(73 days)
Not Found
Not Found
No
The summary describes a standard medical device for fluid delivery and does not mention any AI or ML components or functionalities.
No.
The device facilitates the delivery of fluids, but it does not directly treat a disease or condition.
No
Explanation: The device is described as an Intravascular Administration Set and Extension Set, used for delivering IV fluids. Its function is to administer substances to a patient, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like tubing, connectors, clamps, and injection sites, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a conduit for delivering fluids into a patient's vascular system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a disease state based on laboratory results.
Therefore, this device falls under the category of a medical device used for patient treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.
Product codes
FPA
Device Description
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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
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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.
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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.
Not Found
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Mr. Gary Werschmidt Vice President The Kipp Group 930 Wanamaker Avenue Ontario, California 91761
K991932 Re : Intravascular Administration set Trade Name: Requlatory Class: II Product Code: FPA Dated: June 01, 1999 Received: June 08, 1999
Dear Mr. Werschmidt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Werschmidt
This letter will allow you to begin marketing your device as Inis lecter will arrow you ou begin in the FDA finding described in your 310(x) premaince hevice to a legally marketed of substantial equivalence on your assification for your device and predicate device regarice to proceed to the market. thus, penmits your device for your device on our labeling II you desire specific advice roll promotive 809.10 for in xitro regulation (21 Crk fare our and and submitice of Compliance at diagnostic devices), preade contact contact on the promotion and in (301) 594-4622. Thatersharaj, as a sontact the Office of Also, please note the regulation Compliance at (301) 594-4639. Compliance at (3017-554 4659) into premarket notification' (21 spranding by reference on your responsibilities CFR 807.97). Crk 607.977. Ocher generagened from the Division of Small under the Act may be obcained irem interes number (800) 638-2041 or (301) 443-6597 or at its Internet address (301) = 1 / / www.fda.gov/cdrh/dsmamain.html" .
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
510(k) Number (if known): K991932
Device Name: Intravascular Administration Set/Extension Set
Indications for Use:
Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
۔ ﻣ
OR
S
Over-The-Counter Use
(Optional Format 1-2-96)
Patricio Creciente
Division Sian Off Division of T. Cal, Infection Control, and (. Genera tal Devices 516