(29 days)
The Smith & Nephew ULTRA FAST-FIX Meniscal Repair Systems and ULTRA FAST-FIX AB Meniscal Repair Systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
The Smith & Nephew ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems are all-inside meniscal repair devices. Each device includes two implants, pre-tied with #0 nonabsorbable suture pre-loaded into a needle delivery system. The FAST-FIX Meniscal Repair System is provided sterile for single use only.
The provided text describes the 510(k) summary for the ULTRA FAST-FIX Meniscal Repair System and ULTRA FAST-FIX AB Meniscal Repair System. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria.
Instead, it states that the device is "substantially equivalent" to predicate devices (Smith & Nephew FAST-FIX and FAST-FIX AB Meniscal Repair Systems) in terms of intended use, fundamental scientific technology, and performance. The summary mentions "Performance testing demonstrates that the soft tissue repair achieved using ULTRA FAST-FIX and ULTRA FAST-FIX AB is substantially equivalent to repair achieved with currently marketed meniscal repair devices. Performance testing also affirms that ULTRA FAST-FIX and ULTRA FAST-FIX AB offer substantially equivalent suture sliding characteristics compared to the predicate FAST-FIX and FAST-FIX AB devices."
However, it does not provide:
- A table of specific acceptance criteria and reported device performance values.
- Sample sizes for test sets, data provenance, or details about the study design.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance if relevant (this is a medical device, not an AI/algorithm).
- The type of ground truth used, or sample sizes and ground truth establishment for a training set.
The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed performance data against pre-defined acceptance criteria for a new type of study.
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SEP 1 8 2007
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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.
ULTRA FAST-FIX Meniscal Repair System & ULTRA FAST-FIX AB Meniscal Repair System
Date Prepared: 31 AUG 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC Regulatory Affairs Specialist Phone: (508) 261-3618 FAX: 1508) 261-3620
C. Device Name
| Trade Name: | ULTRA FAST-FIX Meniscal Repair SystemULTRA FAST-FIX AB Meniscal Repair System |
|---|---|
| Common Name: | Meniscal Repair Device |
| Classification Name: | Suture Retention Device/Synthetic NonabsorbablePolyethylene Suture |
| Product Code: | GAT |
| Regulation Number: | 21 CFR §878.5000 |
| Device Class | II |
| Panel | Orthopedic |
D. Predicate Devices
The Smith & Nephew ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair systems are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew FAST-FIX (K002261) and FAST-FIX AB (K020480) Meniscal Repairs Systems.
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Description of Device ﻧﭧ
The Smith & Nephew ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems are all-inside meniscal repair devices. Each device includes two implants, pre-tied with #0 nonabsorbable suture pre-loaded into a needle delivery system. The FAST-FIX Meniscal Repair System is provided sterile for single use only.
F. Intended Use
The Smith & Nephew ULTRA FAST-FIX Meniscal Repair Systems and ULTRA FAST-FIX AB Meniscal Repair Systems are intended for use as suture retention devices 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 ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems are substantially equivalent in design, intended use and fundamental scientific technology to the predicate Smith & Nephew FAST-FIX (K002261) and FAST-FIX AB (K020480) Meniscal Repairs Systems. The component material changes defined in this premarket application have been demonstrated to be substantially equivalent and raise no new issues of safety and efficacy.
H. Summary Performance Data
Performance testing demonstrates that the soft tissue repair achieved using ULTRA FAST-FIX and ULTRA FAST-FIX AB is substantially equivalent to repair achieved with currently marketed meniscal repair devices. Performance testing also affirms that ULTRA FAST-FIX and ULTRA FAST-FIX AB offer substantially equivalent suture sliding characteristics compared to the predicate FAST-FIX and FAST-FIX AB devices.
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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 stylized eagle with three horizontal lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2007
Smith & Newphew. Inc. % Ms. Julie Acker, RAC Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K072322
Trade/Device Name: ULTRA FAST-FIX Meniscal Repair System ULTRA FAST0-FIX AB Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: August 16, 2007 Received: August 20, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Julie Acker, RAC
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K072322 510(k) Number (if known):
Device Name: ULTRA FAST-FIX Meniscal Repair System
ULTRA FAST-FIX AB Meniscal Repair System
The Smith & Nephew ULTRA FAST-FIX Meniscal Repair Systems and ULTRA FAST-FIX AB Meniscal Repair Systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
| 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)
Mark A. Millerson
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
K072322
510(k) Number
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§ 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.