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 Description

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ULTRATINE TransBleph™ Device, which is intended for subperiosteal browplasty fixation. However, the document does not contain a study that proves the device meets specific acceptance criteria through performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be extracted from this document.

Here's what can be gathered based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	The document states: "The ULTRATINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." However, no specific performance data or quantitative acceptance criteria are provided.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence rather than comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a bioabsorbable implant, not an AI algorithm, so an "algorithm only" performance study is irrelevant.

7. Type of Ground Truth Used:

Not applicable. No ground truth is described as the basis for performance evaluation in the context of a study. The evaluation appears to be based on adherence to "applicable standards" and "user specifications" in direct comparison to predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is a physical implant, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above.

Summary of what the document does state regarding performance, without providing specific data:

Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by claiming substantial equivalence to legally marketed predicate devices (ENDOTINE TransBleph™ and Vicryl suture).
Performance Claim: "The ULTRATINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." However, these "applicable standards" and "user specifications" are not detailed, nor are the specific "performance data" presented.
Differences: "The differences between the ULTRATINE TransBleph™ and the predicate devices do not affect the safety and effectiveness of the ULTRATINE TransBleph™." And, "Any differences between the ULTRATINE TransBleph™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness."

In conclusion, while the document asserts that performance data meets requirements and supports substantial equivalence, it does not provide the details of a specific study with defined acceptance criteria and quantitative performance results that would allow for the complete answer to your detailed request. The focus of this 510(k) summary is on demonstrating equivalence rather than presenting an independent performance study.

Summary

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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: (650) 461-7600 Facsimile: (650) 213-9336

CONTACT INFORMATION

Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: lruedy@coaptsystems.com

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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061248 p.2 of 3

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 PMANumber
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.