(304 days)
The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.
The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the outside of the administration set tubing. The warmer includes an LED light to indicate the warmer is operating and a switch that will turn the warmer on and off. The Enteral Nutrition Warmer is reusable and provided non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Enteral Nutrition Warmer:
Acceptance Criteria and Device Performance
The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria derived from clinical performance trials for the proposed device's efficacy in warming enteral fluid. The "acceptance criteria" can be inferred from the comparative table where the proposed device's characteristics are presented against those of the predicate. The "reported device performance" is then what the proposed device demonstrated in the non-clinical tests.
Inferred Acceptance Criteria Table:
| Acceptance Criteria (from Predicate Device Specifications) | Reported Device Performance (Proposed Device) |
|---|---|
| Intended Use: Electronically powered dry warmer, supplies external heat to plastic tubing for intermittent use and low flow rate applications (0-7mL/min). | Same |
| Principle of Operation: Electrically powered, controlled heat to outer wall of extension set delivering enteral fluid. | Same |
| Flow rate: 0 to 7mL/min | 0 to 7mL/min |
| Output temperature range: 32 C to 41 C | 32 C to 41 C |
| Maximum heating plate temperature: 46 C (Predicate) | 48.8 C (Proposed) - Note: Stated not to pose a burn hazard despite being higher. |
| Temperature sensor type: Thermocouple | Thermocouple |
| Safety feature: Temperature fuse shuts off power if sensor inoperable. | Temperature fuse shuts off power if sensor becomes inoperable. |
| Electrical source: Standard 120V electrical outlet. | Standard 120V electrical outlet. |
| Operating condition: 0 C to 40 C | 0 C to 40 C |
| Materials: Fire rated for intended use. | All materials are fire rated for the proposed device's intended use. |
| Maximum temperature outside housing (top) | Tested (specific value not provided in summary) |
| Maximum temperature outside housing (bottom) | Tested (specific value not provided in summary) |
| Maximum temperature heat sink (tubing track) | Tested (specific value not provided in summary) |
| Maximum temperature of enteral fluid (portion under heater) | Tested (specific value not provided in summary) |
| Maximum temperature of enteral fluid (at extension set feeding tube portion) | Tested (specific value not provided in summary) |
| Time to reach nominal temperature | Tested (specific value not provided in summary) |
Study Proving Acceptance Criteria:
The document describes non-clinical tests that were performed to demonstrate that the device is capable of meeting the predicate device's specifications, particularly for the addition of enteral fluids to the intended use.
-
Sample Size for Test Set and Data Provenance:
- The document does not specify a sample size for any "test set" in terms of cases or patients. The performance data section refers to "non-clinical tests" and a "human factors study."
- The document implies laboratory-based, engineering performance testing rather than clinical trials with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the traditional sense.
-
Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided. The study mentioned in the document is a human factors study and non-clinical performance tests, not a diagnostic study requiring expert ground truth for interpretation of cases.
-
Adjudication Method for the Test Set:
- Not applicable, as the tests described are non-clinical engineering and human factors assessments, not diagnostic performance studies requiring adjudication of results against a ground truth from experts.
-
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done or reported. The submission is a 510(k) for a medical device (warmer) where the primary comparison is technical specifications and safety with a predicate device, not diagnostic efficacy with or without AI assistance for human readers.
-
Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is an enteral nutrition warmer, not an AI algorithm.
-
Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" would be the engineered specifications and measurements (e.g., target temperature ranges, maximum surface temperatures, flow rates, time to reach temperature). These are determined by physics and engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.
- For the human factors study, the "ground truth" would relate to identifying and mitigating risks related to usability and safety, likely against established human factors engineering principles and standards.
-
Sample Size for the Training Set:
- Not applicable. This device is a physical warmer, not a machine learning model, so there is no "training set."
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there's no training set, there's no ground truth to establish for it in this context.
§ 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).