ULTRATINE TRANSBLEPH

K060248 · Coapt Systems, Inc. · HWC · Jun 12, 2006 · Orthopedic

Device Facts

• Record ID: K060248
• Device Name: ULTRATINE TRANSBLEPH
• Applicant: Coapt Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Bioabsorbable implant for subperiosteal browplasty fixation; used to secure subdermis to frontal bone. Device supplied sterile for single use. Operates as mechanical fixation fastener. Used by surgeons in clinical settings. Provides stable tissue positioning during healing; benefits patient by maintaining brow elevation post-procedure.

Clinical Evidence

Bench testing only; performance evaluations and comparison testing conducted to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Bioabsorbable implant; metallic bone fixation fastener (Product Code HWC). Design and materials are similar to legally distributed absorbable, implantable general, orthopedic, and plastic surgery devices.

Indications for Use

Indicated for subperiosteal browplasty fixation; specifically for fixating 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 TransBleph™ (K040740)
• Vicryl (K944110)

Submission Summary (Full Text)

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Coapt Systems, Inc.

Kolol248 P. 1.0f 3

510(k) Premarket Notification ULTRATINE TransBleph™

#### 11 510(k) SUMMARY

JUN 1 2 2006

#### 11.0 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the ULTRATINE 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 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

January 31, 2006

## DEVICE TRADE OR PROPRIETARY NAME

ULTRATINE TransBleph™ Device

### DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 878.3040 Class: II Product Code: HWC

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510(k) Premarket Notification ULTRATINE TransBleph™

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

| Name of Predicate Device | Product Code | Name of Manufacturer | 510(k) or PMA<br>Number |
|--------------------------|--------------|----------------------|-------------------------|
| ENDOTINE TransBleph™ | HWC | Coapt Systems, Inc | K040740 |
| Vicryl | GAM | Ethicon | K944110 |

#### DEVICE DESCRIPTION

The ULTRATINE TransBleph™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.

#### INTENDED USE STATEMENT

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

#### SUBSTANTIAL EQUIVALANCE COMPARISON

#### 1. Indications Summary

The "Indication Statement" for the ULTRATINE TransBleph™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices. The selected predicate devices are routinely used in TransBleph lift procedures. The differences between the ULTRATINE TransBleph™ and the predicate devices do not affect the safety and effectiveness of the ULTRATINE TransBleph™.

#### 2. Technological Characteristics Summary

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

#### 3. Performance Summary

The ULTRATINE TransBleph™ 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 ULTRATINE TransBleph™ 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

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the ULTRATINE 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 Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060248

Trade/Device Name: ULTRATINE TransBleph™ Regulation Code: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC Dated: April 28, 2006 Received: April 28, 2006

Dear Ms. Ruedy:

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, Drug, 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.

JUN 1 2 2006

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

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#### Page 2 - Ms. Linda Ruedy

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. 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,

Q.M.M.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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#### 12660248 8. 10f-4

# Indications for Use

510(k) Number (if known): K060248

ULTRATINE TransBleph™ Device Name:

Indications For Use: The ULTRATINE TransBleph™ is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone. >>

Prescription Use X (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

Division of General, Restorative. and Neurological Devices

Page 1 of

510(k) Number_ K060248