(27 days)
The Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Arthrex NanoSuture Anchor is a fully threaded suture anchor pre-loaded with Arthrex suture on a disposable inserter. The anchor is manufactured from titanium and measures 1.7 mm in diameter and 5 mm in length.
The provided document describes the Arthrex NanoSuture Anchor, which is a fully threaded suture anchor. The submission is a Special 510(k) premarket notification to obtain clearance for a line extension to the Arthrex MicroSuture Anchors family (K112237). The device is intended for suture or tissue fixation in various anatomical locations.
Here's the information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Pullout testing was conducted to demonstrate that the proposed Arthrex NanoSuture Anchor perform statistically equivalent to the predicate." It also mentions "Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications." However, specific numerical acceptance criteria or performance metrics for "statistically equivalent" or "pyrogen limit specifications" are not provided in the document.
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size used for the pullout testing or bacterial endotoxin testing. It also does not mention the data provenance (e.g., country of origin or whether it was retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the studies outlined are engineering/laboratory tests (pullout strength and endotoxin levels), not studies requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as this is a medical device (suture anchor) and not an AI or imaging diagnostic device that would involve human readers.
6. Standalone (Algorithm Only) Performance:
This section is not applicable as the device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used:
The ground truth for the performance evaluations (pullout testing and bacterial endotoxin testing) would be:
- Pullout Testing: Direct measurement of mechanical strength parameters (e.g., maximum load, displacement at failure) compared against a defined standard or the performance of the predicate device.
- Bacterial Endotoxin Testing: Laboratory measurement of endotoxin levels against a specified pyrogen limit.
8. Sample Size for the Training Set:
This is not applicable. The device is a physical product, not a machine learning model that requires a training set. The "training" here refers to the development and manufacturing processes of the device itself.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no "training set" in the context of an algorithm. For the device manufacturing and design, the "ground truth" and standards would be established through engineering specifications, material science, biomechanical principles, and regulatory requirements.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized depiction of a human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency written in blue text to the right of the square.
February 12, 2018
Arthrex Inc. Rebecca R. Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K180118
Trade/Device Name: Arthrex NanoSuture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 11, 2018 Received: January 16, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Arthrex NanoSuture Anchor
Indications for Use (Describe)
The Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction |
|---|---|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis |
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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510(k) Summary or 510(k) Statement
| Date Prepared | February 8, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex NanoSuture Anchor |
| Common Name | Screw, fixation, bone |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Fastener, Fixation, Nondegradable, Soft Tissue |
| Regulatory Class | II |
| Predicate Device | K112237: Arthrex MicroSuture Anchors |
| Purpose ofSubmission | This Special 510(k) premarket notification is submitted to obtain clearance for aline extension to the Arthrex MicroSuture Anchors family cleared under K112237. |
| Device Description | The Arthrex NanoSuture Anchor is a fully threaded suture anchor pre-loaded withArthrex suture on a disposable inserter. The anchor is manufactured fromtitanium and measures 1.7 mm in diameter and 5 mm in length. |
| Indications for Use | The Arthrex NanoSuture Anchor is intended to be used for suture or tissuefixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specificindications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or Radial CollateralLigament ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral ReconstructionHand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstructionof collateral ligaments, Repair of Flexor and Extensor Tendons atthe PIP, DIP and MCP joints for all digits, digital tendontransfers, Carpal Ligament Reconstruction and Carpometacarpaljoint arthroplasty (basal thumb joint arthroplasty)Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles TendonRepair, Metatarsal Ligament Repair, Hallux Valgusreconstruction, digital tendon transfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique LigamentRepair, Iliotibial Band Tenodesis |
| Performance Data | Pullout testing was conducted to demonstrate that the proposed ArthrexNanoSuture Anchor perform statistically equivalent to the predicate.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | The Arthrex NanoSuture Anchor is substantially equivalent to the predicate |
| differences between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness. | |
| 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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§ 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.