(295 days)
The Babylog intensive care Ventilator (Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb).
This device provides mandatory pressure-controlled ventilation modes for supporting spontaneous breathing, and ventilation monitoring.
The intensive care ventilators Babylog VN800 and Babylog VN600 were developed and are manufactured by Dräger in Lübeck, Germany.
Babylog VN800 and Babylog VN600 are specified for the ventilation of pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.
Babylog VN800 and Babylog VN600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories.
Babylog VN800 and Babylog VN600 are available with a basic device configuration that comprises the following:
- Trolley with four castors and brakes
- Display unit (graphical user interface)
- Ventilation unit
The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
It appears the provided text describes a 510(k) premarket notification for a medical device, the Babylog VN800/VN600 ventilator. However, the document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and adherence to consensus standards. It does not present a clinical study to prove the device meets acceptance criteria related to its performance in a clinical setting with human subjects or a clinical outcome.
Specifically, the document lists "Non-clinical Testing" including:
- Sterilization
- Biocompatibility
- Software, including cybersecurity
- Electrical safety
- Electromagnetic compatibility (EMC)
- Alarm Systems in medical electrical equipment
- Respiratory gas monitors
- Waveforms, including comparisons to the predicate device and performance
- Technical System Requirements
- Accessories compatibility
- Human factors engineering, usability
The "Conclusion" states that "The conclusions drawn from non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the new product Babylog VN800 / Babylog VN600 is substantially equivalent to the predicate device... and does not raise new questions of safety or effectiveness."
Therefore, based solely on the provided text, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical application. The "performance" mentioned refers to technical performance related to waveforms, not clinical outcomes.
- Sample size used for the test set and data provenance: There is no mention of a human test set. The testing described is non-clinical.
- Number of experts used to establish the ground truth: Not applicable as there is no clinical test set requiring ground truth established by experts.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical ventilator device, not an AI algorithm for diagnosis/detection.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/ML-based device requiring a training set in the typical sense.
- How ground truth for the training set was established: Not applicable.
The document demonstrates that the device functionally meets standards and is similar to a previously cleared device, but it does not detail a study proving clinical performance against specific acceptance criteria in the way you've outlined for an AI-powered diagnostic or similar product.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).