(193 days)
Endoscopic removal of stones in the biliary system and foreign bodies.
The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm).
Diameters of Outer Tube of the device are 1.8mm and 2.3mm, working lengths are 700mm,200mm and 2300mm, and open widths are 10mm, 15mm, 20mm,35mm,40mm, and the devices have eight types of baskets and two kinds of handles (single hand type and two hands type).
It is comprised of guiding head (stainless steel/nitinol), pulling wire (stainless steel), outer tube(PTFE) and handle components (ABS, stainless steel and etc.). Basket is advanced out of and retracted into the polytetrafluoroethylene outer tube using the handle. The device is not compatible with any mechanical lithotripter.
This document is a 510(k) summary for a medical device called "Stone Extraction Baskets." It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for FDA clearance.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it lists the types of non-clinical bench tests performed and concludes that the device "meets the performance criteria required to fulfill the intended use of the device."
| Test Category | Acceptance Criteria (Not explicitly stated as quantitative values) | Reported Device Performance (Implied as "passed") |
|---|---|---|
| Sterilization | Must ensure sterility (implied) | Meets performance criteria required for intended use (implied, as sterilization is a prerequisite for a sterile device) |
| Shelf Life | Must maintain integrity and functionality over its shelf life | Meets performance criteria required for intended use (implied) |
| Biocompatibility | Must be biocompatible with the human body (implied) | Meets performance criteria required for intended use (implied) |
| Endoscope insertion removal | Device must withstand repeated insertion/removal from endoscope | Passed durability test |
| Durability test | ||
| Dimension test | Dimensions must conform to specifications | Passed dimension test |
| Tensile strength test | Components must withstand specified tensile forces | Passed tensile strength test |
| Operational performance test | Device must function as intended (e.g., basket deployment) | Passed operational performance test (including flexibility) |
| (Flexibility Testing included) | ||
| Stone and Foreign Body Capture | Device must effectively capture stones and foreign bodies | Passed stone and foreign body capture test |
| Test |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on sample sizes used for the non-clinical bench tests. It only lists the types of tests performed. There is no information about data provenance (country of origin, retrospective/prospective) because this document describes a pre-market submission, not a clinical study involving patient data. The tests are bench tests performed on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The tests described are non-clinical bench tests and do not involve human expert interpretation of data or images to establish a "ground truth" in the same way a clinical diagnostic study would. The performance is assessed against engineering specifications and functional requirements.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are physical and functional assessments of the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on establishing substantial equivalence through bench testing, not on comparing human reader performance with and without AI assistance. This device is a manual tool (stone extraction basket), not an AI-powered diagnostic or assistive technology.
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 medical instrument, not an algorithm or software. Its operation inherently involves a human operator (a clinician).
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not directly applicable to the bench tests described. For these engineering and functional tests, the "ground truth" is typically defined by:
- Engineering specifications: (e.g., dimensions, tensile strength).
- Functional requirements: (e.g., successful capture of a simulated stone, ability to pass through an endoscope).
- Regulatory standards: (e.g., biocompatibility testing according to ISO standards, sterility assurance level).
8. The Sample Size for the Training Set
There is no mention of a training set sample size because this device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth.
§ 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.