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.

Device Description

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.

AI/ML Overview

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.

Summary

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Ko11587

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Establishment

ENTRACON CORPORATION 22 WINDSOR DR. FOXBOROUGH, MA 02035

Contact Person

Paul Zannechia telephone 888 369 3644 fax 888 370 7144

Date

May 9, 2001

	Device Tradename - SENTINELTM Enteral Feeding PumpLH2001 Enteral Feeding Pump
Common name -	Enteral Feeding Pump
	Classification name - Infusion Pump, Enteral per 21CFR 880.5725

Classification -Class II ·

Predicate devices

This device is substantially equivalent to devices previously cleared for interstate commerce by the FDA 510(k) process. Two such devices are the KM60 reviewed under control number K852965 (08/21/1985) and the Compat-235 / -240 reviewed under control number K940555 (02/01/1995). There are no new concerns relative to pump safety or efficacy.

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Device description

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.

Performance Results

When tested at the extremes of flow rate, operating temperature and nutrient viscosity, and with the cleared-to-market disposable set, the SENTINEL / LH2001 enteral pump delivers within ±10% accuracy.

Additionally, the pump has been tested for electrical and fire hazard safety and conforms with the standard UL544. The pump has also been tested for electromagnetic compatibility per the standard EN60601-1-2.

Conclusion

Based on the above results, the pump has been proven to be safe and effective.

Substantial Equivalence

Based on comparison of the intended use and the principles of operation of the predicate devices, the intended use and the principles of operation of the SENTINEL / LH2001 enteral feeding pump has been shown to be substantially equivalent and are detailed in the table below.

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SUBSTANTIAL EQUIVALENCE COMPARISON

	EMPIRE (KMI)KM-60	SANDOZCOMPAT -235/-240	ENTRACONSENTINEL
FEATURE
510(k) clearance	K852965	K940555	this submission
Intended Use	Enteral Feeding	Enteral Feeding	Enteral Feeding
Pump Type	Peristaltic	Peristaltic	Peristaltic
Mode of Action	Tubing in tensionagainst rotor	Tubing in tensionagainst rotor	Tubing in tensionagainst rotor
Safety Standard	UL544	UL544	UL544
Electromagnetic compatibility	No	No	IEC 601-1-1-2 sec (2)
Hospital and Home Use	Yes	Yes	Yes
Pump Weight	5.6 pounds	5.7 pounds	5.2 pounds
Pump Size	7.4" H x 9.0" W x 5.1"D	7.4" H x 9.5" W x 5.3"D	7.5" H x 9.0" W x 5.2"D
Enclosure	Flame Retarded Plastic	Flame Retarded Plastic	Flame Retarded Plastic
Pole Clamp Mountable	Yes	Yes	Yes
Power Requirement	120VAC, 0.25amp,60Hz	115VAC, 0.19amp,60Hz	120VAC, ¼amp, 60Hz
Battery	Sealed Lead-Acid	Sealed Lead-Acid	Sealed Lead-Acid
Battery Recharge Time	12 hr	12 hr	10 hr
Battery Operating Time	2 hr @ 125 ml/hr	8 hr @ 100 ml/hr	12 hr @ 125 ml/hr
Battery Operation Indicator	Yes	Yes	Yes
Low Battery Indicator / Alarm	Yes	Yes	Yes
Numeric Display, Rate	3-digit LED	3-digit LED	3-digit LED
Delivery Rate	1-50 ml/hr @1 ml/hrincrements50-295 ml/hr @5ml/hrincrements	1 -295 ml/hr @ 1 ml/hrincrements	5 -295 ml/hr @ 1 ml/hrincrements
Accuracy, Delivery	$\pm$ 10% of selected rate	$\pm$ 10% of selected rate	$\pm$ 10% of selected rate
Numeric Display, Dose	4-digit LED	4-digit LED	4-digit LED
Accumulated Dose DisplayOption	No	Yes	Yes
Dose-Limit	No	adjustable 0-9995 mlin 5 ml increments	adjustable 1-2000 mlin 1 ml increments; and2000-9999 mlin 5 ml increments
Dose Complete Indicator /Alarm	No	Yes	Yes
Occlusion/Empty Indicator /Alarm	Yes	Yes	Yes
Dose / Rate Settings Retainedin Memory	No	Yes	Yes
Occlusion Pressure	25 psi maximum	15 psi maximum	15 psi maximum
Flow Monitoring	No	Yes	Yes
Free Flow Indicator / Alarm	No	Yes	Yes
Flow Sensing Means	Drip Chamber	Drip Chamber	Drip Chamber
Administration Set	Disposable	Disposable	Disposable (K862489)

ﺗﻌﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2001

Entracon Corporation C/O Mr. Donald J. Sherratt Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779

K011587 Re : Sentinel Enteral Feeding Pump, Trade/Device Name: LH2001 Enteral Feeding Pump Regulation Number: 880.5725 Regulatory Class: II Product Code: LZH May 21, 2001 Dated: May 23, 2001 Received:

Dear Mr. Sherratt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions or one, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be barger of Becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Mr. Sherratt

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4692. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Turner

imothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use statement

510(k) Number (if known):

Device Name:

External Enteral Infusion Pump

Indications For Use:

The pump is not intended for use with blood or blood products. The pump is not for intravenous delivery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Lucente
(Division Sign Off)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K011587

Prescription use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 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).