Indicated as 10" (or up to 48") CLEAR (or BRAIDED) CONTRAST MEDIA INJECTION LINE WITH ROTATOR, for use in Cardiac catheterization and radiology special procedure

Device Description

High Pressure Tubing (intravascular administration set)

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Abbott Laboratories for a device named "High Pressure Tubing." The letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot answer your request based on the provided text. The document is solely an FDA clearance letter and does not include the technical details of the device's validation or testing.

Summary

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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 eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2003

Abbott Laboratories Hospital Products Division Ms. Nicohl R. Wilding Specialist, Device Registration D-389, Bldg. AP30 200 Abbott Park Road Abbott Park, IL 60064-6157

Re: K024126

Trade/Device Name: High Pressure Tubing Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: 74 DQO Dated: December 13, 2002 Received: December 16, 2002

Dear Ms. Wilding:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 – Ms. Nicohl R. Wilding

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

$\lambda$

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment II

K024126

Indications for Use Statement

510(k) Number (if known)
Device Name:	High Pressure Tubing (intravascular administration set)
Indications For Use:	High Pressure Tubing (intravascular administration set) intended useIndicated as 10" (or up to 48") CLEAR (or BRAIDED) CONTRAST MEDIAINJECTION LINE WITH ROTATOR, for use in Cardiac catheterizationand radiology special procedure

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

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and the comments of the comments of

IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K024126
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Prescription Use(per 21 CFR 801.109)	OR Over-The Counter Use
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Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).