(93 days)
Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.
Weck® Metal Ligating Clips are single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. Each product line possesses a unique design necessary for compatibility with its appropriate Weck® ligating clip applier. The clips are available in a range of sizes, allowing the end user to ligate a wide range of vessels and tissue structures. Weck® Metal Ligating Clips are manufactured from medical grade titanium, tantalum or stainless steel alloys and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Weck® Metal Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
The Weck® Metal Ligating Clips are non-absorbable, non-active implantable devices used for vessel or tissue ligation in general surgical procedures. The clips are made from medical-grade titanium, tantalum, or stainless steel alloys.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| "MR Conditional" Claim | "MR Conditional" for environments of 3-Tesla or less |
| Safety and Compatibility in MR Environment | Demonstrated safe use in 3-Tesla or less MR environments |
| Equivalence to Predicate Devices | Substantially equivalent in performance to K982313 and K841547 |
| No New Safety/Effectiveness Issues | Modifications do not introduce new issues of safety and effectiveness |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical performance testing" was conducted, but specific sample sizes for this testing are not provided.
- Data Provenance: The studies were non-clinical performance testing conducted by the manufacturer, Teleflex Medical, Incorporated, to support a 510(k) submission to the FDA in the USA. This is considered prospective, manufacturer-conducted testing for regulatory approval.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The ground truth for this device (MR Conditional claim, material compliance, and substantial equivalence) was established through non-clinical performance testing and comparison to existing predicate devices, rather than expert interpretation of medical images or data.
4. Adjudication Method
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data where consensus among experts is needed. This submission relies on objective engineering and material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids or AI systems that assist human readers in tasks like image interpretation, and the Weck® Metal Ligating Clips are a physical implantable device.
6. Standalone Performance Study
- Yes, a standalone study was done in the sense that the device's "MR Conditional" performance was tested independently of human intervention. The "Non-clinical performance testing" was conducted on the device itself to determine its behavior in an MR environment. However, this is not "algorithm only" performance as often seen in AI/software substantial equivalence discussions, but rather direct device performance testing.
7. Type of Ground Truth Used
- Engineering and Material Standards: The ground truth for the "MR Conditional" claim was based on established engineering standards (ASTM F2503-08) and FDA guidance for medical devices in MR environments.
- Comparison to Predicate Devices: The ground truth for overall safety and effectiveness was established by demonstrating substantial equivalence to previously cleared predicate devices (K982313 and K841547), implying that if the new device performs similarly to devices already deemed safe and effective, it is also safe and effective.
- Biological Compatibility: Patient-contacting materials compliance with ISO10993-1 provides ground truth for biocompatibility.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is based on physical testing of the device itself.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.