(73 days)
The BioniCare Stimulator, Model BIO-1000™, is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator.
This submission describes a transcutaneous electrical nerve stimulator for pain relief (BioniCare® Stimulator Model BIO-1000™). It is a modification of an existing predicate device (K030332). The new device's signal generator is identical to the predicate. The only modifications are to the electrical connection to the glove electrode and the addition of a garment.
Given that the device is a transcutaneous electrical nerve stimulator and the modifications are minor, it is highly likely that the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" would refer to electrical safety and electromagnetic compatibility (EMC) testing, as well as performance testing of the electrical output to ensure it matches the predicate device. Clinical effectiveness is not typically re-evaluated for such minor modifications to a legally marketed device if the underlying therapeutic mechanism and electrical output are unchanged.
However, the provided text does not contain information about specific acceptance criteria or a study proving performance against them. It primarily focuses on the 510(k) summary, device description, and substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from the provided text.
Based on the typical requirements for such a device and the nature of the modifications described, here's what "acceptance criteria" and "study" would likely entail, even though the specifics are not in the document:
Hypothetical Acceptance Criteria and Study (Based on device type and typical 510(k) requirements for minor modifications):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Electrical Output Parameters | Pulse Amplitude: 0-12 V peak (±5%) | Meets 0-12 V peak throughout adjustable range |
| Fixed Frequency: 100 ± 5 Hz | Consistently measures 100 ± 2 Hz | |
| Pulse Shape: Monophasic spike-shaped pulse | Visually matches predicate's pulse shape on oscilloscope | |
| Output Current: Within specified therapeutic range (dependent on load, not specified here) | Confirmed to be within expected range for 0-12V at specified load | |
| Safety - Electrical Insulation | Electrical isolation between patient circuit and internal circuitry | Meets IEC 60601-1 requirements for insulation |
| Insulating outer glove renders conductive middle glove non-conductive when removed | Verified through resistance/continuity measurements when outer glove is removed | |
| Leakage Current: Below specified limits (e.g., IEC 60601-1) | Measured and confirmed to be below limits | |
| EMC | Emissions: Complies with applicable EMC standards (e.g., IEC 60601-1-2) | Conducted and radiated emissions within limits |
| Immunity: Withstands specified electromagnetic disturbances | Device functions without degradation under tested disturbances | |
| Mechanical/Physical | Durability of lead wire connections to garment | Withstands specified pull force and flex cycles |
| Garment integration: Lead wires travel smoothly, no tangling | Visual inspection and user assessment confirms tangle-free operation | |
| Firmware/Software (if applicable, likely minor for this device) | Firmware functionality matches predicate | Confirmed through functional testing |
Study That Proves the Device Meets Acceptance Criteria (Hypothetical):
For this type of device with minor modifications, the "study" would typically be a benchtop verification and validation (V&V) testing program.
1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Typically, a small number of production units (e.g., 3-5 units or one production lot) are selected for comprehensive bench testing. Since the "signal generator is identical" and the changes are to the glove connection and garment, the focus would be on verifying those specific changes and ensuring the overall system still performs correctly.
* Data Provenance: Prospective, as the tests would be performed on newly manufactured devices. Country of origin for testing is usually where the manufacturer's R&D or quality assurance facilities are located, likely in the USA (given the submitter's location).
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* Not applicable as this is benchtop engineering testing, not a clinical study or expert review for ground truth in a diagnostic context. The "ground truth" would be the established engineering specifications and international standards (e.g., IEC 60601-1 for medical electrical equipment).
3. Adjudication Method for the Test Set:
* Not applicable. Results are typically pass/fail based on objective measurements against predefined specifications. Any discrepancies would lead to investigation and re-testing until compliance is confirmed or design changes are made.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No, this would not be done. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. This device is a therapeutic electrical stimulator, and the modifications are purely mechanical/electrical without altering the core therapeutic mechanism. The predicate device's clinical effectiveness would have already been established.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
* No, this is not applicable. This device does not involve algorithms or AI for standalone performance evaluation in the way a diagnostic AI tool would. Its performance is evaluated by its electrical output characteristics.
6. The Type of Ground Truth Used:
* For the electrical and safety performance testing, the "ground truth" would be the engineering specifications and international consensus standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for EMC) that the device must meet. For verifying the "identical" signal generator, the ground truth would be the specifications and performance characteristics of the predicate device (K030332).
7. Sample Size for the Training Set:
* Not applicable. This device does not use machine learning or AI that requires a "training set."
8. How the Ground Truth for the Training Set was Established:
* Not applicable, as there is no training set.
In summary, the provided 510(k) document is a regulatory submission for substantial equivalence based on minor modifications. It does not detail specific acceptance criteria or studies in the format requested, as those would typically be internal V&V reports rather than part of the public 510(k) summary for such a device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).