(546 days)
The Warrior Blood and Fluid Warmer device is intended for warming blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior EXTREME Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The Warrior Lite Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.
The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:
- Disposable Unit (DU) / Compact Disposable Unit (CDU)
- Base Unit (BU)
- Power source
- Connecting Cable (CC)
- The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.
The provided text describes a 510(k) premarket notification for a medical device, the QinFlow Blood and Fluid Warmer (Warrior, Warrior EXTREME, and Warrior Lite). This document asserts that the new device is substantially equivalent to a previously cleared predicate device (K180154).
The information provided focuses on the device's technical characteristics and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study validating a new acceptance criterion for an AI/ML algorithm or a typical clinical efficacy study. Therefore, many of the requested items related to AI/ML specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable in this context.
However, I can extract the relevant information regarding performance criteria and the testing performed for this medical device submision.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the performance testing requirements and states that the device meets them. The comparison to the predicate device serves as the primary means to demonstrate substantial equivalence.
| Acceptance Criteria (Implied by comparison and testing) | Reported Device Performance (Summary from comparison table and performance data) |
|---|---|
| Intended Use | Warming blood, blood products, and intravenous fluids prior to administration in adults and pediatric patients in hospital, clinics, field and transport environments to help prevent hypothermia. (Matches predicate, with clarified patient population and transport environment) |
| Operating Principle | Resistive heating; Software-controlled electromechanical system with in-line resistive heating at a constant outlet temperature of 100.4 ± 3.6 °F (38 ± 2°C). (Same as predicate) |
| Intended Fluid(s) to be Warmed | IV Fluids, Blood, Blood Products, Plasma. (Same as predicate) |
| Intended Route of Administration | IV. (Same as predicate) |
| Temperature Set Point & Measurement Accuracy | 100.4 ± 3.6 °F (38 ± 2 °C); ± 2°C ( ± 3.6°F). (Same as predicate) |
| Input Temperature Requirements | At least 4°C (39.2°F). (Same as predicate) |
| Warm-up Time | Up to 30 seconds. (Same as predicate) |
| Flow Rate | Based on gravity or fluid pump, up to 180 ml/min (Warrior/Warrior EXTREME), up to 170 ml/min (Warrior Lite). (Within specified range of predicate's 160 – 180 ml/min; differences do not raise new questions of safety/effectiveness). |
| Warmed Volume Capacity | 2.8 - 5L (Warrior/Warrior EXTREME), 1.25 - 2.4L (Warrior Lite). (Warrior Lite capacity is smaller due to smaller battery, but does not raise new safety/effectiveness concerns). |
| Material Compatibility | Biocompatibility testing demonstrates tubing/fluid path to be biocompatible. (Same as predicate). |
| Sterilization Method | Ethylene Oxide (ETO) for Disposable Unit. (Same as predicate). |
| Shelf Life (Disposable Unit/CDU) | 3 years. (Same as predicate). |
| Base Unit Service Life | 5 years. (Same as predicate). |
| Ingress Protection (Water & Particles) | Warrior EXTREME: IP56, Warrior: IP33, Warrior Lite: IP56. (Different from predicate's IP22, but tested successfully per IEC 60601-1-12). |
| Storage Conditions | Warrior/Warrior EXTREME: -4°F to 140°F & 93% RH; Warrior Lite: -20 °C to 70 °C & 93% RH. (Wider range for Warrior Lite successfully tested). |
| Operation Temperature & Humidity | Warrior/Warrior EXTREME: 41°F & 15%RH to 104°F & 90% RH; Warrior Lite: 23°F to 122°F& 90%RH. (Wider range for Warrior Lite successfully tested). |
| Transient Operating Conditions | -4°F & 15%RH to 122°F & 90%RH. (Tested per IEC 60601-1-12). |
| Atmospheric Pressure/Altitude | -400 to 4572 meters (-1312 to 15,000 ft). (Same as predicate). |
| Nominal Input Voltage | 100-240 VAC, 18-25.2 DC. (Same as predicate). |
| Safety Testing (Electrical, EMC, EMS) | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-12 demonstrated. |
| Software Verification & Validation | Conducted per IEC 62304 and FDA guidance for Major level concern. |
| Usability | Simulated use testing in accordance with IEC 62366:2007 and FDA guidance demonstrated safe and effective use. |
2. Sample size used for the test set and the data provenance:
The document describes "Performance Data" which includes various types of engineering and laboratory testing (functional, electrical safety, EMC, software V&V, hemocompatibility, usability, shelf-life, sterilization).
- Sample Size: The specific sample sizes for each type of functional or safety test are not provided in this summary. It states "Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations" and "shelf-life testing and Sterilization assessment... was conducted with acceptable results."
- Data Provenance: This is not a data-driven clinical study in the sense of patient data. The data provenance is from laboratory and engineering testing of the devices themselves. There is no mention of country of origin of data, or if it was retrospective or prospective in the context of clinical patient data, because this is about device performance characteristics, not clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on the engineering and functional performance of a fluid warming device, not on diagnostic accuracy based on expert interpretation of medical images or data. Ground truth here refers to objective measurements against engineering specifications and industry standards, not expert medical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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 is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the device does contain software, the submission reviews its performance as an integrated medical device for fluid warming, not as a standalone AI algorithm for analysis or decision-making without a human in the loop. The software V&V ensures the software functions correctly within the device.
7. The type of ground truth used:
- The "ground truth" for this device's performance evaluation comes from established engineering specifications, recognized industry standards (e.g., IEC 60601 series, ISO 11135, IEC 62304, IEC 62366), and direct physical/electrical measurements. For example, the "ground truth" for temperature accuracy is the target temperature, measured by calibrated instruments. For hemocompatibility, the "ground truth" is the absence of adverse interactions with blood products, demonstrated through specific testing.
8. The sample size for the training set:
- Not applicable. This refers to a traditional medical device submission, not an AI/ML algorithm development. There is no "training set" in the context of machine learning. The device's software is developed and validated through traditional software engineering V&V processes.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).