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 an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on a qualitative assessment of "substantial equivalence" to predicate devices and adherence to general standards.

However, based on the text, we can infer the broad performance and safety "criteria" that were considered met.

Acceptance Criteria (Inferred)	Reported Device Performance
Safety and Effectiveness (General)	"The ENDOTINE Ribbon™ Device is safe and appropriate for the intended use." "No new issues of safety or effectiveness were raised for the ENDOTINE Ribbon™ Device." "Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale."
Similarity to Predicate Devices	"Its similarity to the predicate devices." "The ENDOTINE Ribbon™ is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Ribbon™." (This appears to be a typo in the original document, likely meaning "to predicate devices") "The technological characteristics of the ENDOTINE Ribbon™ are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers." "Any differences between the ENDOTINE Ribbon™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness."
Exceeding User Specifications and USP Standards	"A design pathway that included extensive cadaver modeling and evaluations which exceeded user specifications and USP Standards for absorbable surgical sutures."
Fulfilling Device Requirements (User Specifications)	"The ENDOTINE Ribbon™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications."
Indications for Use Substantiation	"The 'Indication Statement' for the ENDOTINE Ribbon™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices."

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

The document does not specify a numerical sample size for a formal "test set" in the context of controlled clinical trials or efficacy studies. The performance evaluations mentioned are described as:

"Extensive cadaver modeling and evaluations."
"Comparison testing to the predicate devices."

The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed. The phrase "cadaver modeling and evaluations" suggests laboratory-based testing rather than live human studies, and it appears to be a preclinical evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions:

"Feedback and user observation from several leading surgeons."

It does not specify the exact number of surgeons or their detailed qualifications (e.g., specific years of experience, subspecialty). These "experts" appear to have provided qualitative feedback rather than establishing a formal "ground truth" for a statistical test set.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described for a test set. The expert involvement appears to be in the form of "feedback and user observation," suggesting a more informal process rather than a structured adjudication panel for establishing ground truth on a specific dataset.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MCRM comparative effectiveness study was done or reported in this document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to existing predicate devices based on design, materials, and intended use, along with some performance testing. It does not involve assessing the improvement of human readers with AI assistance, as AI is not a component of this device.

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

The ENDOTINE Ribbon™ is a medical device (bioabsorbable implant with insertion tool) and does not contain any AI algorithms. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

The concept of "ground truth" in the context of a diagnostic or AI algorithm study is not directly applicable here. For this device, "truth" is established by:

Demonstrating substantial equivalence to legally marketed predicate devices.
Meeting "user specifications" and "USP Standards for absorbable surgical sutures" (likely referring to material properties, strength, absorption rate, etc.).
"Extensive cadaver modeling and evaluations" for mechanical performance and design validation.
"Feedback and user observation from several leading surgeons" confirming usability and perceived performance.

Essentially, the "ground truth" is inferred from these various forms of evidence aligning with established standards and predicate device characteristics, rather than a single, defined "ground truth" dataset.

8. The Sample Size for the Training Set

The document does not mention a training set as this device is not an AI or algorithmic device that requires training. The design process included "extensive cadaver modeling and evaluations," which could be considered a form of developmental "training" for the device's design, but not in the machine learning sense of a "training set."

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an algorithm, the concept of establishing ground truth for it is not applicable. The design verification process involved cadaver studies and comparison to predicate devices, where the "truth" would be successful performance against engineering and biological requirements.

Summary

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JUN 2 3 2005

KOSI415,1/3

510(k) Premarket Notification ENDOTINE Ribbon™

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 Ribbon™ 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: Iruedy@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

May 31, 2005

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Ribbon™ Device

DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM

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KOS/4/5$_{2/3}$

Coapt Systems, Inc.

510(k) Premarket Notification ENDOTINE Ribbon™

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 Ribbon™Device	Coapt Systems, Inc	K050611
PDS II Suture	Ethicon, Inc.	N18331
Contour Necklift Threads	Surgical Specialties	K050247

DEVICE DESCRIPTION

INTENDED USE STATEMENT

SUBSTANTIAL EQUIVLANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the ENDOTINE Ribbon™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices. The intended use statement for the ENDOTINE Ribbon™ is more specific than that of the PDS II Suture, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in face lift procedures. The differences between the ENDOTINE Ribbon™ and the predicate devices do not affect the safety and effectiveness of the ENDOTINE Ribbon™. The Contour Necklift Thread is intended to be used in a neck lift procedure.

2. Technological Characteristics Summary

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

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3. Performance Summary

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

Its similarity to the predicate devices. .
A design pathway that included extensive cadaver modeling and evaluations . which exceeded user specifications and USP Standards for absorbable surgical sutures.
Feedback and user observation from several leading surgeons. .

The ENDOTINE Ribbon™ 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 ENDOTINE Ribbon™ 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 the ENDOTINE Ribbon™ Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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Image /page/3/Picture/13 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 image of an eagle or bird-like figure with three horizontal lines forming its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2005

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

Re: K051415

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: May 31, 2005 Received: June 1, 2005

Dear Ms. Ruedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encreate) 75 the enactment date of the Medical Device Amendments, or to comments province to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have boon recuire approval of a premarket approval application (PMA). and Cosmetic Act (110-) that to nevice, subject to the general controls provisions of the Act. The r our may, therefore, manner of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 your device is classified dditional controls. Existing major regulations affecting your device it may be subject to saan additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oodo cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drivisation that your device complies with other requirements of the Act that I Drimas made a and regulations administered by other Federal agencies. You must or any 1 catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the 11th of 11th Part 801); good manufacturing practice requirements as set OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Linda Ruedy

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w yourse of substantial equivalence of your device to a legally premation nouried.com "Te 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 11 you desire specific acrepliance 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 other general mionmantial 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D.

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0514/5

Coapt Systems, Inc.

510(k) Premarket Notification ENDOTINE Ribbon™

STATEMENT OF INDICATIONS FOR USE 4

510(k) Number:	Not yet assigned
Device Name:	ENDOTINE Ribbon™
Indications for Use:	The ENDOTINE Ribbon™ is indicated for use inelevation and fixation of tissues in the temporal region,midface, lower face/jowl to the deep temporal fascia andthe neck to the mastoid fascia during cosmetic procedures.

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)

Division of General Restorative

Page 1 of /

KOSITIS

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.