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510(k) Data Aggregation
(183 days)
The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women
The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.
The TensCare itouch Sure Pelvic Floor Exerciser (K103698) is a Class II device intended to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women.
The submission does not include a separate study that establishes acceptance criteria and proves the device meets them in the way clinical performance studies with specific endpoints would. Instead, the FDA's "substantial equivalence" determination for this 510(k) submission is based on a technological comparison to predicate devices. This means the device is deemed safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed, and any differences do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" here are inherent to the regulatory process for substantial equivalence, focusing on whether the new device is as safe and effective as its predicates based on a comparison of their features and performance characteristics.
Here’s an interpretation of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit numerical targets from a performance study but rather the demonstration that the TensCare itouch Sure's technical specifications and safety profile are comparable to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported TensCare itouch Sure Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: Treatment of urinary incontinence | "The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women." (Same as predicates) |
| Technological Equivalence (Key Parameters): | (See detailed comparison table in the "Technological Comparison" section of the 510(k) summary) |
| Frequency (Hz) | 10/20/35/50 (Comparable to predicates, e.g., K941911: 12.5/50; K81480: 2-100) |
| Pulse Width (uS) | 200/250/300 (Comparable to predicates, e.g., K941911: 300; K81480: 50-450) |
| Output Current/Voltage | 0-45V = 0-90mA over 500 Ohm; Constant current 160-500 Ω, Constant voltage 500-1500 Ω (Comparable to predicates, e.g., K941911: 0-60mA (100mA override); K81480: 0-90 mA nominal) |
| Waveform Type & Shape | Bi-phasic, Rectangular at positive (Substantially equivalent to Kegel 8; difference in negative phase not clinically significant) |
| Biocompatibility: Probe materials are safe for patient contact. | Materials (ABS, Stainless Steel) are the same as Kegel 8 probe. Biocompatibility tests (ISO 10993-5:2009 and -10:2002) showed no cytotoxicity, negligible vaginal irritation, no sensitization. |
| Safety: Compliance with relevant safety standards, controlled output energy, no new safety hazards. | Designed to comply with recognized consensus standards. Output energy controlled within safety/effectiveness ranges. Test results, Risk Analysis, FMEA show it is safe. Device controls output at constant voltage > 500 Ω and pseudo-constant current < 500 Ω, reliably making it safe. No significant complaints or adverse events reported during European market experience (since April 2009). EMC tested to EN60601-1-2:2007. |
| Labelling Equivalence: Consistent with predicate devices. | "The Labelling is substantially equivalent to that of the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not discuss a clinical "test set" in the traditional sense of a performance study with patient data. The evaluation primarily relies on engineering tests, comparisons to existing devices, and a review of post-market experience in Europe.
- Sample Size: Not applicable in terms of a clinical test set. The "sample" is the device itself and its components.
- Data Provenance:
- Engineering Test Data: Originates from internal testing conducted by Tenscare Ltd. (United Kingdom) and EasyMed Instrument Ltd. (China) to verify physical and electrical specifications (e.g., frequency, pulse width, output current, EMC testing).
- Biocompatibility Data: Results from tests performed according to ISO 10993 standards. The location of the testing lab is not specified but is likely external or internal testing related to the manufacturing process.
- Post-Market Data: Retrospective review of customer complaints, returned products, and post-market feedback since April 2009 (European market).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study that involved expert interpretation or ground truth establishment from clinical cases. The "ground truth" for substantial equivalence is primarily defined by the performance and safety profiles of the legally marketed predicate devices, as well as validated engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or data, which is not relevant for this electrical stimulator.
6. Standalone (Algorithm Only) Performance Study
No. This device is an electrical stimulator, not an algorithm, so a standalone performance study in that context is not applicable. Its performance is assessed through its physical outputs and safety characteristics.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (EMPI Innova K941911 and Kegel 8 K81480).
- Engineering and Safety Standards: Compliance with recognized consensus standards like IEC 60601-1-2:2007 for EMC and ISO 10993-5:2009 and -10:2002 for biocompatibility.
- Manufacturing Specifications: The device reliably performs according to its documented technical specifications.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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