The ENDOTINE Forehead™ Device is intended for use in subperiosteal browplasty surgery. The ENDOTINE Forehead™ Device is specifically indicated for use to fixate the sub-dermis to the cranial bone in browplasty.

Device Description

The ENDOTINE Forehead™ Device consists of a bioabsorbable implant and an accessory Instrument Kit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The instrument tool kit contains a stainless steel insertion tool, a drill bit and sterilization tray base and lid.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ENDOTINE Forehead™ Device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria, a study demonstrating the device meets those criteria, or any performance metrics.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to an existing device, rather than presenting a detailed performance study with acceptance criteria.

Here's why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., in terms of tensile strength, fixation stability, or clinical outcome metrics) or report any performance data against such criteria for the ENDOTINE Forehead™ Device itself. It only states that the modified drill bit "meets all internal functional performance requirements previously established for the predicate device."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is presented.
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): Not applicable, as no study involving expert interpretation or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a surgical implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document asserts substantial equivalence based on design, materials, function, intended use, and performance evaluations (implicitly, internal functional requirements for the drill bit and the overall device's equivalence to the predicate). It does not present a clinical study or specific performance data against defined acceptance criteria.

Summary

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Special 510(k) Premarket Notification ENDOTINE Forehead™

510(k) SUMMARY 10.0

032770
page 1 of 2

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

September 8, 2003

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE Forehead™ 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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Coapt Systems, Inc.

IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICHEQUIVALENCE IS BEING CLAIMED
Name of Predicate Device	Name of Manufacturer	510(k) or PMANumber
ENDOTINE Forehead™Device	Coapt Systems, Inc	K014153

DEVICE DESCRIPTION

INTENDED USE STATEMENT

The ENDOTINE Forehead™ is intended for use in browplasty surgery. The ENDOTINE Forehead Device is specifically indicated for use to fixate the sub-dermis to the cranial bone in browplasty procedures.

SUBSTANTIAL EQUIVALENCE

In review of the device description, predicate comparison and design control activities incorporated in this submission, no new issues of safety or effectiveness have been raised for the modified drill bit design. The modified device meets all internal functional performance requirements previously established for the predicate device. Due to the new one-piece drill bit design, the risk of collar separation has been eliminated, enhancing the safety of this accessory.

Based on the design, materials, function, intended use, and performance evaluations, Coapt Systems believes the new ENDOTINE Forehead™ Device Drill Bit 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is rendered in black, contrasting with the white background of the seal.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 2003

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

Re: K032770

Trade/Device Name: ENDOTINE Forehead™ Device Regulation Number: 21 CFR 3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 5, 2003 Received: September 8, 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 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 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,

for Mark N Millman

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

032770

510(k) Number:

Not yet assigned

Device Name:

ENDOTINE Forehead™ Device

The ENDOTINE Forehead™ Device is intended for use in Indications for Use: subperiosteal browplasty surgery. The ENDOTINE Forehead™ Device is specifically indicated for use to fixate the sub-dermis to the cranial bone in browplasty.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use Per 21 CFR 801.109

Over-the-Counter Optional Format 1-2-96

for Mark N. Millman

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

K032770 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.