(225 days)
The modified Bird Sentry™ Blender is designed to provide a continuous air/oxygen gas mixture 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 institutional environments where delivery and monitoring of air/oxygen mixtures is required.
The modified Bird Sentry™ Blender, is a compact air/oxygen mixing device which incorporates the use of a battery powered oxygen analyzes/monitor. The gas mixing device (bleader) provides for precise mixing of medical grade sir and oxygen, and the analyzer measures the selected oxygen concentrations from the blender's gas flow and samples and displays the measured concentrations on a digital display.
This document describes the performance testing for the Bird Sentry Blender (Model 15625 and 15642).
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| PHYSICAL CHARACTERISTICS | |||
| Dimensional Envelope | 7.75"H x 4.88"W x 4.75"D | Pass | Yes |
| Weight | Approximately 4.5 lb | Pass | Yes |
| Interface | As described on page 3 | Pass | Yes |
| GAS SUPPLY | |||
| Nominal Supply Pressure | 50 ± 10 PSI | Pass | Yes |
| Normal Operating Pressure | 30 PSI to 70 PSI | Pass | Yes |
| ENVIRONMENTAL WITHSTAND | |||
| Temperature | 59°F to 104°F | Pass | Yes |
| Humidity | 0% to 100% non-condensing | Pass | Yes |
| Media | Air and Oxygen | Pass | Yes |
| Impact | IEC 68-2-27 | Pass | Yes |
| Cleaning and Sterilization | Detergent, isopropyl alcohol | Pass | Yes |
| AIR / OXYGEN MIXER | |||
| %O2 Control | 21%-100%, stability ±1%, accuracy ±3% | Pass | Yes |
| Flow Characteristics (P/N 15625) | 2-100 LPM | Pass | Yes |
| Flow Characteristics (P/N 15642) | 0-30 LPM | Pass | Yes |
| Pressure Drop | ≤ 6 PSI with 50 PSI inlets & 40 LPM flow | Pass | Yes |
| Blender Safety Features | Alarm at ΔP ≥ 20 PSI | Pass | Yes |
| OXYGEN ANALYZER MONITOR | |||
| Monitor Display | 0-100%, resolution 0.1%, accuracy 0.2% | Pass | Yes |
| Monitor Controls | Confirmed to function per list on page 3 | Pass | Yes |
| Alarm / Alert Conditions | ± 1% above/below high limit/low limit | Pass | Yes |
| Monitor Power Source | 2 AA alkaline batteries | Pass | Yes |
| Oxygen Sensor | 335 to 722 µV per %O2 | Pass | Yes |
| OXYGEN BLENDER PERFORMANCE | |||
| O2 Concentration | 0-100%, accuracy ± 3% | Pass | Yes |
| MONITOR/ANALYZER PERFORMANCE | |||
| Display, Controls, Alarms | ½ % increments, controls, alarms function | Pass | Yes |
| System Accuracy | 0-100%, accuracy ± 2%, 1% increments | Pass | Yes |
| EMI/RFI PERFORMANCE | |||
| Standard | IEC 601-1-2 | Pass | Yes |
| ELECTRICAL SAFETY | |||
| Standard | IEC 601-1 | Pass | Yes |
| ENVIRONMENTAL TESTING | |||
| Standard | IEC 68-2-6, 27, 34, 37 | Pass | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Performance testing was conducted in the laboratory to confirm flow and pressure input and output requirements and accurate delivery and monitoring of oxygen concentrations. Production line tests were also performed." and "Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities."
- Sample Size: Not explicitly stated as a specific number of devices. The statement "Production line tests were also performed" suggests testing across manufacturing.
- Data Provenance: The testing was conducted "in the laboratory" and by "certified test facilities," indicating it was likely prospective testing specifically for this device modification. The country of origin of the data is not specified but is implicitly within the context of seeking U.S. FDA 510(k) clearance, suggesting testing adheres to relevant U.S. or internationally harmonized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a medical equipment for gas mixing and monitoring; its "ground truth" is based on objective physical measurements and adherence to engineering and safety specifications, not expert interpretation of subjective outputs like images. The performance specifications are objective and measurable.
4. Adjudication Method for the Test Set:
Not applicable. The tests are based on objective measurements against defined specifications. There is no human adjudication process described for the test results; rather, the results are objectively determined as "Pass" or "Fail" against the established quantitative specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening tools where a human reader's performance with and without AI assistance is evaluated. This device is a medical equipment that delivers and monitors air/oxygen mixtures, and its performance is determined by its technical specifications rather than diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone performance study was done for the device. The data in the table represents the performance of the device itself (mixing and analyzing oxygen) against its specified physical characteristics, gas delivery capabilities, sensor accuracy, and safety features. This testing does not involve a human in a feedback loop to determine the core performance metrics of the blender and oxygen analyzer.
7. Type of Ground Truth Used:
The ground truth used consisted of objective engineering and performance specifications. These are quantitative values (e.g., specific dimensions, pressure ranges, flow rates, percentage accuracy of oxygen concentration, alarm thresholds) that the device must meet. These are derived from established industry standards (e.g., IEC 68, IEC 601-1-2, IEC 601-1) and internal design requirements to ensure safe and effective operation.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device (blender and oxygen analyzer) undergoing performance testing, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The specifications for performance (the "ground truth" for evaluation) were established through engineering design, regulatory requirements, and recognized industry standards.
§ 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).