SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP

{0}------------------------------------------------ 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 Pump<br>LH2001 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. {1}------------------------------------------------ ### 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. #### 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. {2}------------------------------------------------ # SUBSTANTIAL EQUIVALENCE COMPARISON | | EMPIRE (KMI)<br>KM-60 | SANDOZ<br>COMPAT -235/-240 | ENTRACON<br>SENTINEL | |--------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------| | 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 tension<br>against rotor | Tubing in tension<br>against rotor | Tubing in tension<br>against 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,<br>60Hz | 115VAC, 0.19amp,<br>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/hr<br>increments<br>50-295 ml/hr @5ml/hr<br>increments | 1 -295 ml/hr @ 1 ml/hr<br>increments | 5 -295 ml/hr @ 1 ml/hr<br>increments | | 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 Display<br>Option | No | Yes | Yes | | Dose-Limit | No | adjustable 0-9995 ml<br>in 5 ml increments | adjustable 1-2000 ml<br>in 1 ml increments; and<br>2000-9999 ml<br>in 5 ml increments | | Dose Complete Indicator /<br>Alarm | No | Yes | Yes | | Occlusion/Empty Indicator /<br>Alarm | Yes | Yes | Yes | | Dose / Rate Settings Retained<br>in 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ # Indications for use statement - 510(k) Number (if known): Device Name: External Enteral Infusion Pump #### Indications For Use: 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. (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) OR Over-The-Counter Use