(27 days)
The model 4400 series of TENS and Microcurrent devices are indicated for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
The Promax® family of non-invasive nerve stimulation therapy devices are userinteractive microprocessor controlled stimulators, designed for end-user comfort, ease of use, and to assist with therapy compliance. The Promax device has combined two modalities of electrical stimulation: (TENS and Microcurrent) used in a number of legally marketed predicate devices into one device. The Promax family of devices provide low frequency, non-invasive electrical stimulating therapy used for the symptomatic relief of chronic, intractable pain and the management of pain associated with post-traumatic or post-operative conditions. Although only one modality can be operated at a time the Promax with its six available preprogrammed TENS modes and three Microcurrent modes provide a plethora of options, so the patients unique therapeutic requirements can easily be selected. The following ten preprogrammed modes are available within the Promax family: Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated, Positive-DC Microcurrent, Biphasic Microcurrent, and Negative-DC Microcurrent.
Each mode is made of a different pattern of electrical impulses and intensity settings. The SD mode delivers the unique pattern of electrical impulses with maximum intensity of 11microColumbs. The SMP mode delivers its pattern of electrical impulses at the highest intensity level (24 microColumbs) the Promax delivers. The intensity variety is another therapeutic option directed to meet the prescribed patients therapy requirements.
Additional to the therapeutic option menu, the Promax devices provide a variety of features such as; last therapy recall, low battery notification, patient usage timers, open channel notification, as well as a self-diagnostic feature. The self-diagnostic feature is credited with notifying the user if the device requires maintenance prior to use. The many functions and features available with the Promax device-family are attributed to the size of the microprocessor. Many of these features available with the Promax are not available on other devices where the microprocessors size limitation or electrical mechanical controls are a factor. The microprocessor performance and unique operating software in the Promax provides for the pull-tables and algorithms that generate the waveforms, pulses, and duration/ time curves that are not available on other devices. One such feature is the last therapy recall protocol. This software driven feature allows the patient to resume therapy with little effort, following shut down or an open lead occurrence, (a result of poor continuity) with the same therapeutic settings. Another software driven feature is the Strength Duration Compensation protocol. This protocol starts out at zero amplitude or no stimulation to prevent patient-startling, and in a short time span based upon the Power Curve algorithm works the patient to the therapy settings without the patients experiencing uncomfortable sensations. This protocol is not available when the Promax is in the SMP mode.
Different models of the Promax family provide different therapeutic modes to support more specifically the therapist with the modes and modalities needed to implement the prescribed clinical-protocol. Only the Promax XP-4400 model will have all 10 modes serving both the TENS and Microcurrent therapy menu. The Promax TN-4410 will have the TENS modes, while the Promax MC-4440 presents the Microcurrent modes. The Promax-Libra model LBR-4420 is the basic TENS model with a Constant and Burst mode.
Here's an analysis of the provided text regarding the Promax Family of TENS devices, focusing on acceptance criteria and study information:
Based on the provided document, there is no specific study described that establishes explicit acceptance criteria for the Promax Family of TENS devices in terms of clinical performance metrics (e.g., pain reduction percentages, patient satisfaction scores, or objective physiological changes).
Instead, the submission for the Promax Family of TENS primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This is a common pathway for 510(k) submissions where a new device is shown to be as safe and effective as devices already on the market without requiring new clinical trials that establish novel performance criteria.
Therefore, the "acceptance criteria" for this device, as presented in the document, are implicitly met by demonstrating that its technological characteristics and indications for use are comparable to those of the predicate devices, and that it meets relevant electrical safety and performance standards.
Here's a breakdown of the requested information based on the provided text, recognizing the absence of a dedicated performance study with explicit acceptance criteria:
Acceptance Criteria and Study Information for Promax Family of TENS
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Safety & Effectiveness) | The Promax family of devices are of comparable type and are substantially equivalent to legally marketed predicate devices (SMP-Plus, SMP, SX, Max III, Ultrapac II SX, HMC-Home Microcurrent). Performance data for the Promax family Models XP-4400, TN-4410, TN+430, LBR-4420 and MC-4440 are substantially equivalent to the TENS and Microcurrent devices distributed under K982410, K930865 and K935132, respectively. |
| Compliance with Electrical Medical Standards and Safety Requirements | The devices meet the latest electrical medical standards and safety requirements, including the EN-60601 standard for electrical safety, EMC, and the Performance Standard for Electrode Lead wires and Patient Cables, CFR 898. |
| Delivery of Stated Therapeutic Modes/Features | The device provides various preprogrammed TENS (Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated) and Microcurrent (Positive-DC Microcurrent, Biphasic Microcurrent, Negative-DC Microcurrent) modes, as well as features like last therapy recall, low battery notification, patient usage timers, open channel notification, and self-diagnostic. |
| Intensity Delivery | SD mode delivers impulses with maximum intensity of 11 microcoulombs. SMP mode delivers impulses at the highest intensity level (24 microcoulombs). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. The document does not describe a specific clinical "test set" or performance study with a defined sample size for the Promax devices. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.
- Data Provenance: Not applicable. No new clinical data from a test set is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no described test set requiring expert-established ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no described test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. The document does not describe an MRMC comparative effectiveness study where human readers (or users in this context) would be evaluated with or without AI assistance. This device is a TENS/Microcurrent stimulator, not an AI-assisted diagnostic tool.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The "standalone" performance here refers to the device's electrical output and adherence to safety standards, which is addressed by compliance with EN-60601 and CFR 898 (as noted in the table above). The device's modes and features are described, indicating its functional capabilities without human intervention beyond initial setup.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (clinical efficacy and safety data for those devices, and regulatory compliance of those devices). The Promax devices are being cleared based on their similarity to these established devices. The "ground truth" for the device's own characteristics is its adherence to technical specifications and relevant electrical standards.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a hardware/firmware medical device, not a machine learning or AI model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.
§ 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).