(267 days)
The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The main components of the subject device set include the Ultraxx™ Nephrostomy Balloon Catheter (Ultraxx catheter) and Amplatz sheath. The patient-contacting materials of this set include the Amplatz sheath and Ultraxx catheter's balloon, catheter tubing, marker band, and adhesive.
The Ultraxx catheter has a dual lumen shaft with a dilatation balloon on its distal end. One of the lumens accepts a wire guide, and the other is used to inflate the balloon. The catheter material is constructed from a polyether block polyamide copolymer and is available in an outer diameter of 6 Fr with a length of 55 cm. The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated outer diameters of 6 to 10 mm with a length of 15 cm. A platinum radiopaque marker band is positioned on the distal end of the balloon catheter which confirms accurate placement of the catheter. The maximum rated balloon pressure is 20 atm.
The Amplatz sheath is available in either polytetrafluoroethylene (PTFE) or a clear polyvinyl chloride (PVC). Both types of sheaths are available in inner diameters ranging from 18 to 32 Fr with a working length of 17 cm. The distal end has a smoothly rounded beveled tip for ease of insertion. The proximal end has a guidewire notch which functions to secure the wire guide and keep it out of the way during a nephrostomy procedure.
The Ultraxx™ Nephrostomy Balloon Catheter is a short-term use device, sterilized by ethylene oxide, and intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in the provided text. However, the document states, "All predetermined acceptance criteria of the testing were met."
The performance tests conducted include:
- Biocompatibility
- Balloon Rated Burst Pressure, Compliance (pressure-diameter relationship characterization), and Deflation Time
- Tensile Testing of Balloon and Sheath Components, Joints and Bonds
- Balloon Protector Removal Force
- Radiopaque Marker Band Location and Radiopacity Verification
- Component Compatibility and Dimensional Verification
- Shelf Life of Three Years Accelerated Aging
Since "All predetermined acceptance criteria of the testing were met," the reported device performance for each of these tests, by implication, aligns with the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The performance data described appears to be based on engineering and laboratory testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method for a test set, as the testing appears to be based on objective performance measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the technical performance and safety of a medical device (catheter) through a series of engineering and laboratory tests, not on the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a medical catheter, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product. The described tests are for the physical device's performance.
7. The Type of Ground Truth Used
The ground truth for the performance testing appears to be based on objective engineering and laboratory measurements against predefined specifications and industry standards for medical devices (e.g., burst pressure, tensile strength, dimensional verification, biocompatibility). It is not based on expert consensus, pathology, or outcomes data in the context an AI/reader study.
8. The Sample Size for the Training Set
This question is not applicable. The document describes the premarket notification (510(k)) for a physical medical device (catheter), not a device involving an AI algorithm which would typically have a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no mention of a training set or AI algorithm in the provided document.
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