(182 days)
Not Found
No
The description focuses on the mechanical and software control of a peristaltic pump, with no mention of AI or ML technologies for flow rate adjustment, safety feature interpretation, or any other function. The software controls are described as a microcontroller turning the motor on and off at programmed intervals.
Yes
The device is described as "used to dispense liquid nutrients... to patients," which implies a direct role in medical treatment or management for patients requiring nutritional support.
No
This device is described as a pump used to "dispense liquid nutrients," not to diagnose a condition or disease.
No
The device description clearly details hardware components such as a peristaltic pump, motor, microcontroller, batteries, charger, air-in-line sensor, and pressure sensors. While software controls the pump, it is an integral part of a physical medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used to "dispense liquid nutrients" to patients. This is a direct therapeutic intervention, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical and electrical aspects of a pump designed to deliver fluids. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The device is clearly described as an enteral feeding pump, which is a medical device used for delivering nutrition directly into the gastrointestinal tract. This falls under the category of therapeutic or supportive medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
80LZH
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric patients
Intended User / Care Setting
hospital or at home by bed-ridden or ambulatory patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow Accuracy: ± 5% including high viscosity solutions
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for ZEVEX INCORPORATED. The word "ZEVEX" is in large, bold, black letters. Below it, in smaller letters, is the word "INCORPORATED".
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary was prepared on October 6, 1995.
EnteraLite™ Enteral Feeding Pump
ZEVEX. Incorporated Submitter's name: 5175 Greenpine Drive Salt Lake City, UT 84123 (801) 264-1001 (801) 264-1051
Contact Person: David J. McNally
Name of device:
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 (314) 621-7788 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 Enteral.ite 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.
1
INFUSION PUMP DESCRIPTION
The Enteral ite 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 purno 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.
2
| 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 | 576 grams (1.27 pounds) | 635 grams (1.41 pounds) |
| w/ charger | 1,093 gms (2.41 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 |
SUBSTANTIAL EQUIVALENCE COMPARISON
3
| 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 |
ALARM COMPARISON
TUBING SET COMPARISON
| Feature - 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 |
4
REFERENCES
- Guidance on the Content of Premarket Notifications [510(k)] Submissions for (1) External Infusion Pumps, FDA CDRH/ODE, March 1993.
- Infusion Pump State Contract Investigation: Summary Report, HHS Publication FDA (2) 93-4256.
- Medical Device Tracking Requirements, Chapter 21, Code of Federal Regulations, Part (3) 821.
- Infusion Devices, American National Standard ANSI/AAMI ID26-1992. (4)
- Recommendations for Developing User Instructions for Medical Devices Used in Home (ર) Health Care, Write It Right, HHS Publication FDA 93-4258, August, 1993.
- FDA Public Health Advisory, Infusion Pumps, March 1, 1994. (6)
- Medical Electrical Equipment, Part 1: General Requirements for Safety, UL2601-1 (7) Revised December 2, 1994.
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) (8) Review, FDA CDRH/ODE Document, 29 August, 1991.
- Infusion Pump, 21 CFR §880.5725, 80LZH, Class II (9)
- Gastrointestinal Tube and Accessories, 21 CFR §876.5980, 78KNT, Class II (10)