(389 days)
The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, 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, lliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 11 models. It provide non-sterile (user must sterilization before use).
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Fixone Hybrid Knotless Anchor.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | Reported Performance |
|---|---|---|
| Mechanical Testing | ||
| External Surface (ASTM F2502, USP) | Not explicitly stated in table, but implied to meet standards. | Pass |
| Measurement | Within 5% of the dimensions specified in specifications. | Pass |
| Insertion Torque (ASTM F1839) | Not less than 0.15 Nm. | Pass |
| Fixation Strength | Not less than 100 N. | Pass |
| Tensile Strength (suture threads) | Not less than 34.5 N. | Pass |
| Torsional Test | Maximum torque should not be less than insertion torque. Anchor should endure movement of tissues and bones (Arthrex pull-out and cyclic pull-out testing cited as supporting this). | Pass |
| Extraction Test | Not explicitly stated in table. | Pass |
| pH | Difference should be 1.5 and less. | Pass |
| Potassium Permanganate Reducing Substances | Difference of consumption of potassium permanganate should be 2.0 mL and less. | Pass |
| Residue after Evaporation | Weight of the residue should be 1.0 mg and less. | Pass |
| Heavy Metals | Any brown color produced within 10 minutes in the tube containing the extract of the prepared sample does not exceed that in the tube containing the standard lead solution. | Pass |
| UV Spectrum (250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | Pass |
| Property (Visual inspection) | Test solution should be clear and have no foreign particles. | Pass |
| Biocompatibility (Anchor) | ||
| Cytotoxicity (ISO 10993-5) | Meets ISO 10993-5 criteria. | Pass |
| Maximization test for delayed hypersensitivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Intracutaneous reactivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Material-mediated Pyrogen (ISO 10993-11, USP39) | Meets ISO 10993-11 criteria. | Pass |
| Sub acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Bacterial reverse mutation test (ISO 10993-3, OECD 471) | Meets ISO 10993-3 and OECD 471 criteria. | Pass |
| Mammalian erythrocyte micronucleus test (ISO 10993-3, OECD 474) | Meets ISO 10993-3 and OECD 474 criteria. | Pass |
| Implantation test (ISO 10993-6, Annex D for bone) | Meets ISO 10993-6 criteria for local effects after implantation in bone. | Pass |
| Biocompatibility (Suture) | ||
| Cytotoxicity (ISO 10993-5) | Meets ISO 10993-5 criteria. | Pass |
| Maximization test for delayed hypersensitivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Intracutaneous reactivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Material-mediated Pyrogen (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Sub acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Bacterial reverse mutation test (ISO 10993-3, OECD 471) | Meets ISO 10993-3 and OECD 471 criteria. | Pass |
| Mammalian erythrocyte micronucleus test (ISO 10993-3, OECD 474) | Meets ISO 10993-3 and OECD 474 criteria. | Pass |
| Implantation test (ISO 10993-6, 4 & 12 weeks) | Meets ISO 10993-6 criteria for local effects after implantation. | Pass |
| Biological risk assessment | Assessment according to ISO 10993-1, EN ISO 14971, FDA G95-1, EU Medical Device Directive. Examines components, literature, and history of safe use. | - |
| Biocompatibility (Tip) | ||
| Cytotoxicity (ISO 10993-5) | Meets ISO 10993-5 criteria. | Pass |
| Maximization test for delayed hypersensitivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Intracutaneous reactivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Material-mediated Pyrogen (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Sub acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Bacterial reverse mutation test (ISO 10993-3, OECD 471) | Meets ISO 10993-3 and OECD 471 criteria. | Pass |
| Mammalian erythrocyte micronucleus test (ISO 10993-3, OECD 474) | Meets ISO 10993-3 and OECD 474 criteria. | Pass |
| Implantation test (ISO 10993-6, Annex D for bone) | Meets ISO 10993-6 criteria for local effects after implantation in bone. | Pass |
| Biocompatibility (Colored Suture) | ||
| Cytotoxicity (ISO 10993-5) | Meets ISO 10993-5 criteria. | Pass |
| Maximization test for delayed hypersensitivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Intracutaneous reactivity (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Acute Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Material-mediated Pyrogen (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Sub chronic Systemic toxicity (ISO 10993-11) | Meets ISO 10993-11 criteria. | Pass |
| Bacterial reverse mutation test (ISO 10993-3, OECD 471) | Meets ISO 10993-3 and OECD 471 criteria. | Pass |
| Mammalian erythrocyte micronucleus test (ISO 10993-2, OECD 474) | Meets ISO 10993-2 and OECD 474 criteria. | Pass |
| Implantation test (ISO 10993-6, 4 & 12 weeks) | Meets ISO 10993-6 criteria for local effects after implantation. | Pass |
| Biocompatibility (Driver shaft - Stainless steel 304) | ||
| Cytotoxicity (ISO 10993-5) | Meets ISO 10993-5 criteria. | Pass |
| Intracutaneous reactivity test (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Maximization sensitization (ISO 10993-10) | Meets ISO 10993-10 criteria. | Pass |
| Sterilization & Shelf Life | ||
| Pyrogen (Material-mediated) | Meets ISO10993-11, USP39 criteria. | Pass |
| Shelf life testing (Accelerated aging) | Real-time equivalent (RTE) and Accelerated aging temperature (Taa) as per AAMI TIR17 and ASTM F 1980-02 confirmed stability at 55±2°C for 229 days. | Pass |
| Shelf life testing (Real-time) | Physicochemical changes and packaging tested at 0, 1, 2, 3, 4, and 5 years for validity and safety per ISO 11607-1:2006, ISO 11607-2:2006. Valid for 5 years. | Pass |
| EO sterilization Validation (EO residual test) | ISO11135(2014) standards met. | Pass |
| Endotoxin (USP 43 , LAL) | Endotoxin level conforms. | Pass |
2. Sample Size for the Test Set and Data Provenance
The document describes bench testing for mechanical and biocompatibility properties. It doesn't specify a "test set" in the context of patient data or clinical images. The tests were performed on the device components themselves.
- Sample Size: Not explicitly stated as a single number across all tests. Each test (e.g., tensile strength, insertion torque, various biocompatibility tests) would have its own sample size, which is not detailed but assumed to be sufficient for the relevant standards (e.g., ASTM, ISO, USP). For tensile strength, it mentions "measuring 10 suture threads."
- Data Provenance: The studies were bench tests conducted by the manufacturer, AJU Pharm Co., Ltd., which is located in Korea. The details provided do not indicate the use of retrospective or prospective patient data, as this is a physical device rather than a diagnostic or AI-driven system.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of medical device submission. The Fixone Hybrid Knotless Anchor is a physical surgical implant, not a device that generates or interprets diagnostic images or data requiring expert review for ground truth. The "ground truth" here is established through adherence to recognized international and national standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable as there is no "test set" in the clinical imaging or diagnostic sense requiring expert adjudication. The performance is assessed against predefined quantitative and qualitative criteria in bench testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a surgical anchor, not an AI-assisted diagnostic tool or a system that involves human readers interpreting output. Therefore, there is no concept of improving human reader performance with or without AI assistance in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The Fixone Hybrid Knotless Anchor is a physical medical device, not a software algorithm or an AI system.
7. Type of Ground Truth Used
The "ground truth" in this submission is established through:
- International Standards: Adherence to widely recognized standards from organizations like ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging), ASTM (e.g., ASTM F2502, F1839, F1980-02 for mechanical and aging tests), and USP (e.g., USP for material properties, USP39 for pyrogen, USP 43 for endotoxin).
- Predicate Device Comparison: The primary method for proving substantial equivalence is demonstrating that the test results of the Fixone Hybrid Knotless Anchor are comparable to a legally marketed predicate device (Fixone Biocomposite Anchor, K192484) and meet relevant performance benchmarks. The new device is substantially similar, with the only noted difference being the material of the tip (PEEK in the new device versus PLGA + β-TCP in the predicate).
8. Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not a machine learning or artificial intelligence device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons mentioned above.
§ 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.