(51 days)
For removal of biliary stones from the common bile duct.
The DURAglide3 ™ Stone Balloon is a sterile, single patient use, triple lumen stone removal balloon catheter.
The provided text is a 510(k) summary for the DURAglide3™ Stone Balloon, a biliary catheter used for the removal of biliary stones. It is important to note that this document is for a medical device and not a software/AI device. Therefore, many of the typical questions for AI/software devices (such as sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be answered from this type of regulatory submission.
Here's an analysis based on the provided text, focusing on what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All results obtained during design verification activities met our predetermined acceptance criteria." However, the specific acceptance criteria (e.g., tensile strength, burst pressure, flow rates, maneuverability specifications) and the detailed results of the performance testing are not disclosed in this 510(k) summary. These details are typically internal to the manufacturer's design control documentation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in summary | All results met predetermined acceptance criteria |
The study that proves the device meets the acceptance criteria is referred to as "design verification activities."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not applicable in the context of a physical medical device. The "test set" would refer to the samples of the device itself undergoing various physical and functional tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. For a physical device like a catheter, "ground truth" is established through engineering and manufacturing specifications, material testing, and functional performance assessments, not expert consensus on data interpretation.
- Qualifications of Experts: Not applicable. Testing would be performed by engineers, technicians, and quality control personnel.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for ambiguous data interpretation, typically in diagnostic imaging or clinical trials. For a physical device, performance is measured against objective specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- MRMC Study: No. This is a physical medical device, not an AI or diagnostic imaging device.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For a physical medical device, the "ground truth" for performance evaluation consists of established engineering specifications, material properties, biocompatibility standards, and functional requirements. For example, a catheter must have a certain burst pressure, flow rate, and flexibility, and these are objective measurements.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is not an AI/software device that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
§ 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.