INTRAVASCULAR ADMINISTRATION SET by THE KIPP GROUP

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.

Device Description

Intravascular Administration Set/Extension Set

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an "Intravascular Administration Set/Extension Set." It does not contain information about acceptance criteria, device performance studies, or details relevant to the performance evaluation of a medical device based on specific metrics like sensitivity, specificity, or accuracy.

The letter primarily:

Confirms substantial equivalence: States that the device is substantially equivalent to legally marketed devices.
Outlines regulatory requirements: Refers to general controls, special controls, GMP regulations, and other relevant FDA provisions.
Approves marketing: Allows the manufacturer to begin marketing the device.
Specifies intended use: Provides a brief description of the device's function as a conduit for IV fluids and details some of its components.

Therefore, I cannot provide a response to your request as the provided text does not contain the necessary information regarding:

Acceptance criteria and reported device performance: No performance metrics are mentioned.
Sample size and data provenance: No study data is presented.
Number and qualifications of experts for ground truth: Not applicable as no ground truth was established for this type of regulatory submission.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not conducted or mentioned.
Standalone performance: Not conducted or mentioned.
Type of ground truth: Not applicable.
Training set sample size: Not applicable.
Ground truth establishment for training set: Not applicable.

This type of FDA letter is a regulatory approval, not a scientific publication detailing a device's performance study.

Summary

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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

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510(k) Number (if known):

510(k) Number (if known): K991932

Device Name: Intravascular Administration Set/Extension Set

Indications for Use:

(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

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

Regulation Number and Section

§ 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.