(90 days)
The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries
The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.
The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device. It describes the device, its intended use, and its substantial equivalence to predicate devices based on material and performance data. However, it does not contain acceptance criteria or a detailed description of any study that proves the device meets specific performance criteria.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No acceptance criteria: The document states "Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended," but it does not specify what those performance criteria were (e.g., tensile strength, knot security, deployment force).
- No detailed study information: While performance testing is mentioned, there are no details about the study design, sample sizes, data provenance, ground truth establishment, expert involvement, or any quantitative results.
- No direct comparison to acceptance criteria: Without specific acceptance criteria, a table showing reported device performance against those criteria cannot be created.
Therefore, most of the requested information cannot be provided based on the given document.
What can be extracted or inferred:
- Device Type: Meniscal Repair Device (surgical tool for soft tissue approximation).
- Intended Use: To approximate soft tissue, such as during the repair of meniscal tear injuries.
- Predicate Devices: Confirmed in the document (TiCron™ surgical suture, Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Stryker Mini-Mender Meniscal Repair System).
- Testing Conducted: Performance testing and material compliance testing (ISO Standard 10993-1 for biocompatibility).
- Regulatory Decision: The FDA found the device substantially equivalent to predicate devices, indicating that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.
In summary, the provided text from the 510(k) summary is a high-level overview and does not delve into the detailed technical specifications and study results required to answer your specific questions about acceptance criteria and study data.
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K082535
pg192
510(k) Summary of Safety and Effectiveness
SUBMITTER:
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 845-1000
DEC 0 1 2008
CONTACT PERSON:
Tim M. Lohnes Manager, Regulatory Affairs
DATE PREPARED:
August 27, 2008
Covidien Sport Surgery AS Meniscal Repair Device TRADE/PROPRIETARY NAME:
PREDICATE DEVICE(S):
Classification Name:
Device Classification: Common and Usual Name: Proprietary Name: 510(k) Submitter/Holder:
510(k):
Classification Name:
Device Classification: Common and Usual Name: Proprietary Name:
510(k) Submitter/Holder: 510(k) no .:
Classification Name:
Device Classification:
Common and Usual Name:
Proprietary Name: 510/k) Submitter/Holder: 510(k) no .:
DEVICE DESCRIPTION:
Nonabsorbable poly(ethylene terephthalate) surgical suture CFR 878.5000 (GAT) Class II Polyester Nonabsorbable Surgical Sutures (GAT) TiCron™ surgical suture Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) K830591
Suture Retention Device/Synthetic Nonabsorbable Polvethylene Suture 21 CFR 878.5000 (GAT) Class II Meniscal Repair Device Smith & Nephew Ultra Fast-Fix Meniscal Repair System Smith & Nephew, Inc. Endoscopy Div. K072322
Nonabsorbable poly(ethylene terephthalate) surgical suture CFR 878.5000 (GAT) Class II, 21 CFR 888.4540 (LXH) Class I Polyester Nonabsorbable Surgical Sutures, Orthopedic manual surgical instrument Stryker Mini-Mender Meniscal Repair System Stryker Endoscopv K032901
The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single Device is comprised of a suture-passing use needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification
Page 35 of 57 TMTrademark
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K082535
pg 202
INTENDED USE
The Covidien Sports Surgery AS Meniscal Repair Device is intended to be used to approximate soft tissue such as during the repair of meniscal tear injuries.
is substantially equivalent to the predicate devices with regard to passing suture in order to deliver a pre-tied knot for the
The Covidien Sports Surgery AS Meniscal Repair Device
repair of meniscal tear injuries.
TECHNOLOGICAL CHARACTERISTICS
MATERIALS:
PERFORMANCE DATA:
Repair Device are comprised of materials which are in accordance with ISO Standard 10993-1.
All components of the Covidien Sports Surgery AS Meniscal
Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended.
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification
Page 36 of 57 ™Trademark
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgical Devices % Mr. Tim M. Lohnes Manager, Regulatory Affairs 60 Middleton Avenue North Haven. Connecticuit 06473
DEC 0 1 2008
Re: K082535
Trade/Device Name: Covidien Sports Surgery AS Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: August 27, 2008 Received: September 2, 2008
Dear Mr. Lohnes:
We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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 - Mr. Tim M. Lohnes
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 N. Millican
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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K082535
pg 191
Indications For Use
510(k) Number (if known):
Device Name: Covidien Sports Surgery AS Meniscal Repair Device
Indications For Use:
"The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries"
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nitke? Qal for mem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K082535 510(k) Number
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification
Page 33 of 57 Trademark
§ 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.