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The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.

· Differential diagnosis (heart/lungs)

· Disability assessment

• Rehabilitation evaluation

• · Exercise prescription
• · Sports medicine/research
• · Energy assessment, substrate utilization
• · Assessment of supplemental O2 requirement
• · Evaluation of medication effects
• · Pulmonary Function testing for adults and children
• · Document effectiveness of bronchodilator therapy
• Pulmonary disability evaluation
• · Industrial surveillance · Bronchial challenge testing
• · Exercise induced bronchial spasm
• · Pre-surgical risk evaluation
• Bedside lung function

Not Found

This document is an FDA 510(k) clearance letter for the VIP Pulmonary Function System (K080510). It does not contain the information requested about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (listed on page 2). It outlines regulatory requirements and informs the manufacturer that they can market the device.

Therefore, I cannot provide the requested information from the given text.

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