(29 days)
The Arthrex SpeedCinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
The Arthrex SpeedCinch is an implantable suture retention device which consists of implants and an implant delivery mechanism. The implants are composed of PEEK Optima® (polyetheretherketone) anchors and FiberWire (Polyethylene/Polyester) suture offered in #2-0 size. The implant delivery mechanism is a handheld manual surgical instrument with trigger for implant delivery.
The Arthrex SpeedCinch is intended as a suture retention device to facilitate percutaneous or endoscopic soft tissue repairs, specifically meniscal tears. The device's performance was evaluated through mechanical testing to demonstrate substantial equivalence to the predicate device (Arthrex Meniscal Cinch, K073149).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria values that the device needed to meet. Instead, it describes a comparative study showing the device's performance relative to a predicate device. The primary performance metrics were tensile strength (pull-out strength) and cyclic displacement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile strength (pull-out strength) substantially equivalent to or better than predicate device | Tensile strength (pull-out strength) substantially equivalent to or better than the predicate device. |
| Cyclic displacement substantially equivalent to or better than predicate device | Cyclic displacement substantially equivalent to or better than the predicate device. |
| Implant materials and general function comparable to predicate device | Implant materials and general function the same as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Mechanical testing data" but does not specify the sample size used for the mechanical testing of either the Arthrex SpeedCinch or the predicate device.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically prospective testing conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the study involved mechanical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation. Performance was measured objectively through physical tests.
4. Adjudication Method for the Test Set
This question is not applicable for mechanical testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study was mechanical testing comparing device performance to a predicate device. This is not an AI-assisted diagnostic or interpretation study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a physical implantable suture retention device, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" (or the reference for comparison) was the objective mechanical measurements of tensile strength and cyclic displacement, compared against the same measurements from the predicate device. There was no expert consensus, pathology, or outcomes data used in this specific submission for substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. There is no software algorithm or AI model mentioned that would require a training set. The device is a physical medical device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set mentioned or implied for this device.
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2.1510(K) SUMMARY
K132043 Page 1/2
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| Date Summary Prepared | July 30, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Leon Brown II, Ph.D. |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 2028 | |
| Fax: 239/598.5508 | |
| Email: Leon.Brown@Arthrex.com | |
| Trade Name | Arthrex SpeedCinch |
| Common Name | Fastener, fixation, nondegradable soft tissue |
| Product Code -Classification Name | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| GAT - Suture, Nonabsorbable, Synthetic, Polyethylene | |
| CFR | 21 CFR 878.5000: Nonabsorbable poly(ethyleneterephthalate) surgical suture21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener |
| Predicate Device | K073149: Arthrex Meniscal Cinch |
| Purpose of Submission | This special 510(k) premarket notification is submitted toobtain clearance for the Arthrex SpeedCinch. |
| Device Description | The Arthrex SpeedCinch is an implantable sutureretention device which consists of implants and animplant delivery mechanism. The implants are composedof PEEK Optima® (polyetheretherketone) anchors andFiberWire (Polyethylene/Polyester) suture offered in #2-0size. The implant delivery mechanism is a handheldmanual surgical instrument with trigger for implantdelivery. |
| Intended Use | The Arthrex SpeedCinch is an implantable sutureretention device which facilitates percutaneous orendoscopic soft tissue repairs, including the repair ofmeniscal tears. |
| Substantial Equivalence Summary | Based on the intended use, technological characteristicsand comparison to the predicate device, Arthrex, Inc. hasdetermined that the proposed Arthrex SpeedCinch issubstantially equivalent to the currently marketedpredicate device, Arthrex Meniscal Cinch (K073149). |
| The Arthrex SpeedCinch is an implantable sutureretention device which consists of implants and animplant delivery mechanism. The proposed deviceimplant has a smaller diameter than the predicate devicefor lower profile anchoring. Mechanical testing datademonstrates that the tensile strength (pull out strength)and cyclic displacement of the proposed ArthrexSpeedCinch device are substantially equivalent to orbetter than the tensile strength and cyclic displacementof the predicate device. The implant materials andgeneral function of the implant are the same as thepredicate device. | |
| The implant delivery mechanism of the proposed devicehas been modified for ascetics and to move the implantdelivery trigger from being a thumb trigger to being aforefinger trigger for ergonomic ease of use. A nosecover depth stop was added. A downward slant noseoption was added to accommodate physician preference. | |
| Any differences between the Arthrex SpeedCinch and thepredicate are considered minor and do not raisequestions concerning safety and effectiveness. |
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K132043 Page 2/2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The eagle is stylized and abstract, with flowing lines representing its feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Mr. Leon Brown II, Ph.D. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
July 31, 2013
Rc: K132043
Trade/Device Name: Arthrex SpeedCinch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, MBI Dated: July 9, 2013 Received: July 17, 2013
Dear Mr. Brown:
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 10 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 docs 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 cither 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 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
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Page 2 -- Mr. Leon Brown II, Ph.D.
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
" Enclosure
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2.5 INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): '
Device Name:
Arthrex SpeedCinch
Indications For Use:
The Arthrex SpeedCinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Prescription Use _ 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)
PAGE 1 of 1
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132043
§ 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.