(136 days)
The VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.
The proposed VPOD Intrathoracic Pressure Regulator (ITPR) is also intended to be used with patients who would benefit from increased venous return back to the heart for treatment of a number of different clinical conditions associated with severe hypotension but generates its own vacuum via the VPOD Motor and connects with a positive pressure source such as a separate ventilator or manual resuscitator bag.
The provided text is a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator. It describes the device, its indications for use, and its comparison to a predicate device (CirQlator™). The document outlines various tests conducted to demonstrate substantial equivalence but does not explicitly provide a table of acceptance criteria with reported device performance in the format requested.
However, based on the non-clinical testing and comparative performance sections, we can infer some of the performance aspects and the studies that support them.
Here's an attempt to structure the information as requested, though some details like specific numerical acceptance criteria are not explicitly stated in the document.
Acceptance Criteria and Study Details for VPOD™ Intrathoracic Pressure Regulator
The provided document, a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator (K172388), describes various tests and comparisons to establish substantial equivalence with its predicate device, the CirQlator™ (K070490). While explicit numerical acceptance criteria are not tabulated, the document details performance characteristics that were compared and found to be equivalent or superior.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (VPOD™ ITPR) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-mutagenic, margin of safety > 1 per ISO 10993. | PASS: Materials were found to be non-cytotoxic, non-irritating, non-mutagenic, and with a margin of safety > 1 for Externally Communicating, Tissue, Limited durations ( |
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).