ENTERALITE

K954735 · Zevex Intl., Inc. · LZH · Apr 15, 1996 · General Hospital

Device Facts

• Record ID: K954735
• Device Name: ENTERALITE
• Applicant: Zevex Intl., Inc.
• Product Code: LZH · General Hospital
• Decision Date: Apr 15, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The EnteraLite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.

Device Story

EnteraLite is a software-controlled, variable flow rate, rotary peristaltic enteral feeding pump. It accepts liquid nutrients via a disposable tubing set; the pump motor rotates to occlude silicone tubing, forcing fluid toward the patient. Operated by clinicians, nurses, or patients in hospital or home settings, the device is portable via a backpack/fannypack. A microcontroller manages motor speed and duty cycles to achieve programmed flow rates. The device features an LCD display for status, including a battery 'fuel gauge'. Safety mechanisms include an air-in-line sensor and dual pressure sensors (proximal/distal) to detect occlusions, triggering visual and audible alarms. The device provides precise nutrient delivery, improving patient management for those requiring enteral support.

Clinical Evidence

Bench testing only. Performance verified through flow accuracy testing, occlusion detection, air-in-line sensor validation, and software verification/validation. No clinical data presented.

Technological Characteristics

Rotary peristaltic pump; microcontroller-controlled. Materials: silicone tubing (extracorporeal). Power: internal rechargeable Nickel Metal Hydride batteries; 12V DC via external wall-mounted charger. Dimensions: 4.97"H x 4.47"W x 2.00"D. Connectivity: standalone. Software: microcontroller-based, variable flow rate control. Safety: air-in-line sensor, dual pressure sensors. Orientation: omnidirectional.

Indications for Use

Indicated for pediatric and adult patients, including bed-ridden or ambulatory individuals in hospital or home settings, requiring controlled enteral delivery of liquid nutrients.

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

• Kangaroo® PET® Enteral Feeding Pump and Charger Base (K913413)
• Kangaroo® PET® disposable feeding set (K851539)

Submission Summary (Full Text)

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ZEVEX
INCORPORATED
K954735
5175 Greenpine Drive
Salt Lake City, Utah 84123
TEL [phone]
FAX [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This summary was prepared on October 6, 1995.

## Submitter's name:

ZEVEX, Incorporated
5175 Greenpine Drive
Salt Lake City, UT 84123
[phone]
[phone]

## Contact Person:

David J. McNally

## Name of device:

*EnteraLite™* Enteral Feeding Pump

## Common name:

Enteral Infusion Pump

## Classification name:

Infusion Pump, Enteral, External (80LZH) as defined in 21 CFR 880.5725.

## Predicate device:

The predicate device is the Kangaroo® PET® Enteral Feeding Pump and Charger Base manufactured by:

Sherwood Medical
1915 Olive Street
St. Louis, MO 63105-1642
[phone]
FDA Registration Number 1924954

ZEVEX, Incorporated believes the EnteraLite enteral feeding pump is substantially equivalent to the Kangaroo PET device reviewed by FDA under Document Control number K913413 and its introduction into interstate commerce raises no new questions of safety or efficacy.

The predicate device for the disposable feeding set is the disposable set used with the Kangaroo® PET® Enteral Feeding Pump manufactured also by Sherwood Medical. ZEVEX, Incorporated believes the EnteraLite disposable feeding set is substantially equivalent to the Kangaroo PET disposable feeding set reviewed by FDA under document control number K851539 and its introduction into interstate commerce raises no new questions of safety or efficacy.

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ZEVEX, Inc., Summary of Safety & Effectiveness, Page 2

# INFUSION PUMP DESCRIPTION

The EnteraLite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.

The device is a software controlled, variable flow rate, peristaltic pump. It operates up to 24 hours (at a nominal flow rate of 125 ml/hr) from internal rechargeable batteries. The batteries are recharged by a wall mounted charger that plugs into a standard 120 volt alternating current wall socket. The charger is available in various input voltage and plug configurations to accommodate international requirements. The charger converts line voltage to a safe low voltage of 12 volts DC that is supplied from the charger to the pump. A "fuel gauge" type indicator on the pump's LCD display continuously shows the state of battery charge.

The pump motor runs at a single speed and is turned on and off at programmed intervals to obtain the desired flow rate. The motor drive circuit is controlled by a microcontroller that allows the motor to pause longer at lower flow rates with correspondingly shorter pauses at higher flow rates. The software embodied within the microcontroller was extensively validated and verified as part of the design process.

The pump includes several safety features. An air-in-line sensor rapidly detects whenever nutrient flow is interrupted and alerts the user with both a visual and audible alarm. Two pressure sensors detect occlusions both on the nutrient bag (distal) side and the patient (proximal) side of the pump. The user is alerted to proximal or distal occlusions by both visual and audible alarms.

A backpack (convertible to a fannypack) is available for use under ambulatory conditions. The pump may be operated in any orientation.

# DISPOSABLE TUBING SET DESCRIPTION

The ZEVEX disposable nutrient administration set is comprised of nine components. All components of the set remain extracorporeal. The ZEVEX set interfaces with the in vivo apparatus via an industry standard non-I.V. compatible stepped adapter. The disposable set includes a short length of silicone tubing that is stretched around the three feeding pump rollers. As the rollers turn, they occlude the tubing forcing the nutrient solution through the silicone pump tube. The set also includes a unique fail safe device that precludes free-flow when the set is not correctly installed in the pump with the door closed. Pull tests were done to assure that the set would not be easy to inadvertently disconnect when in use.

# STERILIZATION PARAMETERS

Neither the pump nor the disposable set is supplied in a sterile condition.

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ZEVEX, Inc., Summary of Safety & Effectiveness, Page 3

# SUBSTANTIAL EQUIVALENCE COMPARISON

| Feature | EnteraLite™ | Kangaroo® PET™ |
| --- | --- | --- |
| Hospital, Ambulatory, & Home Use | Yes | Yes |
| Pediatric Use | Yes | Yes |
| Pumping Mechanism | Rotary Peristaltic | Rotary Peristaltic |
| Operating Orientation | Any | Upright Only |
| Flow Monitoring | Yes | Yes |
| Size (w/o charger) | 4.97"H x 4.47"W x 2.00"D (12.6 x 11.3 x 5.1 cm) | 5.75"H x 3.81"W x 2.00"D (14.4 X 5.1 X 9.7 cm) |
| Weight w/ charger | 576 grams (1.27 pounds) 1,093 gms (2.41 pounds) | 635 grams (1.41 pounds) 1,578 gms (3.48 pounds) |
| Charger | Yes - Wall mount | Yes - Charger Base |
| Drip-proof | Yes | Yes |
| Dose-limit (ml) | 10 to 3000 x 10ml increments | 1 to 75ml in 1ml increments 75 to 2000ml in 5ml inc. |
| Flow-rate (ml/hour) | 1 to 600 in 1ml increments | 1 to 75 in 1ml increments 75 to 400 in 5ml increments |
| Flow Accuracy | ± 5% including high viscosity solutions | ± 10% |
| Fast prime | 30 sec fast prime @ 600 ml/hr | No prime feature |
| Battery Type | Nickel Metal Hydride | Nickel Cadmium |
| Time between charges | 24 hours | 16 hours |
| Charger Type | External wall mounted | External base |
| Charge time (from full discharge) | Five hours | Eight hours |
| Display | LCD (green electroluminescent) | LED (red) |
| Certification | Designed to meet UL and TÜV requirements | UL-544 |
| Occlusion Pressure | Select 8psi or 12psi (± 2psi) | 15 psi |
| Air-in-line Sensor | Yes | No |
| Continuous Indication of Battery Charge Level | Yes | No |
| Improper Loading Indication | Yes | Yes |
| Charger Power Requirements | 105 to 129 VAC, 60 HZ, 0.5 Amp | 120V ±15%, 50/60 Hz, 0.1 Amp |
| Pole Clamp Mountable | Yes | Yes |
| Supplied Sterile | No | No |
| Backpack | Yes - Convertible to fanny pack | Yes - Upright only |
| 510k clearance | This submission | K913413 |

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ZEVEX, Inc., Summary of Safety & Effectiveness, Page 4

# ALARM COMPARISON

| ALARM | EnteraLite | Kangaroo PET |
| --- | --- | --- |
| DOSE DONE | YES | YES |
| NO FOOD/EMPTY SET | YES | YES |
| LOAD SET | YES | YES |
| UPSTREAM OCCLUSION | YES | YES |
| DOWNSTREAM OCCLUSION | YES | YES |
| LOW BATTERY | YES | YES |
| INTERVAL PROGRAM ERROR | YES | NO |
| MOTOR OBSTRUCTION | YES | YES |
| TIME OUT (HOLD ERROR) | YES | YES |
| SELF DIAGNOSTICS | YES | YES |

# TUBING SET COMPARISON

| Feature | ZEVEX Disposable Set | Kangaroo Disposable Set |
| --- | --- | --- |
| Automatic Anti-free Flow | Yes | No |
| Drip Chamber | No | Yes |
| 1,200 ml Bag | Yes | Yes |
| 500 ml Bag | Yes | Yes |
| Spike Set | Yes | Yes |
| Silicone Pump Segment | Yes | Yes |
| PVC Tubing | Yes | Yes |
| Non-toxic | Yes | Yes |
| In contact with patient’s body | No | No |
| 510(k) | This submission | K851539 |

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ZEV'K, Inc., Summary of Safety & Effectiveness, Page 5

# REFERENCES

(1) Guidance on the Content of Premarket Notifications [510(k)] Submissions for External Infusion Pumps, FDA CDRH/ODE, March 1993.

(2) Infusion Pump State Contract Investigation: Summary Report, HHS Publication FDA 93-4256.

(3) Medical Device Tracking Requirements, Chapter 21, Code of Federal Regulations, Part 821.

(4) Infusion Devices, American National Standard ANSI/AAMI ID26-1992.

(5) Recommendations for Developing User Instructions for Medical Devices Used in Home Health Care, Write It Right, HHS Publication FDA 93-4258, August, 1993.

(6) FDA Public Health Advisory, Infusion Pumps, March 1, 1994.

(7) Medical Electrical Equipment, Part 1: General Requirements for Safety, UL2601-1 Revised December 2, 1994.

(8) Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review, FDA CDRH/ODE Document, 29 August, 1991.

(9) Infusion Pump, 21 CFR §880.5725, 80LZH, Class II

(10) Gastrointestinal Tube and Accessories, 21 CFR §876.5980, 78KNT, Class II

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