SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N by SMITH & NEPHEW, INC.

The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 meniscal repair systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB, AND FAST FIX 360 are indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB AND FAST-FIX 360 devices are intended to be used for anchoring the . allograft to the meniscal rim during allograft transplant procedures.

Device Description

The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are all-inside meniscal repair device includes two polymer implants, pretied with non-absorbable suture pre-loaded into a stainless steel needle delivery system with an adjustable length depth penetration limiter. Product variants are offered with either a straight, curved or reverse curved delivery needle, and are provided sterile for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ULTRA FAST-FIX Meniscal Repair System, ULTRA FAST-FIX AB Meniscal Repair System, and FAST-FIX 360 Meniscal Repair System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in fixation properties to predicate	"Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent to legally marketed predicate device."
No new issues of safety and efficacy compared to predicate	"The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy."
Substantial equivalence in intended use	"The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in intended use... to the following legally marketed devices..."
Substantial equivalence in fundamental scientific technology	"The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent...in Fundamental Scientific Technology to the following legally marketed devices..."

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

The 510(k) summary does not specify numerical sample sizes for the performance testing (cyclic load and ultimate tensile strength). It only refers to "performance testing."
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

This information is not applicable to this submission. The device is a physical medical device (suture retention system), and the performance evaluation is based on mechanical testing (cyclic load, ultimate tensile strength), not on expert assessment of images or clinical data for diagnostic purposes.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study was not done and is not applicable. This device is not an AI/imaging device requiring human reader analysis. The study focused on the physical performance of the device.

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

A standalone performance evaluation was done, in the context of mechanical testing. The device's fixation properties were tested independently to demonstrate equivalence to predicate devices, without human intervention in the device's operational performance during testing.

7. The Type of Ground Truth Used

The ground truth used was the mechanical performance characteristics (cyclic load and ultimate tensile strength) of legally marketed predicate devices. The new devices were compared against these established benchmarks.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device and study. This is a medical device submission based on showing substantial equivalence through mechanical performance, not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

Summary

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OCT.

510(k) Summary

Prepared: 19-June-2012 Updated: 17-October-2012

Submitter Information	Contact Information
Smith & Nephew, Inc., Endoscopy Division150 Minuteman RoadAndover, MA 01810	Karin DesjardinsSenior Regulatory Affairs SpecialistPhone: (508) 261-4035Fax: (508) 261-3620

Device Name: trade, common or proprietary and classification name
Proprietary name	ULTRA FAST-FIX Meniscal Repair System
	ULTRA FAST-FIX AB Meniscal Repair System
	FAST-FIX 360 Meniscal Repair System
Common Name	Suture retention device
Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene

legally Marketed Predicate Devices " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

K041216	ULTRABRAID Suture(cleared June 7, 2004)
K072332	ULTRA FAST-FIX / ULTRA FAST-FIX AB Meniscal Repair System
	(cleared September 18, 2007)
K092508	FAST-FIX 360 Meniscal Repair System
	(cleared January 28, 2010)

Device Description of the September 1978 to 1992 and 1992 and 1992 and 1992 and 1992 and

Intended 0 so a long the contrast of the same of the comments of the comments of the comment

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Technological Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy.

Performance Data Article Callery of Carlos Comments of Children Comments of Children College Clinical literature has demonstrated equivalence between techniques for meniscal repair and meniscal reconstruction procedures such as meniscal allograft transplantation. Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are substantially equivalent to legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, giving it a formal and official appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 8 2012

Smith and Nephew, Incorporated % Ms. Karin Desjardins Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K121861

Trade/Device Name: · ULTRA FAST-FIX Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: September 21, 2012 Received: September 24, 2012

Dear Ms. Desjardins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K121861 510(k) Number (if known):

Device Name:

ULTRA FAST-FIX Meniscal Repair System ULTRA FAST-FIX AB Meniscal Repair System FAST-FIX 360 Meniscal Repair System

Indications for Use:

The ULTRA FAST-FIX Meniscal Repair System is intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

The ULTRA FAST-FIX AB Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX AB System is indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX AB System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. .

The FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The FAST-FIX 360 System is indicated for use in meniscal repairs and allograft transplant procedures. The FAST-FIX 360 System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Daniel Knape by MM

Division of Surgical, Orthopedic, Restorative Devices

510(k) Numbe

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.