(217 days)
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.
The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109.
It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.
The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover.
The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.
Acceptance Criteria and Device Performance Study
The provided document describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called the Neurotech MediTENS PLUS, Type 290. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on showing the new device is as safe and effective as a device already on the market, rather than conducting new clinical trials to prove efficacy from scratch.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating substantial equivalence, largely through non-clinical tests and technological comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Safety and Electrical Performance | Compliance with IEC 601-1: 1998 +A1: 1991+ A2: 1995 (Medical Electrical Equipment - General requirements for safety) | Device was designed to and independently tested to these standards. |
| Specific Performance for TENS Devices | Compliance with IEC 601-2-10:1987 (Medical Electrical Equipment - Particular requirements for the safety of nerve and muscle stimulators) | Device was designed to and independently tested to this standard. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 601-1-2:1993 (Medical Electrical Equipment - Safety requirements - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Device was designed to and independently tested to this standard. |
| Quality System Adherence | Adherence to recognized and established industry practices. | Bio-Medical Research LTD adheres to these practices; all devices subject to final performance testing. |
| Risk Management | Hazard analysis, risk analysis, and failure mode effects analysis (FMEA) performed. | These analyses have been carried out for the device. |
| Functional Equivalence | Deliver stimulation signal "almost identical" to predicate device with similar parameter settings. | The MediTENS PLUS delivers a stimulation signal that is "almost identical with similar parameter settings" to the Promax device. |
| Intended Use | Consistent with the predicate device for symptomatic relief of chronic pain and muscle spasm. | The MediTENS PLUS is intended for symptomatic relief of chronic pain and relaxation of muscle spasm, aligning with the general intended uses of TENS devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" with human subjects in the way
a de novo clinical trial would. The evaluation is primarily based on non-clinical (bench) testing and technological comparison. Therefore, details like "sample size used for the test set," "data provenance," "country of origin," or "retrospective/prospective" are not applicable in their traditional sense for this type of submission.
The "test set" referred to in the context of the IEC standards would be the physical device (MediTENS PLUS) itself, subjected to the various electrical, safety, and EMC tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided document does not report on a study involving human experts establishing ground truth for a set of patient data or images. The "ground truth" here is compliance with established engineering and safety standards, verified by independent testing laboratories.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. No human expert adjudication was involved in validating the device's performance against the technical standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through technical comparison and compliance with standards, not on demonstrating improved human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an electrical stimulator, not an AI or algorithmic device that would have "standalone performance" in the context of image analysis or diagnostic support. Therefore, this question is not applicable. The "standalone" performance here refers to the device operating according to its technical specifications, which was assessed through the non-clinical tests.
7. The Type of Ground Truth Used
The "ground truth" for this submission is compliance with recognized international electrical safety and performance standards (IEC standards) and technical equivalence to a legally marketed predicate device.
- IEC 601-1: general safety requirements.
- IEC 601-2-10: specific safety and performance requirements for nerve and muscle stimulators.
- IEC 601-1-2: electromagnetic compatibility.
- Technological comparison: The stimulation signal's parameters and output characteristics were compared to the predicate device to establish functional equivalence.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI or machine learning product that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this device.
§ 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).