(255 days)
This instrument has been designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
The subject device is designed to be used with Olympus endoscopes to retrieve stones from the biliary tract.
This product consists of the operation portion (Handle) and insertion portion. The insertion portion consists of distal end portion and sheath portion. The distal end portion contains a basket. The Basket is connected to the Control grip of the operating portion through the insertion portion. Activating the Control grip allows the basket to open or close.
The insertion portion and the distal end portion of the subject device are inserted into the biliary tract through the endoscope. The Basket opens to retrieve the stones from the biliary tract.
This document, K170811 for the Olympus Single Use Retrieval Nitinol Basket V, is a 510(k) summary provided to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel device performance.
Therefore, many of the typical elements of an acceptance criteria and study report for an AI/ML medical device will not be present in this document. This device is a mechanical basket for retrieving stones, not an AI-powered diagnostic tool.
Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance:
The document outlines performance testing categories but does not provide a quantitative table of specific acceptance criteria values and the corresponding measured device performance for each metric. Instead, it states that tests were conducted "to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended." This general statement serves as the "reported device performance" in this context.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Performed in accordance with ISO 10993-1, including cytotoxicity, sensitization, and irritation testing. Confirmed to meet standards. |
| Sterilization Validation | Carried out with Half-cycle approach in accordance with ISO 11135:2014. Confirmed. |
| Shelf Life Testing | Conducted based on accelerated aging per ASTM F1980-16. Results support intended shelf life; real-time aging ongoing. |
| Mechanical Performance | Tested for: Insertion/withdrawal, Open/Close basket, Dimensions of the basket, Attachment/Detachment of hook, Injecting fluid, Visual inspection of package, Peel strength of package, Endurance to splitting of package, Integrity of package, Maximum diameter of catheter, Working length of catheter, Position of V marking, Strength of junction. Confirmed that the subject device performs as intended for all tested items. |
| Risk Analysis | Carried out in accordance with ISO 14971:2007. Addressed and resulted in design verification tests. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact number of devices or test repetitions used for each mechanical performance test. This information is typically detailed in the test reports themselves, which are part of the full 510(k) submission but not included in this public summary.
- Data Provenance: Not applicable in the context of mechanical bench testing. The testing was conducted internally by Olympus's manufacturing and R&D facilities (e.g., Aomori Olympus Co., Ltd. in Japan). This is not data from human patients or a clinical setting.
- Retrospective/Prospective: Not applicable. These were bench tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. For a mechanical device like this, "ground truth" is established by engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., ISO, ASTM). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for image analysis. Performance is measured against predefined engineering and material specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to methods for reconciling discordant expert interpretations in clinical data, which is not relevant for bench testing of a mechanical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a mechanical device, not an AI/ML algorithm or a device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance relies on pre-defined engineering specifications, international standards (ISO, ASTM), and internal quality control criteria. For example, a basket dimension might have a specified range (e.g., "within +/- 0.5 mm"), and the "truth" is whether the measured dimension falls within that range. Similarly, "integrity of the package" is generally verified against a standard visually or through specific tests to ensure no punctures or seals breaches.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set or ML model, this question is not relevant.
In summary, this 510(k) submission for a mechanical medical device (a retrieval basket) relies on demonstrating substantial equivalence through a combination of:
- Comparison of technological characteristics to existing predicate devices.
- Verification that the device meets established engineering and quality control specifications through various bench-top performance tests (e.g., mechanical, sterilization, shelf-life, biocompatibility). These tests are designed to ensure the device functions as intended and is safe for its indicated use.
- Compliance with recognized international standards (e.g., ISO 10993, ISO 11135, ISO 14971, ASTM F1980) for medical device development and manufacturing.
The "acceptance criteria" are implied by these standards and the "performance as intended" statement for each test category, indicating successful demonstration of functional and safety attributes.
§ 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.