(95 days)
The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities and can be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Pulse Relief is designed to be used at home, by adults of all genders.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The device delivers pulses across the skin through these electrodes. This activates the underlying sensory nerves. The user can choose 15 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS). the electrodes are placed near the muscle to be stimulated. The device generates electrical pulses and passes these pulses across the surface of the skin to activate the underlying motor nerves. This makes the muscle contract. Contraction helps to condition the muscle in in order to facilitate performance.
The PulseRelief system consists of the following elements:
- Control unit with cable: generates the TENS/EMS pulses; connects to the 1st electrode; communicates with the mobile device; connects to the battery unit. The control unit has an on-off button.
- Battery unit: contains a battery and charging circuit; connects the 200 electrode to the control unit.
- Electrodes: Self-adhesive re-usable hydrogel electrodes with metal target plate for magnetic clamping to the control unit and battery unit.
- App on mobile device. The app controls the functions of the PulseRelief device via a Bluetooth Low Energy connection between the mobile device and the PulseRelief device.
- Adapter: for charging the battery unit via a micro-USB socket. To connect the USB-cable to the battery unit, the control unit needs to be disconnected.
This document, K151035, is a 510(k) submission for the PulseRelief device, a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS). It makes a claim of substantial equivalence to a predicate device (K130802). The document discusses performance data related to safety and electromagnetic compatibility (EMC), software verification, usability, and risk management. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its intended therapeutic efficacy (e.g., pain relief or muscle performance improvement).
The document focuses on demonstrating that the PulseRelief device is as safe and effective as the predicate device by meeting recognized standards for medical device development and manufacturing, rather than presenting a clinical study with performance-based acceptance criteria for its therapeutic claims.
Therefore, the following points will reflect the information available in the provided text.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the "performance" described is primarily related to safety, electrical specifications, and adherence to regulatory standards, rather than direct therapeutic efficacy. Specific numerical acceptance criteria for clinical outcomes (e.g., percentage reduction in pain, improvement in muscle strength) are not provided.
The document indicates compliance with various standards, which serve as performance/acceptance criteria in the context of regulatory submission for substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA Blue Book Memorandum #G95-1 & ISO 10993-1 (Cytotoxicity, Sensitization, Irritation for intact skin contact) | "The biocompatibility evaluation for the Brand X device was conducted in accordance with the FDA Blue Book Memorandum #G95-1... and International Standard ISO 10993-1... As dictated by the application and duration of contact with the intact skin, the battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation." (Implies compliance, as no adverse findings are reported) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10 | "The system complies with the IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 and IEC 60601-2-10 standards for safety." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2, FCC Part 15 (Subpart B - Unintentional Radiators, Subpart C - Intentional Radiators) | "The system complies with... the IEC 60601-1-2 standard for EMC, and IEC 62133 for battery safety. For FCC part 15 RADIO FREQUENCY DEVICES, Subpart B-Unintentional Radiators, Subpart C-Intentional Radiators." |
| Battery Safety | IEC 62133 | "The system complies with... IEC 62133 for battery safety." |
| Software Verification & Validation | FDA's Guidance for Industry and FDA Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," IEC 62304 (for Moderate level of concern) | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'Moderate' level of concern. IEC 62304 was followed." (Implies compliance) |
| Usability | IEC 62366, FDA Guidance 1757 ("Applying Human Factors and Usability Engineering to Optimize Medical Device Design") | "Usability testing according to IEC 62366 and following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted." (Implies compliance/satisfaction of guidance, as no issues are reported) |
| Risk Management | ISO 14971:2007 Medical Devices - Application of risk management to medical devices (Second Edition) | "The risks to people, property and the environment associated with the use of the PulseRelief was managed according to ISO 14971:2007..." (Implies compliance) |
| Symbols | ISO 15223-1:2012 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements (Second Edition) | "The symbols used on the PulseRelief itself, on its packaging or in the associated documentation is conform [sic] ISO 15223-1:2012..." (Implies compliance) |
| Output Specifications (TENS mode) | Adherence to ranges for voltage, current, duration, frequency, net charge, current density, power density. For example, max average power density below 250mW/cm2 as per FDA guidance. | E.g., Maximum Output Voltage: 31 @500Ω, 69 @ 2 kΩ, 70 @ 10 kΩ. Pulse Duration: 60 ~ 350 μs. Frequency: 1 ~ 100 Hz. Max Average Power Density: 0.24 ~ 1.69 @500Ω (stated as "well below 250mW/cm2 as required by the FDA-guidance"). (See tables on pages 9-11 for full details compared to predicate.) |
| Output Specifications (EMS mode) | Adherence to ranges for voltage, current, duration, frequency, net charge, current density, power density. | E.g., Maximum Output Voltage: 31 @500Ω, 69 @ 2 kΩ, 70 @10 kΩ. Pulse Duration: 150 ~ 350 µs. Frequency: 40 ~ 65 Hz. Max Average Power Density: 0.62~1.15 @500Ω. (See tables on pages 9-11 for full details compared to predicate.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily focuses on engineering testing, regulatory compliance, and comparison to a predicate device rather than clinical trials for validating therapeutic efficacy. Therefore, there is no information provided regarding a clinical "test set" sample size or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given the nature of the submission (safety, electrical performance, and regulatory compliance), there is no mention of a "ground truth" derived from experts related to clinical outcomes (e.g., pain assessment or muscle performance). The "ground truth" here is adherence to technical standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned as the submission is not focused on clinical diagnostic or treatment performance that would require such a process.
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 MRMC comparative effectiveness study was done or mentioned. This type of study is not applicable to a TENS/EMS device submission focused on substantial equivalence based on technical and safety specifications. There is no AI component described in the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The PulseRelief device itself is the "standalone" device providing stimulation. The "performance" described here is the device's ability to meet its technical specifications and safety standards, as detailed in Table 1 above. There is no separate algorithm-only performance study mentioned distinct from the device's main function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this submission relates to:
- Compliance with recognized electrical, safety, software, and biocompatibility standards: This is implicitly defined by the standards themselves (e.g., IEC 60601-1, ISO 10993-1).
- Device specifications: The engineering measurements of the device's electrical output parameters (voltage, current, frequency, pulse duration, etc.) are compared against defined design specifications and generally against the predicate device's reported parameters.
- Risk assessment: Compliance with ISO 14971 for risk management.
There is no ground truth related to clinical outcomes data for therapeutic efficacy presented in this document.
8. The sample size for the training set
No training set is mentioned or applicable in the context of this device and submission type. The device is not based on machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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).