(25 days)
No
The device description and intended use focus on a mechanical suture-passing mechanism and suture material, with no mention of AI or ML capabilities.
Yes
The device is intended for the repair of meniscal tear injuries, which is a therapeutic intervention aimed at restoring the function of the soft tissue.
No
This device is described as a surgical tool used for the "approximation of soft tissue such as the repair of meniscal tear injuries," indicating its function is for treatment/repair rather than diagnosis.
No
The device description clearly describes a physical, sterile, single-use device with a suture-passing needle mechanism and pre-loaded suture, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "approximation of soft tissue such as the repair of meniscal tear injuries". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture-passing needle mechanism which is pre-loaded with... suture". This is a surgical instrument used to physically repair tissue.
- 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 of the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is used for surgical repair, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended to be used to approximate soft tissue such as during the repair of meniscal tear injuries.
Product codes
GAT
Device Description
The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing was conducted to verify that the Meniscal Repair Device with High Strength Suture is safe and effective and performs as intended. Standard 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Covidien Sport Surgery AS Meniscal Repair Device
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
K091016
:
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
MAY - 4 2009 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Tim M. Lohnes, Manager, Regulatory Affairs |
| DATE PREPARED: | April 7, 2009 |
| TRADE/PROPRIETARY NAME: | Covidien Sport Surgery AS Meniscal Repair Device with
High Strength Suture |
| PREDICATE DEVICE(S): | Covidien Sport Surgery AS Meniscal Repair Device |
| DEVICE DESCRIPTION: | The Covidien Sports Surgery AS Meniscal Repair Device
with High Strength Suture is a sterile single use device for
the approximation of soft tissue such as the repair of
meniscal tears. The disposable single use Device is
comprised of a suture-passing needle mechanism which is
pre-loaded with Size 2/0 Force Fiber Ultra High Molecular
Weight (UHMW) Non Absorbable Polyethylene suture
(K040472), inclusive of a pre-tied knot. The distal end of the
device will be offered in various angular configurations to
enable access to areas of the meniscal anatomy, and to
allow for user preference. |
| INTENDED USE | The Covidien Sports Surgery AS Meniscal Repair Device
with High Strength Suture is intended to be used to
approximate soft tissue such as during the repair of meniscal
tear injuries. |
| TECHNOLOGICAL
CHARACTERISTICS | The Covidien Sports Surgery AS Meniscal Repair Device
with High Strength Suture is substantially equivalent to the
predicate device with regard to passing suture in order to
deliver a pre-tied knot for the repair of meniscal tear injuries. |
| MATERIALS: | All components of the Covidien Sports Surgery AS Meniscal
Repair Device with High Strength Suture are comprised of
materials which are evaluated in accordance with ISO |
- Performance testing was conducted to verify that the Meniscal PERFORMANCE DATA: Repair Device with High Strength Suture is safe and effective and performs as intended.
Standard 10993-1.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
MAY - 4 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Mr. Tim M. Lohnes Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K091016
Trade/Device Name: Covidien Sports Surgery All Suture (AS) Meniscal Repair Device with High Strength Suture
Regulation Number: 21 CFR 878.5000
Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: April 8, 2009 Received: April 9, 2009
Dear Mr. Lohnes:
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 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 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.
2
Page 2 - Mr. Tim M. Lohnes
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
Neil R. Pogle
Mark N. Melkerson & Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
14091016 510(k) Number (if known):
Device Name:
Covidien Sports Surgery All Suture (AS) Meniscal Repair Device with High Strength Suture
Indications For Use:
"The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries".
Prescription Use × (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)
David Krane fa mxu
(Division of General, Restor Division on on one and Neurological Devic
510(k) Number K091066
Page 19 of 37 Trademark