(331 days)
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- CPAP/PSV
The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The SmartVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the SmartVent™ 201 Software.
This document is a 510(k) summary for the SmartVent™ 201 Portable Ventilator, and it does not contain the detailed information required to describe specific acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document states:
- "Based on a series of safety and performance testing including a comparative study and analysis of similarities and differences we believe that the SmartVent™ 201 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues."
- It also lists several voluntary performance standards that the device complies with (ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1-1, EN 60601-1-2).
However, it does not provide:
- A table of acceptance criteria and reported device performance: While voluntary standards are listed, specific pass/fail metrics and the device's measured performance against them are not detailed.
- Sample size used for the test set and data provenance: The "comparative study" is mentioned but no details on sample size or data origin are provided.
- Number of experts and their qualifications for ground truth: Not applicable for a ventilator's technical performance study.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: This is not a study focused on human reader improvement with AI in image analysis, so it's not applicable.
- Standalone (algorithm only) performance: Not applicable as this is a medical device, not an AI algorithm. Its performance is intrinsic to its design and function.
- Type of ground truth used: Not explicitly stated beyond "safety and performance testing."
- Sample size for the training set: Not applicable for a physical device's performance testing.
- How ground truth for the training set was established: Not applicable.
Therefore, I cannot fulfill the request with the provided input. This document is a regulatory approval letter and a summary, not a detailed performance study report.
§ 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).