(50 days)
The Arthrex Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
The Arthrex Suture is a dyed or non-dyed braided suture construct made of 100% UHMWPE. The Arthrex Suture strands that are dyed black are made of nylon. Suture ends are stiffened with cyanoacrylate. The Arthrex Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Suture constructs meet USP standards for suture. The Arthrex Suture is available in straight and loop configurations; and sizes #2 to #5 for suture, and 1.5mm to 4mm (width) for tape.
The provided document specifies the acceptance criteria and the study conducted for the Arthrex Suture, a non-absorbable surgical suture. However, many requested details regarding the methodology of the study are not present in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile (pull-out) strength | Meets or exceeds established minimum criteria | "The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength..." |
| Knot Pull | Meets or exceeds established minimum criteria | "...and knot pull for the desired indications." |
| USP Standards | Meets USP standards for suture | "The Arthrex Suture constructs meet USP standards for suture." and "the UHMWPE suture meets USP." |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the mechanical testing (tensile/pull-out strength and knot pull).
- Data Provenance: Not specified, but generally, such testing is conducted in a laboratory setting by the manufacturer (Arthrex, Inc. in Naples, FL, USA). It is a prospective study on the device itself.
3. Number of Experts and Qualifications for Ground Truth of Test Set
This information is not provided in the document. Mechanical testing of sutures typically relies on standardized test methods and instrumentation rather than expert interpretation of a 'ground truth' in the clinical sense.
4. Adjudication Method for Test Set
Not applicable. Mechanical testing does not involve adjudication as seen in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating human reader performance, often with AI assistance, in interpreting clinical data (e.g., images). The Arthrex Suture is a physical medical device, and the evaluation focuses on its mechanical properties.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical suture, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the mechanical testing is based on established minimum acceptance criteria for tensile strength and knot pull, and USP standards for suture. These are objective, quantifiable physical properties.
8. Sample Size for the Training Set
Not applicable. As a physical product being evaluated for mechanical properties, there is no "training set" in the context of an algorithm. The "training" for such a device would be the manufacturing process and material selection.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set as it would be understood for an AI or imaging device. The "ground truth" for the device's design and manufacturing would be the material properties, engineering specifications, and adherence to relevant standards (like USP).
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Arthrex SPECIAL 510(k): Arthrex Suture
| 510(k) Summary | |
|---|---|
| Date Summary Prepared | September 20, 2012 |
| Purpose of Submission | To obtain clearance for a line extension to the existing suturedevices |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Ivette GalmezRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1263Fax: 239/598.5508Email: ivette.galmez@arthrex.com |
| Trade Name | Arthrex Suture |
| Common Name | Non-absorbable Surgical Suture |
| Product Code -Classification Name | GAT - 21 CFR 878.5000: Nonabsorbable poly(ethyleneterephthalate) surgical suture |
| Predicate Devices | K041553 - Arthrex FiberWire and FiberTapeK100652 - ACL TightRope |
| Device Description | The Arthrex Suture is a dyed or non-dyed braided sutureconstruct made of 100% UHMWPE. The Arthrex Suture strandsthat are dyed black are made of nylon. Suture ends are stiffenedwith cyanoacrylate. The Arthrex Suture will be supplied in pre-cut lengths with or without various swaged needles. The ArthrexSuture constructs meet USP standards for suture. The ArthrexSuture is available in straight and loop configurations; and sizes#2 to #5 for suture, and 1.5mm to 4mm (width) for tape. |
| Indications for Use | The Arthrex Suture is intended for use in soft tissueapproximation and/or ligation. The suture may be providedindividually or be incorporated as a component, into surgerieswhere constructs including those with allograft or autograft tissueare used for repair. |
| Substantial EquivalenceSummary | The Arthrex Suture is substantially equivalent to the predicatedevices in which the basic features (design configuration, sizeand width) are similar and the intended use is the same. |
| Substantial EquivalenceSummary (continue) | The main differences between the predicate(FiberWire/FiberTape) and the proposed devices are: |
| • Fiber Wire is made of UHMWPE and polyester, the proposeddevice is made of UHMWPE only.• Fiber Wire does not meet the diameter as per USP standards,the UHMWPE suture meets USP.• Fiber Wire sizes range from 4-0 to #5, the UHMWPE sutureranges in size from #2 to #5.• FiberTape sizes range from 2mm to 4mm, the UHMWPEtape ranges in size from 1.5mm to 4mm.• FiberTape ends taper into suture-like strands but the ends ofthe UHMWPE tape do not. | |
| These differences are considered minor and do not raisequestions concerning safety and effectiveness. | |
| The mechanical testing demonstrates that the proposed devicemeets or exceeds the established minimum acceptance criteria fortensile (pull-out) strength and knot pull for the desiredindications. | |
| Based on the indication for use, technological characteristics, andsummary of data submitted, Arthrex, Inc. has determined that theArthrex Suture is substantially equivalent to currently marketedpredicate devices. |
SEP 2 5 2012
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K122374
p2/2
Arthrex SPECIAL 510(k): Arthrex Suture
:
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The overall design is simple and conveys a sense of national identity and governmental authority.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 5 2012
Arthrex Incorporation % Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K122374
Trade/Device Name: Arthrex Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) sur-gical suture Regulatory Class: Class II Product Code: GAT Dated: September 10, 2012 Received: September 13, 2012
Dear Ms. Galmez:
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
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Page 2 – Ms. Ivette Galmez
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. -
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 vours.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex. SPECIAL 510(k): Arthrex Suture
3 Indications for Use Form
Indications for Use
510(k) Number (if known):
Device Name: Arthrex Suture
Indications For Use:
The Arthrex Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
Prescription Use X AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(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)
Mal dMele
Sign-Of
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Suices
510(k) Number K122374
PAGE 1 of 1
§ 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.