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The Vesco Q™ Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.

The Vesco Q™ Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable enteral feed sets. The Vesco Q™ Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. The Vesco Q™ Feed Sets are non-sterile, single patient use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading of the feed set without a pump door. The feed sets incorporate a female ENFit connector which is compatible with devices that have male ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.

Vesco Q™ Feed Sets are available in three different feed set styles: Bag Feed Sets, ENPlus Feed Sets and Screw Cap Feed Sets. All of the feed sets are made of flexible PVC tubing, a silicone tube, a feed set to pump interface, and a plastic ENFit female connecting port. Bag Feed Sets are available in two different volumes, 500mL and 1000mL. The difference between each feed set is how the liquid nutrition is introduced to the set. The Bag Feed Set has a translucent film bag, the Safety Screw Spike Feed Set has a plastic spike connector, and the Screw Cap Feed Set has a plastic 40mm threaded opening to connect to feed containers.

The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices.

This document is a 510(k) premarket notification for a medical device – specifically, the Vesco Q™ Enteral Feeding Pump System. It aims to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed predicate device.

Crucially, this document focuses on establishing substantial equivalence for a physical medical device (an enteral feeding pump and its associated sets), not an AI/ML-driven diagnostic or assistive device that would require performance in terms of accuracy metrics like sensitivity, specificity, AUC, etc., or human-in-the-loop studies (MRMC).

Therefore, the specific acceptance criteria and study designs typically used for AI/ML devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. The "performance testing" section outlines tests for the physical device's mechanical, electrical, and biocompatibility properties, not AI/ML model performance.

Based on the provided text, I cannot provide information on the following as they are not relevant to this type of device submission:

• A table of acceptance criteria and reported device performance related to AI/ML metrics: The acceptance criteria are for physical and functional parameters (e.g., pumping accuracy, battery life, biocompatibility), not diagnostic or classification performance.
• Sample sizes used for the test set and data provenance: The "test set" in this context refers to physical units of the device, not a dataset for AI/ML evaluation.
• Number of experts used to establish the ground truth for the test set and qualifications: Ground truth for this device is based on engineering specifications and physical test results, not expert interpretation of data.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on engineering standards and physical measurements.
• The sample size for the training set: Not applicable as there is no AI/ML model being trained.
• How the ground truth for the training set was established: Not applicable.

However, I can extract and describe the general "acceptance criteria" and "study" (performance testing) that proves the device meets them, as presented in the document for this physical medical device:

The acceptance criteria for the Vesco Q™ Enteral Feeding Pump System are based on establishing "substantial equivalence" to a predicate device (EnteraLite Infinity™ Enteral Feeding Pump) through a series of non-clinical performance and safety tests, and addressing any minor differences.

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

The document defines acceptance implicitly through demonstration of adherence to design requirements, relevant ISO standards, and comparison to the predicate device. The performance is "proven" by stating that "It was found that the pump and feed sets are in compliance with all design and performance requirements based on the completed testing."

Below is a summary of the broad categories of acceptance criteria and the statement of performance:

• Pumping accuracy
• Gear box life cycle
• Freefall
• Air-in-Line
• Button life cycle
• Power adapter life cycle
• Battery run time
• Noise level
• Pole clamp weight
• Occlusion
• Battery charge time
• Bolus accuracy (under various conditions)
• Cleanability and performance |
  | Feed Set Integrity | Compliance with EN ISO 20695:2020 for unaged and aged product for:
• Tensile test
• Pressure leak test
• Kink test (EN 13868:2002)
• Anti-free flow test (Vesco Medical's design requirement)
• Free flow rate test (Vesco Medical's design requirement) |
  | User Interface/Human Factors| Compliance with "Vesco Medical's design requirement" for Human Factors and Usability Validation. (Noted the touchscreen UI was "designed to be easy to read and intuitive to help mitigate user related hazards.") |
  | Electromagnetic Compatibility| Compliance with IEC 60601-1-2. |
  | Hardware, Software, Mechanical Safety| Compliance with IEC 60601-1. |
  | Software Verification & Validation| Compliance with FDA guidance document "Infusion Pump Total Product Life Cycle" recommendations. |
  | Risk Management | Compliance with ISO 14971:2007 (Risk Hazard Analysis) and Vesco Medical's design requirements (DFMEA). |
  | Material Compatibility | "Wipe and soak test for pump housing material selection" in accordance with Vesco Medical's design requirement. |

2. Sample Size and Data Provenance for the Test Set:

• Sample Size: The document does not specify the exact number of physical units (pumps and feed sets) tested for each performance criterion. It generally states that "Verification and validation testing were performed with the Vesco Q™ Enteral Feeding Pump and the Vesco Q™ Feed Sets." Typically, for such devices, a statistically appropriate number of units would be tested to ensure reliability, but the specific quantity is not disclosed in this summary.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The "data" here are the test results from physical devices, which would have been generated in a laboratory or testing facility, likely in the US as the manufacturer (Vesco Medical LLC) is based in Ohio. The testing is non-clinical.

3. Number of Experts/Qualifications for Ground Truth:

• This concept is not relevant here as the "ground truth" for a physical pump's performance (e.g., flow rate accuracy, battery life) is determined by direct physical measurement against engineering specifications and industry standards, not by expert consensus on interpretations of data (like medical images).

4. Adjudication Method for the Test Set:

• Not applicable, as there is no human interpretation or ground truth adjudication process akin to those used for AI/ML diagnostic data.

5. MRMC Comparative Effectiveness Study:

• No MRMC study was done. This type of study (Multi-Reader Multi-Case) is specifically designed to assess how human reader performance changes when assisted by an AI system, typically in diagnostic imaging. The Vesco Q™ Enteral Feeding Pump is a physical medical device, not an AI diagnostic tool, so an MRMC study is not relevant or required.

6. Standalone Performance:

• Not applicable. The device is a functional pump, not a standalone algorithm. Its performance is inherent in its operation (e.g., "Pumping accuracy test" refers to the pump itself, not an algorithm's output).

7. Type of Ground Truth Used:

• The ground truth for this device's performance is based on engineering specifications, direct physical measurements, and compliance with industry standards (e.g., ISO, IEC, USP). This differs significantly from "expert consensus," "pathology," or "outcomes data" that would be used for AI/ML ground truth.

8. Sample Size for the Training Set:

• Not applicable, as there is no AI/ML model being trained. The "training" for this physical device refers to its design, manufacturing processes, and quality control.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no AI/ML model being trained. The "ground truth" here is the established design requirements and performance targets set by the manufacturer and relevant regulatory standards, which the device aims to meet through its engineering and manufacturing.

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