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510(k) Data Aggregation
K Number
K161010Device Name
HICP200 Patient/Monitor Interconnect Cable
Manufacturer
Date Cleared
2016-10-20
(192 days)
Product Code
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
InnerSpace Neuro Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HICP200 is designed for use with any Hummingbird catheter. Together, they comprise a system that is indicated for use in those conditions where continuous monitoring of ICP is required. As dictated by clinical judgment, direct measurement of ICP may be obtained from the subdural, parenchymal, or intraventricular locations.
Device Description
The HICP200 is a reusable patient/monitor interconnect cable with integrated Control and Catheter-Connect Modules. The principle of operation of the HICP200 and Hummingbird intracranial pressure catheter system is air-coupled pressure transduction.
The HICP200 Catheter-Connect Module houses the pressure transducer and provides a high-reliability pneumatic connection to the Hummingbird ICP catheter. The connector provides for audible and tactile feedback indicating a secure connection. The Intracranial Pressure (ICP) waveform is transduced in the Catheter-Connect Module and the analog signal is transmitted to the patient monitor, according to AAMI BP-22 standard protocol of 5u V/V/mmHg.
The HICP200 Control Module monitors the same ICP signal transmitted to the monitor to control and implement system air priming cycle requirements and user interface audio/visual system status.
The HICP200 is configured with a user-specified connector to interface with the patient monitor.
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