME

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

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Coapt Systems, Inc.

1820 Embarcadero Boad Palo Alto, CA 94303

650.331.7670 Mair 650.213.9377 Fax

www.coaptsystems.com

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# 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 Forehead™<br>Device | Coapt Systems, Inc | K023992/K014153 |
| PDS II Suture | Ethicon, Inc. | N18331 |
| Lactosorb® Panels | Walter Lorenz Surgical | K974309 |

#### DEVICE DESCRIPTION

The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution tools are supplied sterile for single use only.

### INTENDED USE STATEMENT

The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

## SUBSTANTIAL EQUIVLANCE COMPARISON

### 1. Indications Summary

The "Indication Statement" for the ENDOTINE Midface™-ST 4.5 is substantiated by the results of the performance evaluations and comparison testing to the PDS II Suture predicate device. The intended use statement for the ENDOTINE Midface™ ST 4.5 is more specific than that of the predicate device, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in the midface lift procedure. The differences between the ENDOTINE Midface™-ST 4.5 and the predicate device do not affect the safety and effectiveness of the ENDOTINE Midface™S Sp 4.5. An appropriate and complete testing program supports the ENDOTINE Midface™ ST 4.5 is suitable to perform and operate as clinically intended.

### 2. Technological Characteristics Summary

The ENDOTINE Midface™ ST 4.5 is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Forehead and Lactosorb Panel predicate devices. Further, the technological characteristics of the ENDOTINE Midface-ST 4.5 are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ENDOTINE Midface™-ST 4.5 and the predicate devices are minor and do not raise issues regarding safety or effectiveness. This statement is substantiated by a history of

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clinical use with the ENDOTINE Forehead device, and an established safety profile of the device material in the midface (bone and tissue).

#### 3. Performance Summary

The ENDOTINE Midface-ST 4.5 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 Midface™-ST 4.5 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 Sysems believes the ENDOTINE Midface™-ST 4.5 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 Midface™-ST 4.5 Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

OCT 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, California 94303

Re: K032698

Trade/Device Name: ENDOTINE Midface™-ST 4.5 Regulation Number: 21 CFR 878.4493, 888.3040 Regulation Name: Absorbable suture, Bone fixation screw Regulatory Class: II Product Code: GAM, IIWC Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. DonDicgo:

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. 17rug. 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 complics 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. Lori DonDiego ・

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 yours.

Sincerely yours,

/ Mark N. Mulhern

Cclia 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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Coapi Systems, Inc.

510(k) Premarket Notification ENDOTINE Midface™SST 4.5

K032698

#### STATEMENT OF INDICATIONS FOR USE 4

| 510(k) Number: | Not yet assigned |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ENDOTINE Midface TM-ST 4.5 |
| Indications for Use: | The ENDOTINE MidfaceTM-ST 4.5 is indicated for use in<br>subperiosteal midface suspension surgery to fixate the<br>cheek subdermis in an elevated position. |

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
or
Over-the-Counter
Per 21 CFR 801.109
Optional Format 1-2-96

ivision Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K032698

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