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510(k) Data Aggregation
(257 days)
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- increasing local blood circulation
- immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle re-education
As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.
The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.
| Characteristic / Specification | Acceptance Criteria (implied by predicate comparison) | Reported Device Performance (TrainFES Advanced) |
|---|---|---|
| Basic Device Characteristics | ||
| Classification | Class II | Class II |
| Prescription/OTC Use | Prescription and Home Use | Prescription and Home Use |
| Environment of Use | Clinics, hospitals, and home | Clinics, hospitals, and home |
| Indications for Use | Similar to predicate (specific conditions) | Similar to predicate, with specific conditions listed, and the functions of powered muscle stimulator and external functional neuromuscular stimulator are exactly the same |
| Power Source | Battery-powered, compliant with IEC 62133 | Battery: Li-Ion 3.7V (4000mAh), compliant with IEC 62133 |
| Method of Line Current Isolation | N/A (Battery) | N/A (Battery) |
| Patient leakage current (Normal) | <100μA | <100μA |
| Patient leakage current (Single fault) | <100μA | <100μA |
| Number of Output Modes | Compliant with IEC 60601-1 and IEC 60601-2-10 | 2, compliant with IEC 60601-1 and IEC 60601-2-10 |
| Software/Microprocessor control | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut Off | Yes | Yes |
| Patient Override Control | Yes | Yes (Button) |
| Indicator Display On/Off Status | Yes (Led) | Yes (Led) |
| Indicator Display Low Battery | Yes | Yes |
| Indicator Display Voltage/Current Level | Yes | Yes |
| Standards | Compliance with relevant IEC standards | ISO 13485:2016, Bluetooth: FCC 15.2473, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133, IEC 62304:2015, IEC 62366 |
| Compliance with 21 CFR 898 | Yes | Yes |
| Weight | Considered acceptable if within safety/effectiveness | 218 g (considered similar enough to 112g of predicate not to raise safety issues) |
| Dimension | Considered acceptable if within safety/effectiveness | 130 x 79 x 33mm (considered similar enough to 91.5 x 68.4 x 24mm of predicate not to raise safety issues) |
| Housing material & Construction | Plastic (ABS) | ABS Plastic |
| Apply Part | BF | BF |
| Powered Muscle Stimulator (PMS) | ||
| Number of channels | Compliant with IEC 60601-1 and IEC 60601-2-10 | 6 Channels, compliant with IEC 60601-1 and IEC 60601-2-10 |
| Synchronous or alternating | Alternating or Synchronous (if safety/effectiveness not impacted) | Alternating (difference from predicate not impacting essential performance or safety) |
| Method of channel isolation | Multiplexer | Multiplexer |
| Regulated Current or voltage | Regulated Current | Regulated Current |
| Time Range | 1 - 60 min | 1 - 60 min |
| Waveform | Biphasic | Biphasic |
| Shape | Rectangular, also other shapes for predicate | Rectangular (tested and compliant with IEC 60601-2-10) |
| Symmetrical or asymmetrical | Symmetrical | Symmetrical |
| Maximum voltage output | Tested and compliant with IEC 60601-2-10 | 50V @500Ω, 164V @2kΩ, 170V @10kΩ (tested and compliant) |
| Maximum output Current | Tested and compliant with IEC 60601-2-10 | 100mA @500Ω, 82 mA @2kΩ, 17 mA @10kΩ (tested and compliant) |
| Current output channel | 0 - 100 mA | 0 - 100 mA (steps 1mA) |
| Pulse Width | 50 µs - 400 µs | 50 µs - 400 µs |
| Frequency | 1 - 140 Hz | 1 - 140 Hz |
| Net charge (µC per pulse) | 0µC (Balanced pulses) | 0µC (Balanced pulses) |
| Max phase charge @500Ω | 40 µC | 40 µC |
| Maximum current density (mA/cm²) @500Ω | Complies with FDA guidance for PMS 510(k)s | 0.224 mA/cm² (25 cm² electrode area) (complies with FDA guidance) |
| max. power density (W/cm²) | Complies with FDA guidance for PMS 510(k)s | 0.00062 W/cm² (25 cm² electrode area) (complies with FDA guidance) |
| Functional Electrical Stimulation (FES) | ||
| All FES parameters | Same as PMS parameters, with differences justified as not impacting essential performance or safety. | Same as PMS parameters, with differences justified as not impacting essential performance or safety. |
2. Sample Size for the Test Set and Data Provenance:
The document explicitly states: "No clinical testing was performed in support of this submission."
Therefore, there is no test set in the sense of clinical data from human subjects described in this document. The evaluation relies on non-clinical (bench) testing, comparison to a predicate device, and compliance with recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that no clinical testing was performed, there were no "experts" involved in establishing ground truth for a clinical test set from human subjects. The assessment relies on the expertise of the engineers and regulatory professionals who performed the non-clinical testing and drafted the 510(k) submission, confirming compliance with engineering standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission relies entirely on non-clinical testing and comparison to a predicate device, without involving human readers or a comparative effectiveness study with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this question doesn't directly apply here. The "TrainFES Advanced" is a physical medical device (a neuromuscular electrical stimulator) that includes software control, not an AI algorithm intended for diagnostic or prognostic purposes on its own. The "device performance" is assessed through its electrical and mechanical characteristics and compliance with safety standards, not through an algorithm's standalone interpretative accuracy.
7. The Type of Ground Truth Used:
For this device, the "ground truth" for the non-clinical testing is based on:
- Engineering specifications and regulatory standards: The device is tested against established limits and requirements defined in standards like IEC 60601 series, IEC 62133, IEC 62304, IEC 62366, and ISO 14971.
- Predicate device characteristics: The predicate device (Stella BIO, K210002) serves as a benchmark for comparison, implying that its established safety and effectiveness characteristics represent a "ground truth" for what is acceptable in this device class.
8. The Sample Size for the Training Set:
Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced or implied in the context of this 510(k) submission for this type of medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no AI/machine learning algorithm training using a specific dataset is referenced.
In summary: The submission for TrainFES Advanced demonstrates substantial equivalence primarily through comprehensive non-clinical (bench) testing against recognized industry standards (IEC series, ISO 14971) and a detailed comparison of its technical specifications to a previously cleared predicate device (K210002). The core argument is that any differences in characteristics do not raise new questions of safety or effectiveness. No clinical studies, human reader studies, or AI algorithm performance evaluations against clinical ground truth were conducted or presented in this document.
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