(52 days)
The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
The provided text is a 510(k) summary for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or provide a table of performance metrics for the Urgent® PC Neuromodulation System itself. The submission is a Special 510(k), which typically relies on comparisons to changes made in a previously cleared device. The key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device.
The "Performance" section explicitly states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a qualitative statement, not a quantified performance metric.
2. Sample Size Used for the Test Set and Data Provenance:
No test set or associated sample size is mentioned. This submission is a Special 510(k) for a modification to an already cleared device, not a new clinical study. The submission focuses on technological equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set is described.
5. 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:
Not applicable. This device is a neuromodulation system, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a neuromodulation system, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth is established as there is no new clinical trial described. The "ground truth" for the 510(k) revolves around demonstrating the device's technological and safety equivalence to its predicate.
8. The Sample Size for the Training Set:
Not applicable. This device is a neuromodulation system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is described.
Summary of what the document does communicate:
- Device: Urgent® PC Neuromodulation System, used for percutaneous tibial nerve stimulation (PTNS) to treat urinary urgency, frequency, and urge incontinence.
- Regulatory Pathway: Special 510(k) (K061333).
- Predicate Device: Urgent® PC Neuromodulation System (K052025).
- Key Argument for Equivalence: The new and predicate devices are "technologically the same" with similar intended uses and principles of action. Any differences are stated not to raise concerns about safety or effectiveness.
- Conclusion: The device is substantially equivalent to the previously cleared predicate.
§ 876.5310 Nonimplanted, peripheral electrical continence device.
(a)
Identification. A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.(b)
Classification. Class II, subject to the following special controls:(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.