(162 days)
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.
The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.
The provided document is a 510(k) premarket notification for the enFlow IV Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/medical device might.
Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes for test and training sets, and expert involvement for ground truth establishment cannot be fully provided from this document.
Here's an explanation based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that the device is substantially equivalent to a predicate device and lists a series of non-clinical studies for verification and validation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states that clinical testing was not required to support substantial equivalence due to the nature of the modifications (minor labeling, shelf life, design, and software modifications). Therefore, there is no clinical test set for which to determine sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set was used for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used for this 510(k) submission.
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. The enFlow IV Fluid Warmer is a physical medical device (an IV fluid warmer), not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's performance would be its ability to warm fluids to a specific temperature range, which is verified through engineering specifications and performance testing, not clinical outcomes in a study. The document mentions "Performance/Functional Verification and Validation" in the non-clinical studies section, implying engineering and bench testing.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (based on the document):
The document states that "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." (Page 2, Section 9).
Instead, the substantiation for this 510(k) submission relies on a series of non-clinical studies and design control measures applied to the development of the enFlow IV Fluid Warming system. These studies confirm that the device, even with the minor modifications, continues to be substantially equivalent to its predicate device (eFlow Model 100 IV Fluid Warmer, K060537).
The "acceptance criteria" in this context are not clinical performance metrics but rather the demonstration through these non-clinical studies that the modified device functions safely and effectively within its intended use and is equivalent to the predicate. The "study" proving this consists of:
- Risk Analysis
- Requirements Development and Reviews
- Software Verification and Validation (for the device's inherent software, not an AI algorithm)
- Performance/Functional Verification and Validation (bench testing to confirm the device performs as intended, e.g., heats fluids to the specified temperature and flow rates)
- Biocompatibility Testing
- Sterilization and Shelf-Life Testing
- Electrical Safety and EMC Testing
The document specifically highlights that "There have been no changes to the fundamental scientific technology of the device" (Page 1, Section 7), further supporting the reliance on non-clinical data for substantial equivalence. The FDA ultimately found the device substantially equivalent based on this information (Pages 3-5).
§ 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).