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510(k) Data Aggregation
(98 days)
The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.
The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components:
- Disposable Unit (DU) - The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
- Base Unit (BU) – The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU or an AC power supply module; the BU contains firmware (SW) and electronics (HW).
- Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.
The provided text concerns a 510(k) premarket notification for a medical device (QiF Blood and Fluid Warmer), focusing on its substantial equivalence to a predicate device. This type of document is for regulatory approval and does not describe a clinical study comparing AI performance. Therefore, many of the requested elements for describing an AI study will not be present.
Instead, the document details performance testing of the device itself to demonstrate its safety and effectiveness, particularly after adding an AC power supply module.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Infusion Temperature | $38 \pm 2^\circ C$ |
| Heating Method | Resistive heating |
| Flow Rate | Up to 160 – 180 ml/min (based on gravity or fluid pump) |
| Safety Features | System self-test, Overheat notification, Overheat cut-off, Battery under-voltage protection (cut-off) |
| Notification Types | Overheat, Under heat, Low battery, Flow irregularity |
| Environmental Conditions | Operating and storage conditions certified within acceptable ranges (specific ranges for AC power supply module detailed in comparison table sections for operating/storage conditions are: Storage: -4°F to 140°F & 93% RH; Operating: 41°F &15%RH to 104°F & 93% RH; Altitude: -1312 to 10,499 ft.) |
| Electrical Safety | Compliance with IEC-60601-1:2005 and IEC 60601-1-2:2010 |
| Usability | Compliance with IEC 60601-1-6:2013 |
| Risk Management | Risk analysis in accordance with ISO 14971:2012 |
Key Finding: The subject device demonstrated equivalent performance to the predicate device in all performance tests, including heating fluid to set-point temperature from various inlet temperatures in various flow rates and system performance through flow rate irregularities.
Regarding AI-specific questions (2-9):
The provided text does not describe an AI medical device or an AI performance study. It describes a physical medical device (blood and fluid warmer) and its regulatory submission for a modification (adding an AC power supply). Therefore, information related to AI model acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.
The "Conclusions" section clearly states: "The modifications to the device do not raise different questions of safety and effectiveness and are supported by risk management activities. The QiF Blood and Fluid Warmer is substantially equivalent to the QiF Blood and Fluid Warmer, cleared under K171215." This confirms the focus is on the equivalence of the hardware device, not an AI algorithm.
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