The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

Device Description

The TFCC FAST-FIX Kit is an all-inside Triangular Fibrocartilage Complex (TFCC) repair system. The kit consists of the delivery device pre-assembled with a disposable split cannula and also packaged with a knot pusher/ suture cutter. The delivery device includes two non-absorbable polymer implants (Polyetheretherketone (PEEK)), pre-tied with #2-0 non-absorbable suture (Ultra High Molecular Weight Polyethylene (UHMWPE)) and preloaded into a needle delivery system.

AI/ML Overview

The provided text describes a 510(k) submission for the Smith & Nephew TFCC FAST-FIX Kit, a medical device for suture retention during Triangular Fibrocartilage Complex (TFCC) repair. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not involve an AI component, clinical studies with human participants, or the use of AI-specific metrics like AUC, sensitivity, or specificity. Therefore, many of the requested fields related to AI performance, clinical study design, and human reader involvement are not applicable/reported in this document.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria (Related to the device's function)	Reported Device Performance (from mechanical testing)
Ultimate Tensile Strength	The TFCC FAST-FIX construct's ultimate tensile strength was confirmed to be at least equivalent to the predicate devices.
Load at 2mm Elongation	The TFCC FAST-FIX construct's load at 2mm elongation was confirmed to be at least equivalent to the predicate devices.
Safety and Effectiveness	The mechanical testing results confirmed that there are no new issues related to the safety and effectiveness of the subject device, and it performed at least equivalently to the identified predicates.

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

Sample Size: Not explicitly stated in terms of number of devices tested. The document mentions "Mechanical testing was conducted," but does not provide specific sample quantities for the tests (e.g., how many kits were used for tensile strength testing).
Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the testing would have been conducted in a laboratory setting, likely in the US by the manufacturer, Smith & Nephew. The document does not specify the location or provide details on the generation of the mechanical test data beyond stating "Mechanical testing was conducted."
Retrospective/Prospective: Not applicable, as this refers to mechanical testing, not a clinical study.

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)

Not applicable. This device is a surgical implant, and its acceptance criteria were met through mechanical testing against predicate devices, not through expert-based ground truth establishment for diagnostic or interpretive tasks.

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

Not applicable. There was no adjudication needed as it was a comparison of mechanical properties, not expert interpretations.

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

Not applicable. This submission is for a physical medical device (suture retention system), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. There is no algorithm or AI component to this device.

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

Comparative Mechanical Performance: The "ground truth" for the mechanical testing was the established performance of legally marketed predicate devices. The subject device's mechanical properties (ultimate tensile strength and load at 2mm elongation) were compared directly to those of the predicate devices. The goal was to demonstrate that the subject device's performance was "at least equivalent."

8. The sample size for the training set

Not applicable. There is no AI model, and therefore no training set.

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

Not applicable. There is no AI model or training set.

Summary

{0}------------------------------------------------

Smith & Nephew TFCC FAST-FIX Kit 510(k) Summary of Safety and Effectiveness

Date prepared: November 13, 2013

Submitter Information	Contact Information
Smith & Nephew, Inc., Endoscopy Division150 Minuteman RoadAndover, MA 01810	Jason SellsGroup Manager, Regulatory AffairsPhone: (901) 399-5520Fax: (901) 566-7084

Device Name (Unmodified)
Trade or proprietary name	TFCC FAST-FIX Kit
Common or usual name	Suture retention device
Classification name	21 CFR §878.5000 Suture, Non-absorbable, Synthetic, Polyethylene
Product code	GAT

Legally Marketed Predicate Device

The Smith & Nephew TFCC FAST-FIX Kit is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

K092508 FAST-FIX 360 Meniscal Repair System (Cleared January 28, 2012)
K072322 ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems (Cleared September 18, 2007)

Device Description

Indications For Use

The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

{1}------------------------------------------------

Technological Characteristics

ﺗﺮ

The Smith & Nephew TFCC FAST-FIX Kit is substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy. Further detail is provided in the table below.

	FAST-FIX 360(Predicate Device)	TFCC FAST-FIX Kit(Subject Device)
510(k)	K092508	K132079
Description	The FAST-FIX 360 Meniscal Repair System isan all-inside meniscal repair device. Eachdevice includes two non-absorbable polymerimplants, pre-tied with #2-0 non-absorbablesuture and preloaded into a needle deliverysystem. The adjustable depth penetrationlimiter is preset to approximately 18 mm fromthe tip of the needle. It can be adjusted downin 2 mm increments to approximately 10 mm.	The TFCC FAST-FIX Kit is an all-inside TFCCrepair system. The kit consists of the deliverydevice pre-assembled with a disposable splitcannula and also packaged with a Knotpusher/ Suture cutter. The delivery deviceincludes two non-absorbable polymerimplants, pre-tied with #2-0 non-absorbablesuture and preloaded into a needle deliverysystem
Implant Material	Polyetheretherketone (PEEK)	Same
T1 Implantdimensions:	0.200 x 0.040 inches	Same
T2 Implantdimensions	0.190 x 0.059 inches	Same
Suture	Ultra high molecular weight polyethylene(UHMWPE)	Same
Suture Knot	Patented one-way self-locking sliding knot tiedwith 2 suture retention bar implants	Same
Suture Size	#2-0	Same
Delivery Needle	Stainless Steel	Same
Needle shaft OD	Outer Diameter 0.058"	Same
Depth LimiterTube	Pebax (White)	Same
Depth LimiterTube length	5.399"	3.94"
SutureRetaining Tube	Nylon 101	Same
Sterilization	100% EtO (SAL 10-5)	Same
How provided	Sterile, Single Use Only	Same
PackagingConfiguration	Carton, Paper Carrier, Two pouches (innerand outer)	Carton and Paper Carrier identical. One pouch only (same as inner pouch of predicate) Device has Split Cannula pre-assembled. There is additional pouch with Knot Pusher/Suture Cutter.
Shelf Life	3 Years	Same

{2}------------------------------------------------

Performance Data

Mechanical testing was conducted and the results were compared to the testing conducted on predicate devices. The Ultimate tensile strength tests and tests to determine load at 2mm elongation confirmed that the TFCC FAST-FIX construct is at least equivalent to the predicate devices and that there are no new issues related to safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject device.

Conclusion

The subject TFCC FAST-FIX Kit may be considered substantially equivalent to the identified predicate devices based on similarities in design and indications for use. The results of mechanical testing performed on the subject device did not raise any new issues of safety or effectiveness, and the TFCC FAST-FIX Kit performed at least equivalent to the identified predicates.

ﺗ

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

Public Health Service

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

Smith & Nephew, Incorporated Mr. Jason Sells Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

December 5, 2013

Re: K132079

Trade/Device Name: TFCC FAST-FIX Kit Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: November 14, 2013 Received: November 15, 2013

Dear Mr. Sells:

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 11 (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

{4}------------------------------------------------

Page 2 - Mr. Jason Sells

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K132079

Device Name: TFCC FAST-FIX Kit

Indications for Use:

The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. .

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132079

Page 1 of

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.