(255 days)
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.
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).
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 |
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).