(197 days)
No
The device description details standard components of an I.V. administration set and makes no mention of AI, ML, or any related computational technologies.
No.
The device administers solutions but does not inherently treat a condition.
No
The device description states its purpose is to administer parenteral solutions intravenously, not to diagnose a condition.
No
The device description clearly outlines physical components like tubing, clamps, and connectors, 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/Indications for Use: The description clearly states the device's purpose is for "administering Parenteral solutions from a standard solution container intravenously to a patient." This is a direct administration of substances into the body, not an in vitro test performed on samples outside the body.
- Device Description: The components listed (spike, tubing, clamp, luer lock connector, injection sites, check valves, air-venting filters) are all consistent with devices used for intravenous fluid administration. None of the components suggest the device is designed to analyze biological samples.
- Lack of IVD Indicators: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the device described is a medical device for administering fluids intravenously, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient.
Product codes
Not Found
Device Description
The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters. Components of the sets are made of the same materials usually used by previously-marketed sets and both packaging and sterilization procedures are consistent with those generally used in the medical device industry.
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
JUL 10 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
RE: 510(k) NOTIFICATION Intravascular Administration Set
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR part 807.92.
The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters. Various configurations are substantially equivalent to pre-amendment devices or to devices found substantially equivalent to prior devices in 510(k) Nos. K944320 and/or K860605. Components of the sets are made of the same materials usually used by previously-marketed sets and both packaging and sterilization procedures are consistent with those generally used in the medical device industry.
Robert T. Merrick Regulatory Consultant
Dated: 12/15/95