(30 days)
No
The summary describes a mechanical suture anchor and its performance in pull-out testing, with no mention of AI or ML technologies.
Yes
The device, the Arthrex Mini Hip PushLock, is intended for suture to bone in the hip for Acetabular Labral Repair. This function directly treats a medical condition (labral tear) by repairing tissue, which falls under the definition of a therapeutic device.
No
The device, Arthrex Mini Hip PushLock, is described as a suture anchor used for repair (suture to bone) and not for diagnosing a condition.
No
The device description clearly states it is a "barbed push-in suture anchor pre-loaded on a disposable inserter" and is made of "PLLA/ $\u03b2$ TCP", indicating it is a physical medical device, not software.
Based on the provided information, the Arthrex Mini Hip PushLock is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "barbed push-in suture anchor pre-loaded on a disposable inserter." This is a surgical implant used to fix tissue to bone.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
The Arthrex Mini Hip PushLock is a surgical device used within the body during a procedure, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, Acetabular Labral
Indicated Patient Age Range
Not Found
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 testing was conducted after a 26-week degradation time period and compared to an acceptance criterion of 20 lbf, as established for acetabular labral repair in the predicate submission, demonstrating that the proposed device is substantially equivalent to the predicate device (K151092).
Biocompatibility testing was not conducted as the materials and processing of the Arthrex Mini Hip PushLock is the same as that of the reference device (K101679).
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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
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
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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)
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510(k) Summary K201786
| Date Prepared | July 8, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Kelsey Roberts |
| Regulatory Affairs Associate | |
| 1-239-598-4302, ext. 72257 | |
| Kelsey.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 appliances |
| accessories | |
| 21 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 Mini |
| Hip PushLock as a line extension to the Arthrex Short Anchors cleared under | |
| predicate K151092. | |
| Device Description | 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. | |
| 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 Summary | |
| of Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed and predicate devices (K151092) have the same intended use and basic |
| device design. The proposed device modifications consist of anchor material (PLLA/ | |
| $\u03b2$ TCP) and sterilization method (gamma). The anchor material, manufacturing | |
| processes and sterilization method are the same as the reference device (K101679). |
The Arthrex Mini Hip PushLock Anchor is substantially equivalent to the predicate
device in which the basic design features and intended uses are the same. Any
differences between the proposed device and the predicate device are considered
minor and do not raise different questions concerning safety or effectiveness. |
| Performance Data | Pull-out testing was conducted after a 26-week degradation time period and
compared to an acceptance criterion of 20 lbf, as established for acetabular labral
repair in the predicate submission, demonstrating that the proposed device is
substantially equivalent to the predicate device (K151092).
Biocompatibility testing was not conducted as the materials and processing of the
Arthrex Mini Hip PushLock is the same as that of the reference device (K101679).
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the
device meets pyrogen limit specifications. |
| Conclusion | The proposed Arthrex Mini Hip PushLock Suture Anchor is substantially equivalent to
the predicate device in which the basic design features and intended uses are the
same. Any differences between the proposed device and the predicate device are
considered minor and do not raise different questions concerning safety or
effectiveness. |
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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.