(287 days)
Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the lon Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, lon Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.
The Arasys Genius (K132179) device's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document establishes substantial equivalence of the Arasys Genius to a predicate device, the Ion Magnum Genius (K123158), rather than setting specific acceptance criteria for a new type of performance. The acceptance criteria are, therefore, based on demonstrating that the Arasys Genius's technical characteristics, indications for use, and safety and effectiveness aspects are "equivalent" to those of the predicate device.
| Acceptance Criteria (based on equivalence to predicate K123158) | Reported Device Performance (Arasys Genius K132179) |
|---|---|
| Intended Use: Muscle conditioning to stimulate healthy muscles; not for therapy of medical conditions; prescription use only; operated by trained professional. | Intended Use: Identical to predicate. |
| Technological Characteristics: | |
| Biphasic Rectangular Waveform | Biphasic Rectangular Waveform |
| Synchronous channels | Synchronous channels |
| Max output voltage (50V @ 500Ω, 200V @ 10kΩ) | 50V @ 500Ω, 200V @ 10kΩ |
| Max output current (100 mA at 500 Ohms) | 100 mA at 500 Ohms |
| Frequencies (90 Hz, 100 Hz, 120Hz) | 90 Hz, 100 Hz, 120Hz |
| Pulse Duration (416-500 µsec) | 416-500 µsec |
| Pulse Width (416-500 µsec) | 416-500 µsec |
| Maximum Phase Charge (50 µC @ 500Ω at 90/100 Hz; 40 µC @ 500Ω at 120 Hz) | 50 µC @ 500Ω at 90 and 100 Hz; 40 µC @ 500Ω at 120 Hz |
| Maximum Current Density (4 mA/cm²) | 4 mA/cm² |
| Maximum Power Density (0.0012 W/cm²) | 0.0012 W/cm² |
| Voltage Driven | Voltage Driven |
| Symmetrical Phases of Waveform | Yes |
| Regulated Voltage | Regulated Voltage |
| Number of Channels (6) | 6 |
| Method of Channel Isolation (separated transformers) | Channels are isolated by separated transformers |
| Self-Adhesive Electrodes (Axelgaard Type K970426) | Identical (K970426) |
| Cables that screw into the device | Identical |
| Current Leakage (0.07 μΑ) | 0.07 μΑ |
| Net Charge (e.g., 10,000 µC at 500Ω) | Identical to predicate specifications listed |
| Method of Line Current Isolation (Separate Transformers) | Separate Transformers |
| Housing Material and Construction (Metal Enclosure) | Metal Enclosure |
| Safety and Effectiveness: | |
| Thermal safety (no thermal energy) | Identical thermal safety (no thermal energy) |
| Chemical safety (not applicable) | Equivalent (not applicable) |
| Sterility (not required) | Equivalent (not required) |
| Disposable pads (not sterilized, cleared K970426, biocompatible) | Identical (cleared K970426, biocompatible by Axelgaard) |
| Cables and connectors designed to insulate | Designed identically to insulate, cables remain screwed in |
| Operating environment (professional setting, operated by professional) | Identical proposed conditions for use |
| Automatic overload trip | Identical (has automatic overload trip, no automatic no load trip) |
| Automatic shut off and patient override control | Identical |
| IEC Class 1 device and IEC 60417-5333, type BF applied part device | Identical |
2. Sample size used for the test set and the data provenance:
The provided document describes a 510(k) Premarket Notification for a muscle stimulator. This type of submission generally relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than conducting new clinical trials with a test set of patients to prove efficacy and safety from scratch.
Therefore, there is no specific "test set" sample size in the traditional sense of a clinical study for product performance validation mentioned here. The device's performance is not demonstrated through a separate clinical trial on a patient cohort for this submission. Instead, the performance is inferred by demonstrating that its technical specifications and other characteristics are equivalent to the predicate device.
The data provenance for the information presented is the technical specifications and design choices of both the Arasys Genius and the predicate device (Ion Magnum Genius K123158), as well as compliance with relevant standards (e.g., IEC 60601-1:2005) and previous FDA clearances for components (e.g., K970426 for electrodes). This represents retrospective data derived from the design and manufacturing of the devices. The source is the manufacturer's internal documentation and comparisons. The country of origin for the manufacturing facility for Ion Genius, Inc. is the UK (UV Innovations Ltd, Enfield, Middlesex).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As explained above, this submission relies on substantial equivalence rather than a new clinical study with a "ground truth" derived from expert assessment of patient data. Therefore, no experts were explicitly used to establish ground truth for a test set in this context. The "ground truth" for the comparison is the established performance and safety profile of the predicate device, accepted by the FDA based on its own prior regulatory clearance (K123158).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since there is no "test set" clinical study described, there was no adjudication method for a test set. The regulatory review process for 510(k) submissions involves the FDA reviewing the manufacturer's documentation and claims of substantial equivalence.
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:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is not relevant to demonstrating substantial equivalence for a powered muscle stimulator in this context, especially as the device does not involve "human readers" or "AI assistance" in interpreting medical images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done. The device is a hardware electrical muscle stimulator, not an algorithm, and its operation inherently involves a trained professional (human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the established regulatory clearance and documented specifications of the predicate device, Ion Magnum Genius (K123158). The Arasys Genius demonstrates substantial equivalence by showing that its design, technical characteristics, materials, and intended use are identical or equivalent to this predicate, which has already been deemed safe and effective for its intended use by the FDA. There is no new clinical outcomes data or pathology review presented for the Arasys Genius in this submission to establish a new ground truth.
8. The sample size for the training set:
There is no "training set" sample size mentioned or implied in this 510(k) submission. Training sets are typically associated with artificial intelligence or machine learning model development. This device is an electrical muscle stimulator, and its development does not involve machine learning.
9. How the ground truth for the training set was established:
As there is no training set for an AI/ML model, this question is not applicable.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).