(139 days)
Not Found
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a suture anchor intended for suture or tissue fixation in the hand and wrist, which is a therapeutic intervention.
No
The device is described as a suture anchor for tissue fixation, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is comprised of a hollow titanium anchor body and a PEEK eyelet, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "suture or tissue fixation in the hand and wrist." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor" made of titanium and PEEK, designed to be implanted. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to be implanted or used directly in surgical repair.
N/A
Intended Use / Indications for Use
The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, MAI
Device Description
The Arthrex Nano SwiveLock Suture Anchor is a two component suture anchor comprised of a hollow titanium anchor body and a PEEK (Polyetheretherketone) eyelet mounted on a disposable driver inserter. The anchor will be offered in a 2.5 mm diameter and 7 mm length. The anchor is sold sterile, single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand/Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 cyclic testing was conducted to demonstrate that the proposed Arthrex Nano SwiveLock Suture Anchor performs statistically equivalent to the predicate device cleared under K063479.
Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.5 mm SwiveLock Anchor utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex Nano SwiveLock Suture Anchor meets pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex Nano SwiveLock Suture Anchor in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product, design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex Nano SwiveLock Suture Anchor does not introduce additional risks or concerns regarding sterilization and shelf-life.
Key results:
The submitted mechanical testing data demonstrates that the pull-out strength of the proposed device is substantially equivalent to that of the predicate device for the desired indications.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K191651
Trade/Device Name: Arthrex Nano SwiveLock Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: September 27, 2019 Received: September 30, 2019
Dear Ms. Homan:
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
1
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 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 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,
Laurence D. Coyne, PhD Acting 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) K191651
Device Name Arthrex Nano SwiveLock Suture Anchor
Indications for Use (Describe)
The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary or 510(k) Statement
| Date Prepared | November 6, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Nano SwiveLock Suture Anchor |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HWC, MBI, MAI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances | |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K063479: Arthrex 2.5 mm PushLock |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Nano SwiveLock Suture Anchor. | |
| Device Description | The Arthrex Nano SwiveLock Suture Anchor is a two component suture anchor |
| comprised of a hollow titanium anchor body and a PEEK (Polyetheretherketone) | |
| eyelet mounted on a disposable driver inserter. The anchor will be offered in a | |
| 2.5 mm diameter and 7 mm length. The anchor is sold sterile, single-use. | |
| Indications for Use | The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or |
| tissue fixation in the hand and wrist. Specific indications are listed below: |
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament
Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor
and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon
transfers |
| Performance Data | Pull-out and cyclic testing was conducted to demonstrate that the proposed
Arthrex Nano SwiveLock Suture Anchor performs statistically equivalent to the
predicate device cleared under K063479.
Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.5 mm SwiveLock
Anchor utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in
compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR
Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex
Nano SwiveLock Suture Anchor meets pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,
Subchronic/Subacute Toxicity, Implantation and Material Characterization testing
was conducted on the Arthrex Nano SwiveLock Suture Anchor in accordance with
ISO 10993-1:2018.
Assessment of physical product attributes including product, design, size, and
materials as well as the conditions of manufacture and packaging has determined
that the Arthrex Nano SwiveLock Suture Anchor does not introduce additional
risks or concerns regarding sterilization and shelf-life. |
| Conclusion | The Arthrex Nano SwiveLock 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. |
| | The submitted mechanical testing data demonstrates that the pull-out strength
of the proposed device is substantially equivalent to that of the predicate device
for the desired indications. |
| | Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |
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