The ENDOTINE Forehead™ Triple is intended for use in subperiosteal browplasty surgery. The ENDOTINE Forehead™ Triple Device is specifically indicated for use to fixate the subcutaneous tissues to the cranial bone in browplasty.

Device Description

The ENDOTINE Forehead™ Triple Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.

AI/ML Overview

This 510(k) summary (K042078) for the ENDOTINE Forehead™ Triple Device does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the manner typically seen for performance studies in AI/ML medical devices.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K014153 and K023922) based on design, materials, fundamental technology, and intended use. The key statement regarding performance is: "The modified device meets all internal functional performance requirements previously established for the predicate device."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about specific study details like sample sizes, expert qualifications, adjudication methods, or MRMC studies, as these types of studies are not described in this submission.

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

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

Cannot provide. The document states that the device "meets all internal functional performance requirements previously established for the predicate device," but it does not specify what those requirements are or what performance metrics were evaluated.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot provide. No information on a test set or its provenance is included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot provide. No information on ground truth establishment or expert involvement in a test set is included.

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

Cannot provide. No information on an adjudication method is included.

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

Cannot provide. This is a hardware device (bioabsorbable implant) and not an AI/ML diagnostic or assistive device. Therefore, MRMC studies involving human readers and AI assistance are not applicable and not mentioned.

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

Cannot provide. This is a hardware device. The concept of "standalone algorithm performance" does not apply.

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

Cannot provide. No specific ground truth methodology is described. The approval is based on substantial equivalence, implying that the safety and effectiveness of the updated device are inferred from the predicate devices' established performance.

8. The sample size for the training set

Cannot provide. No information on a training set is included, as this is a hardware device, not a machine learning model.

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

Cannot provide. As there's no training set, there's no ground truth establishment for it.

Summary from the provided document:
The approval for the ENDOTINE Forehead™ Triple Device (K042078) is based on substantial equivalence to its predicate devices (K014153 and K023922). The submission states that "no different issues of safety or effectiveness have been raised for the modified Forehead device. The modified device meets all internal functional performance requirements previously established for the predicate device." This means the assessment was primarily a comparison of design, materials, and intended use, rather than a new clinical or performance study with defined acceptance criteria and statistical analysis as would be expected for a novel device or an AI/ML product.

Summary

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Ko42078 P/2

AUG 2 7 2004

10.0 510(k) SUMMARY

Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Forehead™ Triple 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

July 30, 2004

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Forehead™ Triple Device

DEVICE COMMON OR CLASSIFICATION NAME

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

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IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO EQUIVALENCE IS BEING CLAIMED

Name of Predicate Device	Name of Manufacturer	510(k) or PMANumber
ENDOTINE Forehead™Device	Coapt Systems, Inc	K014153 and K023922

DEVICE DESCRIPTION

INTENDED USE STATEMENT

The ENDOTINE Forehead™ Triple is intended for use in subperiosteal browplasty surgery. The ENDOTINE Forehead Triple Device is specifically indicated for use to fixate the subcutaneous tissues to the cranial bone in browplasty.

SUBSTANTIAL EQUIVALENCE

In review of the device description, predicate comparison and design control activities incorporated in this submission, no different issues of safety or effectiveness have been raised for the modified Forehead device. The modified device meets all internal functional performance requirements previously established for the predicate device.

Based on the design, materials, fundamental technology, intended use, and performance evaluations, Coapt Systems believes the proposed ENDOTINE Forehead™ Triple Device is substantially equivalent to the unmodified predicate 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

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

Re: K042078

Trade/Device Name: ENDOTINE Forehead™ Triple Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 30, 2004 Received: August 2, 2004

Dear Ms. DonDiego:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abo surveior to May 28, 1976, the enactment date of the Medical Device Amendments, or to eoniner of prox 8 120 2011 11 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 r ou may, merelevy mans 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 if your device to such additional controls. Existing major regulations affecting your device can may be subject to back academal 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 r loast be device that I Dr mination that your device complies with other requirements of the Act that + 27 Maxal statutes and regulations administered by other Federal agencies. You must or any I cueral battler and strengents, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wating of substantial equivalence of your device of your device to a legally promative notificated on " *************************************************************************************************************************************************** to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire 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 other general informational 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,

Muriam C. Provost

+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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Coapt Systems, Inc.

042078

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Not yet assigned

Device Name:

ENDOTINE Forehead™ Triple Device

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 ____________________________________________________________________________________________________________________________________________________________________

510(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.