(458 days)
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No
The summary describes a standard enteral administration set and infusion pump with no mention of AI or ML capabilities.
No.
The device components are administration sets that deliver nutrition to the patient, but they do not directly treat a disease or condition. They are accessories to an enteral feeding pump.
No.
The device is an enteral administration set designed to deliver nutrition to patients, not to diagnose a condition.
No
The device description clearly details physical components like administration sets, bags, and adapters, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide nutrition to patients who have an impaired ability to orally ingest their food." This describes a device used for delivering substances into the body for therapeutic or nutritional purposes.
- Device Description: The description details components for administering enteral formula, including a pumping segment, bag, and enteral adapter. These are all related to the delivery of substances, not the testing of samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the delivery of nutrition, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
IVAC 72 Series Enteral Administration Sets and Model 7100 Infusion Pump
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 2 1 1954
- 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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(continued)
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.