The ENDOTINE Chin ™ 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin ™ 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.

Device Description

The ENDOTINE Chin™ 3.5 Device kit consists of the chin implant with insertion tool and a drill bit. The Chin device along with its insertion tool and drill bit are supplied sterile for single use only.

AI/ML Overview

The provided text describes the ENDOTINE Chin™ 3.5 Device, a medical device intended for use in subperiosteal chinplasty surgery to fixate the subdermis to the mentum. The submission details a summary of the device's safety and effectiveness information in accordance with 21 CFR §807.92.

Acceptance Criteria and Study for ENDOTINE Chin™ 3.5 Device:

The documentation does not explicitly state numerical acceptance criteria in the format of precision, recall, or F1 score, or specific thresholds for strength. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices and meeting design specifications through performance studies.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Similarity to predicate device (ENDOTINE Forehead Device)	Demonstrates substantial equivalence in design, materials, and fundamental scientific technology.
Design performance studies (cadaveric modeling and evaluation)	Performed and results exceeded specifications.
Strength testing results	Results exceeded specifications.
Material safety profile (for forehead and chin regions)	Established safety profile of the device material.
Suitability to perform and operate as clinically intended	Supported by an appropriate and complete testing program.

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

The document mentions "cadaveric modeling and evaluation" as part of the design performance studies. However, the specific sample size (number of cadavers) and the country of origin of this data are not provided. It is implied to be a prospective study for device validation, as it's part of the pre-market submission.

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

The document mentions "Feedback and user observation from several leading surgeons." This suggests expert input was gathered, but the exact number of surgeons, their specific qualifications (e.g., years of experience, subspecialty), and how their feedback established a formal "ground truth" are not detailed. It appears to be qualitative feedback rather than a structured ground truth establishment process for a test set in the context of AI/ML evaluation.

4. Adjudication Method for the Test Set:

Given the nature of the device (a physical fixation system) and the type of performance studies (cadaveric modeling, strength testing), the concept of an adjudication method typical for AI/ML evaluation (like 2+1, 3+1 consensus) does not apply and is not mentioned. Performance was likely evaluated directly against engineering specifications and clinical observations rather than expert consensus on interpretive tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to this physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm-only performance study was not done. The ENDOTINE Chin™ 3.5 Device is a physical implant, not an algorithm. Its performance is inherent to its design, materials, and mechanical properties when surgically implanted.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance appears to be established through:

Engineering Specifications: Strength testing results exceeding pre-defined technical requirements.
Clinical Observations/Feedback: User observation and feedback from surgeons, likely assessing functional performance and ease of use in a simulated or actual surgical context (implicitly, this would be expert opinion on the device's effectiveness and safety).
Material Science Data: Established safety profile of the device material.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device, not an AI/ML algorithm. Therefore, no sample size for a training set is provided.

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

As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's development was derived from design requirements, engineering principles, material properties, and feedback, rather than a labeled dataset for algorithm training.

Summary

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K033524
p/3

DEC 1 8 2003 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 Chin™ 3.5 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 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

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

November 6, 2003

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Chin™ 3.5 Device

DEVICE COMMON OR CLASSIFICATION NAME

Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 888.3040 Class: II Product Code: HWC

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

Name of Predicate Device	Name of Manufacturer	510(k) or PMANumber
ENDOTINE Forehead™Device	Coapt Systems, Inc	K014153/K023992
Lactosorb® Panels	Walter Lorenz Surgical	K974309

DEVICE DESCRIPTION

INTENDED USE STATEMENT

The ENDOTINE Chin™ 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin™ 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.

SUBSTANTIAL EQUIVLANCE COMPARISON

1. Indications Summary

The ENDOTINE Forehead™ Device intended use statement is nearly identical to the the new ENDOTINE Chin Device intended use. Both ENDOTINE devices (Forehead and Chin) are intended to elevate and fixate soft tissue in facial surgeries. Moreover, the anchoring methods are very similar for both devices, applying a pulling force to the skeletal system for support. Both devices are intended for soft tissue suspension using the patented multi-point technology developed by Coapt Systems.

The different anatomical sites for use between the ENDOTINE Chin™ 3.5 and ENDOTINE Forehead™ Device do not suggest new issues of safety and effectiveness when used in the chin region that could affect the substantial equivalence determination.

2. Technological Characteristics Summary

The ENDOTINE Chin™ 3.5 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 Chin 3.5 are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by device manufacturers. Any differences between the ENDOTINE Chin™ 3.5 and the predicate devices are minor and do not raise new issues regarding safety or effectiveness. This statement is substantiated by the clinical history to

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date for the ENDOTINE Forehead Device and an established safety profile of the device material in both the forehead and chin regions.

3. Performance Summary

The ENDOTINE Chin™ 3.5 Device is safe and appropriate for the intended use due to the following:

Its similarity to the predicate device, the ENDOTINE Forehead Device. .
Design performance studies that included cadaveric modeling and evaluation, and . strength testing results that exceeded specifications.
Feedback and user observation from several leading surgeons. .

The ENDOTINE Chin™ 3.5 performance data meet the applicable standards and fulfill the device requirements as defined in the design specifications.

An appropriate and complete testing program supports the ENDOTINE Chin™ 3.5 is suitable to perform and operate as clinically intended.

SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the design, materials, function, intended use, and performance evaluations discussed hercin, Coapt Systems believes the ENDOTINE Chin™ 3.5 Device is substantially equivalent to the selected predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the ENDOTINE Chin™ 3.5 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 U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

Ms. Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, California 94303

Re: K033524 Trade/Device Name: ENDOTINE Chin™ 3.5 Regulation Number: 21 CFR 888.3040; 21 CFR 878.4493 Regulation Name: Smooth or threaded metallic bone fixation fastener; Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: HWC, GAM Dated: November 6, 2003 Received: November 7, 2003

Dear Ms. DonDiego:

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 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Miriam C. Provost

for Celia 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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STATEMENT OF INDICATIONS FOR USE 4

510(k) Number:	K033524
Device Name:	ENDOTINE Chin TM 3.5 Device
Indications for Use:	The ENDOTINE Chin TM 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin TM 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.

Prescription Use X ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

K 033524
3(k) Number

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.