(29 days)
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "suture anchors intended to be used for suture (soft tissue) fixation to bone in the shoulder," specifically for "rotator cuff repair," which clearly defines a therapeutic purpose to treat a medical condition.
No
The device is a suture anchor used for soft tissue fixation to bone, specifically for rotator cuff repair. Its function is to physically attach tissue, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical implant (suture anchors made of PEEK, PLLA/βTCP) and a disposable inserter, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "suture anchor" intended for "suture (soft tissue) fixation to bone in the shoulder." This is a surgical implant used directly within the body to repair tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, based on the provided information, the Arthrex Self Punching SwiveLock® Suture Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
Indicated Patient Age Range
skeletally mature pediatric and adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pull-out and insertion testing was performed on the proposed and predicate devices. The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Tiffany Mentzel |
| Title: Principal Regulatory Affairs Specialist | |
| Phone: 1 (239) 643-5553 x75833 | |
| Email: 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 component |
| metallic bone fixation appliances and accessories | |
| 21CFR 888.3040: Smooth or threaded metallic | |
| bone fixation fastener | |
| Regulatory Class | II |
| Primary Predicate Device | K191226: Arthrex SwiveLock Suture Anchor |
| Reference Devices | K203495: Arthrex SwiveLock Anchor |
| K193503: Arthrex SwiveLock Suture Anchor | |
| Purpose of Submission | This Special 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex Self | |
| Punching SwiveLock Suture Anchors as a line | |
| extension to the Arthrex SwiveLock Suture Anchors | |
| cleared in K191226. | |
| Device Description | 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. | |
| Indications for Use | 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. | |
| Performance Data | Pull-out and insertion testing was performed on the |
| proposed and predicate devices. The acceptance | |
| criteria were met for all samples, demonstrating | |
| substantial equivalence to the predicate. | |
| Technological | |
| Comparison | The proposed device has the same technological |
| characteristics (anchor design, material, | |
| sterilization method and biocompatibility profile). | |
| The proposed device modification consists of a | |
| PEEK self punching eyelet. The Arthrex Self | |
| Punching SwiveLock® Anchors are substantially | |
| equivalent to the predicate device in which the | |
| design features and intended uses are the same. | |
| Any differences between the proposed device and | |
| the predicate devices are considered minor and do | |
| not result in new or different questions concerning | |
| safety or effectiveness. | |
| Conclusion | The Arthrex Self Punching SwiveLock® Anchors |
| are substantially equivalent to the predicate | |
| devices in which the basic design features and | |
| intended use are the same. Any differences | |
| between the proposed device and the predicate | |
| devices are considered minor and do not result in | |
| new or different questions concerning safety or | |
| effectiveness. Based on the indications for use, | |
| technological characteristics, and the summary of | |
| data submitted, Arthrex has determined that the | |
| proposed device is substantially equivalent to the | |
| currently 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.