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510(k) Data Aggregation
K Number
K092733Device Name
PYTON
Manufacturer
ARM MEDICAL DEVICES, INC.
Date Cleared
2010-02-26
(175 days)
Product Code
BSK, BTR
Regulation Number
868.5750Why did this record match?
Applicant Name (Manufacturer) :
ARM MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure, and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes. The PYTON is intended for use on patients who are intubated. The PYTON is to be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics where a patient may be intubated.
Device Description
The PYTON measures the ETT cuff pressure, and automatically adjusts the air pressure inside the ETT Cuff to a level selected by the user who is intended to be a professional respiratory practitioner. Room air is the "fluid" that is utilized to inflate the ETT Cuff, so there is not any use of (or contact to) any of the patient's biological fluids by the PYTON. The monitoring function is achieved by use of a pressure sensor. The automatic ETT cuff pressure regulation is achieved by activation of either a small air pump (of the same type used in many automatic blood pressure cuff measurement systems) in order to raise the ETT cuff pressure, or by activation of a "dump" valve to lower the ETT cuff pressure. The PYTON provides an LED back-lit LCD digital display to report the ETT cuff pressures to the user, and four pushbuttons that provide the user with the ability to select the target ETT cuff pressure, and check battery charge level. The PYTON includes a mechanical pressure relief valve as a safety precaution that ensures a maximum ETT cuff pressure (in the case of a PYTON failure) to a level of 1.5 p.s.i. (105 cmH2O) +/-20%. The PYTON includes a battery back-up power supply allowing the PYTON to be used for up to 10 hours without mains power.
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