(258 days)
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal consists of a wireless enabled enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. The new Kangaroo™ Connect Enteral Feeding Pump wireless accessories include a communication hub and the Kangaroo™ Connect Portal. The communication hub collects short-range data from the pump through a Zigbee signal and sends the data through either WiFi or a cellular signal to the device cloud where the Kangaroo™ Connect Portal can access the data for monitoring. The wireless enabled pump, when used in conjunction with the wireless accessories, will provide a platform for remote data collection allowing clinicians to more efficiently monitor feeding rates and review actual history of nutritional delivery.
The provided document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal (K153074). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance statistics for each feature.
Therefore, the information requested in the prompt, especially specific numerical acceptance criteria, reported device performance for those criteria, and detailed study parameters (like sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance, and ground truth establishment methods), is not explicitly available within this 510(k) summary.
However, I can extract the general categories of performance testing that were conducted to support the device's safety and effectiveness. The document refers to a "safety assurance case" and "Performance Testing evidence."
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific numerical acceptance criteria and reported performance metrics are not provided in this summary. The summary describes categories of tests conducted.
| Acceptance Criteria (Category) | Reported Device Performance (Summary) |
|---|---|
| Flow Rate Accuracy | Performance testing conducted to evaluate essential performance attributes. Specific accuracy metrics are not listed. |
| Downstream Occlusion Detection | Performance testing conducted to evaluate essential performance attributes. Specific detection metrics are not listed. |
| Pump Alarms | Performance testing conducted for various alarms (Feed Bag Empty, Supply Tube Blocked, Cassette Dislodged, Rotor Stuck, Cassette Error). Specific performance metrics for alarms are not listed. |
| Cleaning and Disinfection Validation | Validation performed to ensure appropriate cleaning and disinfection. |
| Human Factors Testing | Conducted to evaluate the usability of the device. |
| Electrical Safety Testing | In accordance with IEC 60601-1:2005 (AAMI ES 60601-1:2005). |
| Electromagnetic Compatibility | In accordance with IEC 60601-1-2:2014. |
| Software Verification and Validation | Conducted as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. The studies mentioned (e.g., system verification and validation activities, performance testing) would typically be conducted by the manufacturer (Covidien/Medtronic) without specific country of origin or retrospective/prospective details being disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The assessment of device performance for general medical devices like enteral feeding pumps typically relies on objective physical measurements and engineering standards rather than expert-established ground truth in the way it's used for AI/diagnostic devices. Human factors testing involves users, but the specifics of expert qualifications are not within the scope of this type of summary.
4. Adjudication method for the test set
- This information is not provided and is generally not applicable to the type of performance testing (e.g., flow rate accuracy, electrical safety) described for an enteral feeding pump. Adjudication methods are more commonly associated with subjective assessments or diagnostic interpretability studies.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices involving human readers. The Kangaroo™ Connect Enteral Feeding Pump is a medical device for delivering nutritional formula, and its wireless accessories are for remote data collection and monitoring, not for diagnostic interpretation by human readers. The summary mentions human factors testing to evaluate usability, which is different from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The performance testing described (e.g., "Flow Rate Accuracy," "Downstream Occlusion Detection," "Pump Alarms") would typically be conducted on the device (pump and software/firmware) independently of human interaction, to ensure the device itself performs according to its specifications. The "wireless enabled-disabled performance testing of essential performance attributes" refers to the inherent function of the device and its system. These tests assess the algorithm's performance in controlling the pump and detecting issues.
7. The type of ground truth used
- The "ground truth" for the performance testing of this device would be established by engineering standards and objective measurements. For example:
- Flow Rate Accuracy: Measured flow rates would be compared against the programmed rates using calibrated instruments.
- Occlusion Detection: Artificially induced occlusions would be tested for detection by the device's sensors.
- Alarms: Specific conditions (e.g., empty bag, blocked tube) would be simulated or created to verify alarm functionality.
- Electrical Safety/EMC: Compliance with relevant IEC standards would be assessed through standardized test procedures and equipment.
- Software Verification/Validation: Code reviews, unit testing, integration testing, and system testing against design specifications.
8. The sample size for the training set
- This information is not provided and generally not applicable in the context of traditional medical device development where specific "training sets" are primarily associated with machine learning or AI algorithm development. While there are software elements (mentioned as "on board custom software"), the development process described is standard software verification and validation, not a machine learning model training process that would require a distinct "training set" in the AI sense.
9. How the ground truth for the training set was established
- This information is not provided and generally not applicable (see point 8). The "ground truth" for ensuring the functionality of the device's software would be its design specifications and requirements.
§ 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).