(114 days)
No
The 510(k) summary describes a mechanical meniscal repair system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "meniscal repair system" used in "meniscal repairs and allograft transplant procedures" to "facilitate percutaneous or endoscopic soft tissue procedures," which clearly indicates its therapeutic purpose.
No
The device description and intended use clearly state that it is a meniscal repair system used for surgical procedures, not for diagnosis.
No
The device description clearly outlines physical components like polymer implants, suture, stainless steel needles, and a delivery system, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures," specifically "meniscal repairs and allograft transplant procedures." This describes a surgical device used in vivo (within the body) to repair tissue.
- Device Description: The description details a system with polymer implants, suture, and a needle delivery system. This is consistent with a surgical implant and delivery tool, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used to physically repair tissue within the body.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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OCT.
510(k) Summary
Prepared: 19-June-2012 Updated: 17-October-2012
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc., Endoscopy Division | |
| 150 Minuteman Road | |
| Andover, MA 01810 | Karin Desjardins |
| Senior Regulatory Affairs Specialist | |
| Phone: (508) 261-4035 | |
| Fax: (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
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.
Intended 0 so a long the contrast of the same of the comments of the comments of the comment
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.
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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.
2
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
3
Page 2 - Ms. Karin Desjardins
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,
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
4
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