ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

K011868 · Debio Tech SA · LZH · Sep 4, 2001 · General Hospital

Device Facts

• Record ID: K011868
• Device Name: ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
• Applicant: Debio Tech SA
• Product Code: LZH · General Hospital
• Decision Date: Sep 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Enteral Exprés is a portable enteral feeding pump system for programmed delivery of nutrition fluids. It utilizes a cassette-based peristaltic mechanism where a motor-driven shaft rotates three rollers to crush silicone tubing against the cassette wall, creating a progressive pumping action. The system supports continuous, progressive, and progressive intermittent delivery modes with rates from 1 to 999 mL/hr. Operated by clinicians or patients in hospitals, outpatient, or home settings, the device features a keypad, display, and battery/AC power. A microprocessor controls the motor, using an encoder signal synchronized with a programmable frequency divider to ensure delivery accuracy. Redundant circuitry, self-check routines, and watchdog timers monitor system integrity. Output is delivered via enteral giving sets. The device benefits patients by providing precise, programmable nutrition delivery in various care environments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Peristaltic pump system consisting of a pump unit and a snap-in cassette assembly. Pumping mechanism uses three rollers and silicone tubing. Energy source: AC or battery power. Control system: Microprocessor-based with encoder feedback, sprag clutch, and redundant monitoring circuitry (watchdog timers, self-check routines). Form factor: Small, lightweight, portable. Connectivity: None specified.

Indications for Use

Indicated for patients in hospital or alternate care settings requiring delivery of standard enteral nutrition fluids.

Regulatory Classification

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.

Predicate Devices

• Sherwood Medical Kangaroo Pump (K945964)

Submission Summary (Full Text)

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K011868

# SEP - 4 2001

#### 510(k) Summary

Debiotech S.A. Sponsor:

Immeuble "Le Portique" Address: Rue de Sevelin 28 Lausanne Switzerland CH-1004

Phone number: (011) 41 21 623 6000

Fax number: (011) 41 21 623 6061

Sean Curry, Certified Software Solutions, Inc. US Contact person: 16787 Bernardo Center Drive, Suite A-1 San Diego, CA 92128 [phone] [phone]

Original Date prepared: June 13, 2001

| Proprietary name: | Enteral Exprés Pump Unit<br>Enteral Exprés Giving Sets |
|-------------------|--------------------------------------------------------|
|-------------------|--------------------------------------------------------|

Enteral Pump Common name: Intravascular Administration Sets

Classification name: LZH - External Enteral Infusion Pump FPA - Intravascular (IV) Administration Set

Substantial equivalence claimed to: Sherwood Medical Kangaroo Pump - K945964

### Description:

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

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- · 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

### Intended use:

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.

## Summary of technological characteristics:

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.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract quality. Encircling the central image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2001

Debiotech S.A. C/O Mr. Sean Curry Chief Operating Officer Certified Software Solutions 16787 Bernardo Center Drive, Suite A-1 San Diego, California 92128-2504

Re : K011868 Enteral Expres Pump Unit, Enteral Trade/Device Name: Expres Giving Sets Regulation Number: 880.5725 Requlatory Class: II Product Code: LZH Dated: June 13, 2001 Received: June 14, 2001

Dear Mr. Curry:

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). You may, therefore, 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 regulations affecting 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. Curry

In addition, FDA may publish further announcements action. action. In addition, This the Federal Register. Please note: conceining your actro premarket notification submission does this response to your promas wight have under sections 531 not arrect any obligation devices under the Electronic Chrough 542 Or the not is not is one other Federal laws or requlations.

This letter will allow you to begin marketing your device as Info recei will areas) () premarket notification. The FDA described in your six\n promience of your device to a legally Linding of Subscanceal Cquiraliation of Classification for your marketed predicate device robated to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcorre and additionally 809.10 for in regulation (21 of Fares), please contact the Office of Compliance at [phone]. Additionally, for questions on Compilance at (301) 337 ising of your device, please contact the Office of Compliance at [phone]. 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, obtained from the Division on imaance at its toll-free number incernational and [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy 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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510(k) Number (if known):_ : (2 || 868

Devicc Name:

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺎ (Per 21 CFR 801.109)

OR

Over-the-Counter Use_

Vick Holland for Pat Cirenti

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices (1) Number_10011