(75 days)
Not Found
Not Found
No
The summary describes a standard intravascular catheter and does not mention any AI or ML components or functionalities.
No.
The device administers fluids and samples blood, which are diagnostic and supportive functions, not therapeutic.
No
The device is used to administer fluids, sample blood, and monitor blood pressure, which are therapeutic or monitoring functions, not diagnostic ones. It provides access to the vascular system rather than analyzing symptoms to identify the nature or cause of a disease.
No
The device description clearly states it is a physical catheter, a stainless steel needle set with butterfly wings and an extension set, which are hardware components.
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 access to the vascular system to administer fluids intravenously," "sampling blood," and "monitoring blood pressure." These are all procedures performed on the patient's body, not on a sample taken from the patient's body to diagnose a condition.
- Device Description: The device is described as an "intravascular administration set," a "stainless steel needle set with butterfly wings and a short extension set." This is a physical tool used for accessing the vascular system, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on sample analysis.
In summary, this device is a medical device used for accessing the vascular system for therapeutic and monitoring purposes, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.
Product codes
80 FPA
Device Description
The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
The Becton Dickinson Vascular Access E-Z SET and SAF-T E-Z SET® brand infusion sets.
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
K970259
April 8, 1997
SUMMARY OF SAFETY AND EFFICACY
-
A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: 801-565-2535. Prepared: January 22, 1997 -
B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Intravascular Administration Set Brand: E-Z SET® and Saf-T E-Z SET® Infusion Sets Common Name: Infusion Set Classification Name: Intravascular Administration Set (80 FPA) -
C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Vascular Access E-Z SET and SAF-T E-Z SET® brand infusion sets. -
D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set. -
E. Statement of intended use of the device.
The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure. -
F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed infusion sets differ from the E-Z SETC and SAF-T E-Z SET® brand infusion sets currently marketed in that the intended use clarifies the suitability for additional uses. The device is unchanged.