(29 days)
The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.
The proposed Arthrex Self Punching SwiveLock® Suture Anchors are fully threaded suture anchors comprised of a PEEK eyelet and a hollow anchor body preassembled on a disposable inserter. The anchor body is manufactured from either PLLA/βTCP or PEEK. The Arthrex Self Punching SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to the bone in the shoulder.
The document describes the Arthrex Self Punching SwiveLock® Suture Anchors and its substantial equivalence to a predicate device. It briefly mentions performance data but lacks the detailed information requested for acceptance criteria and a comprehensive study description.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." |
Missing Information: The specific quantitative acceptance criteria for "pull-out and insertion testing" and the actual numerical results of the device performance are not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not specified. The document only states "all samples."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- This information is not applicable as the study described is a performance/mechanical test, not one involving expert review of data for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable for a mechanical performance test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. The study described is a mechanical performance test.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (suture anchor), not an algorithm or AI system.
7. Type of Ground Truth Used
- For the mechanical performance study, the "ground truth" would be the physical measurements obtained from pull-out and insertion testing, compared against pre-defined engineering or performance specifications. The document indicates these were met.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8).
Summary of the Study:
The provided text indicates that Arthrex Inc. performed "Pull-out and insertion testing" on the proposed Arthrex Self Punching SwiveLock® Suture Anchors and a predicate device (K191226: Arthrex SwiveLock Suture Anchor). The purpose of this testing was to demonstrate substantial equivalence to the predicate device. The results reported state that "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." This suggests that the mechanical performance of the new device in terms of its ability to be inserted and its pull-out strength was comparable and within acceptable limits when compared to the established predicate device. However, the specific details of these acceptance criteria and the quantitative performance data are not included in this document.
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August 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Arthrex Inc. Tiffany Mentzel Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K222263
Trade/Device Name: Arthrex Self Punching SwiveLock® Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: July 27, 2022 Received: July 28, 2022
Dear Tiffany Mentzel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, PhD Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K22263
Device Name
Arthrex Self Punching SwiveLock® Suture Anchors
Indications for Use (Describe)
The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of a surgical instrument. The surgical instrument appears to be a type of clamp or forceps, with a handle and two circular ends. The logo is simple and modern, and it is likely used to represent a medical device company.
510(k) Summary
| Date Prepared | July 27, 2022 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Name: Tiffany MentzelTitle: Principal Regulatory Affairs SpecialistPhone: 1 (239) 643-5553 x75833Email: tiffany.mentzel@arthrex.com |
| Trade Name | Arthrex Self Punching SwiveLock® Suture Anchors |
| Common Name | Suture Anchor |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3030: Single/multiple componentmetallic bone fixation appliances and accessories21CFR 888.3040: Smooth or threaded metallicbone fixation fastener |
| Regulatory Class | II |
| Primary Predicate Device | K191226: Arthrex SwiveLock Suture Anchor |
| Reference Devices | K203495: Arthrex SwiveLock AnchorK193503: Arthrex SwiveLock Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification issubmitted to obtain clearance for the Arthrex SelfPunching SwiveLock Suture Anchors as a lineextension to the Arthrex SwiveLock Suture Anchorscleared in K191226. |
| Device Description | The proposed Arthrex Self Punching SwiveLock®Suture Anchors are fully threaded suture anchorscomprised of a PEEK eyelet and a hollow anchorbody preassembled on a disposable inserter. Theanchor body is manufactured from eitherPLLA/βTCP or PEEK. The Arthrex Self PunchingSwiveLock® Suture Anchor is intended to be usedfor suture (soft tissue) fixation to the bone in theshoulder. |
| Indications for Use | The Arthrex Self Punching SwiveLock® SutureAnchors are intended to be used for suture (softtissue) fixation to bone in the shoulder in skeletally |
| mature pediatric and adult patients. Specifically,rotator cuff repair. | |
| Performance Data | Pull-out and insertion testing was performed on theproposed and predicate devices. The acceptancecriteria were met for all samples, demonstratingsubstantial equivalence to the predicate. |
| TechnologicalComparison | The proposed device has the same technologicalcharacteristics (anchor design, material,sterilization method and biocompatibility profile).The proposed device modification consists of aPEEK self punching eyelet. The Arthrex SelfPunching SwiveLock® Anchors are substantiallyequivalent to the predicate device in which thedesign features and intended uses are the same.Any differences between the proposed device andthe predicate devices are considered minor and donot result in new or different questions concerningsafety or effectiveness. |
| Conclusion | The Arthrex Self Punching SwiveLock® Anchorsare substantially equivalent to the predicatedevices in which the basic design features andintended use are the same. Any differencesbetween the proposed device and the predicatedevices are considered minor and do not result innew or different questions concerning safety oreffectiveness. Based on the indications for use,technological characteristics, and the summary ofdata submitted, Arthrex has determined that theproposed device is substantially equivalent to thecurrently marketed predicate device. |
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Image /page/4/Picture/1 description: The image shows the logo for Arthrex, a medical device company. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word "Arthrex" is an image of a surgical instrument, possibly scissors or forceps. The logo is simple and modern, and it is likely used on the company's products and marketing materials.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.