(238 days)
EV-803 Digital TENS is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
In particular, this device is indicated for use for:
- Symptomatic relief and management of chronic (long term) intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
EV-803 Digital Tens is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.
The electronics of the EVERYWAY EV-803 DIGITAL TENS create electrical impulses whose intensity, duration, number per second and modulation may be altered with the controls/switches. Press buttons are very easy to use and the large liquid crystal display showing the exact mode and values of parameters are very convenient for patients.
Here's an analysis of the provided text regarding the EV-803 Digital TENS device, structured according to your requested information.
It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For TENS devices, the regulatory pathway generally focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. This means the "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of equivalence and compliance with relevant standards, rather than a traditional clinical outcome study.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, especially for a device like a TENS unit, the "acceptance criteria" are typically met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness. The performance is then judged against this equivalence.
| Criteria (as implied by Substantial Equivalence) | Reported Device Performance (EV-803 Digital TENS) |
|---|---|
| Indications for Use | Identical to predicate device (Transamerica Digital EMS, 510k #K010782) |
| Target Population | Identical to predicate device |
| Design | Identical to predicate device |
| Materials | Identical to predicate device |
| Performance | Identical to predicate device |
| Sterility | Identical to predicate device |
| Biocompatibility | Identical to predicate device |
| Mechanical Safety | Identical to predicate device |
| Chemical Safety | Identical to predicate device |
| Anatomical Sites | Identical to predicate device |
| Human Factors | Identical to predicate device |
| Energy used and/or delivered | Identical to predicate device |
| Compatibility with environment and other devices | Identical to predicate device |
| Where used (intended environment) | Identical to predicate device |
| Standards met | Identical to predicate device (and listed specific standards: EN 60601-1, EN60601-1-2, ISO 9002, EN 46002, ISO 13488) |
| Electrical Safety | Identical to predicate device |
| Thermal Safety | Identical to predicate device |
| Radiation Safety | Identical to predicate device |
| Overall Safety and Effectiveness | Claimed to be safe and effective as the predicate device because it is identical. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific "test set" in the sense of a clinical trial or a dataset of patients/images. The demonstration of safety and effectiveness relies on the declaration of conformity to standards and the assertion of identical technological characteristics to the predicate device. Therefore, no explicit sample size or data provenance (country, retrospective/prospective) related to a test set for performance comparison is provided, as the study type isn't a direct comparative performance study against a ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" requiring ground truth established by experts in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as there was no test set requiring expert ground truth adjudication.
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 is a TENS device, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a TENS device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for regulatory clearance in this case is effectively the established safety and effectiveness of the legally marketed predicate device and the compliance with recognized electrical and medical device standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
Summary of the "Study" and Regulatory Pathway:
The "study" described in the 510(k) submission is a demonstration of substantial equivalence to a predicate device (Transamerica Digital EMS, K010782) and conformance to recognized consensus standards. The manufacturer, Everyway Medical Instruments Co., Ltd., is stating that their EV-803 Digital TENS device is identical to the predicate device, which had previously received 510(k) clearance.
The evidence for meeting "acceptance criteria" is primarily:
- Performance Comparison Table (Paragraph 19): This table asserts "Identical" across all listed technological characteristics when compared to the predicate device.
- Declaration of Conformity: The device explicitly conforms to international and European standards for medical electrical equipment, quality management systems, and electro-magnetic compatibility (e.g., EN 60601-1, EN60601-1-2, DIN EN ISO 9002, DIN EN 46002, ISO 13488). This compliance is assessed by TUV Rheinland Product Safety GmbH.
- Predicate Device Clearance: The regulatory clearance relies on the fact that an identical device (manufactured by Everyway but previously marketed by another distributor) has already been cleared by the FDA.
§ 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).