(82 days)
The Enteral Expres enteral fluid delivery system is intended to provide delivery of standard enteral nutrition fluids to patients in the hospital and in alternate site care.
The Enteral Expres enteral feeding pump system is intended for the programmed delivery of enteral nutrition fluids to the patient. It may be used in hospitals, outpatient, or home healthcare sites on immobilized or ambulatory patients. The "Enteral Exprés" system offers the following capabilities: CONTINUOUS, PROGRESSIVE, and PROGRESSIVE INTERMITTENT delivery modes to meet different patient needs; Wide range of programmable delivery rates: from 1 to 999 mL/hr; One way, snap-in cassette simplifies giving set loading; Safety features that help prevent tampering with the pump include keypad lock and program lock; Keypad and display are simple and easy to use, and display provides English or Spanish information; Battery or AC-powered operation. Battery life monitored by internal battery gauge; Small, quiet, and lightweight to enhance patient comfort. The Enteral Expres pumping mechanism is comprised of a cassette assembly and the pump. The majority of the pumping mechanism is incorporated into the cassette assembly, with the motor and it's controlling electronics and shaft being incorporated in the pump. The cassette incorporates three rollers and a length of silicone tubing housed in a closed cassette assembly. Loading the cassette onto the motor shaft causes the rollers to expand outward, crushing the tubing against the inside walls of the cassette body and occluding ourity flow through the system. As the motor shaft rotates, the rollers rotate and the crushed portion of the tubing translates across the inner circumference of the cassette body. This portion of the tuones attiblements action. The accuracy of the system is largely determined fesults in a rotal y persuative pulliging assist of the inner diameter of the tubing is the primary factor in determining the volumetric output per rotation. Within the pump the motor is directly coupled to the drive shaft through a sprag clutch to writting the punp the motor is controlled by the microprocessor and redundant province is used to verify the proper rotation of the shaft. The accuracy of the motor's rotation entently is as a long onchronizing the signal from the motor's encoder with a signal generated by a programmable frequency divider. The accuracy of the frequency divider is monitored by an independent microprocessor clock circuit. Microprocessor integrity is, in turn, monitored with self-check routines and watchdog circuitry.
The provided text is a 510(k) Summary for the Debiotech S.A. Enteral Exprés Pump Unit and Enteral Expres Giving Sets. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Sherwood Medical Kangaroo Pump - K945964).
Unfortunately, the document does not contain specific acceptance criteria, study details to prove the device meets these criteria, or detailed performance data beyond a general description of capabilities and accuracy mechanisms. The summary focuses on the device's technological characteristics, safety features, and regulatory classification process.
Therefore, I cannot provide the requested table or detailed study information as it is not present in the provided text.
Here's what I can extract based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volumetric Accuracy (Implicit standard for enteral pumps) | "The accuracy of the system is largely determined...of the inner diameter of the tubing is the primary factor in determining the volumetric output per rotation." |
| "The accuracy of the motor's rotation...synchronizing the signal from the motor's encoder with a signal generated by a programmable frequency divider." | |
| Programmable Delivery Rates | "Wide range of programmable delivery rates: from 1 to 999 mL/hr" |
| Safety Features | "Safety features that help prevent tampering with the pump include keypad lock and program lock" |
| Ease of Use (Display/Interface) | "Keypad and display are simple and easy to use, and display provides English or Spanish information" |
| Loading Mechanism | "One way, snap-in cassette simplifies giving set loading" |
| Power Options | "Battery or AC-powered operation. Battery life monitored by internal battery gauge" |
| Physical Characteristics (Size/Weight/Noise) | "Small, quiet, and lightweight to enhance patient comfort" |
| Delivery Modes | "CONTINUOUS, PROGRESSIVE, and PROGRESSIVE INTERMITTENT delivery modes" |
Note: The "Reported Device Performance" column is derived from the "Description" and "Summary of technological characteristics" sections, describing features and how accuracy is achieved, rather than presenting test results against explicit numerical acceptance criteria.
Regarding the Study Information:
The provided document doesn't include details about a specific study that demonstrates the device meets acceptance criteria. A 510(k) summary typically presents a summary of information that supports a claim of substantial equivalence, which may include performance testing results, but these are often summarized or referenced rather than fully detailed in the publicly available summary.
Specifically, the document does not contain any of the following information:
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance. (This is irrelevant for this type of medical device which is an enteral pump, not an AI-assisted diagnostic tool).
- If a standalone (algorithm only) performance study was done. (Also irrelevant for this device type).
- The type of ground truth used (pathology, outcomes data, etc.). (Again, not relevant for this device type which performs a physical function).
- Sample size for the training set.
- How the ground truth for the training set was established. (These two points are relevant for machine learning/AI devices, which this is not).
The document is a regulatory submission for an enteral pump, focusing on its design, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results that would typically be required for diagnostic or AI-powered devices. The "accuracy" mentioned relates to the mechanical and electronic control of fluid delivery, not diagnostic accuracy.
§ 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).