(135 days)
The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.
The Penguin In-Line Warmer is an external dry-heat thermal warmer. The Penguin In-Line Warmer warms nutritional feedings for patients being fed via a gastrointestinal tube.
This document describes a 510(k) premarket notification for the "Penguin In-Line Warmer," a device used to warm enteral nutrition. The information provided focuses on the device's technical characteristics and performance testing to demonstrate its substantial equivalence to predicate devices. It does not contain information about studies involving human readers or AI assistance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing the technical characteristics of the Penguin In-Line Warmer with its predicate devices. While it lists various characteristics, it doesn't explicitly define "acceptance criteria" in a quantitative sense for each characteristic. Instead, it indicates "SAME" where characteristics are identical to the predicate. For those that differ, the reported performance is simply the characteristic itself.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Penguin In-Line Warmer) |
|---|---|---|
| Overall Technological Characteristics | Dry-heat, external thermal warmer | Dry-heat, external thermal warmer. |
| Principle of Operation | Gastrointestinal tubing fed through warming channel, warming nutritional feeding before entering patient. | The gastrointestinal tubing is fed through the warming channel of the warmer, which warms the nutritional feeding before entering the patient. |
| Power Requirements | 230V~, 50/60Hz, 60W/hr AND 115V~, 50/60Hz, 100W/hr | 240V~, 50/60Hz, 60W/hr AND 100V~, 50/60Hz, 100W/hr |
| Temperature Display | No | Yes, Celsius and Fahrenheit, LED |
| Warming Temperature | 32-41C | 36-38C |
| Warming Time | 2-3 minutes | 2-3 minutes |
| Warming patient proximity | At point of care | At point of care |
| Temperature control | Pre-Set at manufacturer | Pre-Set at manufacturer |
| Number of heaters | One (for one predicate, unknown for other) | One |
| User controls | ON/OFF button OR ON/OFF switch | ON/OFF button, F°/C° button (toggles display) |
| Materials of Construction | Aluminum heating plate (for one predicate, unknown for other) | Aluminum heating plate |
| Heating channel | "S" shaped OR Exaggerated "S" Shape | Multi-"S" shaped |
| Tube compatibility | 4.1-5.0 dia mm OR 2.4mm | 2.0-3.0 dia mm |
| Flow rate | 0-7ml/min | 0.25-1 ml/min |
| Thermal cut-off | Fuse | Fuse |
| Operating Condition | 0-40C | 0-40C |
| Water resistant case/housing | Yes (for one predicate, unknown for other) | Yes |
| Fluid Path Contact | No | No |
| Direct Patient Contact | No | No |
| How provided | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
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 in the document. The document states "All necessary verification and validation testing has been performed," but does not detail the sample sizes, test setup (e.g., specific number of tests run for temperature verification), 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)
This information is not applicable and therefore not provided. The device is an enteral nutrition warmer, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The testing mentioned (cleaning/disinfection, temperature verification, electrical safety, EMC, software validation) would be performed by engineers and technicians against established technical standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation (e.g., by radiologists) is required to establish ground truth for a diagnostic device. The device in question is a medical warmer, and its performance is evaluated against objective technical standards, not subjective human interpretations.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers (e.g., radiologists, pathologists) and AI assistance. The Penguin In-Line Warmer is a physical device that warms fluids, and its evaluation does not involve human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical warmer, not an algorithm, so a "standalone algorithm only" performance evaluation is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification and validation testing mentioned, the "ground truth" would be established by:
- Established industry standards and regulatory requirements: For electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
- Engineering specifications and design documents: For temperature verification (e.g., ensuring the device warms to a specific range), cleaning/disinfection effectiveness, and software functionality.
- Physical measurements and observations: For parameters like warming temperature accuracy, warming time, flow rate, and tube compatibility.
This is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set and associated ground truth establishment.
§ 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).