ZipE Knotless Tissue Repair and Attachment Devices

• K Number: K162429
• Device Name: ZipE Knotless Tissue Repair and Attachment Devices
• Manufacturer: ZIPTEK, LLC
• Date Cleared: 2017-03-13 ( 195 days)
• Product Code: MAI , KGS , MBI
• Regulation Number: 888.3030
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K983843 , K151200 , K974847 , K071704 , K071177

Intended Use

The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue.

This product is intended for the following indications:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
• . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
• . Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Device Description

The ZipE® Knotless Tissue Repair and Attachment Devices are implantable soft tissue fixation and suture retention devices comprising of a resorbable pledge('button disc ("suture capture"), a titanium screw or biocomposite bone anchor ("plug"), an ultra-high polyethylene (UHMWPE) braided #2 suture having pre-tied half hitched protuberances along its length, a nitinol wire capture holder and a nitinol wire suture shuttle. All components are preloaded onto a stainless steel insertion driver having a TPE tip protector and a silicone O-ring encircling the diameter of the handle to hold the system in place. The implantable elements of the system are the bone anchor, suture and capture; the other components are part of the driver insertion system.

The capture is designed to interact with the knotted suture by locking with the protuberances on the suture so that once advanced across the protuberance, it cannot move backward. Once the anchor is inserted into the bone, the pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue.

The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a medical device submission beyond the non-clinical testing listed. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a clinical study with an AI component.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the provided text:

• Device Name: ZipE® Knotless Tissue Repair and Attachment Devices
• Non-clinical Testing Performed:
  • Bench testing (Static pullout testing, Cyclic pullout testing, Degradation testing, Insert Torque testing)
  • Biocompatibility testing (Systemic toxicity, Reverse mutation, Intracutaneous injection, Kligman maximization, Micronucleus assay, Lymphoma mutagenesis, Intramuscular implantation, Pyrogen test, Systemic injection test, MEM elution test, Neutral red uptake test)
  • Sterilization validation (Bioburden, EO residual testing, Endotoxin (LAL) Validation)
  • Package and transportation testing (Transportation validation, Packaging testing, Accelerated aging)

Information that is not available in the provided text, as it pertains to AI-enabled device studies and clinical performance:

• A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or report device performance against such criteria. The reported performance is only a list of non-clinical tests.
• Sample sized used for the test set and the data provenance: Not applicable as no clinical study or AI performance evaluation is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided as a basis for substantial equivalence."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This document describes a traditional 510(k) clearance for a physical medical device (tissue repair and attachment devices), not an AI-enabled medical device. Therefore, the questions related to AI-specific performance criteria, ground truth, expert review, and clinical study designs (like MRMC) are not addressed by this submission. The "acceptance criteria" for this device were likely based on the successful completion of the listed non-clinical tests, demonstrating that the device meets safety and performance standards equivalent to predicate devices within an engineering context (e.g., pullout strength exceeding a certain threshold), rather than statistical performance metrics for diagnostic or prognostic accuracy.

Regulation Number and Section

§ 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.