(159 days)
The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.
The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.
The document describes the Maxtec MaxBlend 2+p, a medical device combining an air/oxygen blender, oxygen monitor, pressure monitor, and flowmeter. The 510(k) submission seeks substantial equivalence to existing predicate devices (Maxtec MaxBlend 2 - K161718 and MaxO2ME+p - K221734), particularly highlighting the addition of a pressure monitoring feature.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for several performance aspects are implicitly derived from the comparative tables (Table 1 and 2) where the subject device's specifications are listed and compared to the predicate devices. The "Reported Device Performance" for the subject device is simply its stated characteristics, which are claimed to meet or be identical to the predicate device specifications, thereby meeting the acceptance criteria based on substantial equivalence.
| Feature / Performance Aspect | Acceptance Criteria (from predicate devices) | Reported Device Performance (Maxtec MaxBlend 2+p) |
|---|---|---|
| Air/Oxygen Mixer Features | ||
| Gas Supply Type | Air / Oxygen | Air / Oxygen |
| Pressure | 30 to 75 psi | 30 to 75 psi |
| Mixed gas stability | ± 1% oxygen | ± 1% oxygen |
| Flow range of Blenders | Low flow model – 0-30 Lpm; High flow model – 0-100 Lpm | Low flow model – 0-30 Lpm; High flow model – 0-70 Lpm (Primary Predicate) / 0-100 Lpm (Secondary Predicate) |
| Pressure supply differential alarm | Air / oxygen pressure |
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).