EXEL I.V. ADMINISTRATION SET

• K Number: K963659
• Device Name: EXEL I.V. ADMINISTRATION SET
• Manufacturer: EXEL INTL.
• Date Cleared: 1997-12-16 ( 469 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria, the study details, or the device performance as requested. The document is a 510(k) clearance letter from the FDA for an "Exel I.V. Administration Set," indicating that the device has been deemed substantially equivalent to a predicate device.

The letter discusses regulatory aspects, such as:

1. Device Type: Exel I.V. Administration Set.
2. Regulatory Class: II.
3. Product Code: FPA.
4. Indications For Use: "THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT."
5. FDA Clearance Date: December 18, 1997.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any studies.
• Information on expert usage, adjudication methods, or MRMC comparative effectiveness studies.
• Specifics on standalone algorithm performance or training set details.

This document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based solely on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three swooping lines. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1997

Mr. Armand Hamid Exel International P.O. Box 3194 Culver City, California 90231-3194

Re : Kae3659 Exel I.V. Administration Set Trade Name: Requlatory Class: II Product Code: FPA October 10, 1997 Dated: Received: October 28, 1997

Dear Mr. Hamid:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Hamid

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 requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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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K963659.

Indications For Use

510(k) Number (if known)_K963659

Device Name: KKEL I.V. ADMINISTRATION SET

Indications For Use:

THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

(PLEASE DO NOT WHITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cassinate

and General H 510(k) Numb

Prescription Use

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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.