(127 days)
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen 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, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The 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.
The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.
This document is a 510(k) Premarket Notification from Maxtec, LLC, regarding their MaxBlend 2 and MaxBlend Lite devices. It aims to demonstrate substantial equivalence to a predicate device, the Bird Sentry Blender (K973646), and references other cleared devices (K153659 – Maxtec MaxO2ME, K883038 - CareFusion / Bird - Blender, K925982 - BioMed Devices - Blender).
Here's an analysis based on your request, highlighting that this document outlines non-clinical testing for a medical device that mixes and monitors breathing gases, not a typically AI-powered diagnostic imaging device. Therefore, many of the requested categories (like MRMC studies, roles of experts for ground truth, sample sizes for training/test sets for AI models, etc.) are not applicable or are addressed differently in the context of hardware device performance testing.
Acceptance Criteria and Device Performance (Non-Clinical/Hardware)
The acceptance criteria are primarily based on meeting the performance specifications of the predicate device and established standards for medical devices of this type. The "reported device performance" is generally stated as "passed" or "meets the acceptance criteria" for various tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate / Standards Equivalent) | Reported Device Performance (MaxBlend 2 and MaxBlend Lite) |
|---|---|---|
| Indications for Use | Continuous air/oxygen gas mixture, monitor O2 concentration for infant, pediatric, adult patients in institutional settings; not life supporting. | Continuous air/oxygen gas mixture, continuously monitor O2 concentration for infant, pediatric, adult patients in professional healthcare settings (hospital, sub-acute, nursing-care facilities); not life supporting. |
| Environments of Use | Institutional (healthcare settings), Not for MRI. | Professional healthcare settings (hospital, sub-acute, nursing-care facilities), Not for MRI. |
| Patient Population | Infant, pediatric, and adult patients. | Infant, pediatric, and adult patients. |
| Weight | 2 kg | 2.4 kg |
| Power source of oxygen monitor | 2 x AA Alkaline batteries | 4 x AA Alkaline batteries |
| Gas Supply Type | Air / Oxygen, 30 to 75 psi | Air / Oxygen, 30 to 75 psi |
| % Oxygen Control | 21 - 100%, Accuracy ± 3% | 21 - 100%, Accuracy ± 3% |
| Mixed Gas Stability | ± 1% oxygen | ± 1% oxygen |
| Flow Range of Blenders | Low flow: 0-30 Lpm; High flow: 0-100 Lpm. | Low flow: 0-30 Lpm; High flow: 0-100 Lpm. |
| 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).