(238 days)
The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.
The Applied Cystic Duct Dilator consists of a non-distensible dilating balloon with a inflation profile of 15 French.
The provided text describes a 510(k) submission for the Applied Medical Cystic Duct Balloon Dilating Catheter (K983154). This document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets explicit acceptance criteria in the manner one might find for a novel Artificial Intelligence or software-driven medical device.
Therefore, the requested information categories related to AI/software performance, such as sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable or available in this submission. This is a traditional medical device submission for a physical catheter.
Below is an attempt to address the request based on the available information regarding the device.
Acceptance Criteria and Device Performance Study for K983154: Applied Medical Cystic Duct Balloon Dilating Catheter
This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against pre-defined quantitative acceptance criteria through a clinical study with human readers or AI.
The "acceptance criteria" in this context refer to passing all required tests to prove the device's safety and effectiveness are equivalent to the predicate devices and that it introduces no new safety or effectiveness issues.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | The device passed all testing to demonstrate substantial equivalence to the predicate devices: Applied Medical Obturator (part of Cystic Duct Access Kit K929224/A) and Cook Guided Biliary Dilator Set. |
| Safety and Effectiveness | The device introduces no new safety and effectiveness issues when used as instructed. (Implicitly, this means safety and effectiveness are comparable to the predicates for the stated indications). |
| Inflation Profile | The device has an inflation profile of 15 French. This is a characteristic feature and presumed to meet design specifications, contributing to its equivalence with predicate devices designed for similar purposes. |
| Intended Use | The device is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures. This matches the intended use of predicate devices, supporting equivalence. |
| Regulatory Compliance | The device complies with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, and labeling), and thus was cleared by the FDA. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. This submission does not detail a clinical "test set" with specific cases or patient data in the manner of an AI or diagnostic imaging device. The "testing" referred to is likely a series of engineering, biocompatibility, and performance bench tests to ensure the physical catheter meets design specifications and is equivalent to the predicate. No information on data provenance (country of origin, retrospective/prospective) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. This type of expert review to establish ground truth is typical for diagnostic algorithms; it is not relevant for a physical device like a balloon dilating catheter in a 510(k) submission focused on substantial equivalence.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods are not described as this is not a diagnostic or AI performance study requiring such an approach.
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. An MRMC study was not done. This device is a physical medical instrument, not an AI or software-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or software device, so "standalone" performance in that context is not relevant.
7. The type of ground truth used
- Not applicable for a clinical "ground truth" derived from patient outcomes or pathology. The "ground truth" in this context would be derived from engineering specifications, material testing standards, and established performance characteristics of the predicate devices. For instance, burst pressure, inflation/deflation times, material compatibility, and dimensional accuracy would be verified against engineering standards assumed to be met by the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set (as defined in machine learning), there is no ground truth established for one.
§ 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.