Arthrex Nano SwiveLock Suture Anchor by Arthrex Inc.

The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Device Description

The Arthrex Nano SwiveLock Suture Anchor is a two component suture anchor comprised of a hollow titanium anchor body and a PEEK (Polyetheretherketone) eyelet mounted on a disposable driver inserter. The anchor will be offered in a 2.5 mm diameter and 7 mm length. The anchor is sold sterile, single-use.

AI/ML Overview

The document provided is a 510(k) summary for the Arthrex Nano SwiveLock Suture Anchor, a medical device. It details the device's characteristics and its substantial equivalence to a predicate device, rather than providing a study evaluating the performance of an AI-powered device. Therefore, I cannot extract information related to AI system acceptance criteria, reader studies, or ground truth establishment for AI.

However, I can provide information about the acceptance criteria and the study conducted for this specific medical device, which is a suture anchor.

Here's the information based on the provided text, adapted to the context of a medical device rather than an AI system:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance (Result)
Mechanical Performance:
Pull-out strength	Statistically equivalent to the predicate device (K063479: Arthrex 2.5 mm PushLock).
Cyclic testing	Statistically equivalent to the predicate device (K063479: Arthrex 2.5 mm PushLock).
Biocompatibility:
Bacterial Endotoxins Test (BET)	Meets pyrogen limit specifications (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14).
Cytotoxicity	Testing conducted in accordance with ISO 10993-1:2018.
Sensitization	Testing conducted in accordance with ISO 10993-1:2018.
Irritation	Testing conducted in accordance with ISO 10993-1:2018.
Genotoxicity	Testing conducted in accordance with ISO 10993-1:2018.
Systemic Toxicity	Testing conducted in accordance with ISO 10993-1:2018.
Subchronic/Subacute Toxicity	Testing conducted in accordance with ISO 10993-1:2018.
Implantation	Testing conducted in accordance with ISO 10993-1:2018.
Material Characterization	Testing conducted in accordance with ISO 10993-1:2018.
Other Attributes:
Sterilization and Shelf-life	Assessment determined that the device does not introduce additional risks or concerns regarding sterilization and shelf-life, considering product, design, size, materials, manufacturing, and packaging.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact sample sizes used for the mechanical (pull-out and cyclic) testing or the biocompatibility tests (BET, cytotoxicity, etc.). However, it indicates testing was conducted for these aspects.
Data Provenance: Not specified in terms of country of origin. The mechanical testing was performed to demonstrate equivalence to a predicate device. Biocompatibility testing was done in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211, and 820, and in accordance with ISO 10993-1:2018. It is retrospective in the sense that results are being presented for a device that has already undergone testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the device is a physical medical implant, not an AI system that requires expert ground truth for interpretation or diagnosis. The "ground truth" for this device's performance is established through objective physical and biological testing standards and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation where adjudication methodologies (like 2+1, 3+1) would be used. Device performance is determined through laboratory testing against predefined specifications and comparison to a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for AI systems or diagnostic tools where human interpretation or decision-making is involved. The Arthrex Nano SwiveLock Suture Anchor is a surgical implant.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's mechanical, physical, and biological properties were evaluated independently (e.g., pull-out strength, biocompatibility tests). These tests are inherent to the device itself. The results were then compared to those of a predicate device to establish substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" or reference standard for this device's evaluation is primarily:

Physical/Mechanical Performance Data: Measured forces (e.g., pull-out strength) and cycles under specific test conditions.
Biological Standards: Compliance with pyrogen limits (BET) and established biocompatibility standards (e.g., ISO 10993-1:2018).
Predicate Device Performance: The performance of the legally marketed Arthrex 2.5 mm PushLock (K063479) serves as a benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is not an AI system and therefore does not have a "training set" in the machine learning context.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K191651

Trade/Device Name: Arthrex Nano SwiveLock Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: September 27, 2019 Received: September 30, 2019

Dear Ms. Homan:

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

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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 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 (OS) 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 mediation-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,

Laurence D. Coyne, PhD Acting 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) K191651

Device Name Arthrex Nano SwiveLock Suture Anchor

Indications for Use (Describe)

The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below:

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary or 510(k) Statement

Date Prepared	November 6, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanSenior Regulatory Affairs Associate1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex Nano SwiveLock Suture Anchor
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Product Code	HWC, MBI, MAI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K063479: Arthrex 2.5 mm PushLock
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Nano SwiveLock Suture Anchor.
Device Description	The Arthrex Nano SwiveLock Suture Anchor is a two component suture anchorcomprised of a hollow titanium anchor body and a PEEK (Polyetheretherketone)eyelet mounted on a disposable driver inserter. The anchor will be offered in a2.5 mm diameter and 7 mm length. The anchor is sold sterile, single-use.
Indications for Use	The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture ortissue fixation in the hand and wrist. Specific indications are listed below:Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal LigamentReconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexorand Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendontransfers
Performance Data	Pull-out and cyclic testing was conducted to demonstrate that the proposedArthrex Nano SwiveLock Suture Anchor performs statistically equivalent to thepredicate device cleared under K063479.Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.5 mm SwiveLockAnchor utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. Testing was performed incompliance with US FDA good manufacturing practice (GMP) regulations 21 CFRParts 210, 211 and 820. The testing conducted demonstrates that the ArthrexNano SwiveLock Suture Anchor meets pyrogen limit specifications.Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterization testingwas conducted on the Arthrex Nano SwiveLock Suture Anchor in accordance withISO 10993-1:2018.Assessment of physical product attributes including product, design, size, andmaterials as well as the conditions of manufacture and packaging has determinedthat the Arthrex Nano SwiveLock Suture Anchor does not introduce additionalrisks or concerns regarding sterilization and shelf-life.
Conclusion	The Arthrex Nano SwiveLock Suture Anchor is substantially equivalent to thepredicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate deviceare considered minor and do not raise different questions concerning safety oreffectiveness.
	The submitted mechanical testing data demonstrates that the pull-out strengthof the proposed device is substantially equivalent to that of the predicate devicefor the desired indications.
	Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.