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 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; 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. 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Debiotech S.A. Enteral Exprés Pump Unit and Enteral Expres Giving Sets. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Sherwood Medical Kangaroo Pump - K945964).

Unfortunately, the document does not contain specific acceptance criteria, study details to prove the device meets these criteria, or detailed performance data beyond a general description of capabilities and accuracy mechanisms. The summary focuses on the device's technological characteristics, safety features, and regulatory classification process.

Therefore, I cannot provide the requested table or detailed study information as it is not present in the provided text.

Here's what I can extract based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Volumetric Accuracy (Implicit standard for enteral pumps)	"The accuracy of the system is largely determined...of the inner diameter of the tubing is the primary factor in determining the volumetric output per rotation." "The accuracy of the motor's rotation...synchronizing the signal from the motor's encoder with a signal generated by a programmable frequency divider."
Programmable Delivery Rates	"Wide range of programmable delivery rates: from 1 to 999 mL/hr"
Safety Features	"Safety features that help prevent tampering with the pump include keypad lock and program lock"
Ease of Use (Display/Interface)	"Keypad and display are simple and easy to use, and display provides English or Spanish information"
Loading Mechanism	"One way, snap-in cassette simplifies giving set loading"
Power Options	"Battery or AC-powered operation. Battery life monitored by internal battery gauge"
Physical Characteristics (Size/Weight/Noise)	"Small, quiet, and lightweight to enhance patient comfort"
Delivery Modes	"CONTINUOUS, PROGRESSIVE, and PROGRESSIVE INTERMITTENT delivery modes"

Note: The "Reported Device Performance" column is derived from the "Description" and "Summary of technological characteristics" sections, describing features and how accuracy is achieved, rather than presenting test results against explicit numerical acceptance criteria.

Regarding the Study Information:

The provided document doesn't include details about a specific study that demonstrates the device meets acceptance criteria. A 510(k) summary typically presents a summary of information that supports a claim of substantial equivalence, which may include performance testing results, but these are often summarized or referenced rather than fully detailed in the publicly available summary.

Specifically, the document does not contain any of the following information:

Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance. (This is irrelevant for this type of medical device which is an enteral pump, not an AI-assisted diagnostic tool).
If a standalone (algorithm only) performance study was done. (Also irrelevant for this device type).
The type of ground truth used (pathology, outcomes data, etc.). (Again, not relevant for this device type which performs a physical function).
Sample size for the training set.
How the ground truth for the training set was established. (These two points are relevant for machine learning/AI devices, which this is not).

The document is a regulatory submission for an enteral pump, focusing on its design, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results that would typically be required for diagnostic or AI-powered devices. The "accuracy" mentioned relates to the mechanical and electronic control of fluid delivery, not diagnostic accuracy.

Summary

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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 (858) 675-8200 (858) 675-8201

Original Date prepared: June 13, 2001

Proprietary name:	Enteral Exprés Pump UnitEnteral Exprés Giving Sets
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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 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 (301) 594-4618. Additionally, for questions on Compilance at (301) 337 ising 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, obtained from the Division on imaance at its toll-free number incernational and (301) 443-6597 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)

Over-the-Counter Use_

Vick Holland for Pat Cirenti

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

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).