(263 days)
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.
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.
This appears to be a 510(k) premarket notification for a medical device, specifically automated reprocessors for ultrasound probes. The document focuses on demonstrating substantial equivalence to a predicate device ("TD-100 Transesophageal Probe Disinfector").
The information provided does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone study. Therefore, sections pertaining to these aspects (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text.
The acceptance criteria relate to the physical and functional performance of the device, focusing on its ability to control the high-level disinfectant (HLD) process and user safety. The "study" mentioned refers to verification and validation testing to ensure the device meets these performance specifications and is substantially equivalent to the predicate.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Attribute | Reported Device Performance |
|---|---|
| Control of HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae at each site tested using FDA cleared Metricide OPA. | Device repeatedly maintains time and temperature required for disinfection. (This implies facilitating ≥6 Log reduction based on HLD specifications.) |
| Maintain time and temperature required for disinfection as per HLD specifications | Passed |
| Safety and EMC (Electromagnetic Compatibility) testing | Passed |
| Simulated use and residual testing | Passed (6 log reduction of M. terrae, residual testing ISO10993-5 cytotoxic effect of |
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.