(266 days)
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft(Nitinol) for anchor insertion. This product is sterilized product and single use only.
Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.
This document describes the Suture Wing device, an orthopedic suture anchor intended for fixation of soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Suture Wing device are primarily based on demonstrating substantial equivalence to a predicate device (Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures, K133224) in terms of material, mechanical performance, sterilization, and biocompatibility. The reported device performance confirms adherence to various ASTM and ISO standards for these aspects.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Material | Compliance with specifications for medical-grade materials. | UHMWPE (Anchor and Suture): ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns. |
| Nitinol (Driver Shaft): ASTM F2063: 2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. | ||
| Mechanical Performance | Ability to withstand stress and perform as intended for bone fixation. | ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws (likely for overall anchor integrity/strength). |
| ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments (used for insertion testing). | ||
| Bench tests conducted to verify all design specifications. | ||
| Sterilization | Effective sterilization, maintenance of sterility, and proper packaging. | ISO 11135:2014 (Ethylene oxide sterilization requirements). |
| ISO 11138-1:2006, ISO 11138-2:2009 (Biological indicators for EO sterilization). | ||
| ISO 11140-1:2014 (Chemical indicators). | ||
| ISO 11737-1:2018 (Estimation of microorganisms). | ||
| ISO 11737-2:2009 (Tests of sterility). | ||
| ISO 11607-1:2006/AMD1:2014, ISO 11607-2:2006/AMD1:2014 (Packaging for terminally sterilized medical devices). | ||
| ASTM F1980:2016 (Accelerated aging of sterile barrier systems). | ||
| ASTM F88/F88M:2015 (Seal strength). | ||
| ASTM F1929:2015 (Detecting seal leaks). | ||
| Biocompatibility | Absence of harmful biological responses. | USP Bacterial Endotoxin Test. |
| USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | ||
| USP Pyrogenicity Test. | ||
| ISO 10993-11: Tests for systemic toxicity. | ||
| Insertion Performance | Successful and safe insertion capability. | FDA guidance: Bone Anchors Premarket notification (510(K)) Submissions. |
| ASTM F1839: 2008 (Reapproved 2016) (used as a standard material for testing orthopaedic devices and instruments for insertion). | ||
| Substantial Equivalence | Demonstrating that the device is as safe and effective as the predicate device (K133224) based on intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf-life. | The device demonstrates "Same" or "Similar" equivalence across all criteria shown in Table 1 (page 5 of the document). This includes identical product code, regulatory class, regulation number, intended use, operating principles, sterilization method, single use status, packaging, and shelf-life. Materials (UHMWPE for anchor/suture) and structure are similar, and product size (1.7mm/2.8mm vs 1.8mm/2.8mm) is also similar and deemed acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench tests conducted to verify design specifications and compliance with various standards. It does not mention a "test set" in the context of patient data or clinical studies. The tests are focused on physical and chemical properties of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document describes bench testing against established industry standards for material, mechanical, sterilization, and biocompatibility properties, not the establishment of ground truth from expert clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This document pertains to a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to recognized industry standards (ASTM, ISO, USP) and FDA guidance for bone anchors. For example:
- Material properties: Compliance with ASTM F2848 and F2063 ensures the materials meet specific requirements for medical use.
- Mechanical strength: Conformance to ASTM F543 and demonstration through bench tests indicates the device's structural integrity.
- Sterility: Meeting ISO 11135 and related standards confirms the device is sterile and remains so.
- Biocompatibility: Tests like USP and ISO 10993-11 verify the absence of harmful biological reactions.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "study" described involves physical testing of the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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.