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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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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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