(91 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
The IF-100507 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the IF-100507 can provide results from this electrical stimulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EVERLIFE Interferential Current Therapy, IF-100507:
It is critical to note that the provided documentation is a 510(k) summary for a medical device cleared via the substantial equivalence pathway. This means there was no clinical study explicitly performed to prove the device meets specific performance acceptance criteria defined by the manufacturer for this submission. Instead, the clearance is based on demonstrating equivalence to a predicate device that was already legally marketed.
Therefore, many of the requested sections below will reflect the absence of a direct clinical study for this specific device model.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, there are no specific quantitative "acceptance criteria" for clinical performance established for this device within this document. The device's performance is implicitly accepted as equivalent to the predicate device.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safety: | The device is as safe as the predicate device (APEX Interferential Current Therapy, IF-4000, K952683). Non-clinical tests were conducted for electrical safety, electromagnetic compatibility, and particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements. |
| Effectiveness: | The device is as effective as the predicate device for its intended use. Provides symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain. |
| Functionality: | The device functions in a manner equivalent to the predicate device. System-level testing including waveform testing was performed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. No clinical test set data was provided or generated for this 510(k) submission.
- Data Provenance: Not applicable. No clinical data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set requiring expert-established ground truth was performed for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed.
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 for this device as part of the 510(k) submission. The clearance is based on substantial equivalence to a predicate device, not a comparative clinical trial.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a standalone stimulator, no standalone performance study (in the context of an algorithm's output or diagnostic accuracy) was done. The non-clinical tests focused on electrical safety, EMC, and waveform generation.
7. The Type of Ground Truth Used
Not applicable for a clinical performance study. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (APEX Interferential Current Therapy, IF-4000, K952683).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and no "training set" in that context was used or described. The device's design and functionality are based on established engineering principles for interferential current therapy.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).