The DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use during coronary angiography procedures as a connecting line for the injection of radio-opaque dye or saline.

Device Description

The DeRoyal Industries, Inc. Ultra High Pressure Injector Lines are comprised of PVC tubing ranging in length from 10" to 48". These devices have been tested to withstand up to 3 injections with a limiting pressure of 1200 psi.

Device DesignMaterials Used/Physical Properties: The DeRoyal Industries, Inc. Ultra High Pressure Injector Lines are made of PVC material commonly used in the industry for their purpose.

AI/ML Overview

The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Ultra High Pressure Injector Lines, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical specifications and intended use. It does not contain information about a study based on acceptance criteria, reader studies, ground truth establishment, or sample sizes related to clinical performance evaluations.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance using the provided text. The document is a regulatory submission for premarket notification, not a report of a clinical performance study with the details you are asking for.

However, I can extract the acceptance criteria and stated performance as described in the document, which are related to the device's physical properties and intended function, not clinical study results.

Here's what can be extracted:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Withstand up to 3 injections	Device has been tested to withstand up to 3 injections
Limiting pressure of 1200 psi	Device has been tested to withstand a limiting pressure of 1200 psi

The document does not provide the following information:

Sample size used for the test set and the data provenance: There is no mention of a test set for clinical performance or any data provenance. The "testing" mentioned refers to engineering performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth assessment is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable as no clinical ground truth is established or used.
The sample size for the training set: Not applicable as this is a physical medical device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be "L023591". The characters are written in a dark ink, and the handwriting style is somewhat cursive.

JUN 1 8 2003

DeRoyal Industries, Inc.

Ultra High Pressure Injector Lines

510{k} Summary

Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based

SUBMITTER INFORMATION:

NAME:	DeRoyal Industries, Inc.	TELEPHONE:	(865) 362-6157
ADDRESS:	200 DeBusk Lane	CONTACT:	Sharon Cook
	Powell, TN 37849	DATE OF PREPARATION:	March 20, 2003

DEVICE NAMES

Name:	Ultra High Pressure Injector Lines
COMMON/USUAL NAME:	Pressure Line
CLASSIFICATION NAME:	DQO, Percutaneous CatheterClass II device per 21 CFR 870.1250

PREDICATE OR LEGALLY MARKETED DEVICES

NAMIC - flexClL® Contrast Injection Lines (K822100) Maxxim Modical Inc. - High Pressure Lines (K963749)

DEVICE DESCRIPTION

Device DesignMaterials Used/Physical Properties: The DeRoyal Industries, Inc. Ultra High Pressure Injector Lines are made of PVC material commonly used in the industry for their purpose.

DEVICE INTENDED USE

The DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use during coronary angiography procedures as a connecting line for the injection of radio-opaque dye or saline.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICES

Characteristic	DeRoyal Device	Other Devices
Material	Plastic Polymers	Plastic Polymers
Flexible	Yes	Yes
Sterility	Sterile and Non-Sterile	Sterile and Non-Sterile
Disposable	Yes	Yes
Package	Bulk, single put-ups or as acomponent in trays or kits	Bulk, single put ups or as acomponent in trays or kits
Disposable	Yes	Yes
Pressure Rating	1200 psi	1200 psi

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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2003

Ms. Sharon Cook Regulatory Affairs Group Manager DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849

Re: K023591

Ultra High Pressure Injector Lines Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQO Dated: March 20, 2003 Received: March 24, 2003

Dear Ms. Cook:

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 vour device in the Federal Register.

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And Comment

Page 2 - Ms. Sharon Cook

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 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 (QS) 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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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 vours.

l. K. Oesterle

ram 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 11

INDICATIONS FOR USE STATEMENT

DeRoyal Industries, Inc. Applicant:

510(k) Number (if known): K023591

Device Name: Ultra High Pressure Injector Lines

Indications for Use: .
The DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use during coronary anglography procedures as a connecting line for the injection of radioopaque dye or saline.

(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)

Over-The-Counter Use_

Vola Th

510(k) Number K023591

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).