(73 days)
R-C1 TENS and EMS Stimulator
For TENS mode:
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- Symptomatic relief of chronic intractable pain;
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- Post traumatic pain;
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- Post surgical pain;
For EMS mode:
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- Relaxation of muscle spasm;
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- Increase of local blood flow circulation;
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- Prevention or retardation of disuse atrophy;
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- Muscle re-education;
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- Maintaining or increasing range of motion;
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- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- R-E1 EMS Stimulator
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- Relaxation of muscle spasm;
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- Increase of local blood flow circulation;
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- Prevention or retardation of disuse atrophy;
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- Muscle re-education;
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- Maintaining or increasing range of motion;
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- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- R-T1 TENS Stimulator
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- Symptomatic relief of chronic intractable pain;
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- Post traumatic pain;
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- Post surgical pain.
The RW Series A Electrical Stimulator, which includes models R-C1, R-E1 and R-T1, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The stimulator is used with electrodes. For the electrodes are provided by the manufacturer Top-Rank Health Care Equipment Co. Ltd, cleared under K070612.
The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and critical components, the main differences are software and color. The R-C1 have TENS mode (12 programs), EMS mode (9 programs). The R-E1 only have EMS mode (9 programs) and R-T1 only have TENS mode (12 programs). The R-C1 was combination the function of R-E1 and R-T1.
The provided document is a 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator, R-E1 EMS Stimulator, and R-T1 TENS Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device or algorithm.
Therefore, much of the requested information regarding acceptance criteria and studies (especially for AI/ML performance) is not applicable or cannot be directly extracted from this type of regulatory submission. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
However, I can extract information related to non-clinical testing and performance standards used to demonstrate safety and performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily compliance with recognized consensus standards for safety and performance. The performance reported is that the device "meets the requirements of its pre-defined acceptance criteria and intended uses."
| Item | Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|---|
| Safety | IEC 60601-1:2005+A1:2012 (Medical electrical equipment – General requirements for basic safety and essential performance) | Conform |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances – Requirements and tests) | Conform |
| Home Healthcare Environment | IEC 60601-1-11:2015 (Medical electrical equipment – Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | Conform |
| Performance | IEC 60601-2-10:2012+A1:2016 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Conform |
| Software | IEC 62304:2006 (Medical device software – Software life cycle processes) | Conform |
| Usability | IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices) | Conform |
| Risk Management | ISO 14971:2007 (Medical devices – Application of risk management to medical devices) | Conform |
| Shelf life | N/A (Internal company specification) | Meets requirements |
| Software Validation | N/A (Internal company specification) | Meets requirements |
| Electrical Safety (Patient Leakage Current) | IEC 60601-1 requirements (e.g., limits for normal and single fault conditions) | Normal condition: 11.4 uA; Single fault condition: 9.6 uA (Meets requirements) |
| Average DC current through electrodes | IEC 60601-2-10 requirements (0 when no pulses applied) | 0 (for TENS and EMS modes, when no pulses applied) |
| Electrode Pads Biocompatibility | ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Compliance claimed |
Study Proving Acceptance Criteria
The study performed was a series of non-clinical safety and performance tests conducted on the subject device (RW series A Electrical stimulator: R-C1, R-E1 and R-T1). The document states: "All the test results demonstrate RW series A Electrical stimulator (R-C1, R-E1 and R-T1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."
The specific types of non-clinical tests mentioned are:
- Shelf life
- Software validation
- Electromagnetic compatibility and electrical safety (verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10)
- Function test
- Usability (verified against IEC 62366-1)
- Risk management (verified against ISO 14971)
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated, however, for non-clinical engineering and performance testing as described, it typically involves a small number of devices (e.g., 3-5 units) undergoing specific tests to demonstrate compliance with standards. It does not refer to a "test set" in the context of clinical trials or AI/ML validation data.
- Data Provenance: The tests were performed on the devices manufactured by Shenzhen Roundwhale Technology Co., Ltd. The document refers to "non-clinical laboratory studies and safety testing data." This implies the data was generated internally as part of the device development and validation process, likely in China where the manufacturer is based. It is retrospective in the sense that these tests were performed on the final device design to support regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. This submission relates to a physical medical device (electrical stimulator) which demonstrates safety and performance through engineering tests against recognized standards, not through clinical data where expert-established ground truth would be required.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. This is not a clinical study involving ambiguity or subjective assessments. Compliance with engineering standards is typically determined by objective measurements and pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is not an AI/ML device or an imaging device for which an MRMC study would be relevant. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This is a hardware medical device; it does not involve a standalone algorithm for diagnostic or prognostic purposes.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is compliance with established international and FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, IEC 62366-1) and internal design specifications for the device's electrical characteristics and functionality. These standards define the acceptable range of performance and safety parameters.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that requires a training set.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: 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).