(229 days)
The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy.
The Rüsch Guided Cholangiography Catheter is a sterile, singleuse device that consists of the following components:
- 10Fr, 30cm, Silicone-Sealed, Curved Polyurethane Guide Catheter . with Guide Handle
- 4Fr, 120cm, Curved, Polyvinylchloride Cystic Duct Catheter with ● Luer-Lock Syringe Connector 5mm OD, 27cm length, Silicone-Sealed Polyurethane Introduction Tub
The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle.
The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement.
Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear poly pouch with a medical paper seal. Each device will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed 5 units per box.
The provided text is a 510(k) summary for a medical device called the "Rüsch Guided Cholangiography Catheter." This document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical study or performance verification test might.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document because it describes a regulatory submission for clearance, not a performance study report.
The document states:
- The device is "substantially equivalent in design and materials" to existing predicate cholangiography catheters.
- "The following technological characteristics are the same as or equivalent to the predicate devices listed above: Materials: The materials used in the cystic duct catheter, the guide catheter and the introducer tube have all been used in predicate Rüsch devices."
This implies that the acceptance criteria were primarily about demonstrating this substantial equivalence in terms of materials, design, and intended use, aligning with the regulatory requirements for a 510(k) submission. Performance is inferred through equivalence, not explicitly detailed with quantitative metrics in this summary.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Design Equivalence: Catheter design and components are similar to predicate devices. | "The Rüsch Guided Cholangiography Catheter is substantially equivalent in design and materials to: The COOK Unger Endoscopic Cholangiography Set, The COOK Franklin Endoscopic Cholangiography Set, The COOK Directable Coaxial Catheter Set." |
| Material Equivalence: Materials used are safe and functionally similar to predicate devices. | "The materials used in the cystic duct catheter, the guide catheter and the introducer tube have all been used in predicate Rüsch devices." |
| Intended Use Equivalence: Device's purpose matches that of predicate devices. | "The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy." (Matches the general intended use of predicate cholangiography catheters). |
| Sterilization: Device can be manufactured sterile. | "Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide..." |
| Basic Functionality (Inferred): Tip directability, cystic duct catheter placement assistance. | "The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle." |
| "The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. A 510(k) submission for substantial equivalence generally focuses on engineering design, materials, and comparison to existing devices, rather than a clinical trial-style test set performance evaluation with sample sizes.
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)
- This information is not provided as there is no mention of a formal clinical test set with expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided as there is no mention of a formal clinical test set with expert ground truth establishment.
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
- No, a MRMC comparative effectiveness study was not done. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical catheter, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is primarily the established safety and effectiveness of the predicate devices and the established safety and biocompatibility of the materials used. No specific clinical ground truth based on expert review or pathology for a new performance claim is mentioned.
8. The sample size for the training set
- This information is not provided as this is a physical device submission, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as this is a physical device submission, not an AI/machine learning algorithm.
§ 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.