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510(k) Data Aggregation
(259 days)
PUGGLE Enteral Feeding Pump and Feeding Set
The PUGGLE® Enteral Feeding Pump and Feeding Set are 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 PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.
The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.
The provided text is a 510(k) summary for the PUGGLE® Enteral Feeding Pump and Feeding Set. It outlines the device's technical characteristics and how it compares to a predicate device (Kangaroo™ Connect Enteral Feeding Pump and Set K143263). The document primarily focuses on demonstrating substantial equivalence to the predicate, rather than detailing a specific clinical study with acceptance criteria and device performance in the way a traditional clinical trial report would.
However, based on the Performance Testing section, we can extract information regarding acceptance criteria in the form of standards and general performance attributes, and the "reported device performance" is indicated by the statement that the device was verified and validated to meet these requirements.
Here's an attempt to structure the information based on your request, acknowledging that some fields may not be directly available in the provided document:
1. Table of Acceptance Criteria (based on standards and essential performance) and an indication of Device Performance
| Acceptance Criteria (Standards/Requirements) | Reported Device Performance (as stated in the document) |
|---|---|
| Software Verification & Validation per FDA Guidances | Software verification and validation were successfully performed for a Major Level of Concern, in accordance with FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices" and "Infusion Pump Total Product Life Cycle." |
| Cybersecurity Evaluation per FDA Guidances | Cybersecurity was evaluated, and the risk associated with cybersecurity-related hazards was determined to be low, following FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Electrical Safety per IEC 60601-1 | Electrical Safety testing was successfully completed in accordance with IEC 60601-1:2005 AAMI ES 60601-1:2005. |
| EMC per IEC 60601-1-2:2014 | Electromagnetic compatibility evaluation was successfully performed against IEC 60601-1-2:2014. |
| Administration Set Compatibility | Verification of essential pump performance was completed with the indicated administration sets. |
| Essential Performance Requirements (e.g., Flow Rate Accuracy, Occlusion Detection, Alarms) | The essential performance requirements (including feeding sets) were verified through performance testing in accordance with the intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle." This included: System V&V, Performance testing of essential attributes, Stability testing of feeding set, Flow Rate Accuracy testing across all operating conditions, Downstream Occlusion Detection, Pump Alarms (Air presence, upstream/downstream occlusions, set dislodged, rotor stuck, cassette error). |
| The device's flow rate accuracy is +/- 5%. (Compared to predicate's +/-5% or 0.5 mL/h according to IEC standard 60601-2-24, where the subject device confirmed +/-5% for "all flow rates" not just those in the standard). | |
| The maximum occlusion pressure is 16 psi (110 kPa), and the device has a more sensitive detection of occlusions and raises an alarm in a shorter period compared to the predicate's 20 psi (138 kPa). | |
| Battery Safety per IEC 62133 | NiMH battery safety was successfully tested per IEC 62133. |
| Human Factors per FDA Guidance | Human factors studies were conducted with the intended user population, use environment, and scenarios to simulate clinical conditions. The results demonstrate validation of the device per its intended use, in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Reprocessing/Cleaning per AAMI TIR30 | Compliance with AAMI TIR30:2011/R 2016 for cleaning reusable medical devices. (Implies successful verification). |
| Biocompatibility per ISO-10993 (FDA Guidance) | Biocompatibility testing demonstrated the biological safety of parts of the medical device that may indirectly contact the patient, as outlined in FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
The study that proves the device meets the acceptance criteria is detailed under the "Performance Testing" section within the 510(k) summary. It describes a "safety assurance case" approach.
Detailed Information about the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a numerical sample size for individual performance tests (e.g., how many pumps or feeding sets were tested). It refers to "performance testing of essential performance attributes" and "stability testing of feeding set" but doesn't give a number of units tested.
- Data Provenance: Not specified in the document. It does not mention country of origin or whether the data was retrospective or prospective, as these are typically not relevant for bench performance testing of this nature.
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 question is Not Applicable (N/A) in this context. The testing described is primarily bench and engineering validation (e.g., electrical safety, EMC, flow rate accuracy). "Ground truth" established by experts, as in clinical image interpretation, is not relevant here. The "ground truth" for these tests would be the measured physical parameters against defined engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of medical images. For engineering performance testing, the results are typically objectively measured against pre-defined specifications.
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
- N/A. This is an enteral feeding pump, not an AI-assisted diagnostic device. Therefore, MRMC studies or human reader improvement with AI are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is partially applicable in the sense that the device's technical functions (e.g., pump mechanism, sensors, alarms) were tested in isolation (standalone performance) against technical specifications. The "Performance Testing" section confirms that the "essential performance requirements of the device (including feeding sets) were verified through performance testing". This implies testing the device's inherent functionality. However, this is not "algorithm only" in the context of AI but rather the entire device's automated functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests is based on established engineering specifications, national and international standards (e.g., IEC standards), and regulatory guidance documents (e.g., FDA guidance for Infusion Pumps). For example, flow rate accuracy is measured against a defined percentage deviation. Occlusion detection is measured against specified pressure thresholds and response times.
8. The sample size for the training set
- N/A. As an enteral feeding pump, there is no "training set" in the context of machine learning or AI that would require a data sample for training. The device operates based on programmed logic and hardware, not a learned model from a dataset.
9. How the ground truth for the training set was established
- N/A. Since there is no training set, this question is not applicable.
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