(458 days)
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.
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.
The provided text is a 510(k) summary for medical devices, specifically enteral administration sets and infusion pumps. It describes the devices, their intended use, and technological characteristics compared to predicate devices to establish substantial equivalence.
However, the document does not contain any information regarding clinical studies, acceptance criteria for device performance based on measurable outcomes, or any of the detailed data provenance, expert ground truth establishment, or multi-reader studies that your request asks for.
The text focuses on demonstrating "substantial equivalence" based on manufacturing methods, components, and primary functions, which is common for 510(k) submissions for devices that are not high-risk and are similar to already marketed devices. It does not include performance metrics or clinical trial data in the way an AI/ML device submission would.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: IVAC CORPORATION 1. 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
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DEVICE NAME: Proprietary Name: 1) IVAC Enteral Admin. Sets
- IVAC Infusion Pumps
Common Names: 1) Enteral Admin. Set 2) Infusion Pump
Classification Names: 1) Gastrointestinal Tube and accessories 2) Infusion Pump
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- PREDICATE DEVICE: IVAC 72 Series Enteral Administration Sets and Model 7100 Infusion Pump
- 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.
- ട്. 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.
- દ. 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
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TECHNOLOGICAL 6. 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.
§ 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).