(25 days)
No
The summary describes a mechanical fixation device made of suture material and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, which is a structural support function, not a therapeutic or diagnostic treatment.
No
Explanation: The device is described as a "suture loop manufactured from polyester suture" used for "fixation of tendons and ligaments during orthopedic reconstruction procedures." This indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of it being used to identify or characterize a disease or condition.
No
The device description clearly states it is a "suture loop manufactured from polyester suture," indicating it is a physical, hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Smith & Nephew Continuous Loop Fixation Device is a surgical implant used to physically fix tendons and ligaments during orthopedic procedures. It is a mechanical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states it's for "fixation of tendons and ligaments during orthopedic reconstruction procedures." This is a surgical function, not a diagnostic one.
The information provided about the device's description, performance testing (comparing it to a predicate surgical device), and lack of mention of any diagnostic processes further confirms it is not an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
Product codes
GAT
Device Description
The Smith & Nephew Continuous Loop Fixation Device is a suture loop manufactured from polyester suture. The Continuous loop is used in the same way as surgical suture with the benefit of pre-measured lengths and no need for knot tying. The device is available in 20, 40 & 60 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendons and ligaments
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)
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K052652,1/2
OCT 2 1 2005
SECTION V
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.
Smith & Nephew Continuous Loop Fixation Device
Date Prepared: September 23, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Deana Boushell Principle Regulatory Affairs Specialist (508) 337-6624 Phone: (508) 261-3620 FAX:
C. Device Name
| Trade Name: | Smith & Nephew Continuous Loop Fixation Device |
|---|---|
| Common Name: | Suture Loop |
| Classification Name: | Nonabsorbable polypropylene surgical suture |
Predicate Devices D.
The Smith & Nephew Continuous loop is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew Endobutton CL (K980155).
E. Description of Device
1
052652²/₂
The Smith & Nephew Continuous Loop Fixation Device is a suture loop manufactured from polyester suture. The Continuous loop is used in the same way as surgical suture with the benefit of pre-measured lengths and no need for knot tying. The device is available in 20, 40 & 60 mm.
F. Intended Use
The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
G. Comparison of Technological Characteristics
The Smith & Nephew Continuous Loop Fixation Device is substantially equivalent in design, materials, function and intended use to the Smith & Nephew Endobutton CL, cleared in K980155. The proposed and the predicate devices both have the same intended use, suture material and are offered in a similar size range.
H. Summary Performance Data
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155 . The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Deana Boushell Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K052652
K032032
Trade/Device Name: Smith & Nephew Continuous Loop Fixation Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: September 23, 2005 Received: September 26, 2005
Dear Ms. Boushell:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars manatinent date of the Medical Device American be on to commerce prior to May 28, 1776, the enastinen with the provisions of the Federal Food. Drug, devices that have been icclassified in accreaned with the mail and over all application (PMA). and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, belyer to readers for annual registration, listing of general controls provisions of the fise, 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 If your device is classified (see aboro) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations in may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Obas neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuates of would on and other requirements of the Act that IDA has made a dotermination administered by other Federal agencies. You must of ally it cach statutes and regularents and and limited to: registration and listing (21 Compry with an the Act STequirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Deana Boushell
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your end finding of substantial equivalence of your device to a legally premaince holicated and caresults 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Barbara Buehrig
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ຮູ້ເ.D
Indications for Use
510(k) Number (if known): K052652
Device Name: Smith & Nephew Continuous Loop Fixation Device
Indications For Use:
The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and The Simill & Nephtw Continuous Esop I hander = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
NEEDED)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Poueluns for muxin
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
10
510(k) Number Kos 2452