← Product Code [LZH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH) · K946168 # IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS (K946168) _Ivac Corporation · LZH · Mar 21, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K946168 ## Device Facts - **Applicant:** Ivac Corporation - **Product Code:** [LZH](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH.md) - **Decision Date:** Mar 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 2946168 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 1. SUBMITTER'S NAME: IVAC CORPORATION 10300 Campus Point Drive San Diego, CA 92121-1579 (619) 458-7825 CONTACT PERSON: Jennifer S. Hankard Regulatory Affairs Specialist DATE PREPARED: December 15, 1994 2. DEVICE NAME: Proprietary Name: 1) IVAC Enteral Admin. Sets 2) IVAC Infusion Pumps Common Names: 1) Enteral Admin. Set 2) Infusion Pump Classification Names: 1) Gastrointestinal Tube and accessories 2) Infusion Pump 3. PREDICATE DEVICE: IVAC 72 Series Enteral Administration Sets and Model 7100 Infusion Pump 4. DEVICE DESCRIPTION: The IVAC enteral administration sets (Series 28XXX, 28XX6, 52XXX, 52XX6, 59XXX, 59XX6) incorporate standard IVAC set components and materials. The sets include an enteral adapter and, with some configurations, a pre-attached bag which holds the enteral formula during delivery. The enteral adapter is incompatible with standard ANSI IV set luers which prevents the user from accidentally attaching the enteral adapter to an intravenous set. The infusion pumps regulate fluid flow at the desired rate. 5. INTENDED 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. 6. TECHNOLOGICAL CHARACTERISTICS: The IVAC enteral administration sets (Series 28XXX, 28XX6, 52XXX, 52XX6, 59XXX, 59XX6) and the IVAC 72XXX and 72XX6 enteral sets use the same method of manufacture, incorporate standard set 002 {1} (continued) ## 6. TECHNOLOGICAL CHARACTERISTICS: components, and use standard materials. The primary function of the enteral administration sets are the same. The IVAC infusion pumps (MedSystem, 560, 570, 590, 599) and the IVAC 7100 infusion pump use the same method of manufacture, and incorporate similar components. The primary function of the infusion pumps are the same. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. IVAC Corporation concludes that the 28, 52, and 59 series enteral sets and the related infusion pumps are substantially equivalent to the legally marketed IVAC 72 series enteral set and 7100 infusion pump. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K946168](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZH/K946168) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com