(30 days)
The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.
The Arthrex Mini Hip PushLock is a barbed push-in suture anchor pre-loaded on a disposable inserter. The anchor is manufactured from PLLA/ $\u03b2$ TCP and is offered sterile, single use.
The provided document is an FDA 510(k) Premarket Notification for a medical device called the "Arthrex Mini Hip PushLock." This type of submission is for non-AI/software medical devices, specifically a suture anchor.
Therefore, the requested information about acceptance criteria, study design for AI devices (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data, etc.) is not applicable to this document. The document describes a traditional medical device, not an AI/ML-driven device.
The "Performance Data" section in the document details mechanical testing (pull-out testing) and biocompatibility, which are standard for physical medical devices.
Here's a breakdown of what is in the document regarding "acceptance criteria" and "study":
1. Acceptance Criteria and Device Performance (for a physical device):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out strength of 20 lbf (pounds-force) | Demonstrated to meet 20 lbf after 26-week degradation. (The document states "demonstrating that the proposed device is substantially equivalent to the predicate device") |
| Meets pyrogen limit specifications | Bacterial endotoxin testing per EP 2.6.14/USP <85> demonstrates the device meets these specifications. |
| Biocompatibility (implicit) | Not directly tested on this device. Satisfied by being made of the same materials and processed the same way as a previously cleared reference device (K101679). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for pull-out testing, but mechanical testing typically involves a statistically relevant number of samples.
- Data Provenance: The testing was conducted by or for Arthrex Inc. as part of their 510(k) submission. The document doesn't specify if it was external lab testing or internal, but it's part of the regulatory submission process.
3. Number of Experts Used to Establish Ground Truth / Qualifications of Experts:
- Not applicable for this type of mechanical and biocompatibility testing. The "ground truth" is based on established engineering and materials science principles and validated testing methods.
4. Adjudication Method for the Test Set:
- Not applicable. Mechanical and biological tests are typically objective and follow standardized protocols, rather than requiring human adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical device, not an AI system. MRMC studies are for evaluating diagnostic performance of imaging interpretation, often with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an AI system. "Standalone performance" refers to the accuracy of an algorithm.
7. The Type of Ground Truth Used:
- For pull-out strength: Engineering specifications (20 lbf) established for acetabular labral repair.
- For pyrogenicity: Regulatory standards (EP 2.6.14/USP <85>) for bacterial endotoxin limits.
- For biocompatibility: Equivalence to a previously cleared device (referencing its known biocompatibility).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set."
In summary, the document describes the regulatory clearance of a physical medical device based on mechanical and material performance attributes, not an AI-driven diagnostic or therapeutic system.
{0}------------------------------------------------
July 30, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The seal features an eagle with its wings spread, and the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
Arthrex Inc. Kelsey Roberts Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K201786
Trade/Device Name: Arthrex Mini Hip PushLock 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: June 25, 2020 Received: June 30, 2020
Dear Kelsey Roberts:
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 (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 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, Ph.D. Acting 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Arthrex Mini Hip PushLock
Indications for Use (Describe)
The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| [X] | Registration Use (Part 21 CFR 201.1 Subpart D) |
|---|---|
| [ ] | Over-The-Counter Use (21 CFR 201.1 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary K201786
| Date Prepared | July 8, 2020 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Kelsey RobertsRegulatory Affairs Associate1-239-598-4302, ext. 72257Kelsey.Roberts@arthrex.com |
| Name of Device | Arthrex Mini Hip PushLock |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MAI, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesaccessories21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Predicate Device | K151092: Arthrex Short Suture Anchors |
| Reference Device | K101679: Arthrex PushLock |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to add the Arthrex 2.4 MiniHip PushLock as a line extension to the Arthrex Short Anchors cleared underpredicate K151092. |
| Device Description | The Arthrex Mini Hip PushLock is a barbed push-in suture anchor pre-loaded on adisposable inserter. The anchor is manufactured from PLLA/ $\u03b2$ TCP and is offeredsterile, single use. |
| Indications for Use | The Arthrex Mini Hip PushLock Anchor is intended to be used for suture (soft tissue)fixation to bone in the hip. Specifically, Acetabular Labral Repair. |
| Comparison Summaryof TechnologicalCharacteristics andModificationsProposed | The proposed and predicate devices (K151092) have the same intended use and basicdevice design. The proposed device modifications consist of anchor material (PLLA/$\u03b2$ TCP) and sterilization method (gamma). The anchor material, manufacturingprocesses and sterilization method are the same as the reference device (K101679).The Arthrex Mini Hip PushLock Anchor is substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device are consideredminor and do not raise different questions concerning safety or effectiveness. |
| Performance Data | Pull-out testing was conducted after a 26-week degradation time period andcompared to an acceptance criterion of 20 lbf, as established for acetabular labralrepair in the predicate submission, demonstrating that the proposed device issubstantially equivalent to the predicate device (K151092).Biocompatibility testing was not conducted as the materials and processing of theArthrex Mini Hip PushLock is the same as that of the reference device (K101679).Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications. |
| Conclusion | The proposed Arthrex Mini Hip PushLock Suture Anchor is substantially equivalent tothe predicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate device areconsidered minor and do not raise different questions concerning safety oreffectiveness. |
{4}------------------------------------------------
Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex Mini Hip PushLock is substantially equivalent to the currently marketed predicate device.
§ 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.