(164 days)
K002261, N18331
Not Found
No
The document describes a mechanical surgical device and does not mention any AI or ML components or functionalities.
No
The device is described as a "suture retention device to facilitate percutaneous or endoscopic soft tissue procedures," indicating it's used to hold tissues in place during repair rather than to directly treat a disease or condition itself.
No
The device description clearly states it is a "suture retention device to facilitate percutaneous or endoscopic soft tissue procedures" and an "all-inside meniscal repair device," indicating it is used for treatment/repair rather than diagnosis.
No
The device description explicitly states it includes physical components: "two non-absorbable polymer implants, pre-tied with #2-0 non-absorbable suture and pre-loaded into a needle delivery system." This indicates it is a hardware device, not software-only.
Based on the provided information, the Smith & Nephew FAST-FIX 360 Meniscal Repair System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "suture retention device to facilitate percutaneous or endoscopic soft tissue procedures". This describes a surgical device used in vivo (within the body) to repair tissue.
- Device Description: The description details a physical implant and delivery system used for surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing biological samples outside of the body. The FAST-FIX 360 is a surgical implant and delivery system used directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Smith & Nephew 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 pre-loaded into a needle delivery system. The FAST-FIX 360 Meniscal Repair System is provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, rotator cuff, meniscal
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)
Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices.
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.
Smith & Nephew FAST-FIX Meniscal Repair System (K002261), Ethicon PDS Suture (N18331)
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
SECTION IV 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.
FAST-FIX 360 Meniscal Repair System
Date Prepared: 24 NOV 2009
A. Submitter's Name:
JAN 9 8 2010
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC
Senior Regulatory Affairs Specialist
Phone: (508) 261-3618
FAX: (508) 261-3620
- C. Device Name
| Trade Name: | FAST-FIX 360 Meniscal Repair System |
|---|---|
| Common Name: | Suture Retention Device |
| Classification Name: | Suture Retention Device/Synthetic Nonabsorbable |
| Polyethylene Suture | |
| Product Code: | GAT |
| Regulation Number: | 21 CFR §878.5000 |
| Device Class | II |
| Panel | General & Plastic Surgery |
D. Predicate Devices
The Smith & Nephew FAST-FIX 360 Meniscal Repair Systems is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N18331)
E. Description of Device
The Smith & Nephew 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 pre-loaded into a needle delivery system. The FAST-FIX 360 Meniscal Repair System is provided sterile for single use only.
1
K092508
pg 2082
F. Intended Use
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
G. Comparison of Technological Characteristics
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is substantially equivalent in design, intended use and fundamental scientific technology to the predicate devices defined in this submission. The proposed devices have been demonstrated to be substantially equivalent and raise no new issues of safety and efficacy.
H. Summary Performance Data
Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Julie Acker, RAC Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
JAN 2 8 2010
Re: K092508
Trade/Device Name: FAST-FIX 360 Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 24, 2009 Received: November 27, 2009
Dear Ms. Acker:
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
3
Page 2 - Ms. Julie Acker, RAC
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: FAST-F1X 360 Meniscal Repair System
Indications for Use:
The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
Prescription Use (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 Krone for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092508