(99 days)
The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.
The H-Wave® model H4 consists of 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 stimulation at frequencies of 1-70 Hz depending on the physician instructions and patient settings.
Here's an analysis of the provided text regarding the H-Wave® Electrical Stimulator (model H4) and its acceptance criteria, structured according to your request:
Acceptance Criteria and Device Performance Study for the H-Wave® H4 Electrical Stimulator
Based on the provided 510(k) summary (K112485), the acceptance criteria for the H-Wave® H4 device are primarily demonstrated through compliance with recognized consensus standards and by establishing substantial equivalence to previously cleared predicate devices. The study proving the device meets these criteria is a bench testing/technical comparison study, not a clinical trial with human subjects.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from recognized standards & predicate comparison) | Reported Device Performance (from H-Wave® H4) | Met/Not Met |
|---|---|---|---|
| Safety - Electrical | IEC 60601-2-10 1987/Amendment 1 2001: Particular requirements for the safety of nerve and muscle stimulators. | Complies with IEC 60601-2-10 1987/Amendment 1 2001 | Met |
| IEC 60601-1 1988/Amendment 1 1991/Amendment 2 1995 subclause 56.3(c): General Requirements for Safety. | Complies with IEC 60601-1 1988/Amendment 1 1991/Amendment 2 1995 subclause 56.3(c) | Met | |
| Safety - EMC | IEC 60601-1-2 2001: Electromagnetic Compatibility - Requirements and Tests. | Complies with IEC 60601-1-2 2001 | Met |
| Safety - Leakage Current | Normal condition patient leakage current = 0 | 0 µA | Met |
| Single fault condition patient leakage current = 0 | 0 µA | Met | |
| Safety - DC Current | Average DC current through electrodes (device on, no pulses) = 0 | 0 µA | Met |
| Safety - Isolation | Line Current Isolation: Battery operated | Yes (battery operated) | Met |
| Method of Channel Isolation: Galvanic | Galvanic | Met | |
| Performance - Intended Use | Treatment of chronic pain, acute pain, postsurgical pain, and temporary pain (Substantially similar to predicate devices). | Indicated for treatment of chronic pain, acute pain, postsurgical pain, and temporary pain. | Met |
| Performance - Frequency Range | Within accepted therapeutic ranges and comparable to predicate devices. | 1-70 Hz | Met (comparable to predicates 14-66 Hz, 1-70 Hz, 2-60 Hz) |
| Performance - Power Source | Rechargeable battery | Ni-MH rechargeable battery (7.2 V; 1800 mA/h) | Met (comparable to predicates) |
| Performance - Output Channels | Multiple output channels (comparable to predicate devices) | 2 channels | Met (comparable to predicates 1, 2, 3 channels) |
| Performance - Alternating Output | Alternating channels | Alternating | Met |
| Performance - Current Control | Regulated Voltage | Regulated Voltage | Met |
| Features - Software/Firmware | Presence of software/firmware/microprocessor. | Yes | Met (comparable to K103738 and K021496 predicates) |
| Features - Automatic No-Load Trip | Presence of Automatic No-Load Trip feature. | Yes | Met (comparable to K103738, an improvement over K813601 and K021496) |
| Features - Patient Override Control | Presence of patient override control. | Yes | Met (comparable to all predicates) |
| Features - Indicator Display | On/Off Status, Low Battery, Voltage/Current Level indicators. | Yes for all three | Met (comparable to predicates) |
| Features - Timer Range | Programmable timer. | 0-60 minutes | Met (comparable to predicates, e.g., 0-60 min and 10-60 min) |
| Labeling Compliance | Complies with 21 CFR Part 898 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components) (Note: This seems like a slight misreference for a stimulator, but it's listed as a compliance point.) | Yes | Met |
| Physical Characteristics | Weight, dimensions, housing materials comparable to predicate devices. | Weight: 1.6 lb, Dimensions: 7" x 4.5" x 1.5", Housing: ABS plastic | Met (comparable to predicates) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" here refers to the device itself being tested against standards and compared to predicate devices in a bench environment.
- Data Provenance: The data comes from the technical specifications and testing of the H-Wave® H4 device itself, and comparison against the technical specifications of three predicate devices as documented in their 510(k) clearances. This is primarily retrospective in terms of referencing predicate devices and their cleared specifications, combined with prospective bench testing of the new device against recognized standards. The country of origin for the H-Wave® H4 device is implied to be the USA (Electronic Waveform Lab, Inc. of Huntington Beach, CA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as part of the submission documentation.
- Qualifications of Experts: The ground truth for compliance with recognized standards (IEC 60601 series) would be established by experts in electrical safety, electromagnetic compatibility, and medical device performance testing, typically within a certified testing laboratory. For the substantial equivalence comparison, the "experts" were the reviewers at the FDA's Office of Device Evaluation (Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices), who are physicians and scientific reviewers responsible for assessing medical device safety and effectiveness.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This submission relies on compliance with objective performance standards and direct comparison of technical specifications against predicate devices, rather than subjective interpretation by multiple human readers that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No.
- Effect Size of Human Readers: Not applicable, as this is a physical electrical stimulator and the submission focuses on its technical characteristics and safety, not on diagnostic performance or human-in-the-loop clinical interpretation tasks.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study Done: Yes, in a sense. The "standalone" performance is assessed through the device's compliance with the cited IEC standards (IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2) which are objective tests of the device's electrical safety and performance parameters without human intervention or interpretation during the testing. The comparison table also provides standalone technical characteristics of the device.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Recognized Consensus Standards: For electrical safety and electromagnetic compatibility (IEC 60601 series).
- Predicate Device Specifications: The technical specifications (e.g., frequency, power source, channels, features) of legally marketed, cleared predicate devices (K813601, K103738, K021496).
- Device Technical Specifications: The measured or designed technical specifications of the H-Wave® H4 device itself.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for this device would be its engineering and design process, ensuring it meets technical specifications.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device's submission. The closest analogy would be the engineering design requirements and regulatory standards that guide the device's development to ensure it meets its intended function and safety profiles.
§ 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).