(120 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 or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.
The Primary Relief is designed to aid in the reduction of post-operative pain by the method of cranial electrical stimulation at the auricular stimulation points. The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over three 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 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 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 information for the Primary Relief device, based on the provided FDA 510(k) summary:
Description of Acceptance Criteria and Proving Study
The acceptance criteria for the Primary Relief device appear to be primarily focused on demonstrating its effectiveness in reducing post-operative pain, specifically after cardiac surgery, to support its expanded indications for use. The study aimed to show a statistically significant reduction in pain scores compared to a sham device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Primary Endpoints) |
|---|---|
| Statistically significant reduction in pain intensity at rest. | **Group A (Treatment) score was 1.19 units (SE=0.16; 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).