The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.

Device Description

The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.

AI/ML Overview

Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, specifically focusing on the requested information.

It's important to note that this document is a 510(k) summary for a Special 510(k) Premarket Notification. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the intended use or alter the fundamental scientific technology of the device. This usually means that extensive new clinical studies or detailed performance data comparing the new device to the predicate are not provided in the 510(k) summary itself, as the substantial equivalence is often based on the previous clearance and controlled design changes.

Therefore, much of the requested information regarding detailed study design, sample sizes for test/training sets, expert qualifications, and specific acceptance criteria with device performance results are not present in this type of summary. The primary claim here is substantial equivalence to a predicate device already on the market (K051415), which is also an ENDOTINE Ribbon™ from the same company.

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

1. Table of acceptance criteria and the reported device performance:

This 510(k) summary does not include a table of specific acceptance criteria or detailed reported device performance. The document states:

"The Subject Device meets all internal functional performance requirements."
"Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act."

For a Special 510(k) like this, specific acceptance criteria and performance data are usually not provided in the summary. The "acceptance criteria" are generally that the modified device performs comparably to the predicate device and meets established internal design controls and functional requirements, which are often not explicitly detailed in the public 510(k) summary. The comparison is primarily focused on demonstrating that the modifications do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified. Given the nature of a Special 510(k) for a modification, any testing would likely be internal (e.g., benchtop, mechanical, or limited animal/cadaver studies) rather than a full clinical trial. The document doesn't mention clinical data used specifically for "testing" this modified device, relying instead on substantial equivalence to the previously cleared predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This document does not describe a clinical study where experts established ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This document does not describe a clinical study with an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an absorbable surgical suture/fixation platform, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not specified. The assessment of this device for substantial equivalence relies on design, materials, manufacturing processes, fundamental technology, intended use, and performance specifications compared to its predicate. There isn't a "ground truth" in the diagnostic sense.

8. The sample size for the training set:

Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable/Not specified.

Summary of Device and Approval Process based on the provided text:

Device Name: ENDOTINE Ribbon™
Manufacturer: Coapt Systems, Inc.
Submission Type: Special 510(k) Premarket Notification (K060828)
Submission Date: March 22, 2006
Clearance Date: April 19, 2006
Classification Name: Absorbable Surgical Suture
Regulation Number: 21 CFR 878.4493
Intended Use: Elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
Predicate Device: ENDOTINE Ribbon™ (K051415) by Coapt Systems, Inc.
Basis for Clearance: Substantial equivalence to the predicate device, stating "no significant new issues of safety or effectiveness have been raised" and that the "Subject Device meets all internal functional performance requirements." This implies that while specific details aren't provided, internal company testing and analysis demonstrated that the modifications did not negatively impact the safety and effectiveness relative to the cleared predicate.

Summary

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Coapt Systems, Inc.

Special 510(k) Premarket Notification ENDOTINE Ribbon™

APR 1 ° 2006

K060828/2

510(k) SUMMARY 10.0

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™ (Subject) . This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 8807.92 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 Ruedv Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Iruedy@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

March 22, 2006

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Ribbon™

DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Absorbable Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM

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Coapt Systems, Inc.

2060828
2/2

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

Name of PredicateDevice	Name of Manufacturer	510(k) orPMANumber
ENDOTINE Ribbon™	Coapt Systems, Inc	K051415

DEVICE DESCRIPTION

INTENDED USE STATEMENT

SUBSTANTIAL EQUIVALENCE

In review of the device description, predicate comparison and design control activities incorporated in this submission, no significant new issues of safety or effectiveness have been raised for the ENDOTINE Ribbon™ (Subject). The Subject Device meets all internal functional performance requirements.

Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The bird in the center is composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

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

Re: K060828

Trade/Device Name: ENDOTINE Ribbon™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 30. 2006 Received: March 31, 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. `

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 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 vours.

'Qmee

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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Coapt Systems, Inc.

Special 510(k) Premarket Notification ENDOTINE Ribbon™

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Not yet assigned

ENDOTINE Ribbon™

Device Name:

Indications For Use:

Prescription Use × (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)

2m00

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

1111
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510(k) Number_KCC 65 28

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
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.(b)
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.