(163 days)
The enFlow IV Fluid Warmer System 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 infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/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 basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Strap device:
Important Note: The provided document (K121775) is for a modification to an already cleared device (enFlow IV Fluid Warmer, K112902). The modification is specifically the addition of a Strap as an accessory. Therefore, the core performance of the fluid warmer itself is not being re-evaluated in this submission. The focus is on the impact of the strap.
Acceptance Criteria and Reported Device Performance
The submission states: "The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm." And "[t]here have been no changes to either the intended use of the device or the fundamental scientific technology of the device."
Given this, the acceptance criteria are implicitly that the addition of the strap does not negatively impact the safety and effectiveness of the previously cleared enFlow IV Fluid Warmer.
| Acceptance Criteria (Implicit for Strap Addition) | Reported Device Performance (Impact of Strap) |
|---|---|
| No degradation in the performance of the enFlow IV Fluid Warmer. | "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." |
| No new safety concerns introduced by the strap. | Risk Analysis and Biocompatibility Testing were applied to the "enFlow IV Fluid Warming system" (including the modification, as implied by the context of the submission). This suggests no new unacceptable risks were identified. |
| The strap effectively secures the warmer to the arm as intended. | Performance Testing was applied to the "enFlow IV Fluid Warming system." While specific results for the strap's securing function aren't detailed, the overall conclusion of substantial equivalence implies this function was met without issues. |
| The device remains substantially equivalent to the predicate device. | "Vital Signs, Inc. a GE Healthcare Company, considers the enFlow IV Fluid Warmer to be as safe, as effective, and the performance to be substantially equivalent to the predicate device." |
Study Details
Based on the provided K121775 submission:
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Sample size used for the test set and the data provenance:
- No specific test set sample size is mentioned for the strap itself.
- The document explicitly states: "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." This means there was no clinical test set in the traditional sense for the strap.
- Non-clinical studies (Risk Analysis, Biocompatibility Testing, Performance Testing) were conducted, but details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests specific to the strap are not provided in this summary. These would typically be detailed in a more comprehensive testing report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth was performed for this specific modification.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was performed.
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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 fluid warmer, not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (Risk Analysis, Biocompatibility, Performance Testing), the ground truth would be based on engineering specifications, regulatory standards, and established laboratory testing methodologies. No human-derived ground truth (like expert consensus or pathology) is relevant here.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the Study for this Specific Submission (K121775):
The submission K121775 is a "Special 510(k) Premarket Notification" for a minor change (adding a strap) to an already cleared device. As such, the "study" is primarily a demonstration of substantial equivalence to the predicate device (K112902) despite the modification, based on non-clinical data.
The relevant non-clinical studies mentioned are:
- Risk Analysis: To ensure the strap does not introduce new unacceptable risks.
- Biocompatibility Testing: To ensure the strap material is safe for patient contact (if applicable, though its primary function is to secure the warmer to the arm, not direct patient contact, the material's interaction with the warmer itself or incidental human contact could be considered).
- Performance Testing: To ensure the strap functions as intended (securing the warmer) and does not impede the warmer's performance.
The key finding is that these non-clinical tests supported substantial equivalence and that clinical testing was not required due to the nature of the modification. This implies that the strap was assessed to be safe and effective and did not alter the fundamental characteristics or performance of the 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).