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510(k) Data Aggregation
(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 < 20 psi an alarm sounds | Air / oxygen pressure < 20 psi an alarm sounds |
| Pressure Drop | < 6 psi @ 50 psi | < 6 psi @ 50 psi |
| Bleed flow | 3-13 Lpm at 50 psi depending upon model | 3-13 Lpm at 50 psi depending upon model |
| Oxygen Monitor Features | ||
| Oxygen measurement range | 0-100% | 0-100% |
| Total Accuracy | ±3% Actual oxygen level over full operating temperature range | ±3% Actual oxygen level over full operating temperature range |
| Response Time | 90% of final value in approx. 15 seconds at 23°C | 90% of final value in approx. 15 seconds at 23°C |
| Warm-up Time | None required | None required |
| High alarm range | 16 – 100% | 16 – 100% |
| Operating Temperature | 15°C – 40°C (59°F – 104°F) | 15°C – 40°C (59°F – 104°F) |
| Storage Temperature | -15°C – 50°C (5°F – 122°F) | -15°C – 50°C (5°F – 122°F) |
| Humidity | 0-95% (non-condensing) | 0-95% (non-condensing) |
| Expected use-life of sensor | 1,500,000 O2% hours (approx. 2 years) | 1,500,000 O2% hours (approx. 2 years) |
| Flowmeter Features | ||
| Accuracy | ± 10% of indicated value when inlet pressure is 50 psi | ± 10% of indicated value when inlet pressure is 50 psi |
| Flow meter ranges | 0 – 3 Lpm, 0 – 15 Lpm, 0 – 30 Lpm, 0 – 70 Lpm (some predicates mention 0-100Lpm as well) | 0 – 3 Lpm, 0 – 15 Lpm, 0 – 30 Lpm, 0 – 70 Lpm |
| Pressure Monitor Features | (Based on Secondary Predicate MaxO2 ME+p K221734) | (Maxtec MaxBlend 2+p) |
| Technology | Microprocessor controlled device | Microprocessor controlled device |
| Pressure sensor type | Solid-state pressure transducer | Solid-state pressure transducer |
| Pressure Measurement Range | -15 to +60 cmH2O | -15 to +60 cmH2O |
| Pressure Resolution | 1 cmH2O | 1 cmH2O |
| Display resolution | 0.5 cm H2O | 0.5 cm H2O |
| Total Accuracy | ± 1 cmH2O | ± 1 cmH2O |
| Low alarm range | 1 - 30 cmH2O | 1 - 30 cmH2O |
| High alarm range | 1 - 60 cmH2O | 1 - 60 cmH2O |
| Alarm delay | 3 seconds (pressure only) | 3 seconds (pressure only) |
| Zero calibration | Yes | Yes |
| Operating Temperature | 15°C - 40°C, 0-95% RH | 15°C - 40°C, 0-95% RH |
| Storage Temperature | -15°C - 50°C @ 95% RH | -15°C - 50°C @ 95% RH |
| Atmospheric Pressure | 800 – 1013 mBars | 800 – 1013 mBars |
| Power requirements | 4x - AA alkaline batteries | 4x - AA alkaline batteries |
| Battery Life | 5000 hours | 5000 hours |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states:
- Non-clinical Testing: "We performed a number of tests to demonstrate that the proposed device performed as intended." It then lists several international standards that the device met. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily related to engineering and performance validation against standards rather than clinical data.
- Clinical Testing: "No human clinical testing was performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since "No human clinical testing was performed," and the primary testing involved adherence to international standards and non-clinical performance, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical testing would be the defined requirements and specifications within the cited standards.
4. Adjudication Method for the Test Set
Not applicable, as no human clinical test set is mentioned, and the testing focuses on compliance with technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical gas mixer and monitor, not an AI-assisted diagnostic or interpretation tool that would involve human readers or image analysis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a hardware product with integrated monitoring capabilities. Its "standalone" performance is measured through its adherence to the technical specifications and international standards listed under "Non-clinical Testing." The document states: "In all cases the subject device met the standard requirements." This implicitly confirms standalone performance against established benchmarks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance specifications (e.g., oxygen accuracy, pressure accuracy, flow rates), the ground truth is based on metrological standards and calibrated equipment used in accordance with the listed international standards (e.g., ISO 80601-2-55, ISO 11195). For biocompatibility, the ground truth is established by adherence to ISO 10993 and ISO 18562 standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device with integrated sensors and controls, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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