(164 days)
The Ligaclip® Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
The Ligaclip® 10mm M/L Endoscopic Rotating Multiple Clip Applier is a sterile, single-patient use device, designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The device contains 20 medium-large titanium clips that individually advance after each firing. The device shaft rotates 360° in either direction. The rotating knob is located on the handle to allow for a one-handed technique.
The provided FDA 510(k) summary for the LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier details performance testing. Here's a breakdown based on your request, keeping in mind that this document focuses on demonstrating substantial equivalence rather than a clinical effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Trocar Compatibility | Verified to meet design requirements. |
| Retention Strength of Unformed Clip in Jaws | Verified to meet design requirements. |
| Ratchet Mechanism Strength | Verified to meet design requirements. |
| Ergonomic Torque to Fire Device | Verified to meet design requirements. |
| Tactile Indication Torque for "No-Clip Lockout" Function | Verified to meet design requirements. |
| Low Clip Indicator Bar Performance | Verified to meet design requirements. |
| Clip Occlusion of the Formed Clip | Verified to meet design requirements. |
| Clip Security of the Formed Clip | Verified to meet design requirements. |
| Clip Leak Resistance | Demonstrated in hydrodynamic testing on excised porcine vessels. |
| Biocompatibility | Met compliance with ISO 10993-1 and FDA Blue Book Memorandum #G95-1. Pyrogenicity testing conducted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices, number of clips, number of tests) for each individual ex-vivo test. It broadly states "Ex-vivo tests were performed."
- Data Provenance: The tests are described as "Ex-vivo tests" and "hydrodynamic testing on excised porcine vessels." This indicates the data is from laboratory bench testing using non-human biological material (porcine vessels) and the device itself.
- The document explicitly states: "This submission does not include data from Clinical Studies." This confirms the data is retrospective in the sense that it's laboratory-generated and not from human clinical trials. The country of origin of this lab data is not specified, but given the manufacturer is Ethicon Endo-Surgery, LLC (with an address in Puerto Rico, USA), it's highly likely to be U.S.-based or internally generated by the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document.
- For ex-vivo bench testing of this nature, "ground truth" is typically established by engineering specifications, validated test methods, and potentially comparison to predicate device performance, rather than expert clinical consensus as might be the case for image interpretation.
4. Adjudication Method for the Test Set
- This information is not provided as it's not relevant for this type of ex-vivo mechanical and biological performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done.
- The document states: "This submission does not include data from Clinical Studies." An MRMC study would be a type of clinical study.
- Therefore, no effect size for human readers improving with or without AI (as the device is a mechanical clip applier, not an AI diagnostic tool) can be reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a mechanical clip applier, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the performance tests: Engineering design requirements and specifications serve as the ground truth/acceptance criteria for mechanical and functional aspects.
- For the hydrodynamic testing: The successful demonstration of clip leak resistance in excised porcine vessels serves as the "ground truth" for that functional aspect.
- For biocompatibility: Compliance with specified international standards (ISO 10993-1) and FDA guidance serves as the ground truth.
8. The Sample Size for the Training Set
- This question is not applicable because the device is a mechanical clip applier and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
§ 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.