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The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.

Device Description

The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).

AI/ML Overview

This document refers to the Mindray A7 Anesthesia System (K171292). It outlines its indications for use, device description, and a comparison to a predicate device (K151954), along with reference devices, to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mindray A7 Anesthesia System are implicitly derived from its comparison to a predicate device (also an A7 Anesthesia System, K151954) and several reference devices. The core principle is "substantial equivalence," meaning the new device performs at least as well as, or comparably to, the established devices.

The table below summarizes the key technical characteristics and their reported performance/specifications for both the subject device and its direct predicate. Since the document states "The functional and system level testing showed that the device continues to meet specifications and the performance of the device is equivalent to the predicate," the performance of the subject device is presented as matching the predicate.

Characteristic	Acceptance Criteria (from Predicate/Reference)	Reported Device Performance (Subject Device)
Vaporizers	Two or Three, variable bypass	Two or Three, variable bypass
Agent Support	Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane	Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane
Automatic Ventilator	Yes	Yes
Bellows	Yes	Yes
Bellows Volume	1500mL	1500mL
Ventilation Modes	VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS (and additional modes from reference: SIMV-VG, CPAP/PS, APRV)	VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS (and additional modes: SIMV-VG, CPAP/PS, APRV)
Tidal Volume Range	20 to 1500 ml	20 to 1500 ml
Rate (bpm)	4 to 100 bpm	4 to 100 bpm
I:E Ratio	4:1 to 1:8 with 0.5 increment	4:1 to 1:8 with 0.5 increment
Inspiratory Pause	Off, 5 to 60% of insp. Period	Off, 5 to 60% of insp. Period
Air Flow Range	0 to 15 L/min	0 to 15 L/min
N2O Flow Range	0 to 12 L/min	0 to 12 L/min
O2 Flow Range	0 to 15 L/min	0 to 15 L/min
Individual Gas Flow Accuracy	±50 ml/min or ±5% of setting value, whichever is greater	±50 ml/min or ±5% of setting value, whichever is greater
Pressure Limit	0 to 100cm H₂O	0 to 100cm H₂O
PEEP	Off, 3 to 30, 1 cm H₂O increment	Off, 3 to 30, 1 cm H₂O increment
System Checks	Auto at start	Auto at start
Airway Pressure Measured at	Inspiratory	Inspiratory
High/Low Airway Pressure Alarm	Yes	Yes
Pressure Limiting Alarm	Yes	Yes
Sub Atmospheric Pressure Alarm	Yes	Yes
Continuous Press Alarm	Yes	Yes
Apnea >2 Minute Alarm	Yes	Yes
Apnea Alarm	Yes	Yes
High/Low Minute Volume Alarm	Yes	Yes
High/Low O₂ Concentration Alarm	Yes	Yes
Heated Breathing Circuit	Yes	Yes
Spirometry	Pressure-Volume and Flow-Volume loops	Pressure-Volume and Flow-Volume loops
AG Module Sampling Rate	Adult/pediatric: 120, 150, 200mL/min; Neonate: 70, 90, 120mL/min	Adult/pediatric: 120, 150, 200mL/min; Neonate: 70, 90, 120mL/min
AG Module Sampling Delay Time

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