(41 days)
The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.
The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone retrieval device consisting of nitinol basket with a 1.5 cm wide diameter when fully expanded and a 2.4 Fr shaft diameter sheath. The device is packaged with a Touhy-Borst adapter accessory.
The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity | Materials are biocompatible (per ISO 10993-1) | All materials found to be biocompatible. |
| Mechanical Properties | Dimensional and Compatibility Evaluation | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Radiopacity Evaluation | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Performance | Multiple Stone Retrieval Testing | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Basket Formation | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Basket Coil | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Basket Sheath | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Basket Sheath to Handle Connection | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Basket Assembly to Shaft Connection | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
| Mechanical Properties | Tensile Test: Cannula to Basket Coil Connection | Met pre-determined acceptance criteria | All pre-determined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each of the listed tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified. These are typically details found in the full test reports, not a 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The tests performed are primarily engineering and material science tests, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).
4. Adjudication Method for the Test Set:
This information is not applicable/provided. The tests described are objective engineering and performance tests, not those that typically require adjudication by multiple experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and material testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a medical instrument (stone extractor), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
For the tests described (biocompatibility, dimensional, radiopacity, mechanical, multiple stone retrieval), the "ground truth" would be established by:
- Established standards and specifications: For biocompatibility, ISO 10993-1 is explicitly mentioned. For dimensional, tensile, and radiopacity tests, there would be internal design specifications and recognized test methods.
- Physical measurements and objective observations: Test results are compared against predefined numerical or qualitative criteria.
8. The Sample Size for the Training Set:
Not applicable. The device is a medical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no training set for this type of device.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.