(287 days)
Pain Management for use with interferential and/or TENS mode programs/parameters
Stimulate peripheral nerves for the purpose of providing pain relief. Management and symptomatic relief of chronic (long-term) intractable pain. Adjunctive treatment of post-traumatic pain. Adjunctive treatment in the management of post-surgical pain.
Muscle Stimulation for use with muscle stimulation programs
Increasing local blood circulation. Maintaining or increasing range of motion. Muscle Re-education. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
NeuroMed Electroanalgesic Delivery Systems consist of a system console with a control and display panel, control electronics and software and device accessories including a suction cup electrode applicator, electrodes and cables. The device uses regular household current as a power source. The physical measurements of the device are 17.5" long x 11.5" wide x 5.5" high at a weight of approximately 9 Ibs.
NeuroMed Electroanagesic Delivery Systems is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy. Alternatively, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
This 510(k) summary describes a traditional premarket notification where the predicate pathway is used to prove substantial equivalence rather than a clinical study with acceptance criteria. As such, the requested information (acceptance criteria, study details, sample sizes, ground truth, etc.) is not present in the provided document.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is a 510(k) summary for a device seeking substantial equivalence to predicate devices, not a report of a new clinical study with predefined acceptance criteria. The "performance" is demonstrated by showing that the new device has "similar characteristics" and "the same intended use" as the predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or clinical study data of this nature is presented. The submission relies on a comparison of device characteristics.
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):
- Not Applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication process is detailed.
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:
- Not Applicable. This device is an "Electroanalgesic Delivery System" (a TENS/Interferential Current Therapy device), not an AI-powered diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm, so a standalone performance evaluation is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical study with a test set is described, no ground truth type is relevant. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable. No training set for an algorithm is mentioned or relevant.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is relevant.
Summary of Device Comparison (as presented in the document):
The submission demonstrates substantial equivalence by comparing the NeuroMed Electroanalgesic Delivery Systems to two predicate devices: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897) and Metron Vectorsurge 5 (K03048).
The key findings for "proving" that the device meets the (unlisted) acceptance criteria for substantial equivalence are:
- Intended Use: The NeuroMed device has the "same intended use" as the predicate devices. This is a critical point for demonstrating substantial equivalence.
- NeuroMed Intended Use: Stimulate peripheral nerves for pain relief, stimulate motor nerves for muscle rehabilitation, management/symptomatic relief of chronic pain, adjunctive treatment of post-traumatic pain, adjunctive treatment of post-surgical pain, increasing local blood circulation, maintaining/increasing range of motion, muscle re-education, relaxation of muscle spasms, prevention/retardation of disuse atrophy, immediate post-surgical stimulation of calf muscles to prevent phlebothrombosis. These are explicitly stated as "the same as for the predicate devices."
- Technological Characteristics: The NeuroMed device and the predicates are described as:
- Console type electrical signal generators.
- Apply sinusoidal current through two pairs of contact electrodes.
- Output currents consist of "similar intensity and frequency range."
- Have electronic control circuits with embedded software.
- Use common household current as a power source.
- Are in compliance with equivalent IEC standards.
- Conclusion on Equivalence: The submission concludes that "any differences in their technological characteristics do not raise any new concerns of safety or effectiveness." Therefore, it is determined to be substantially equivalent.
§ 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).