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The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Ultraxx™ Nephrostomy Balloon Catheter is a double-lumen catheter indicated for a nephrostomy procedure by dilating the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The device is intended for limited duration use, not to exceed 24 hours in the body.

The Ultraxx Nephrostomy Balloon Catheter Set is comprised of the Ultraxx balloon catheter, Amplatz sheath, and inflation device. The Ultraxx Nephrostomy Balloon Catheter is constructed from a radiopaque nylon tubing with a dilatation balloon on its distal end. The outer diameter of the catheter is available in 6 French (Fr) with a working length of 55 centimeters (cm). The balloon of the catheter is constructed from polyethylene terephthalate (PET) and is available in nominal inflated diameters of 6 to 10 millimeters (mm) with a length of 15 cm. A 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 sheaths are available in inner diameters of 18, 24, or 32 Fr with a working length of 17 cm. The Cook Sphere Inflation Device was cleared on March 3, 2004 under K032840. The inflation device is a one-piece, plastic, disposable inflation device with a lock lever design to control the piston, a manometer, and a connecting tube with a male rotating adapter.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

This document, K181713, is a 510(k) premarket notification for a medical device (Ultraxx™ Nephrostomy Balloon Catheter Set). For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a traditional clinical study with a detailed test set, ground truth, and statistical analysis as one might find for a novel class III device or a new AI/ML-based diagnostic.

Therefore, the information typically included in a "Description of acceptance criteria and the study that proves the device meets the acceptance criteria" for a novel device, especially an AI one, is largely not applicable to this submission. This 510(k) explicitly states there were no changes to the subject device that would affect biocompatibility, sterility, or performance compared to the predicate devices.

However, I can extract the relevant information regarding the comparative claims made and the assessment of equivalence:

Device: Ultraxx™ Nephrostomy Balloon Catheter Set

Summary of Acceptance Criteria and Device Performance (as pertains to a 510(k) for substantial equivalence):

Further Details (as per the provided document):

1. Sample size used for the test set and the data provenance:

   • Not applicable in the typical sense. This submission is based on demonstrating substantial equivalence to pre-existing, cleared devices. The "test set" here refers to the device itself and its components.
   • The document mentions "Packaging integrity testing following simulated distribution was performed." The sample size for this specific test is not detailed, but it would have been an engineering/bench test rather than a clinical or data-driven evaluation of performance against a "test set" of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for a 510(k) for substantial equivalence relies on comparison to a predicate device's known characteristics and performance, not on expert labeling of a dataset.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No such adjudication process is described or implied for this type of submission.

4. 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. This device is a physical medical device (catheter set) used in a procedure, not an AI/ML-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. As stated above, this is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. The "ground truth" for this 510(k) is the established performance and characteristics of the predicate devices (K171601 and K032840), which presumably met their own regulatory requirements (likely via prior 510(k)s based on bench testing, limited animal/clinical data, and comparison to even older predicates).

7. The sample size for the training set:

   • Not applicable. No training set is used as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is used.

In conclusion, this 510(k) submission (K181713) for the Ultraxx™ Nephrostomy Balloon Catheter Set explicitly states that there were no changes to the device (Ultraxx balloon catheter, Amplatz sheath, and the Cook Sphere Inflation Device) that would affect biocompatibility, sterility, or performance compared to its predicate devices. The only "modification" from the predicate devices was that the two predicate devices (Ultraxx™ Nephrostomy Balloon Catheter and Cook Sphere Inflation Device) are now provided together as a convenience kit.

Therefore, the "study" proving the device meets acceptance criteria is primarily the demonstration of identical characteristics to the already cleared predicate devices, supported by specific bench testing for the new "packaging configuration" (packaging integrity testing following simulated distribution). The success criterion for this submission was demonstrating "substantial equivalence" to the predicates, which was met as indicated by the FDA’s clearance letter.

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