(298 days)
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)
- AURA™ Sensor (Model 10025G)
- Disposable Scalp Retractor (Model OS0001B)
- Disposable Drill Bit with Collar (Model 10008C)
- Disposable Torque Wrench (Model OS0004C)
- Disposable Antenna Holster (Model 10007A)
Package 2) AURA™ Monitor Pack (Model TK101-A) - AURA™ Monitor (Model T0011B)
- AURA™ Antenna (Model T0010A)
- 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
- Two-bay battery charger (Model T0014A)
Package 3) AURA™ Data Receiver Pack (Model DG101-A) - AURA™ Data Receiver (Model D0004B)
Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| ICP Monitor performance testing (ANSI/AAMI NS28:1988(r)2010) | Meets pre-defined acceptance criteria (implied compliance with standard) |
| Pressure measurement resolution testing | Meets pre-defined acceptance criteria (implied satisfactory resolution) |
| Barometric pressure compensation testing | Meets pre-defined acceptance criteria (implied satisfactory compensation) |
| System response time testing | Meets pre-defined acceptance criteria (implied satisfactory response time) |
For Biocompatibility, specific results are provided:
| Test (ISO 10993 Series) | Acceptance Criterion (implicitly, "non-cytotoxic," "non-sensitizer," etc.) | Reported Device Performance |
|---|---|---|
| MEM Elution (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic: score of 0. |
| Sensitization Maximization Extract (ISO 10993-10) | Non-sensitizer | Non-sensitizer: No irritation was found on any of the negative control or test animals. |
| Intracutaneous Reactivity (ISO 10993-10) | Non-Irritant | Non-Irritant: The test device score for both extracts was 0. |
| Acute Systemic Injection (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No test or control animals exhibited signs of toxicity. |
| Subacute and Subchronic Toxicity (IV) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Subacute and Subchronic Toxicity (IP) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Genotoxicity - Ames (ISO 10993-3) | Non-mutagenic | Non-mutagenic: The test article did not cause an increase in revertant colonies for any strain greater than two-fold over negative control values. |
| Genotoxicity - Mutagenicity (ISO 10993-3) | Non-clastogenic & non-genotoxic | Non-clastogenic & non-genotoxic: No statistical significant differences (p ≥ 0.05) were noted between the test and control extracts. |
| Genotoxicity - Mouse Lymphoma (ISO 10993-3) | Non-mutagenic & non-clastogenic | Non-mutagenic & non-clastogenic: RTG was > 10%. |
| Subcutaneous Implantation (ISO 10993-6) | Acceptable tissue reaction | Macroscopic reaction not significant compared to control; microscopically, slight irritant. |
| Brain Tissue Implantation (ISO 10993-6) | Acceptable tissue reaction | Neurobehavioral, gross pathological, clinical reactions not significant; histologically, minimal or no reaction. |
| Mediated Material Pyrogenicity (ISO 10993-11) | Non pyrogenic | Non pyrogenic: Temperature increase was |
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).