ENDOTINE TRANSBLEPH DEVICE

K040740 · Coapt Systems, Inc. · HWC · May 10, 2004 · Orthopedic

Device Facts

• Record ID: K040740
• Device Name: ENDOTINE TRANSBLEPH DEVICE
• Applicant: Coapt Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

Device Story

The ENDOTINE TransBleph™ is a sterile, single-use kit containing a brow implant, insertion tool, and drill bit. Used by surgeons in subperiosteal browplasty, the device employs multi-point anchoring technology to suspend and fixate soft tissue to the frontal bone. The implant provides mechanical support to elevate the brow, replacing traditional fixation methods. The device is intended for clinical use by surgeons; it functions as a permanent or semi-permanent mechanical anchor to maintain tissue position during the healing process, potentially improving aesthetic outcomes in browlift procedures.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing, including cadaveric evaluation and mechanical strength/compression testing that exceeded design specifications, alongside surgeon feedback and clinical history of predicate devices.

Technological Characteristics

Absorbable implantable device for bone fixation. Utilizes multi-point anchoring technology for soft tissue suspension. Supplied sterile for single use. Mechanical performance validated via strength and compression testing.

Indications for Use

Indicated for patients undergoing subperiosteal browplasty surgery requiring fixation of the subdermis to the frontal bone.

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 Forehead™ Device (K014153/K023992)
• Lactosorb® Panels (K974309)
• ENDOTINE Chin™ 3.5 Device (K033524)

Submission Summary (Full Text)

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#### MAY 1 0 2004 11 510(k) SUMMARY

K040740
//

#### 11.0 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE TransBleph™ 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 Telephonc: [phone] Facsimile: [phone]

### CONTACT INFORMATION

Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: [phone] Facsimile: [phone] Fmail: Idondiego@@coaptsystems.com

#### DATE OF PREPARATION OF 510(K) SUMMARY March 15, 2003

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE TransBleph™ Device

## DEVICE COMMON OR CLASSIFICATION NAME

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

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Coapt Systems, Inc.

Ki04 o 748

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

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| Name of Predicate Device | Name of Manufacturer | 510(k) or PMA<br>Number |
|------------------------------|------------------------|-------------------------|
| ENDOTINE Forehead™<br>Device | Coapt Systems, Inc. | K014153/K023992 |
| Lactosorb® Panels | Walter Lorenz Surgical | K974309 |
| ENDOTINE Chin™ 3.5<br>Device | Coapt Systems, Inc. | K033524 |

## DEVICE DESCRIPTION

The ENDOTINE TransBleph™ Device kit consists of the brow implant with inscrtion tool and a drill bit. The TransBleph device along with its insertion tool and drill bit are supplied sterile for single use only.

## INTENDED USE STATEMENT

The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

# SUBSTANTIAL EQUIVLANCE COMPARISON

### 1. Indications Summary

The ENDOTINE Forehead™ Device intended use statement is nearly identical to the new ENDOTINE TransBleph Device intended use. Both ENDOTINE devices (Forehead and TransBleph) are intended to elevate and fixate soft tissue in facial browlift surgeries. Moreover, the anchoring methods are very similar for both devices, applying a pulling force to the skeletal system for support. Both devices are intended for soft tissue suspension using the patented multi-point technology developed by Coapt Systems.

The similar anatomical sites for use between the ENDOTINE TtransBleph™ and ENDOTINE Forchead™ Device suggest no new issues of safety and effectiveness that could affect the substantial equivalence determination.

### 2. Technological Characteristics Summary

The ENDOTINE TRansBleph™ is substantially cquivalent in design, materials and fundamental scientific technology to the ENDOTINE Forehead, Lactosorto Panel and ENDOTINE Chin predicate devices. The technological characteristics of the F.NDOTINE TransBleph are similar to many absorbable, implantable general, orthopedic

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Coapt Systems, Inc.

K04 0748

and plastic surgery devices legally distributed by device manufacturers. Any differences between the ENDOTINE TransBleph™ and the predicate devices are inconsequential and do not raise new issues regarding safety or effectiveness. This statement is substantiated by the mechanical performance data for TransBleph. clinical history to date for the ENDOTINE Forchead/Chin Device and an established safety profile of the device material in both the forehead and other craniofacial sites.

## 3. Performance Summary

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

- Its similarity to the predicate device, the ENDOTINE Forehead Device, .
- Design performance studies that included cadaveric evaluation, and strength and . compression testing results that exceeded specifications,
- . Feedback and user observation from several leading surgeons.

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

An appropriate and complete testing program supports the ENDOTINE TransBleebh™ is suitable to perform and operate as clinically intended.

## SUBSTANTIAL EQUIVALENCE CONCLUSION

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

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal bars that curve downwards, resembling a human form. The logo is rendered in black and white.

MAY 1 0 2004

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

Rc: K040740

Trade/Device Name: ENDOTINE TransBleph™ Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 19, 2004 Received: March 22, 2004

Dear Ms. DonDiego:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your so 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). and Ocometie for ( 10) 2017 - 10:10 pm ( 10 the general controls provisions of the Act. The r ou mays atores provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practicc, 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 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 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 premits to modicate 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,

-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.

K040740

#### STATEMENT OF INDICATIONS FOR USE 4

| 510(k) Number: | K 040746 (not yet assigned) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ENDOTINE TransBlephTM Device |
| Indications for Use: | The ENDOTINE TransBlephTM Device is intended for use<br>in subperiosteal browplasty fixation. The ENDOTINE<br>TransBlephTM is specifically indicated for use to fixate the<br>sub-dermis to the frontal bone. |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

uriam C. Provost

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

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