The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

Device Description

The ENDOTINE TransBleph™ 3.0/3.5 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 document is a 510(k) summary for the ENDOTINE TransBleph™ 3.0/3.5 Device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

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

Cannot be provided. The document does not specify quantitative acceptance criteria or a reported device performance study for the ENDOTINE TransBleph™ 3.0/3.5 Device. The submission is based on substantial equivalence to a predicate device and states, "The Modified Device meets all internal functional performance requirements," but no specific criteria or results are listed.

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

Cannot be provided. There is no mention of a test set or clinical study data in this 510(k) summary.

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 be provided. No test set or ground truth establishment is described.

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

Cannot be provided. No test set or adjudication process 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

Cannot be provided. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

Cannot be provided. This is a physical surgical device, not an algorithm.

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

Cannot be provided. No ground truth establishment related to a performance study is described.

8. The sample size for the training set

Cannot be provided. This document does not describe the development or training of an algorithm or model.

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

Cannot be provided. No training set or ground truth establishment for a training set is described.

Summary of what the document does provide:

Device: ENDOTINE TransBleph™ 3.0/3.5 Device (bioabsorbable implant, insertion tool, drill bit).
Intended Use: Subperiosteal browplasty surgery, specifically to fixate the subdermis to the cranial bone.
Regulatory Pathway: 510(k) Premarket Notification.
Substantial Equivalence: Claimed against the unmodified ENDOTINE TransBleph™ Device (K040740) and other ENDOTINE devices. The basis is similarity in design, materials, fundamental technology, intended use, and performance evaluations (though details of these evaluations are not provided beyond the statement that "The Modified Device meets all internal functional performance requirements").

Summary

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10.0 510(k) SUMMARY NOV - 5 2004

Coapt Systems is providing a summary of the safety and effectiveness information Coapt Systems is proPriams a canesBleph™ 3.0/3.5 Device. This 510(k) summary of available for the LADO FINE Frances is submitted in accordance with the requirements of salery and encest vehicless mission 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

Bankim Mehta Vice President, Operations, QA and RA Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7640 Facsimile: (650) 213-9336 Email: bmehta@coaptsystems.com

DATE OF PREPARATION OF 510(K) SUMMARY

October 8, 2004

DEVICE TRADE OR PROPRIETARY NAME

ENDOTINE TransBleph™ 3.0/3.5 Device

DEVICE COMMON OR CLASSIFICATION NAME

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

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

Name of PredicateDevice	Name of Manufacturer	510(k) orPMANumber
ENDOTINETransBleph™ Device	Coapt Systems, Inc	K040740
ENDOTINE Forehead™Devices	Coapt Systems, Inc.	K014153 K023992
ENDOTINE Chin™Devices	Coapt Systems, Inc.	K033524

DEVICE DESCRIPTION

INTENDED USE STATEMENT

The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis 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 significant new issues of safety or effectiveness have been raised for the Modified TransBleph™ 3.0/3.5 Device. The Modified Device meets all internal functional performance requirements.

Based on the design, materials, fundamental technology, intended use, and performance evaluations, Coapt Systems believes the proposed ENDOTINE TransBleph™ 3.0/3.5 Device is substantially equivalent to the unmodified predicate device, the ENDOTINE TransBleph™ 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 circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2004

Mr. Bankim Mahta Vice President, Operations, QA and RA Coapt Systems, Inc. 1820 Embarcadero Road Palo Atlo, California 94566

Re: K042796

Trade/Device Name: ENDOTINE TransBleph™ 3.0/3.5 Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: October 6, 2004 Received: October 7, 2004

Dear Mr. Mahta:

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 (OS) 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 - Mr. Bankim Mahta

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 (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 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

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.

Image /page/4/Picture/1 description: The image shows the text "Special 510(k) Premarket Notification ENDOTINE TransBleph™ 3.0/3.5". Above the text is a handwritten number, K042796. The text appears to be part of a document or label, possibly related to medical devices or regulatory submissions. The "510(k)" likely refers to a premarket submission to the U.S. Food and Drug Administration (FDA).

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):	Not yet assigned
Device Name:	ENDOTINE TransBleph™ 3.0/3.5 Device
Indications For Use:	The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

Prescription Use X

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)

Meriam C. Provost

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

Page 1 of _ |

510(k) Number K042776

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.