(124 days)
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.
The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There are three stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
Here's a breakdown of the acceptance criteria and study details for the DyAnsys Primary Relief device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in the traditional sense of specific quantitative thresholds the device needed to meet. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SPRINT PNS System) and safety/effectiveness through clinical and non-clinical testing.
Here’s a table summarizing the performance aspects evaluated and the reported results:
| Feature/Criterion | Acceptance/Evaluation Approach | Reported Device Performance | Comments |
|---|---|---|---|
| Preamble (Substantial Equivalence) | Comparison to predicate device (SPRINT PNS System K202660) and reference device (Drug Relief K173861) based on intended use, indications for use, and basic operating principle. | Demonstrated substantial equivalence to identified predicate device. | Formally stated as the conclusion of the 510(k) submission. |
| Indications for Use | Show that the indications for use do not alter the intended therapeutic use or affect safety/effectiveness relative to the predicate. | "The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery." | Differs from predicate but deemed not to raise new safety/effectiveness questions. |
| Technological Characteristics | Comparison of design, power, pulse characteristics, battery, dimensions, materials, etc., with predicate(s). | Minor technological differences (electrode placement, duration of patient contact) do not raise new safety/effectiveness questions. | Detailed comparisons provided in Tables 6.1 and 6.2. |
| Electrical Safety (EMC & Safety) | Nonclinical testing | Performed and validated effectiveness. | Standard regulatory requirement for electrical devices. |
| Biocompatibility | Nonclinical testing | Performed. | Essential for devices with tissue contact. |
| Performance Bench Testing | Validate effectiveness of each unit, verify and compare effectual output with reference device, monitor continuous performance for 72 hours. | Equivalent performance specifications when compared to predicate and reference devices. Pulse width, duration, amplitude, and current values captured for Drug Relief. | Confirms functional integrity and consistency. |
| Software Verification & Validation | Nonclinical testing | Performed. | Ensures software functions as intended and safely. |
| Primary Efficacy Endpoint (Pain Intensity Reduction) | Clinical study: Comparison of pain scores (NRS) between intervention (Primary Relief) and control (standard analgesics) groups. | Minimally invasive nerve stimulation reduces pain score faster. High least-square means difference post six hours (p-value |
§ 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).