(148 days)
Not Found
Not Found
No
The description focuses on a standard medical device for fluid administration and does not mention any AI/ML components or functionalities.
No.
The device facilitates fluid administration but does not directly treat a disease or condition.
No
The device description states its purpose is for administering fluids, not for diagnosing conditions.
No
The device description clearly states it is a physical device (administration set, needle, catheter) used for administering fluids, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids directly into a patient's vascular system (vein). This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of delivering fluids, not on analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of providing information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances into the body.
N/A
Intended Use / Indications for Use
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a containers vascular system through the administration set's needle or catheler (which is Inserted into a vein).
Product codes
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Device Description
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged,
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
vascular system
Indicated Patient Age Range
Not Found
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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/2 description: The image shows the text "P. 05/06" on the top line and "K964435" on the second line. The text is black and the background is white. The text appears to be handwritten.
ICU Medical Inc.
Intravascular Administration Set
Appendix F. 510(k) Summary of Safety and Effectiveness 14.
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ K96443 S
Applicant Information:
Date Prepared: Name: Address:
May 29, 1996 ICU Medical Inc. 951 Calle Amanecer San Clemente, CA 92673
Contact Person: Phone Number: Fax Number:
Richard Waters (714) 366-4330 (714) 366-8368
Device Information:
Trade Name: Common Name: Classification Name: Intravascular Administration Set IV Set Intravascular Administration Set
Equivalent Devices:
Medical Product Specialists I.V./Secondary Sets McGaw Intravenous Administration Sets Churchill Medical Systems IV/Extension Sets
Device Description:
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged,
Intended Use:
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a containers vascular system through the administration set's needle or catheler (which is Inserted into a vein).
1
ICU Medical Inc.
Intravascular Administration Set
510(k) Notification Page 18 of 50
Comparison To Predicate Device:
| Characteristic Compared | ICU MEDICAL INTRAVASCULAR
ADMINISTRATION SET | PREDICATE INTRAVASCULAR
ADMINISTRATION SET |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Labeling | Single Use, Non-pyrogenic, Sterile
fluid pathway in un-opened,
undamaged package.
Directions for use on labeling | Single Use, Non-pyrogenic, Sterile
fluid pathway In un-opened,
undamaged package.
Directions for use on labeling |
| Intended Use | Single use, Sterile, non-pyrogenic
device which provides access for the
administration of fluids from a
container to a patient's vascular
system through the administration
set's needle or catheter (which is
inserted into a vein). | Single use, Sterile, non-pyrogenic
device which provides access for the
administration of fluids from a
container to a patient's vascular
system through the administration
set's needle or catheter (which is
inserted into a vein). |
| Design | Tubing of various lengths and inside
diameters are configured with some or
all of the following: spike/drip
chambers (as part of a set only),
clamps, injection site(s), filters,
backcheck valves and male luer
fitments. Packaged in medical grade
fiber-free peelable paper lidding and
pouching material. | Tubing of various lengths and Inside
diameters are configured with some
or all of the following: spike/drip
chambers, clamps, injection site(s),
filters, backcheck valves and male
luer fitments, huber needle.
Packaged in medical grade fiber-free
peelable paper lidding and pouching
material. |
510(k), Primary Sets