IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
Device Facts
| Record ID | K946168 |
|---|---|
| Device Name | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS |
| Applicant | Ivac Corporation |
| Product Code | LZH · General Hospital |
| Decision Date | Mar 21, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The intended use for the IVAC enteral administration sets is to provide nutrition to patients who have an impaired ability to orally ingest their food. The pumping segment or cassette of the enteral administration set interacts with the pumping mechanism of the infusion pump to regulate fluid flow at the desired rate.
Device Story
Enteral administration sets (Series 28XXX, 28XX6, 52XXX, 52XX6, 59XXX, 59XX6) and infusion pumps (MedSystem, 560, 570, 590, 599) deliver enteral nutrition. Sets include enteral adapter and optional pre-attached formula bag; adapter design prevents accidental connection to standard ANSI IV luers. Pumping segment/cassette interfaces with infusion pump mechanism to regulate flow rate. Used in clinical settings to provide nutrition to patients unable to ingest food orally. Healthcare providers operate pumps to set delivery rates, facilitating nutritional support.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Enteral administration sets and infusion pumps. Sets utilize standard components and materials; enteral adapter incompatible with ANSI IV luers. Infusion pumps (MedSystem, 560, 570, 590, 599) utilize standard manufacturing and components. Mechanical flow regulation via pump-cassette interface.
Indications for Use
Indicated for patients with impaired ability to orally ingest food requiring enteral nutrition delivery.
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
- IVAC 72 Series Enteral Administration Sets (K94xxxx)
- IVAC Model 7100 Infusion Pump (K94xxxx)
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- K150286 — Medline Enteral Feeding Sets · Medline Industries, Inc. · Apr 27, 2015
- K142539 — EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set · Zevex, Inc. · Jan 8, 2015
- K181276 — CONOD Enteral Feeding Sets · Conod Medical Co., Limited · Jul 12, 2018
