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510(k) Data Aggregation
(29 days)
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
The Mistral-Air® Warming System comprises of the following devices:
- One warming unit of models: ● MA1200-PM Mistral-Air® - SYK (forced air warming unit 100-125 V~, 50/60 Hz) c Connected to
- One warming blanket of models: Non-sterile Accessory: Stryker REF / Stryker Proprietary name MA02010-PM Faceshield - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA0220-PM / Adult White - SYK MA0230-PM / Paediatric White - SYK MA0250-PM / Lower Body White - SYK MA0260-PM / Upper Body White - SYK MA0265-PM / Half Upper Body White - SYK MA0270-PM / Torso White - SYK MA0290-PM / Surgical Access White - SYK MA0320-PM / Adult Reflective - SYK MA0330-PM / Paediatric Reflective - SYK MA0340-PM / Neonatal Reflective - SYK MA0350-PM / Lower Body Reflective - SYK MA0360-PM / Upper Body Reflective - SYK MA0365-PM / Half Upper Body Reflective - SYK MA0400-PM / Full Underbody Reflective - SYK MA0450-PM / Underbody Reflective - SYK MA0510-PM / Tube - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA0280-PM / Surgical Access White (sterile) - SYK MA0285A-PM / Lower Surgical Access White (sterile) - SYK MA0286-PM / Cardiac Blanket (sterile) - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA1610-PM / Premium Warming Suit S - SYK MA1620-PM / Premium Warming Suit M - SYK MA1630-PM / Premium Warming Suit L - SYK MA1640-PM / Premium Warming Suit XL - SYK MA1710-PM / Warming Suit S - SYK MA1720-PM / Warming Suit M - SYK MA1730-PM / Warming Suit L - SYK MA1740-PM / Warming Suit XL - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA2220-PM / Adult Plus - SYK MA2230-PM / Paediatric Plus - SYK MA2240-PM / Neonatal Plus - SYK MA2250-PM / Lower Body Plus - SYK MA2260-PM / Upper Body Plus - SYK MA2265-PM / Half Upper Body Plus - SYK MA2270-PM / Torso Plus - SYK MA2290-PM / Surgical Access Plus - SYK MA2400-PM / Full Underbody Plus - SYK MA2450-PM / Half Underbody Plus - SYK MA2475-PM / Paediatric Underbody Plus - SYK MA3320-PM / Premium Adult - SYK MA3330-PM / Premium Paediatric - SYK MA3340-PM / Premium Neonatal - SYK MA3350-PM / Premium Lower Body - SYK MA3360-PM / Premium Upper Body - SYK MA3365-PM / Premium Half Upper Body - SYK MA3400-PM / Premium Full Underbody - SYK MA3450-PM / Premium Half Underbody - SYK MA3475-PM / Premium Paediatric Underbody - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA2280-PM / Surgical Access Plus (sterile) - SYK MA2285-PM / Lower Surgical Access Plus (sterile) - SYK MA2286-PM / Cardiac Blanket Plus (sterile) - SYK
The principle of operation is an electrically powered forced air warming unit (consists of a control circuit, an air filter, a fan, a heating element and temperature sensors) that propels warmed air via a flexible hose to a warming blanket (sterile or non-sterile, depending on the model) draped over the patient. Some warming blankets allow for the patient to be placed on top of the blanket or surrounded by a warming tube. All warming blankets are intended for single patient use only.
This document describes the premarket notification for the Mistral-Air Warming Unit, a medical device for patient warming. The document is a 510(k) submission to the FDA, which demonstrates substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present an explicit table of acceptance criteria with numerical targets and direct measurement results in the way one might expect for an AI/ML device's performance metrics (e.g., sensitivity, specificity). Instead, it states that the device was tested against recognized standards and specifications for medical electrical equipment and patient warming devices.
The acceptance criteria are implicitly defined by compliance with these standards and the demonstration of equivalent performance to the predicate device.
| Acceptance Criteria (Defined by Standards/Tests) | Reported Device Performance |
|---|---|
| Air flow performance | In compliance |
| Air pressure performance | In compliance |
| Filtering performance | In compliance |
| Temperature performance | In compliance |
| Endurance test | In compliance |
| Extreme Temperatures | In compliance |
| Keyboard test | In compliance |
| AAMI/ANSI ES60601-1 (Basic Safety & Essential Performance) | Pass |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Pass |
| IEC 60601-1-6 (Usability) | Pass |
| IEC 60601-1-8 (Alarm Systems) | Pass |
| IEC 62304 (Medical Device Software Life Cycle) | Pass |
| IEC 62366-1 (Usability Engineering) | Pass |
| IEC 60529 (Degrees of protection by enclosures) | Pass |
| IEC 80601-2-35 (Heating Devices w/ Blankets/Pads) | Pass |
| ISTA 3A (Packaged-Products for Parcel Delivery) | Pass |
| ASTM D4169 (Performance testing of shipping containers) | Pass |
| ASTM D642 (Compressive resistance of shipping containers) | Pass |
| ISO 10993-1 (Biological Evaluation Of Medical Devices) | Pass |
| ISO 11135 (Sterilization - Ethylene Oxide) | Pass |
| Intended Use (raise and maintain patient temperature by surface warming) | Same as predicate |
| Technological characteristics | Same or similar as predicate |
2. Sample size used for the test set and the data provenance:
The document describes bench tests (non-clinical tests) to verify the performance of the device. It does not mention a "test set" in the context of patient data or clinical trials, nor does it specify sample sizes for these bench tests. The provenance of this data is effectively internal laboratory testing conducted by The Surgical Company International BV. The study is prospective in that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., temperature measurements, airflow properties, electrical safety, EMC compatibility). It's not based on expert consensus for interpreting medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of expert opinions or labels.
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 warming unit, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance evaluation is entirely "standalone" in the sense that the device's operational parameters (e.g., temperature output, airflow) are measured directly against specifications and standards, independent of human interaction beyond operating the device for the testing. There is no algorithm providing diagnoses or interpretations where "human-in-the-loop" performance would be a separate consideration.
7. The type of ground truth used:
The ground truth for the device's performance is based on:
- Engineering specifications and design requirements: For parameters like air flow, air pressure, temperature, and endurance.
- Recognized industry standards (Table 1): These standards define safety, essential performance, electromagnetic compatibility, usability, software lifecycle processes, biological compatibility, and packaging requirements for medical devices. Compliance with these standards serves as the "ground truth" for acceptable and safe device operation.
8. The sample size for the training set:
Not applicable. This device is a mechanical/electrical warming unit, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML model is involved.
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