(182 days)
The Enteral ite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients.
The Enteral ite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.
The device is a software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 120 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 12 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.
The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller was extensively validated and verified as part of the design process.
The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.
A backpack (convertible to a fannypack) is available for use under ambulatory conditions. The pump may be operated in any orientation.
The ZEVEX disposable nutrient administration set is comprised of nine components. All components of the set remain extracorporeal. The ZEVEX set interfaces with the in vivo apparatus via an industry standard non-I.V. compatible stepped adapter. The disposable set includes a short length of silicone tubing that is stretched around the three feeding purno rollers. As the rollers turn, they occlude the tubing forcing the nutrient solution through the silicone pump tube. The set also includes a unique fail safe device that precludes free-flow when the set is not correctly installed in the pump with the door closed. Pull tests were done to assure that the set would not be easy to inadvertently disconnect when in use.
The provided text is a Summary of Safety and Effectiveness Information for the EnteraLite™ Enteral Feeding Pump, submitted to the FDA on October 6, 1995.
This document describes the device and claims substantial equivalence to a predicate device (Kangaroo® PET® Enteral Feeding Pump), rather than presenting a study to prove acceptance criteria. Therefore, most of the requested information regarding study details (sample size, experts, adjudication, MRMC, standalone performance, training set) is not available in this document.
However, we can infer the acceptance criteria from the comparison tables and the claim of substantial equivalence. The "reported device performance" would be the characteristics and alarms listed for the EnteraLite™ device.
Here's an attempt to answer the questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the "SUBSTANTIAL EQUIVALENCE COMPARISON" and "ALARM COMPARISON" tables, the acceptance criteria are implicitly the performance characteristics and alarm functions of the predicate device, the Kangaroo® PET® Enteral Feeding Pump. The reported device performance is that of the EnteraLite™ pump.
| Feature / Acceptance Criteria (Predicate) | Reported Device Performance (EnteraLite™) |
|---|---|
| General Use & Features | |
| Hospital, Ambulatory, & Home Use | Yes |
| Pediatric Use | Yes |
| Pumping Mechanism: Rotary Peristaltic | Rotary Peristaltic |
| Operating Orientation: Upright Only | Any |
| Flow Monitoring: Yes | Yes |
| Physical Characteristics | |
| Size (approx. 14.4x5.1x9.7 cm) | 12.6 x 11.3 x 5.1 cm (Smaller form factor) |
| Weight (approx. 635g w/o charger) | 576 grams (1.27 pounds) (Lighter) |
| Charger Base | Wall mount (Different type) |
| Drip-proof: Yes | Yes |
| Flow & Accuracy | |
| Dose-limit (1 to 2000 ml) | 10 to 3000 ml x 10 ml increments (Wider range) |
| Flow-rate (1 to 400 ml/hour) | 1 to 600 ml/hour in 1 ml increments (Wider range) |
| Flow Accuracy: ± 10% | ± 5% including high viscosity solutions (Improved accuracy) |
| Fast prime: No | 30 sec fast prime @ 600 ml/hr (New feature) |
| Battery | |
| Battery Type: Nickel Cadmium | Nickel Metal Hydride (Different type) |
| Time between charges: 16 hours | 24 hours (Improved duration) |
| Charger Type: External base | External wall mounted (Different type) |
| Charge time (from full discharge): 8 hours | Five hours (Improved charge time) |
| Continuous Indication of Battery Charge Level: No | Yes (New feature) |
| Safety Features | |
| Display: LED (red) | LCD (green electroluminescent) (Different type) |
| Occlusion Pressure: 15 psi | Select 8psi or 12psi (± 2psi) (Adjustable/different) |
| Air-in-line Sensor: No | Yes (New safety feature) |
| Improper Loading Indication: Yes | Yes |
| Pole Clamp Mountable: Yes | Yes |
| Supplied Sterile: No | No |
| Alarms | |
| DOSE DONE: YES | YES |
| NO FOOD/EMPTY SET: YES | YES |
| LOAD SET: YES | YES |
| UPSTREAM OCCLUSION: YES | YES |
| DOWNSTREAM OCCLUSION: YES | YES |
| LOW BATTERY: YES | YES |
| INTERVAL PROGRAM ERROR: NO | YES (New alarm) |
| MOTOR OBSTRUCTION: YES | YES |
| TIME OUT (HOLD ERROR): YES | YES |
| SELF DIAGNOSTICS: YES | YES |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document states a "summary was prepared," implying it's based on internal testing and comparison to the predicate device, but no specific study data or provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a clinical study involving expert interpretation or ground truth establishment in this manner.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The document does not describe a clinical study with an adjudication process.
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. This device is an enteral feeding pump, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone system. The document states: "The software embodied within the microcontroller was extensively validated and verified as part of the design process." However, details of this "validation and verification" are not provided. The performance criteria (e.g., flow accuracy, occlusion pressures, battery life) are intrinsic to the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance characteristics (e.g., flow accuracy, battery life, alarm thresholds) would have been established through design specifications, engineering testing, and adherence to relevant industry standards like ANSI/AAMI ID26-1992 and UL2601-1 (as mentioned in the references). For safety features like occlusion pressure and air-in-line, the ground truth is the physical conditions detectable by the device's sensors and its ability to respond as designed.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model document.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model document.
Summary of the document's approach:
The document establishes safety and effectiveness through a substantial equivalence claim to a legally marketed predicate device. This involves:
- Detailed comparison of features, performance specifications, and safety mechanisms (alarms).
- Highlighting where the new device meets or exceeds the predicate's performance (e.g., better flow accuracy, longer battery life, additional safety features like air-in-line sensor).
- Citing adherence to relevant FDA guidance documents and industry standards for infusion pumps.
The "study" or evidence provided is primarily this detailed comparative analysis and the implicit assumption that if a device is "substantially equivalent" to one already approved, and addresses any potential concerns outlined in guidance documents, its safety and effectiveness are established. Specific engineering test results (e.g., for flow accuracy) are typically part of the full 510(k) submission but are only summarized in terms like "± 5% including high viscosity solutions" in this summary.
§ 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).