(61 days)
The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
The Ranger Rapid Flow blood/fluid warming system is a stand-alone system that warms fluid, detects fluid level within the bubble trap, controls a patient valve, and delivers high volumes of fluid under pressure. The warming system consists of warming plates, fluid detection, valve control, pressure infusors and a fluid warming disposable set.
The provided text describes a 510(k) premarket notification for the "Ranger Rapid Flow Blood/Fluid Warming System." This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for a new AI/diagnostic device.
Therefore, many of the requested categories (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission.
The document emphasizes that clinical tests were not necessary for the Ranger Rapid Flow blood/fluid warming system to demonstrate substantial equivalence, which further confirms the absence of the specific types of studies you've inquired about.
Here's an attempt to fill in what information is available, and explicitly state what is not applicable or not provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the typical sense of a diagnostic device's performance metrics (e.g., sensitivity, specificity). Instead, the comparison is based on technological characteristics and intended use to demonstrate substantial equivalence to predicate devices. The table provided compares features of the new device to two predicate devices.
| Feature | Ranger Rapid Flow Blood/Fluid Warming System | Bair Hugger Blood/Fluid Warmer | Level 1 H-1028 Fluid Warming System |
|---|---|---|---|
| Flow rates | KVO-1200 mL/min | KVO-500 mL/min | KVO-1400 mL/min |
| Method of operation | Aluminum plate heated by electrical resistance; disposable cassette contacts plates | Aluminum plate heated by electrical resistance; disposable cassette contacts plates | Fluids warmed through a sealed heat exchanger with recirculating solution; uses water bath technology |
| Electronics | PID-controlled | PID-controlled | Uses water bath technology controlled electronics |
| Temperature Control | Electronically Controlled | Electronically Controlled | Electronically Controlled |
| Alarms | Audible & visual under/over temperature; activate at 25°C, 45.5°C, 46°C | Audible & visual under/over temperature; activate at 33°C, 43°C, 46°C | Audible & visual over temperature; activate at 43.9°C |
| Tubing | 144" long, 0.185" min ID, 0.273 max OD; Patient Line: 84" long, 0.185" min ID, 0.273 max OD | 144" long, 0.185" min ID, 0.273 max OD; Patient Line: 84" long, 0.185" min ID, 0.273 max OD | 68" long, 0.185" max ID, 0.273" min ID; Patient Line: 87" long, 0.185" min ID, 0.273 max OD |
| Sterilization method | 100% Ethylene Oxide, reference Isomedix Soft Cycle | 100% Ethylene Oxide, reference Isomedix Soft Cycle | 100% Ethylene Oxide, reference Isomedix Soft Cycle |
| Disposable packaging | Manufactured/assembled in filtered air; each set placed in box then sealed in polyethylene/tyvek pouch | Manufactured/assembled in filtered air; each set placed in box or sealed in polyethylene/tyvek pouch | Disposable set placed within a box |
The general "acceptance criterion" for this 510(k) submission is that the device demonstrates substantial equivalence to existing legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The conclusion states: "The Ranger Rapid Flow blood/fluid warming system has similar technological characteristics, components, and materials, and the same intended use as devices currently on the market. Therefore, because of the similarities to the predicate devices, Arizant Healthcare this new device does not raise any new safety or effectiveness issues."
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 explicitly states: "Clinical tests were not necessary regarding the use of the Ranger Rapid Flow blood/fluid warming system." This implies no formal clinical test set or data was used in the context of human patient data for this submission. The comparison is based on engineering specifications and intended use.
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. No ground truth establishment by experts for a test set is described, as clinical testing was deemed unnecessary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and thus no adjudication method is described.
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 blood/fluid warming system, not an AI or diagnostic imaging device. An MRMC study is irrelevant for this product type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device requiring standalone performance evaluation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth in this context was established or used, as no clinical studies with human data were performed for this submission. The "truth" for this submission is based on the functional specifications and performance characteristics of the device being sufficiently similar to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a training set.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth establishment for it.
§ 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).