(65 days)
The Empi Active Transcutaneous Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma-acute pain
The Empi Active Transcutaneous Nerve Stimulator is a battery powered single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy. This device is intended to be easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity. It is a single-function electrotherapy device with one mode of treatment that allows for Transcutaneous Electrical Nerve Stimulation (TENS).
The provided text describes a 510(k) summary for the "Empi Active Transcutaneous Nerve Stimulator." This document confirms that no clinical studies were required or performed to demonstrate the safety and efficacy of this device.
The submission asserts that the device is substantially equivalent to a predicate device (Empi SELECT Model 4600, K061650) because it has the same intended use, technological characteristics, and does not significantly influence clinical endpoints where prospective clinical studies would be necessary. Therefore, the device meets the criteria for exemption from clinical testing as per FDA guidance document 95-4158.
As no clinical study was conducted, the following information cannot be provided from the given document:
- Table of acceptance criteria and reported device performance: No clinical performance data is presented.
- Sample size used for the test set and the data provenance: No test set was used for clinical evaluation.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
- Adjudication method for the test set: Not applicable as no clinical test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted.
- Standalone (algorithm only without human-in-the-loop performance) study: Not conducted, as this is a medical device, not an algorithm.
- Type of ground truth used: Not applicable as no clinical ground truth was established.
- Sample size for the training set: Not applicable as no clinical training set was used.
- How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical Testing and Acceptance Criteria (as described in the document):
The Empi Active Transcutaneous Nerve Stimulator underwent non-clinical testing to demonstrate compliance with product specifications and user needs.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical tests | Meets product specifications over a range of operating and storage conditions. |
| Mechanical tests | Meets product specifications over a range of operating and storage conditions. |
| Software tests | Meets product specifications over a range of operating and storage conditions. |
| User needs | Meets user needs according to marketing requirements. |
| Voluntary Standards Conformance | Conforms to: |
- UL 60601-01 Medical electrical equipment Part 1: General requirements for safety. 2003
- CAN/CSA C22.2 No.601.1-M90 with Amendment A2. 2005
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety – Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was non-clinical verification and validation testing. This included:
- Electrical testing: To ensure electrical safety and performance within specified parameters.
- Mechanical testing: To assess the durability and physical integrity of the device.
- Software testing: To verify the functionality and reliability of the device's embedded software.
- Validation testing: To confirm the device meets user needs and marketing requirements.
The document explicitly states: "No prospective clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance in the target markets." The justification for this is that the device "does not differ from the predicate device in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence."
§ 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).