(54 days)
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
This looks like a 510(k) summary for a medical device called a "Stone Retrieval Balloon Catheter." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
However, the document does not contain the information you requested about acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document explicitly states: "No clinical study is included in this submission." This means there isn't a study proving the device's clinical performance against acceptance criteria in the way you've described for AI/diagnostic devices.
The "Non-Clinical Performance Testing" section lists various standards (e.g., ISO, ASTM, USP) that the device complies with, but it does not provide specific acceptance criteria (e.g., "sensitivity > 90%") or the results of meeting those criteria in the context of an AI-driven or diagnostic device study. The non-clinical tests are primarily focused on material properties, biocompatibility, sterilization, and packaging integrity, which are standard for this type of medical device.
Therefore, I cannot fulfill your request for these particular details based on the provided text, as this document pertains to a medical device clearance application that relies on demonstrating substantial equivalence to a predicate device rather than a clinical performance study with AI components.
§ 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.