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The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffering from respiratory insufficiency. Typical treatment consists of hyperinflating the patient's lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.

The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis.

This looks like a 510(k) clearance letter for the SIMS Hyperinflation Bag System. Unfortunately, the provided text does not contain the acceptance criteria or details of a study used to prove the device meets such criteria.

The document is purely administrative, confirming the substantial equivalence of the SIMS Hyperinflation Bag System to legally marketed predicate devices. It discusses regulatory product codes, general controls, and other administrative information related to market authorization.

To answer your request, I would need a different document, such as:

• A summary of safety and effectiveness (SSE), which often accompanies 510(k) submissions and details the studies conducted.
• The 510(k) submission itself, which would contain the full details of performance testing and acceptance criteria.
• Clinical study reports or bench testing reports for the device.

Without that specific information, I cannot provide the details you've requested about acceptance criteria and the supporting study.

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