(491 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 Ltd. QiF Blood and Fluid Warmer device is a portable, sterile Fluid Path, in-line Blood and Fluid Warmer. The device is comprised of a Base Unit and a sterile disposable cartridge (Disposable Unit). The device is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient's body. The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The disposable unit cartridge (blood/fluid) is provided with inlet and outlet luers that connect to standard IV tubing.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: QiF Blood and Fluid Warmer
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (where explicitly stated) | Reported Device Performance |
|---|---|---|
| Hemolysis Study | Hemolysis of up to 1% (in compliance with ASTM 2172:[(2002) Reapproved 2011)]) | All samples met the acceptance criteria (hemolysis of up to 1%). Tested under normal and worse-case conditions (stop flow, high flow rate, air bubble), and with old RBC blood product at high and low flow rates. No protocol deviations. |
| Temperature Indication Accuracy | Determined according to product design input requirement specifications (not explicitly stated in document) | All tests met the acceptance criteria. |
| Outflow Temperature Profile | Determined according to product design input requirement specifications (not explicitly stated in document) | All tests met the acceptance criteria. Tested under normal and abnormal (stop flow, high flow rate, air bubble) flow scenarios. |
| Fluid Path Integrity under Pressure | Determined according to product design input requirement specifications (in compliance with ASTM 2172:[(2002) Reapproved 2011)]) | All tests met the acceptance criteria. |
| Battery Capacity | Determined according to product design input requirement specifications (in terms of minimal heated volume) | All tests met the acceptance criteria. |
| Leachability Testing | No significant change in the concentration of new materials not present in the fluid prior to heating; no significant change in the concentration of any of the detected materials between control sample and test article. | All test samples met the acceptance criteria. Analysis performed by external certified lab. No protocol deviations. |
| Software V&V | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and EN IEC 62304:2006/AC:2008. | Performed in compliance. Software level of concern is moderate. |
| Biocompatibility | Compliance with ISO 10993-5:2009, 10993-10:2010, 10993-11:2006, ASTM F756:2008 | Testing performed. (Implied compliance by "performed the following testing... to evaluate the QiF Blood and Fluid Warmer device and demonstrate substantial equivalence") |
| Sterilization & Shelf Life | Compliance with ISO 11135-1:2007, ISO 11737-1:2006, ISO 10993-7:2008, and FDA CDRH, Shelf Life of Medical Devices guidance, April 1991 | Validation conducted in compliance. (Implied device meets criteria by "conducted in compliance") |
| Electrical Safety & EMC | Compliance with IEC 60601-1:2012, 60601-1-2:2007 ed. 3.0, 60601-1-6:2010, 60601-1-11:2010 | Testing performed. (Implied compliance by "performed the following testing...") |
| Battery Testing | Compliance with IEC 62133:2012 | Testing performed. (Implied compliance by "performed the following testing...") |
Study That Proves the Device Meets Acceptance Criteria:
The document describes a series of bench testing and design control activities performed by Quality In Flow Ltd. to evaluate the QiF Blood and Fluid Warmer device. These tests were conducted according to established international standards and internal product design input requirement specifications.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of units tested for hemolysis, temperature accuracy). It refers to "all samples" meeting criteria for hemolysis and leachability, suggesting multiple samples were indeed tested.
- Data Provenance: The studies were performed by Quality in Flow Ltd., the device manufacturer. The data is prospective, as it was generated specifically for the 510(k) submission to demonstrate device performance. The country of origin of the data is Israel, where Quality in Flow Ltd. is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for these performance tests is typically the measured physical properties against objective standards or specifications, rather than expert consensus on subjective interpretations. For example, for hemolysis, the ground truth is the chemical measurement of free hemoglobin in the fluid.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective performance measurements against defined criteria, not subjective assessments requiring adjudication.
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 warming device, not an imaging or diagnostic AI device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not explicitly stated in these terms. However, the performance data presented (hemolysis, temperature accuracy, etc.) represents the intrinsic performance of the device's hardware and software (algorithm only) without direct human intervention during the measurement process, aside from setting up and operating the device. The software verification and validation is a key component of this "algorithm only" assessment.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is primarily objective physical and chemical measurements against:
- Established international standards (e.g., ASTM 2172 for hemolysis and fluid path integrity, ISO 10993 for biocompatibility, IEC 60601 for electrical safety).
- The manufacturer's own product design input requirement specifications (e.g., for temperature indication accuracy, outflow temperature profile, battery capacity).
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (fluid warmer), not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would be its iterative design, engineering, and prototyping phases.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The design and performance specifications were established through engineering principles, regulatory requirements, and user needs for a medical fluid warmer.
§ 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).