(161 days)
The H-Wave® is indicated for the following conditions:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy;
- Increasing local blood circulation;
- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion.
The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.
This 510(k) submission describes the H-Wave® Electrical Stimulator (model H4). The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, the H-Wave (model P-4). Therefore, the study presented focuses on verification and validation testing of changes to the device and its compliance with recognized standards, rather than a clinical trial demonstrating specific clinical performance metrics against predefined acceptance criteria for indications for use.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are primarily defined by compliance with specific electrical medical equipment safety and performance standards, and comparison with the predicate device's features. The "reported device performance" refers to the H-Wave H4's demonstrated adherence to these standards and its characteristics.
| Acceptance Criteria (Standard / Feature) | Reported Device Performance (H-Wave H4) |
|---|---|
| Safety and Electrical Standards Compliance: | |
| IEC 60601-2-10 (Safety of nerve and muscle stimulators) | Conforms to IEC 60601-2-10 1987/Amendment 1 2001 |
| IEC 60601-1 (General Requirements for Safety) | Conforms to IEC 60601-1 1988; Amendment 1, 1991-11, Amendment 2, 1995 subclause 56.3(c) |
| IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Conforms to IEC 60601-1-2: 2001 |
| Predicate Device Equivalence - Key Electrical Parameters: | |
| Patient Leakage Current (Normal Condition) | 0 (Matches predicate) |
| Patient Leakage Current (Single Fault Condition) | 0 (Matches predicate) |
| Average DC current through electrodes (device on, no pulses) | 0 (Matches predicate) |
| Frequency Range | 1-70 Hz (Matches predicate) |
| Number of Output Channels | 2 (Matches predicate) |
| Synchronous or Alternating | Alternating (Matches predicate) |
| Method of Channel Isolation | Galvanic (Matches predicate) |
| Regulated Current or Regulated Voltage | Regulated Voltage (Matches predicate) |
| Patient Override Control | Yes (Matches predicate) |
| Indicator Display (On/Off Status) | Yes (Matches predicate) |
| Indicator Display (Low Battery) | Yes (Matches predicate) |
| Indicator Display (Voltage/Current Level) | Yes (Matches predicate) |
| Compliance with 21 CFR Part 898 (Radiation Control for Electronic Products) | Yes (Matches predicate) |
| Predicate Device Equivalence - Other Features/Dimensions: | |
| Intended Uses | Same as original cleared H-Wave (Predicate) |
| Output Parameters | Same as original cleared H-Wave (Predicate) |
| Housing materials and constructions | ABS plastic housing fastened with screws (Matches predicate) |
| Weight | 1.6 lb (Predicate: 2 lb - a minor difference deemed not to raise new questions of safety/effectiveness) |
| Dimensions | 7" x 4.5" x 1.5" (Predicate: 6" x 2.34" x 6" - a minor difference deemed not to raise new questions of safety/effectiveness) |
| Power Source | Ni-MH rechargeable battery (7.2 V; 1800 mA/h) (Predicate: NiCad rechargeable battery (10.8V; 700 mA/h) - a minor difference that required verification/validation, but deemed not to affect safety/effectiveness) |
| Software/firmware/microprocessor | Yes (Predicate: No - a minor difference that required software verification testing, but deemed not to affect safety/effectiveness) |
| Automatic No-Load Trip | Yes (Predicate: No - a minor difference that did not raise new questions of safety/effectiveness) |
| Timer Range | 0-60 min (Predicate: N/A - a minor difference that did not raise new questions of safety/effectiveness, as it adds functionality and the device still allows for patient override control). |
| Automatic Overload Trip | No (Matches predicate) |
| Automatic Shut Off? | No (Matches predicate) |
| Number of output modes | N/A (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for clinical performance. The testing described is primarily bench testing and software verification/validation on the device itself and its components.
- Data Provenance: Not applicable, as this is not a study involving patient data. The testing is internal to the manufacturer, verifying the device's adherence to engineering specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of this submission, refers to the established technical specifications and recognized consensus standards (e.g., IEC standards). The "truth" is dictated by these objective, pre-defined technical benchmarks.
- Qualifications of Experts: N/A for establishing "ground truth" as it would apply to a clinical study. Technical experts within the manufacturer and potentially third-party testing labs would have been involved to ensure compliance with the specified engineering and safety standards.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study that requires adjudication of findings, as it focuses on technical compliance and equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device that relies on established physiological principles of electrical stimulation and seeks substantial equivalence to a predicate device based primarily on technical specifications and safety standards, not a comparative clinical performance trial involving multiple readers or human-AI interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The H-Wave is an electrical stimulator, not an AI/algorithm-driven diagnostic or therapeutic system that would have a "standalone" performance in the context of an algorithm. While it contains software, its function is to deliver electrical impulses, and its performance is evaluated by its adherence to specified electrical output parameters and safety.
7. The Type of Ground Truth Used
- The "ground truth" for the verification and validation testing is defined by:
- Recognized Consensus Standards: IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2.
- Regulatory Requirements: 21 CFR Part 898 and general controls provisions of the Act.
- Engineering Specifications: Internal design specifications for the device's electrical output, safety features, and mechanical performance.
- Predicate Device Specifications: The technical parameters and performance characteristics of the H-Wave (model P-4) served as a benchmark for equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The "training" in the device's development refers to its design and engineering process to meet specified technical parameters.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used for an AI/ML algorithm. The "truth" for the device's design and manufacturing is established by engineering principles, regulatory compliance, and a detailed understanding of the intended physiological effects of electrical stimulation.
§ 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).