The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and Iigaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.

Device Description

The ENDOBUTTON CL is a machined titanium implant assembled with a continuous loop of polyester tape. It is oblong in shape with four holes through which suture is threaded. The polyester loop is preattached to the center holes. The device is designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point. The device is available with premeasured loops of tape ranging from 20mm-50mm to accommodate different graft sizes.

The ENDOBUTTON is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. It is oblong in shape with four holes through which suture is threaded. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point.

AI/ML Overview

This document describes the Endobutton Continuous Loop (CL), a suture retention device used for fixation of tendons and ligaments. The submission is for an indication expansion for this existing device, not for a new device requiring extensive performance testing for novel functionality. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to demonstrating substantial equivalence for the expanded indications to a legally marketed predicate device through performance testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., "tear strength must be X N"). Instead, the acceptance criterion for this 510(k) submission is substantial equivalence to a predicate device for the expanded indications.

Acceptance Criterion	Reported Device Performance (Summary)
Substantial Equivalence to Predicate Device for Expanded Indications	"The performance testing conducted demonstrates substantial equivalence to the Arthrex Tightrope™ Acromioclavicular (AC) Device, cleared via K052776."
No New Issues of Safety and Efficacy	"The testing also demonstrates that the expanding the indications for use do not raise any new issues of safety and efficacy."

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

The document does not provide details on:

The specific sample size (N-number) used for any mechanical or performance testing.
The explicit data provenance (e.g., country of origin, retrospective or prospective) of the performance testing data.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" for medical decisions or diagnoses made by experts is typically relevant for AI/ML or diagnostic device submissions where human interpretation is being evaluated or augmented. For a mechanical fixation device, validation relies on engineering and biomechanical testing, not expert consensus on medical images or patient outcomes in the same way.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for diagnostic devices where multiple readers interpret cases. This submission is for a surgical implant (fixation device), not a diagnostic tool requiring human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. This device is a physical surgical implant, not an algorithm or software. Its "performance" is assessed through biomechanical testing, not algorithmic output.

7. Type of Ground Truth Used

Ground truth in this context would implicitly be derived from biomechanical testing standards and engineering principles that simulate the forces and stresses the device would experience in vivo. The performance is compared to the predicate device to show similar mechanical properties for the expanded indications. The document implies performance testing, which would involve quantifiable physical measurements.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This is not applicable for the reasons stated in point 8.

Summary

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K081098 page 1 of 2

SECTION IV

JUL 1 6 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Indication Expansion - ENDOBUTTON Continuous Loop Fixation Devices

Date Prepared: April 16, 2008

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover MA, 01810

B. Company Contact

Christina Flores Regulatory Affairs Specialist Phone: (508) 261-3705 FAX: (210) 690-2559

C. Device Name

Trade Name: ENDOBUTTON Continuous Loop

Common Name: Suture Retention device, Non-absorbable (polyester) surgical suture

Classification Name: Fastener, Fixation, Non-degradable, Soft tissue Non-absorbable surgical suture

D. Predicate Devices

The indication for fixation of tendons and ligaments in orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions is substantially equivalent to the currently marketed indications for use of the following legally marketed devices in commercial distribution: the ConMed Linvatec XO Button™ (cleared via K070780) and the Arthrex Tightrope™ Acromioclavicular (AC) Device (cleared via K052776).

E. Description of Device

ENDOBUTTON CL

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ENDOBUTTON

F. Intended Use

The intended use of the currently available ENDOBUTTON Fixation Devices remains unchanged. The Smith & Nephew ENDOBUTTON Fixation Devices are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.

G. Comparison of Technological Characteristics

There are no changes to the existing devices. Technological Characteristics remain the same.

H. Summary Performance Data

The performance testing conducted demonstrates substantial equivalence to the Arthrex Tightrope™ Acromioclavicular (AC) Device, cleared via K052776. The testing also demonstrates that the expanding the indications for use do not raise any new issues of safety and efficacy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew % Endoscopy Division Ms. Christina Flores Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

JUL 1 6 2008

K081098 Trade/Device Name: Endobutton Continuous Loop (CL) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class Il Product Code: JDR, MBI, HWC Dated: April 16, 2008 Received: April 17, 2008

Dear Ms. Flores:

Re:

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 iscuance 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. Christina Flores

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ro8109

5 10(k) Number (if known):

Device Name: ENDOBUTTON Continuous Loop (CL)

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use No

(Per 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)

Jarbare Bneim

Division of General, Restorative, and Neurological Devices

510(k) Number K081098

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.