(29 days)
The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.
The provided text describes a 510(k) premarket notification for a medical device, the Inspiration™ Ventilator System. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a study proving those criteria were met for this particular submission.
Instead, the document states generally that: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." It also mentions "Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as a guidance and per internal company requirements."
The modification in this 510(k) is the addition of the capability to set tidal volumes in volume-targeted modes down to 5 ml, compared to the previous lower limit of 10 ml.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details based on the provided text. The document confirms that testing was performed to demonstrate substantial equivalence, but it does not specify the quantitative acceptance criteria, the study design, or the results in the level of detail requested.
§ 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).