(299 days)
The intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.
The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.
This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device. The device is intended for pain relief.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Performance | Complies with EN 60601-1, -1-2, -1-4, -1-6, -1-2-10 |
| Electrical Safety | Complies with EN 60601-1, -1-2, -1-4, -1-6, -1-2-10 |
| Software Verification | Carried out according to FDA software guidance |
| Usability | Labeling sufficient for users to operate device safely (demonstrated by Usability Study) |
| Substantial Equivalence to Predicate Device | Same intended use, similar technological characteristics, minimal differences that do not present safety/effectiveness issues compared to Well-Life Model WL-2402 (K063660) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size for a test set related to clinical performance. The studies mentioned are primarily related to engineering standards, software verification, and a usability study. There is no mention of a clinical test set from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention experts used to establish ground truth for a clinical test set. The validation appears to be primarily technical and based on compliance with international standards, software guidance, and a usability study.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set requiring expert review, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is a TENS unit, not an AI-assisted diagnostic tool that would typically involve a multi-reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a TENS unit, a physical medical device, not an algorithm or AI system for diagnosis or interpretation that would operate in a "standalone" mode. The software component refers to its internal control, not an interpretative algorithm.
7. Type of Ground Truth Used
For the safety and performance evaluation:
- Technical Specifications/Standards: Compliance with various EN 60601 standards for electrical safety and functional performance.
- FDA Software Guidance: Used for software verification.
- Usability Study Observations: Used to determine if labeling was sufficient for safe operation.
- Predicate Device Comparison: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device (Well Life-Healthcare LTD. OTC TENS for Back Pain Relief, Model WL-2407, K063660).
8. Sample Size for the Training Set
The document does not specify a training set sample size related to clinical performance or algorithm development. The device is a TENS unit, and its development seems to have followed engineering design principles and compliance with standards rather than machine learning methodologies that would involve training sets.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set in the context of an algorithm, this question is not applicable. The device's "training" would be its design, manufacturing, and testing to meet established engineering and safety standards.
§ 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).