(82 days)
The NURO Neuromodulation System (Stimulator model NURO 100) is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.
The NURO Neuromodulation System is designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The NURO Neuromodulation System is a combination of the Stimulator with permanently attached single insulated lead wire, and number of single-use accessories which are sold separately, including: the acupuncture needle (provided in a single-use sterile package), needle holder, and electrode pad. The Stimulator is a small and portable pulse generator, and should only be used in conjunction with the lead wire and the single-use items listed above. The system also includes a micro USB-to-USB cable, and a USB wall charger. The Stimulator device provides treatment functions by purchasing therapy credits from a commercial website. Therapy credits are downloaded to the device through the micro-USB connection to a computer with a USB port and internet access. The Stimulator stores a record of the therapy credits purchased and available. Each therapy cycle uses a single credit. A therapy credit is required to be available on the Stimulator device in order to begin a patient treatment session. These therapy credits may be purchased with 99 as the maximum purchase. The Stimulator does not store or transfer via the USB cable any patient data. The credit transfer function is strictly a financial transaction. No patient data is stored or transferred by the Stimulator. There is no impact on safety or efficacy with purchase of therapy credits.
The NURO Neuromodulation System is a medical device designed to treat Overactive Bladder (OAB) and its associated symptoms. The submission K132561 focuses on establishing substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria met by specific device performance metrics in a clinical context. Therefore, the information typically requested for a study proving device performance against acceptance criteria (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available in this 510(k) summary.
The document describes nonclinical performance testing focusing on meeting recognized electrical safety and electromagnetic compatibility standards, indicating that the device meets these technical requirements to ensure safety and effectiveness comparable to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards) | Reported Device Performance and Compliance |
|---|---|
| IEC 60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance) | Compliance demonstrated |
| IEC 60601-1-2:2007 (Medical electrical equipment - General requirements for safety - Collateral standard: Electromagnetic compatibility) | Compliance demonstrated |
| IEC 60601-2-10:2012 (Medical electrical equipment - Particular requirements for the safety of nerve and muscle stimulators) | Compliance demonstrated |
| Cleaning Validation (for NURO Stimulator) | Validation performed and successful |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The submission focuses on non-clinical performance testing against safety and electrical standards, not on a clinical test set with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical ground truth was established as part of this submission. The ground truth refers to the compliance with established electrical and safety standards.
4. Adjudication Method for the Test Set:
Not applicable. No clinical adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted or reported. This submission establishes substantial equivalence based on technological characteristics and non-clinical performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. This device is a neuromodulation system for physical treatment and does not involve an algorithm with "standalone" performance in the context of diagnostic or interpretive AI. Its "performance" refers to its electrical output and safety characteristics.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing was the established requirements and specifications within the referenced IEC and cleaning validation standards.
8. Sample Size for the Training Set:
Not applicable. This submission does not involve a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There was no training set for an AI/ML algorithm.
§ 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.