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

Device Description

The ENDOTINE system includes the bioabsorbable ENDOTINE Implant, a stainless steel step drill-bit intended to be used in conjunction with the drill handle, and the ENDOTINE installation instrument and a sterilization tray.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coapt Systems ENDOTINE Device, based on the information available:

This 510(k) submission (K023922) is for a substantially equivalent device, not a novel device requiring extensive clinical trials to establish new performance criteria. The core of this submission is to demonstrate that the revised ENDOTINE device (with a material change) is as safe and effective as the previously cleared ENDOTINE device (K014153). Therefore, the provided text does not contain the kind of detailed clinical study information a de novo device submission would.

Based on the provided text, here's what can be inferred or explicitly stated regarding your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a modification to an already cleared device, primarily a material change. Therefore, specific performance metrics (e.g., tensile strength, fixation stability) would have been used to demonstrate equivalence to the predicate device, rather than patient-focused clinical acceptance criteria. The document does not explicitly state numerical acceptance criteria or performance results (e.g., "The device demonstrated a fixation strength of X N, meeting the acceptance criterion of >Y N"). Instead, it relies on the concept of "substantial equivalence" across various attributes.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Similar intended use	Intended use remains unchanged (browplasty surgery, fixation of subdermis to cranial bone).
Similar fundamental scientific technology	Technology is considered similar.
Similar labeling	Labeling is considered similar.
Similar design	Design is considered similar.
Similar dimensional specification	Dimensional specifications are considered similar.
Similar performance specification	Performance specifications are considered similar to the predicate, demonstrating equivalence despite material change.
Similar ergonomics of the patient-user interface	Ergonomics are considered similar.
Similar packaging and expiration dates	Packaging and expiration dates are considered similar.
Similar sterilization methods	Sterilization methods are considered similar.

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

The provided summary does not describe a clinical "test set" in the sense of patient data. The basis of equivalence is likely through bench testing and possibly animal studies to compare the performance characteristics of the new material variant to the predicate device. The document does not specify the number of samples or specimens used in such tests, nor does it mention any clinical data provenance (country, retrospective/prospective) for a test set. This is typical for a 510(k) based on substantial equivalence for a material change.

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

This information is not applicable and not provided. The "ground truth" here would relate to the performance characteristics of the device itself (e.g., mechanical properties, biocompatibility), established through engineering tests and scientific principles, not clinical expert consensus on patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome assessment by multiple experts, which is not the primary focus of this "substantial equivalence" submission for a material change.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging devices where human readers interpret medical images with or without AI assistance. The ENDOTINE device is a surgical fixation device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, this is a surgical fixation device, not an algorithm. Standalone performance studies are for AI/ML-based algorithms.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" would be established through:

Bench Test Results: Mechanical properties (e.g., strength, degradation profile, pull-out force), biocompatibility, and possibly sterile barrier integrity testing.
Scientific Principles: Demonstrating that the new material (bioabsorbable) meets the functional requirements and safety profile of the predicate device.
Historical Data from Predicate Device (K014153): The successful clinical use and safety record of the predicate device serve as the ultimate "ground truth" for the intended use and performance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable.

In summary, this 510(k) submission (K023922) focuses on demonstrating substantial equivalence to a previously cleared device (K014153) due to a change in material. It is not a submission for a new device requiring extensive clinical trials to establish de novo safety and effectiveness or algorithm performance. The "acceptance criteria" are implicitly met by demonstrating that the device with the new material performs equivalently to the predicate device across various non-clinical and design attributes. The provided text outlines the declaration of substantial equivalence but does not detail the specific test results or clinical studies that would support such a claim beyond stating similarity in fundamental scientific technology, design, and performance specification.

Summary

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KO23922

Summary of Safety and Effectiveness

Trade Name:

Coapt Systems ENDOTINE Device TM

Manufacturer Information:

Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA 94303 Phone: 650.331-7680 (Daniel Jacobs, MD) Site Registration number: 3003644133 e-mail: djacobs@coaptsystems.com

Contact:

Shellev Trimm 1152 Navarro Street Santa Rosa, CA 95401 Phone: 707.545-7337 FAX: 707.545-7734 e-mail: shelleytrimm@telocity.com

SZ NON ZO

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DEC 2 0 2002

A13

Establishment Registration Number: 3003644133

FDA Device Classification:

Standard Product Nomenclature:	Smooth or Threaded Metallic Bone Fixation Fastener
Product Code:	HWC
CFR Number:	888.3040
Risk Class:	Class II
Classification Panel:	General Restorative & Neurological Devices

Intended Use and Indication for Use:

The ENDOTINE device intended use and indication for use will remain unchanged.

The ENDOTINE device will continue to be intended for use in browplasty surgery.

The ENDOTINE device will continue to be labeled with the indication for use of:

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

.age 17

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K023922 page 24

Product Description:

Substantial Equivalence:

Establishment of equivalence is based on similarities of intended use, fundamental scientific technology, labeling, design, dimensional specification, performance specification, ergonomics of the patient-user interface, packaging and expiration dates, and sterilization. Based on the criteria set forth in 21 CFR 807.87 and under the New 510(k) Paradigm, it is the belief of Coapt Systems that the ENDOTINE device cleared to market in K014153 and the proposed ENDOTINE device are substantially equivalent in all aspects expect material.

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized human profiles incorporated into the design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coapt Systems, Inc. c/o Ms. Shelley Trimm RCO Consulting 1152 Navarro Street Santa Rosa, California 95401

Re: K023922

Trade/Device Name: Coapt Systems ENDOTINE Device™ Regulation Number: 21 CFR 888.3040 -Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 22, 2002 Received: November 25, 2002

Dear Ms. Trimm:

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. Iisting 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 - Ms. Shelley Trimm

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/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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CONFIDENTIAL

STATEMENT FOR INDICATIONS FOR USE

Page 1 of 1

510(k) Number: 14044153

Device Name: Coapt Systems ENDOTINE Device

Indication for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

Yes

(Division Sign-Off)

510(k) Number:

sion Sign-Oil) Givision of General, Restorative and Neurological Devices

Number K023922

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.