(448 days)
- AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.
- AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor
The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are non-absorbable threaded suture anchor manufactured in PEEK Material. Generally, it is indicated for the attachment of soft tissue to the bone.
The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue.
AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is a fully threaded suture anchor featuring dual threads to maximize cortical and cancellous fixation. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor has a flat tip to protect the sutures and to facilitate the insertion. The anchor is particularly suitable for repairing rotator cuff and associated pathologies. AUXILOCK® PEEK OPTIMA Screw-In Suture anchor is available in diameter of 4.5, 5.5 and 6.5mm. This anchor is available with two or three BioBraid suture. The anchors are also available with needles which are ideal for mini-open rotator cuff repair procedures.
AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchors are fully threaded knotless anchors. These anchors are designed to be used with sutures or tapes for rotator cuff repair employing the 'bridge' technique. Moreover, the 'knotless' technique consists of passing sutures or tapes of the medial row anchors through the tissue. They are finally inserted into the bone socket once they're loaded through the Rotador anchor eyelet. This technique eliminates possible complications caused by knots compared to other conventional anchors. The anchor is available in 4.75, 5.5 and 6.25mm diameter with PEEK OPTIMA anchor body and eyelet.
These implants are sold in sterile conditions (Ethylene Oxide Sterilization).
The system is indicated for use in adult patients only. All implants are for single use only.
The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor consists of Peek OPTIMA (Grade LT1) as per ASTM F2026-17 implantable Class II, Anchors, UHMWPE (Ultra-High Molecular Weight Polyethylene) Suture as per ASTM F2848-17.
This document is a 510(k) Premarket Notification from Auxein Medical Private Limited for two suture anchors: AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor. It seeks to demonstrate substantial equivalence to legally marketed predicate devices.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
The document describes a submission for Class II medical devices (AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor) under the regulation 21 CFR 888.3040 for "Smooth or threaded metallic bone fixation fastener" (Product Code MBI). The primary intention of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices, not to prove clinical superiority or a novel mechanism of action requiring robust, comparative clinical trials with human subjects.
Therefore, the "acceptance criteria" and "study" described are primarily focused on bench testing and material compliance to demonstrate that the new device performs equivalently to the predicate devices and meets relevant industry standards for safety and fundamental function. There is no mention of an AI algorithm, human-in-the-loop performance, MRMC studies, or complex ground truth establishment for diagnostic accuracy as would be typical for AI/ML-based medical devices or diagnostic tools.
1. A table of acceptance criteria and the reported device performance:
The document does not present a formal table of "acceptance criteria" for clinical performance against a specific standard endpoint (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on demonstrating equivalence in terms of design, material, operating principle, indications for use, sterilization, shelf-life, and mechanical properties compared to the predicate devices. The "performance" reported is primarily in the context of meeting various ASTM and ISO standards for materials, biocompatibility, sterilization, and mechanical integrity.
Here's a summary of the comparative criteria and implied performance from the document:
| Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (vs. Predicate) |
|---|---|
| Product Code (MBI for subject device, HWC for K120449, MBI for K170327) | Subject device uses MBI, which is for soft tissue fixation, justifying the difference from predicate K120449 (HWC - screw, fixation, bone) by stating design, material, and indications are identical. |
| Regulation Number (21 CFR 888.3040) | Subject device conforms to 21 CFR 888.3040, same as both predicates. |
| Regulatory Class (Class II) | Subject device is Class II, same as both predicates. |
| Indications for Use | "Identical" for AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor to K120449. "Identical" for AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor to K170327. |
| Sterilization Method (EO Sterilization) | Subject device uses EO sterilization, same as both predicates. EO residual tests conform to ISO 10993-7. |
| Dimensional Verification | "The same dimensions are found" for the new devices as well as predicate devices. |
| Shelf-life (5 Years) | Subject device has a 5-year shelf-life, same as both predicates. Stability studies were conducted per ASTM F1980, ASTM F88/F88M, ASTM F1929. |
| Single Use/Reuse (Single Use) | Subject device is single use, same as both predicates. |
| Operating Principle (Single incision, soft tissue, or bone-tendon-bone fixation) | Subject device applies the same operating principle as both predicates. |
| Material Standards Compliance | Complies with ASTM F2026-17 (PEEK), ASTM F2848-17 (UHMWPE Yarns), ASTM F899-12 (Stainless Steels). |
| Biocompatibility | Evaluated for biocompatibility according to ISO 10993-3. |
| Mechanical Performance (Bench Tests) | Performed Insertion Test, Pull-Out Tensile Static, and Pull-out following Cyclic Loading Test. Results "demonstrated that the subject device complies with all design specifications" and "no significant differences" from predicates. Specific numerical results are not provided in this summary. |
| Packaging Compliance | Complies with ISO 11607-1, ISO 11607-2 for Tyvek double sterile barrier packaging. |
| Bacterial Endotoxin | Performed per USP and ANSI/AAMI ST72:2019, acceptance criterion |
§ 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.