(64 days)
The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.
The RSH Biliary Stone Removal Device is a single-use quad lumen polyurethane balloon catheter system which can be placed with or without the need of a guide-wire. The balloon is inflated using saline with the supplied 10ml syringe. The device is equipped with two flush ports, proximal and distal to the balloon, for contrast injection. The device is provided sterile. The device is similar to the predicate device, except the balloon is polyurethane rather than latex, the fill is saline rather than air, and 4 lumens are used rather than ≤ 3 lumens. With more lumens, a somewhat larger balloon diameter range, 9 -25 mm, is achieved in one size rather than three sizes.
The RSH Biliary Stone Removal Device is a medical device for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.
Here's an analysis of its acceptance criteria and the study that proves it meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity | Yielded passing results |
| Sensitization | Yielded passing results |
| Irritation | Yielded passing results |
| Bench Testing | |
| Balloon - Sizing/Compliance, Multiple Inflation, Burst, and Leak | All catheters performed through a range of 9mm - 25mm without failure, leak, or rupture; inflated multiple times without failure, and inflated to 25mm without leakage. The working range was demonstrated. |
| Flush Volume | All catheters flushed lumens at or above the specified minimum flow rate demonstrating acceptable flushing capability. |
| Manifold – Leak | All catheters held the minimum pressure at all three ports demonstrating acceptable leak resistance. |
| Balloon – Inflation/Deflation | All catheters inflated and deflated as required demonstrating acceptable balloon performance. |
| Manifold – Tensile Strength | All catheters met the minimum bond strength with 95% Confidence/ 95% Reliability demonstrating acceptable break resistance. |
| Model / Wire Loading, Endoscope Compatibility, Kink Resistance (flexibility) | All catheters loaded and advanced over a .035" guide wire, were delivered through the endoscope channel, endured a 90° deflection without kinking or breaking, and endured minimum tensile load without bursting when pulled back against endoscope. Acceptable handling characteristics were demonstrated. |
| Stone Dislodgement Effectiveness | All catheters and the predicate devices tested dislodged the stone without balloon rupture. The catheter demonstrated comparable effectiveness to the predicate device. (This indicates the new device is at least as effective as the predicate in its primary function of stone removal.) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided information describes a 510(k) premarket notification for a medical device. This typically involves bench testing and biocompatibility testing, not clinical studies with patients. Therefore, terms like "test set" in the context of patient data, data provenance (country of origin), and retrospective/prospective study design are not applicable here.
The "test set" for this device consists of the physical devices themselves and the environmental conditions under which they were tested. The provenance of the data is from the bench testing laboratories conducting the specified tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information (number of experts, qualifications) is not applicable for a 510(k) submission focusing on bench testing and biocompatibility. Ground truth in this context is established by the performance of the device against predefined engineering specifications and validated test methods, rather than expert interpretation of a diagnostic outcome. The tests are designed to objectively measure physical properties and biological responses.
4. Adjudication Method for the Test Set:
An adjudication method (like 2+1, 3+1, etc.) is not applicable for this type of device submission. Adjudication methods are used in clinical trials, particularly for imaging studies, where independent experts review cases to arrive at a consensus for ground truth. For this device, the "ground truth" is determined by whether the device's physical properties and performance meet the specified engineering and biocompatibility criteria through validated testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to diagnostic devices (often imaging algorithms) where human readers interpret medical images or data. This device is an interventional tool, and its efficacy is primarily demonstrated through bench testing simulating its intended use and comparison to a predicate device. Therefore, questions of "human readers improve with AI vs without AI assistance" are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, and it is intended to be used by a human operator (endoscopist). Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is primarily established by:
- Engineering Specifications: Predefined performance metrics and acceptable ranges for physical properties (e.g., balloon size range, flush volume, tensile strength, leak resistance, inflation/deflation speed).
- Validated Test Methods: Standardized procedures to conduct the bench tests and measure the device's performance against these specifications.
- Biocompatibility Standards: Established criteria for cytotoxicity, sensitization, and irritation based on ISO standards and FDA guidance.
- Predicate Device Performance: Direct comparison to the established performance of the legally marketed predicate device (Extractor™ Retrieval Balloon catheters) to demonstrate comparable effectiveness in stone dislodgement.
8. The Sample Size for the Training Set:
Not applicable. This submission focuses on a physical medical device, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
§ 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.