(172 days)
The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use.
The provided text is a 510(k) summary for the Arthrex AlloSync™ PushLock® Suture Anchor, a medical device used for soft tissue fixation to bone. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does not contain information related to a study involving artificial intelligence (AI) or machine learning (ML) models. Specifically, it does not discuss the following:
- Acceptance criteria for an AI/ML model's performance.
- A test set for an AI/ML model.
- Ground truth establishment by experts for an AI/ML model.
- Adjudication methods for an AI/ML model's test set.
- Multi-Reader Multi-Case (MRMC) studies for AI assistance.
- Standalone performance of an AI algorithm.
- Training set for an AI/ML model or how its ground truth was established.
Instead, the performance data discussed in this document relates to the mechanical and biological testing of the physical suture anchor device, comparing its strength, biocompatibility, and pyrogenicity to existing predicate devices.
Therefore, I cannot provide the requested table and study details as the input document does not contain information about an AI/ML device or its performance evaluation.
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June 4, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex, Inc. Emmarie Halteman Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K233971
Trade/Device Name: Arthrex AlloSync PushLock Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: May 8, 2024 Received: May 9, 2024
Dear Emmarie Halteman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by
Jesse Muir -S Jesse Muir -S
Date: 2024.06.04
15:32:02 -04'00'
Jesse Muir, Ph.D. 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
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Enclosure
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Indications for Use
510(k) Number (if known) K233971
Device Name Arthrex AlloSync™ PushLock® Suture Anchor
Indications for Use (Describe)
The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a sans-serif font, with a stylized image of surgical scissors replacing the "x". The scissors are depicted in a simple, line-art style, and the overall logo has a clean and modern look.
510(k) Summary
| Date Prepared | May 22, 2024 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Emmarie Halteman |
| Title: Senior Regulatory Affairs Specialist | |
| Phone: 1-239-643-5553 ext. 74232 | |
| Email: emmarie.halteman@arthrex.com | |
| Trade Name | Arthrex AlloSync™ PushLock® Suture Anchor |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | MAI - Fastener, Fixation, Biodegradable, Soft TissueHWC - Screw, Fixation, Bone |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories; Fastener, Fixation, Biodegradable, Soft Tissue21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K063479: Arthrex 2.5mm PushLock |
| Reference Device | K070347: Allofix Push-In Anchor |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex AlloSync™ PushLock® Suture Anchor |
| Device Description | The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use. |
| Indications for Use | The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior to Posterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction |
| Performance Data | The submitted mechanical test data, pull-out, insertion, and degradation, demonstrates that the Arthrex AlloSync™ PushLock® Suture Anchor results in statistically equivalent strength to the predicate device Arthrex 2.5mm PushLock (K063479). |
| Bacterial Endotoxin Testing (BET) was performed on the ArthrexAlloSync™ PushLock® Suture Anchor utilizing the KineticTurbidimetric limulus amebocyte lysate (LAL) method inaccordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP<85>, EP 2.6.14. Testing was performed in compliance with US FDAgood manufacturing practice (GMP) regulations 21 CFR Parts 210,211 and 820. The testing conducted demonstrates that the ArthrexAlloSync™ PushLock® Suture Anchor meets pyrogen limitspecifications. | |
| All donors have been screened and tissues recovered, processed,stored, tested, and distributed in accordance with current U.S.federal regulations as promulgated in 21 CFR 1270 and 1271,current Standards for Tissue Banking set forth by the AmericanAssociation of Tissue Banks (AATB) and international laws andregulations as required. This allograft was deemed suitable forimplantation by LifeNet Health. A physician medical directorevaluated the following donor variables to determine donorsuitability: infectious disease test results, current donor medicalhistory, behavioral risk assessment interview, physical assessment,relevant medical records, including previous medical history,laboratory test results, and autopsy or coroner reports (ifperformed). All donors are tested for relevant infectious diseases.Testing is performed by laboratories that are registered with theU.S. Food and Drug Administration (FDA) and certified under theClinical Laboratory Improvement Amendments of 1988 (CLIA) and42 CFR 493. Test methods that are FDA-licensed, approved, orcleared for donor screening are used as available. The followingtest criteria were met for the donor of this allograft bio-implant:Hepatitis B virus (HBV) surface antigen, HBV core antibody,Hepatitis C virus (HCV) antibody, HIV-1/12 antibody, Syphilis, HIV-1NAT, HCT NAT, and HBV NAT. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute SystemicToxicity, Implantation, Material Mediated Pyrogenicity, andMaterial Chemical Characterization was conducted on the ArthrexAlloSync™ PushLock® Suture Anchor in accordance with ISO 10993-1:2018 and deemed biocompatible when used as intended. | |
| Technological Comparison | Compared to the predicate device Arthrex 2.5mm PushLock(K063479), the proposed Arthrex AlloSync™ PushLock® SutureAnchor has the same intended use/indications for the shoulder,fundamental scientific technology, sterility, and shelf-life. Theproposed Arthrex AlloSync™ PushLock® Suture Anchor's anchorbody is made of human cortical bone; whereas the primarypredicate device Arthrex 2.5mm PushLock is made of Poly (I-lactide) (PLLA). However, the anchor body cleared under reference |
| device Allofix Push-In Anchor (K070347) is made of human allograftbone and they both comply with all requirements in 21 CFR 1271to reduce the risk of the introduction, transmission, and spread ofcommunicable diseases by human cells, tissues, and cellular andtissue-based products (HCT/Ps). | |
| Any differences between the proposed device and the predicatedevice are considered minor and do not raise new or differentquestions concerning safety or effectiveness. | |
| Conclusion | The Arthrex AlloSync™ PushLock® Suture Anchor is substantiallyequivalent to the predicate device in which the basic designfeatures and intended uses are the same. Any differences betweenthe proposed device and the predicate device are consideredminor and do not raise different questions concerning safety oreffectiveness. Based on the indications for use, technologicalcharacteristics, and the summary of data submitted, Arthrex Inc.has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device. |
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Image /page/5/Picture/1 description: The image shows the word "Arthrex" in a stylized font. The "x" in "Arthrex" is stylized to look like a medical instrument. The logo is simple and modern.
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Image /page/6/Picture/0 description: The image shows the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool, possibly scissors or forceps. The tool is depicted in a simple, stylized manner, with its handles open and blades visible. The logo is likely for a medical device company specializing in arthroscopic surgery.
§ 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.