The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Device Description

The EndoButton Continuous Loop consists of two components. The first is the EndoButton which is made of Titanium 6AL 4V ELI allov (ASTM F136). Its length is from 12 to 18 mm and its width is from 4 to 6 mm. It is oblong in shape with four holes through which suture is threaded. The second component is the polvester suture which is preattached to the center holes. The loop soan lengths range from 10 to 80 mm and is approximately 5 mm in diameter. The suture portion of the EndoButton Continuous Loop is made of polyester. Poly(ethylene terepthalate). The suture is prepared from fibers of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. The suture meets the applicable requirements established by the United States Pharmacopeia (U.S.P.) for non-absorbable surgical suture.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Attribute	Acceptance Criteria (Implied)	Reported Device Performance
Tensile Strength	Equivalent to EndoButton with EndoButton Tape	"EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape."
Stiffness	Equivalent to EndoButton with EndoButton Tape	"EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape."
Cyclic Fatigue Testing	Equivalent to EndoButton with EndoButton Tape	"EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape."
Residual Tensile Strength	Equivalent to EndoButton with EndoButton Tape	"EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape."
Dimensions (EndoButton)	Width: 4-6 mm, Length: 12-18 mm (Matching predicate)	Width: 4-6 mm, Length: 12-18 mm
Suture Loop Span Length	10-80 mm (Acceptable range, wider than predicate tape)	10-80 mm
Material (EndoButton)	Titanium 6AL 4V ELI (ASTM F136) (Matching predicate)	Titanium 6AL 4V ELI (ASTM F136)
Material (Suture)	Polyester, Poly(ethylene terephthalate) (Matching predicate)	Polyester, Poly(ethylene terephthalate), meets USP for non-absorbable surgical suture
Sterilization	Gamma irradiation (Matching predicate EndoButton)	Gamma irradiation
Labeling	Sterile, Single Use Only (Matching predicate)	Sterile, Single Use Only

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

Sample Size: The document does not explicitly state the sample size used for the tensile strength, stiffness, cyclic fatigue, and residual tensile strength tests. It only mentions "After the testing was completed."
Data Provenance: Not specified. The study appears to be a laboratory-based equivalency testing of device components, likely conducted by the manufacturer (Smith & Nephew, Inc., Endoscopy Division). There is no mention of human subject data, country of origin, or whether it was retrospective or prospective in the context of clinical data.

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

This information is not applicable to this submission. The "ground truth" for this device's performance is based on direct physical and mechanical testing (tensile strength, stiffness, etc.) comparing it to a legally marketed predicate device, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The performance evaluation was based on objective mechanical tests, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typical for diagnostic imaging AI devices, which is not the nature of the EndoButton Continuous Loop.

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

This information is not applicable. The EndoButton Continuous Loop is a surgical implant, not an AI algorithm. Its "performance" is mechanical and physical, not computational.

7. Type of Ground Truth Used

The ground truth used was the performance of a legally marketed predicate device (EndoButton with EndoButton Tape) as determined by specific mechanical and material testing standards. The new device's performance was evaluated for equivalence against these established benchmarks. The physical properties of the materials (Titanium 6AL 4V ELI, Polyester) and their compliance with standards (ASTM F136, USP) also serve as a form of ground truth for material specifications.

8. Sample Size for the Training Set

This information is not applicable. As this is a medical device (surgical implant) and not an AI/machine learning algorithm, there is no "training set."

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

This information is not applicable, as there is no training set for this type of device.

Summary

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APR - 1998

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

5980155 The assigned 510(k) number is :

This summary was prepared on January 15, 1998

A. Submitter

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

B. Company Contact

Demetrios Tsakonas Clinical/Regulatory Specialist

். Device Name

EndoButton Continuous Loop Trade Name:

Common Name: · · Suture Retention Device; Surgical Button; Retention Bridge

Polyester Surgical Suture .
Classification Name: · Button, Surgical · Non absorbable surgical suture (Poly[ethylene terephthalate])

D. Predicate/Legally Marketed Devices

EndoButton & EndoButton Tape Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

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E. Device Description

The second component is the polvester suture which is preattached to the center holes. The loop soan lengths range from 10 to 80 mm and is approximately 5 mm in diameter. The suture portion of the EndoButton Continuous Loop is made of polyester. Poly(ethylene terepthalate). The suture is prepared from fibers of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. The suture meets the applicable requirements established by the United States Pharmacopeia (U.S.P.) for non-absorbable surgical suture.

F. Performance

The EndoButton Continuous Loop was tested against the EndoButton with EndoButton Tape to determine if it was equivalent in strength. Tensile strength, Stiffness, Cyclic Fatigue Testing and Residual Tensile Strength were examined. After the testing was completed, it was determined that the EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape.

G. Intended Use

The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction ..

H. Substantial Equivalence

The EndoButton Continuous Loop and the EndoButton & EndoButton Tape have similar designs. Both are used in fixating soft tissue ligaments. The EndoButton components are the same. The suture lengths are similar. The EndoButton tape comes in only one total length 60 cm. where as the suture portion of the EndoButton Continuous Loop will come in a variety of lengths ranging from 10 to 80 mm.

Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.

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A summary comparison of the characteristics of the EndoButton Continuous Loop and the substantially equivalent devices is presented in the table below.

Attribute	Current Product	Substantially Equivalent Product	Substantially Equivalent Product
Indication	EndoButton ContinuousLoopFixation of tendons andligaments duringorthopedic reconstructionprocedures such asAnterior CruciateLigament (ACL)Reconstruction.	EndoButtonK922559	EndoButton TapeK952535
Dimensions	EndoButton:width: 4 - 6 mmlength: 12 - 18 mmSuture loop span length:10 - 80 mm	EndoButton:width: 4 - 6 mmlength: 12 - 18 mm	EndoButton TapeTotal Suture length:60 cm
Material	EndoButton: TitaniumSuture: Polyester	Titanium	Polyester
Sterilization	gamma irradiation	gamma irradiation	ethylene oxide
Labeling	Sterile, Single Use Only	Sterile, Single UseOnly	Sterile, Single Use Only

Applicant Demetrice Jackson

Date 1/15/98

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing the head, body, and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 1998

Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Endoscopy Division Smith & Nephew, Incorporated 130 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K980155 Trade Name: EndoButton Continuous Loop Regulatory Class: II Product Code: GAT and MBI Dated: January 15, 1998 Received: January 16, 1998

Dear Mr. Tsakonas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set .... forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Tsakonas

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Hia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If Known): (c 980) 55

Device Name: EndoButton Continuous Loop

Indications for Use: The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ligament (ACL) Reconstruction. : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Division of General 510(k) Numbe

Prescription Use
(Per 21 CFR 801.109)

or Over-The-Counter Use _

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.