(308 days)
The Level 10 NORMOFLO® Irrigation Warming Set (Disposable Set) is a disposable irrigating fluid administration set, designed for use by trained medical professionals, for warming irrigating fluids. The Disposable Set is intended for use with the Level 1 8 H-1100 series NORMOFLO® Irrigation Fluid Warmers only.
The Level 1® NORMOFLO® Irrigation Fluid Warmer (Fluid Warmer) is designed for use by trained medical personnel for in-line warming of irrigating fluids.
The Level 1® NORMOFLO® Irrigation Fluid Warmer has been designed for safe, rapid, inline warming of irrigating fluids as they are administered to patients. This method employs single-use, disposable, irrigating sets that include a Heat Exchanger and may include a Gas Vent. The gas vent releases micro-bubbles of gas from fluids as they are warmed.
The Irrigation Fluid Warmer employs a safe re-circulating solution heating system, inherently free of any "hot spots". The primary temperature control circuit sets the recirculating solution to a temperature of approximately 41.7℃ for efficient heat exchange and maximum fluid warming.
The H-1129 provides pressurized fluid dclivery through the use of an on-board compressor and two 3-Liter (3L) pressure chambers. The pressure chambers pressurize the fluid bags for fast fluid delivery. A control panel on each pressure chamber displays the pressure in the chamber. A pressure regulator knob lets you select the desired pressure; a dial gauge displays the selected pressure.
There are 6 Irrigation Fluid Warming sets available for use on the Irrigation Fluid Warming units. Y-set adapters are available to adapt from 2 spike sets to 4.
This document is a 510(k) premarket notification for a medical device, the Normoflo® Irrigation Warming Set. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the manner typically seen for AI/software-as-a-medical-device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this type of regulatory submission. The device is a physical fluid warming system, not an AI or software device.
Here's an attempt to address the prompts based on the provided document, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or reported device performance in this format. The entire submission is built around demonstrating "substantial equivalence" to predicate devices, implying that its performance is comparable and safe/effective for its intended use, rather than meeting specific numerical performance thresholds.
However, the "Non-Clinical Data" section states: "Non-clinical performance testing has been performed to ensure the device is safe and effective and meets the clinical requirement of irrigation systems." This suggests internal testing was done, but the results and criteria are not detailed in this public summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The "Non-Clinical Data" refers to performance testing, but no details on sample size, data type, or provenance are given.
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)
This is not applicable and not provided. "Ground truth" as understood for AI/diagnostic devices doesn't apply to this physical fluid warming system. The "Clinical Data" section mentions "clinician surveys," which might be interpreted as a form of expert input, but details are not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided.
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
This is not applicable. The device is a physical fluid warmer, not an AI system designed to assist human readers/diagnosticians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hardware product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable for this type of device. The verification and validation would likely rely on engineering tests, temperature measurements, flow rates, material compatibility, and potentially some form of user feedback or observational studies. The "Clinical Data" mentions "clinician surveys to ensure the product meets the clinical guidance of the intended uses," which is a form of user feedback rather than establishing a diagnostic "ground truth."
8. The sample size for the training set
This is not applicable. The device is a hardware product undergoing a 510(k) clearance process based on substantial equivalence, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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).