(9 days)
The enteral feeding pump accurately controls the flow of liquid feeding solution to patients who are unable or unwilling to consume adequate nutrients. Liquid feedings may consist of commercially prepared formulas or blenderized foods and are most often delivered by means of nasogastric, nasoduodenal of nasojenjunal feeding tubes. In some cases a surgically placed esophagostomy, gastrostomy or enterostomy tube may be used. The pump is not intended for use with blood or blood products. The pump is not for intravenous delivery.
The SENTINEL / LH2001 is a peristaltic pump intended for controlled delivery of liquid nutrients. The pump requires cleared disposable delivery tube sets approved by ENTRACON CORPORATION. The pump is used to feed hospital or long term care patients. The microprocessor controlled pump operates while normally connected to a 120 VAC outlet. In the event of AC power loss, or when moving patients, the pump operates on an internal backup battery. The battery is always being charged by during AC power use. With a fully charged battery, the pump can operate for 12 hours at a set delivery rate of 125 ml/hr. The pumping mechanism is a rotor, driven by a stepper motor. The stepper motor runs at a constant speed with delivery rate dependent on on/off timing. The pump includes an integral pole clamp for securing it, typically to an IV pole. Visual and auditory alarms warn of flow-related problem conditions; either occluded flow or excessive flow. Flow detection is accomplished by optically sensing falling drops of nutrient in the pump-mounted drip chamber. Additionally, other warning actions occur when liguid nutrient container is empty, when the pump has completed delivery of a preprogrammed dose, when the pump has been idle for more than 2½ minutes, or when, during battery operation, the battery requires recharging.
The provided 510(k) summary for the SENTINEL/LH2001 Enteral Feeding Pump includes information about its performance criteria and the testing conducted to demonstrate its safety and effectiveness.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Delivery Accuracy: Within ±10% of the selected flow rate | Delivery Accuracy: Delivers within ±10% accuracy when tested at the extremes of flow rate, operating temperature, and nutrient viscosity, and with the cleared disposable set. |
| Electrical and Fire Hazard Safety Conformance: Conforms to UL544 standard | Electrical and Fire Hazard Safety Conformance: Tested for electrical and fire hazard safety and conforms with the standard UL544. |
| Electromagnetic Compatibility: Conforms to EN60601-1-2 standard | Electromagnetic Compatibility: Tested for electromagnetic compatibility per the standard EN60601-1-2 (also listed as IEC 601-1-1-2 sec (2) in the comparison table). |
| Battery Operating Time: (Equivalent to predicate devices) | Battery Operating Time: 12 hours @ 125 ml/hr (improved compared to predicate devices: KM60: 2 hr @ 125 ml/hr; Compat-235/-240: 8 hr @ 100 ml/hr) |
| Occlusion Pressure: (Equivalent to predicate devices) | Occlusion Pressure: 15 psi maximum (equivalent to Compat-235/-240, lower than KM-60: 25 psi maximum) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the test set (number of pumps, disposable sets, or test runs). It broadly states:
- "When tested at the extremes of flow rate, operating temperature and nutrient viscosity, and with the cleared-to-market disposable set..."
- "Additionally, the pump has been tested for electrical and fire hazard safety..."
- "The pump has also been tested for electromagnetic compatibility..."
The data provenance is prospective testing conducted by Entracon Corporation to demonstrate compliance with performance and safety standards. There is no mention of country of origin for the data explicitly, but as Entracon Corporation is located in Foxborough, MA, USA, and the submission is to the FDA, it can be inferred the testing was conducted to U.S. and international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device submission. The acceptance criteria and performance evaluation for an enteral feeding pump are based on measurable physical parameters and compliance with established engineering and safety standards, not on expert interpretation of subjective data like medical images.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or diagnostic studies involving human interpretation. For this device, performance is objectively measured against predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted and is not applicable to this type of medical device (an enteral feeding pump). This kind of study is typically used to evaluate the impact of a diagnostic tool (like AI) on physician performance.
6. Standalone Performance:
Yes, a standalone performance evaluation was conducted. The reported performance results ("the SENTINEL / LH2001 enteral pump delivers within ±10% accuracy," and compliance with UL544 and EN60601-1-2) describe the inherent performance of the device itself, without human interaction impacting these specific technical measurements. The device's operation is microprocessor-controlled and its accuracy is an intrinsic characteristic.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation is based on objective measurements against established engineering specifications and recognized safety standards.
- Delivery Accuracy: Measured against a specified tolerance (±10% of selected rate).
- Safety (Electrical, Fire, EMC): Compliance with published consensus standards (UL544, EN60601-1-2/IEC 601-1-1-2).
- Functional Parameters (e.g., battery life, occlusion pressure): Measured against design specifications and compared to predicate devices.
8. Sample Size for the Training Set:
This information is not applicable as the SENTINEL/LH2001 Enteral Feeding Pump is a mechanical/electronic device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its "training" is the engineering design, calibration, and manufacturing process.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8. The device's operational parameters and performance are determined by its design and physical properties, not by learning from a labeled dataset.
§ 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).