(29 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The intended use states "suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair," which is a therapeutic intervention.
No
Explanation: The device is a suture anchor used for the fixation of soft tissue to bone, specifically for rotator cuff repair in the shoulder. It is a surgical implant and does not perform any diagnostic function.
No
The device description clearly states it is a physical suture anchor made of PEEK Optima, PLLA/βTCP, and a disposable inserter. It is a hardware device intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "push-in, fully threaded barbed suture anchor" made of materials like PEEK Optima and PLLA/βTCP. This is a physical implant used to secure tissue to bone.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests outside of the body (in vitro)
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The Arthrex self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder:
- Shoulder: Rotator Cuff Repair
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC, MBI
Device Description
The Arthrex Self-Punching PushLock Anchor is a push-in, fully threaded barbed suture anchor comprised of a PEEK Optima eyelet and a hollow anchor body pre-assembled on a disposable inserter. The anchor body is made of either PLLA/βTCP or PEEK Optima. The Arthrex Self-Punching PushLock Anchor is intended to be used for suture (soft tissue) fixation to 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
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)
Ultimate load testing and insertion testing was performed on the subject device and compared to the predicate device cleared under K101679 to demonstrate that the modifications do not negatively impact mechanical strength.
The shelf life of the Biocomposite Arthrex Self-Punching PushLock suture anchor is 4 years. The same methods and protocols were used which were reviewed by FDA in K173240.
The Arthrex Self-Punching PushLock suture anchors are MR safe as they are nonmetallic, nonconducting materials that do not contain ferromagnetic materials or any other metallic markers that can interfere with magnetic resonance imaging (MRI). There are no concerns with the performance of the devices in an MRI environment. These devices are labeled MR safe per ASTM F2503.
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.
K061863, K082810, K173240, K193503
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
May 13, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K221099
Trade/Device Name: Arthrex Self-Punching 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, MBI Dated: April 13, 2022 Received: April 14, 2022
Dear Ms. 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 (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 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.
For:
Laura C. Rose, 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
Enclosure
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Arthrex In®EPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Arthrex Self-Punching PushLock® Suture Anchors
Indications for Use (Describe)
The Arthrex self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder:
· Shoulder: Rotator Cuff Repair
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) | K221099 |
|---|---|
| Date Prepared | May 13, 2022 |
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Kelsey Roberts |
| Sr. Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 72257 | |
| Kelsey.Roberts@arthrex.com | |
| Name of Device | Arthrex Self-Punching PushLock® Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MAI – Fastener, Fixation, Biodegradable, Soft Tissue |
| HWC – Screw, Fixation, Bone | |
| MBI – Fastener, Fixation, Nondegradable, Soft Tissue | |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener. |
| Regulatory | |
| Classification | II |
| Predicate Device | K101679: Arthrex PushLock Anchors |
| Reference Device | K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio- |
| Corkscrew FT Suture Anchors | |
| K082810: Bio-Composite Suture Anchors, Expansion of Indications to include | |
| Hip | |
| K173240: Arthrex PushLock | |
| K193503: Arthrex SwiveLock Suture Anchor | |
| Purpose of | |
| Submission | This Special 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Self-Punching PushLock Suture Anchors as a line extension to the | |
| Arthrex PushLock Suture Anchors cleared via K101679. | |
| Device Description | The Arthrex Self-Punching PushLock Anchor is a push-in, fully threaded |
| barbed suture anchor comprised of a PEEK Optima eyelet and a hollow | |
| anchor body pre-assembled on a disposable inserter. The anchor body is | |
| made of either PLLA/βTCP or PEEK Optima. The Arthrex Self-Punching | |
| PushLock Anchor is intended to be used for suture (soft tissue) fixation to | |
| bone in the shoulder. | |
| Comparison | |
| Summary of | |
| Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed device has the same technological characteristics (anchor |
| design, material, sterilization method, and biocompatibility profile) as the | |
| predicate device cleared under K101679. The proposed device modification | |
| consists of a PEEK self-punching eyelet; whereas the eyelet of the predicate | |
| device cleared under K101679 was non-self-punching. | |
| Indications for Use | The Arthrex self-punching PushLock suture anchors are intended to be used |
| for suture (soft tissue) fixation to bone in the shoulder: | |
| Shoulder: Rotator Cuff Repair | |
| Performance Data | Ultimate load testing and insertion testing was performed on the subject |
| device and compared to the predicate device cleared under K101679 to | |
| demonstrate that the modifications do not negatively impact mechanical | |
| strength. | |
| The shelf life of the Biocomposite Arthrex Self-Punching PushLock suture | |
| anchor is 4 years. The same methods and protocols were used which were | |
| reviewed by FDA in K173240. | |
| The Arthrex Self-Punching PushLock suture anchors are MR safe as they are | |
| nonmetallic, nonconducting materials that do not contain ferromagnetic | |
| materials or any other metallic markers that can interfere with magnetic | |
| resonance imaging (MRI). There are no concerns with the performance of the | |
| devices in an MRI environment. These devices are labeled MR safe per ASTM | |
| F2503. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate | |
| that the device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex Self-Punching Pushlock Suture 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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