(153 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML terms or functionalities.
No
The device is a suture retention device intended to facilitate TFCC repair procedures, which are surgical procedures, rather than providing therapy itself.
No
The device is described as a suture retention device and repair system for the Triangular Fibrocartilage Complex, not a tool for diagnosing medical conditions.
No
The device description explicitly details hardware components including a delivery device, cannula, knot pusher/suture cutter, polymer implants, and suture.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure to repair the Triangular Fibrocartilage Complex (TFCC). This is a direct intervention on the patient's body.
- Device Description: The device is a surgical tool and implant system used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed for testing biological samples to provide information about a person's health status. This device is a surgical instrument used for repair in vivo (within the body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Triangular Fibrocartilage Complex (TFCC)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Division | |
| 150 Minuteman Road | |
| Andover, MA 01810 | Jason Sells |
| Group Manager, Regulatory Affairs | |
| Phone: (901) 399-5520 | |
| Fax: (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
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.
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 is
an all-inside meniscal repair device. Each
device includes two non-absorbable polymer
implants, pre-tied with #2-0 non-absorbable
suture and preloaded into a needle delivery
system. The adjustable depth penetration
limiter is preset to approximately 18 mm from
the tip of the needle. It can be adjusted down
in 2 mm increments to approximately 10 mm. | The TFCC FAST-FIX Kit is an all-inside 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, pre-tied with #2-0 non-absorbable
suture and preloaded into a needle delivery
system |
| Implant Material | Polyetheretherketone (PEEK) | Same |
| T1 Implant
dimensions: | 0.200 x 0.040 inches | Same |
| T2 Implant
dimensions | 0.190 x 0.059 inches | Same |
| Suture | Ultra high molecular weight polyethylene
(UHMWPE) | Same |
| Suture Knot | Patented one-way self-locking sliding knot tied
with 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 Limiter
Tube | Pebax (White) | Same |
| Depth Limiter
Tube length | 5.399" | 3.94" |
| Suture
Retaining Tube | Nylon 101 | Same |
| Sterilization | 100% EtO (SAL 10-5) | Same |
| How provided | Sterile, Single Use Only | Same |
| Packaging
Configuration | Carton, Paper Carrier, Two pouches (inner
and 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
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