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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 document is a 510(k) Pre-market Notification for the Urgent® PC Neuromodulation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission states that the new device and the predicate device are "technologically the same" and that the new device "allows for the successful performance of the product's intended use," implying that its performance is equivalent to the predicate, but no specific performance metrics or acceptance criteria are given.
2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical study data is presented for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The Urgent® PC Neuromodulation System (K071822) is being cleared as substantially equivalent to a previously cleared device (Urgent® PC Neuromodulation System, K061333). The basis for this equivalence is that:

• Both devices have the same intended use: to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
• They are technologically the same: percutaneous tibial nerve stimulator devices with lead sets, intended to deliver retrograde access to the sacral nerve.
• Both have the same principles of action.
• The only difference is in the Instructions for Use.

The submission concludes that the new device allows for the successful performance of its intended use based on its substantial equivalence to the predicate, implying that the predicate's performance history and regulatory clearance serve as the "proof" for the new device.

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