ENDOTINE MIDFACE B 4.5 DEVICE

K041835 · Coapt Systems, Inc. · HWC · Sep 28, 2004 · Orthopedic

Device Facts

• Record ID: K041835
• Device Name: ENDOTINE MIDFACE B 4.5 DEVICE
• Applicant: Coapt Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

Device Story

The ENDOTINE Midface™ B 4.5 is a bone fixation fastener used in midface suspension surgery. The device consists of a fixation platform with an anchoring leash and a screw anchor. It is deployed by a surgeon using a dedicated instrument kit, which includes a drill bit for the infra-orbital rim, a tapping tool for thread creation, an insertion tool for the anchor, and a clipper tool for trimming the leash. The device functions by mechanically anchoring subcutaneous tissues to the bone to provide suspension. It is intended for single-use and is supplied sterile, while the instrument kit is provided non-sterile. The device provides a mechanical solution for tissue fixation, aiding in surgical outcomes for midface lifting.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing of performance characteristics and comparative studies with the predicate device.

Technological Characteristics

Metallic bone fixation fastener. Components include a fixation platform with anchoring leash and a screw anchor. Supplied sterile for single use. Instrument kit includes sterilization tray, drill bit, tapping tool, insertion tool, and clipper tool. Mechanical fixation principle.

Indications for Use

Indicated for patients undergoing subperiosteal midface suspension surgery requiring suspension of subcutaneous midface tissues from the infra-orbital rim or zygoma.

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

• ENDOTINE Midface™-ST 4.5 Device (K032698)
• LactoSorb® Panels (K974309)

Submission Summary (Full Text)

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K041835 1/3

SEP 2 8 2004 510/k) Premarket Notification ENDOTINE Midface™ B 4.5

#### 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 Midface™ B 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 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

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 July 6, 2004

#### DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Midface™ B 4.5 Device

#### DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 888.3040 Class: II HWC Product Code:

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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 Midface™-ST<br>4.5 Device | Coapt Systems, Inc | K032698 |
| LactoSorb® Panels | Walter Lorenz Surgical | K974309 |

#### DEVICE DESCRIPTION

The ENDOTINE Midface™-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and (2) a screw anchor. This device is supplied sterile for single use only.

The ENDOTINE Midface™ B Instrument Kit is packaged separately from the implant device and is provided to the user non-sterile. The kit is comprised of the following tools that aid in the deployment and anchoring of the implant device:

- Sterilization tray (lid, base and mat) to house the instruments for transport and . sterilization
- Drill bit for creating a hole in the infra-orbital rim .
- Tapping tool to create the threads in the drilled hole to conform to the anchor . screw
- . Insertion tool to grasp and deploy the anchor screw
- Clipper tool to remove the screw flange and excess leash length .

#### INTENDED USE STATEMENT

The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

# SUBSTANTIAL EQUIVLANCE COMPARISON

#### 1. Indications Summary

The "Indication Statement" for the ENDOTINE Midface™ B 4.5 and its predicate, the ENDOTINE Midface™-ST 4.5, are nearly identical. Both devices are effective in securely lifting midfacial tissues, and this is substantiated by bench and performance testing presented.

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# 2. Technological Characteristics Summary

The ENDOTINE Midface™ B 4.5 is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Midface™-ST 4.5 and LactoSorb Panel predicate devices.

# 3. Performance Summary

A study of the comparative performance of the ENDOTINE Midface™ B 4.5 and its predicates raised no different questions of safety or effectiveness for the proposed device, and the results suggest the ENDOTINE Midface™ B 4.5 performs as well as the selected predicate for its intended use.

# SUBSTANTIAL EQUIVALENCE CONCLUSION

The ENDOTINE Midface™ B 4.5 is an innovative and effective application of the FDAapproved ENDOTINE™ Multi-Point Technology. Based on the design, materials, function, intended use, and performance evaluations, the ENDOTINE Midface™ B 4.5 is substantially equivalent to the two selected predicate devices. All of the predicate devices listed in this application are currently marketed under the Federal Food, Drug and Cosmetic Act.

The ENDOTINE Midface™ B 4.5 raises no new or different safety or effectiveness issues when compared to the predicate devices. The safety and effectiveness of the ENDOTINE Midface™ B 4.5 is supported by appropriate tests and evaluations, including bench testing of performance characteristics and comparison studies with the Midface ST predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2004

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

Re: K041835

Trade/Device Name: Endotine Midface™ B 4.5 Device Regulation Number: 21 CFR 888.3040 Regulation Name: Bone fixation screw Regulatory Class: II Product Code: HWC, GAN Dated: July 6, 2004 Received: July 7, 2004

Dear Ms. DonDiego:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer a read 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 encreated of the enactment date of the Medical Device Amendments, or to commerce prices to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Cosmetic Act (710-) that to nov requent to the general controls provisions of the Act. The r ou may, morelore, mainer of the Act include requirements for annual registration, listing of general oonlines provider proctice, 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 onasmod (600 ac 10) als. Existing major regulations affecting your device can may be subject to back access as 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 I lease oc advisou that I be a letermination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cacal statutes and reguirements, including, but not limited to: registration and listing (21 Comply with an the five (21 CFR Part 801); good manufacturing practice requirements as set Of It rate 677, accems (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) I mb letter with ation. The FDA finding of substantial equivalence of your device to a legally premated predicated 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 If you attire 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,

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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Coapt Systems, Inc.

KOH P35 510(k) Premarket Notification ENDOTINE Midface™ B 4.5

#### STATEMENT OF INDICATIONS FOR USE 4

Not yet assigned 510(k) Number (if known): ENDOTINE Midface™ B 4.5 Device Device Name: The ENDOTINE Midface™ B 4.5 is intended for Indications For Use: use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

Prescription Use X

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)

Miriam C. Provost

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

Page 1 of

510(k) Number_LC4/835_

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