(113 days)
The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.
The Nexus Ligating Clip is a titanium clip used during surgical procedures. The clips are supplied sterile in four sizes: small, medium-large, and large; six clips per cartridge. The size of clip should be chosen based on experience, judgment, and needs, ensuring that the tissue to be occluded fits completely within the clip. The devices are heart-shaped to provide a firm grip on the structure to be ligated, and there are transverse grooves on the inner surface of each clip to resist slippage.
This 510(k) summary (K053255) describes the Nexus Ligating Clip, a titanium clip used in surgical procedures. The submission focuses on demonstrating substantial equivalence to a predicate device, the Horizon Ligation Clips (K982313) from Weck Closure Systems, rather than establishing de novo acceptance criteria through clinical studies.
As such, the document does not contain information on dedicated clinical studies to proactively establish and meet acceptance criteria for a novel device. Instead, it relies on demonstrating similar characteristics and performance to an already legally marketed device. Therefore, many of the requested sections (sample size, expert qualifications, ground truth, MRMC study, training set details) are not applicable in the context of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Cycle Validation In accordance with accepted international standards. | "The sterilization cycle was validated in accordance with accepted international standards." |
| Shelf Life Support a labeled shelf life period of five years. | "Shelf life testing was performed to support the labeled shelf life period of five years. The results of all testing were within acceptable limits." |
| Technological Characteristics | "The indications for use, principles of operation, and device design of the Nexus Ligating Clip are virtually identical to those of the predicate device." |
| Performance Specifications | "There are no significant differences in either technology nor performance specifications [compared to the predicate device]." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided because the submission relies on demonstrating substantial equivalence through comparison of technical characteristics and existing validated processes (sterilization, shelf life) rather than a clinical test set. No specific patient data or test set data provenance is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. No "ground truth" for a clinical test set was established in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable. No clinical test set requiring adjudication was conducted or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. The focus is on device characteristics, not human reader performance with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable, as the device is a titanium ligating clip, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth concept, as typically applied in AI/clinical studies (e.g., pathology, outcomes data), is not relevant here. The "ground truth" for this submission revolves around:
- Adherence to international sterilization standards.
- Successful completion of shelf-life testing.
- Demonstrated similarity in design, materials (titanium), indications for use, and principle of operation to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
§ 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.