The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution tools are supplied sterile for single use only.

AI/ML Overview

The provided text describes a 510(k) summary for the ENDOTINE Midface™-ST 4.5 Device, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving device performance against those criteria.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a tabular format. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general standards.

Acceptance Criteria (Inferred)	Reported Device Performance
Similarity to predicate devices in design, materials, and function	The device is substantially equivalent to predicate devices (ENDOTINE Forehead, PDS II Suture, Lactosorb Panels) in design, materials, and fundamental scientific technology.
Compliance with user specifications and USP Standards for absorbable surgical sutures	Performance data meet applicable standards and fulfill device requirements as defined in user specifications and USP Standards for absorbable surgical sutures.
Safety and appropriateness for intended use	Safe and appropriate for intended use due to similarity to predicate devices, extensive cadaver modeling/evaluations, and positive user feedback. No new issues of safety or effectiveness raised.

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

Sample size for test set: Not mentioned. The document refers to "extensive cadaver modeling and evaluations" but does not specify a sample size for these evaluations related to performance testing.
Data provenance: Not explicitly stated as a test set. The "cadaver modeling and evaluations" would typically be prospective laboratory/pre-clinical data. The "user observation from several leading surgeons" is feedback, not a structured test set.

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

Number of experts: Not specified. The document mentions "several leading surgeons" provided feedback and user observation, but it doesn't describe their role in establishing a ground truth for a test set.
Qualifications of experts: Described as "leading surgeons," but no specific details on their experience (e.g., years of experience, specialization) are provided.

4. Adjudication method for the test set

Adjudication method: Not mentioned. No dedicated "test set" with ground truth established through adjudication is described.

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

MRMC study: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Ground truth: Not explicitly defined in the context of a "test set" for performance evaluation against a specific clinical outcome. The nearest equivalents are:
- Predicate devices: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.
- USP Standards: Compliance with established industry standards for absorbable sutures.
- User specifications: Device requirements as defined by user needs.

8. The sample size for the training set

Sample size for training set: Not applicable based on the information provided. The document describes pre-clinical evaluations (cadaver modeling) and feedback, not a formalized "training set" in the context of machine learning.

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

Ground truth for training set: Not applicable. As there's no mention of a training set, the establishment of its ground truth isn't discussed.

Summary

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10/23/03

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11 510(k) SUMMARY

11.0 510(k) Summary

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Midface™-ST 4.5 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 Mirchelles of 21

81000 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

Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Idondiego@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

August 29, 2003

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Midface™-ST 4.5 Device

DEVICE COMMON OR CLASSIFICATION NAME

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

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Coapt Systems, Inc.

1820 Embarcadero Boad Palo Alto, CA 94303

650.331.7670 Mair 650.213.9377 Fax

www.coaptsystems.com

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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 Forehead™Device	Coapt Systems, Inc	K023992/K014153
PDS II Suture	Ethicon, Inc.	N18331
Lactosorb® Panels	Walter Lorenz Surgical	K974309

DEVICE DESCRIPTION

INTENDED USE STATEMENT

The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

SUBSTANTIAL EQUIVLANCE COMPARISON

1. Indications Summary

The "Indication Statement" for the ENDOTINE Midface™-ST 4.5 is substantiated by the results of the performance evaluations and comparison testing to the PDS II Suture predicate device. The intended use statement for the ENDOTINE Midface™ ST 4.5 is more specific than that of the predicate device, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in the midface lift procedure. The differences between the ENDOTINE Midface™-ST 4.5 and the predicate device do not affect the safety and effectiveness of the ENDOTINE Midface™S Sp 4.5. An appropriate and complete testing program supports the ENDOTINE Midface™ ST 4.5 is suitable to perform and operate as clinically intended.

2. Technological Characteristics Summary

The ENDOTINE Midface™ ST 4.5 is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Forehead and Lactosorb Panel predicate devices. Further, the technological characteristics of the ENDOTINE Midface-ST 4.5 are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ENDOTINE Midface™-ST 4.5 and the predicate devices are minor and do not raise issues regarding safety or effectiveness. This statement is substantiated by a history of

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clinical use with the ENDOTINE Forehead device, and an established safety profile of the device material in the midface (bone and tissue).

3. Performance Summary

The ENDOTINE Midface-ST 4.5 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 Midface™-ST 4.5 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 Sysems believes the ENDOTINE Midface™-ST 4.5 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 Midface™-ST 4.5 Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 2 3 2003

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

Re: K032698

Trade/Device Name: ENDOTINE Midface™-ST 4.5 Regulation Number: 21 CFR 878.4493, 888.3040 Regulation Name: Absorbable suture, Bone fixation screw Regulatory Class: II Product Code: GAM, IIWC Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. DonDicgo:

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. 17rug. 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 complics 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 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 (301) 594-4659. 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.

Sincerely yours,

/ Mark N. Mulhern

Cclia 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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Coapi Systems, Inc.

510(k) Premarket Notification ENDOTINE Midface™SST 4.5

K032698

STATEMENT OF INDICATIONS FOR USE 4

510(k) Number:	Not yet assigned
Device Name:	ENDOTINE Midface TM-ST 4.5
Indications for Use:	The ENDOTINE MidfaceTM-ST 4.5 is indicated for use insubperiosteal midface suspension surgery to fixate thecheek subdermis in an elevated position.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
or
Over-the-Counter
Per 21 CFR 801.109
Optional Format 1-2-96

ivision Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K032698

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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.