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510(k) Data Aggregation
K Number
K150504Device Name
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Manufacturer
PCI MEDICAL, INC.
Date Cleared
2015-11-16
(263 days)
Product Code
PSW
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
PCI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transsophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.
Device Description
The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.
The GUS ASTRA TEE and GUS ASTRA VR are automated reprocessors which are identical with the exception of the disinfection chamber configuration necessary to compensate for two different types of ultrasound probes. The GUS ASTRA TEE is an automated reprocessor which enables high-level disinfection and rinsing for transesophageal (TEE) ultrasound probes. The GUS ASTRA VR is an automated reprocessor which enables high-level disinfection and rinsing for endovaginal and/or endorectal ultrasound probes.
Both ASTRA systems utilize predefined programs based upon the high-level liquid disinfectant (HLD) used during the disinfection and potable water rinsing cycles. The system controls the HLD temperature and cycle times which are fixed, no user configuration is available. The device will perform the defined automated disinfection and rinsing cycles based upon the HLD specifications. The microprocessor controlled interface monitors temperature and liquid levels of the HLD in the disinfection chamber and the reservoir. Optical sensors are used for HLD reservoir presence and probe identification. Additional user inputs include unique probe identification (for disinfection records) and the results entry of the Minimum Recommended Concentration (MRC) test using test strips and minimum concentration levels as defined by the HLD manufacturer. A sensor located on the disinfection chamber door is used to initiate the cycle after the user has input the required information. User retrievable data/information regarding reprocessing is accessible through a USB port.
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