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510(k) Data Aggregation
(149 days)
NerveGuard NRFit, NerveGuard LUER
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.
The NerveGuard NRFit and NerveGuard LUER are single use sterile devices.
The NerveGuard NRFit and NerveGuard LUER are packed in a soft blister package.
The procedure requires connection to a needle intended for peripheral neve block and an injection device, typically a 10/20ml syringe (not subject to this 510(k)).
The NerveGuard is attached between the hub of the needle and the syringe via male and female connector.
Upon starting injection the pressure is monitored while the needle is inserted into the patients' skin. When exceeding the maximum pressure the NerveGuard limits the injection pressure. The user can slightly release force and proceed injection beyond the limitation value.
The NerveGuard pressure monitor is a disposable manometer for objective monitoring of injection pressure during administration of peripheral nerve blocks (PNB). Monitoring opening injection pressure with the NerveGuard helps identify unsafe injections before they start. When the NervGuard measures high opening injection pressure and limits this pressure down to a maximum of 18Psi. the needle can be repositioned and the injection resumed.
Usually the operator creates a force on the plunger (Fo) on the filled syringe which leads to normal flow of anesthetic through a valve in the NerveGuard. At this time, the resistance force of the locking mechanism Fs is higher when Fo. The locking mechanism closes the valve as soon as the force Fo overshoots Fs. The flow is stopped immediately. The NerveGuard will prevent a flow of anesthetic and fullfill it's protective function. Upon release of pressure Fo the valve reopens and the procedure can move on.
Here's a breakdown of the acceptance criteria and study information for the NerveGuard device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Detail | Standard / Protocol | Result (Reported Device Performance) |
|---|---|---|
| For Sterilization: | ||
| Sterilization Assurance Level (SAL) | ISO 11135 | 10^-6 (Pass) |
| Ethylene Oxide (EtO) Gas Type | ISO 11135 | Ethylene Oxide 99.99% |
| Exposure Time | ISO 11135 | 300 min. |
| Aeration Method | ISO 11135 | Evacuation, 2 airwashes |
| Aeration Period | ISO 11135 | Minimum 48h at 40°C (±5) |
| Residuals (EtO, ECH) | ISO 10993-7 | Pass ( |
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