(247 days)
Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).
Here's a summary of the acceptance criteria and study information for the Amsel Endo Occluder device based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner for specific device functions. Instead, it states that the device was tested to demonstrate compliance with international and FDA-recognized consensus standards and FDA guidance documents, and that it "Meets the acceptance criteria and is adequate for its intended use and specifications."
The provided information focuses on the type of tests conducted rather than specific numerical acceptance criteria and performance outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 14971:2007:2012 (Risk Management) | Demonstrated compliance. |
| Compliance with ISO 11135-1:2014 (Sterilization - Ethylene Oxide) | Demonstrated compliance (Sterility). |
| Compliance with ISO 10993-1:2009 (Biological Evaluation) | Demonstrated compliance (Biocompatibility). |
| Compliance with ANSI/AAMI/ISO 10993-7:2012 (Ethylene Oxide Sterilization Residuals) | Demonstrated compliance. |
| Compliance with ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems) | Demonstrated compliance (Sterility). |
| Compliance with AMI/ANSI/ISO 11607-1:2006 (Packaging for Sterilized Medical Devices) | Demonstrated compliance (Sterility). |
| Compliance with ASTM F-2063 (Wrought Nickel-Titanium Shape Memory Alloys) | Demonstrated compliance (Material properties). |
| Compliance with ASTM F899 – 12b (Wrought Stainless Steels for Surgical Instruments) | Demonstrated compliance (Material properties). |
| Compliance with ASTM 2129-17 (Cyclic Potentiodynamic Polarization Measurements - Corrosion Susceptibility) | Demonstrated compliance. |
| Compliance with ASTM F3044-14 (Galvanic Corrosion for Medical Implants) | Demonstrated compliance. |
| Occlusion Performance (Safety and Effectiveness) | Demonstrated safety and effectiveness during preclinical in-vivo tests. |
| Functionality and Performance Claims | All defined functionality requirements and performance claims were met. |
| Adequacy for Intended Use and Specifications | Adequate for its intended use and specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Preclinical in-vivo tests, including acute and chronic tests, were conducted." However:
- Specific sample sizes for these in-vivo tests are not provided in the summary.
- Data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The summary focuses on preclinical testing and does not mention the involvement of experts for establishing ground truth as typically seen in clinical device evaluations involving human diagnosis or interpretation.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the preclinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Amsel Endo Occluder device did not require clinical studies to support equivalence." Biomedical devices like ligating clips are often cleared based on non-clinical performance and substantial equivalence to predicate devices, rather than comparative clinical efficacy studies with human readers.
6. Standalone Performance Study (Algorithm Only):
This section is not applicable as the Amsel Endo Occluder device is a mechanical medical device (ligating clip applier and clips), not an AI/algorithm-driven device.
7. Type of Ground Truth Used:
For the preclinical in-vivo tests, the ground truth was based on demonstrating the safety and effectiveness of occlusion performance. This would likely involve direct observation, measurement, and pathological analysis of the ligated vessels/structures in animal models or cadaveric tissue.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training set" concept is typically for machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above (not an AI/algorithm).
§ 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.