ULTRA HIGH PRESSURE INJECTOR LINES

K023591 · Deroyal Industries, Inc. · DQO · Jun 18, 2003 · Cardiovascular

Device Facts

• Record ID: K023591
• Device Name: ULTRA HIGH PRESSURE INJECTOR LINES
• Applicant: Deroyal Industries, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

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.

Device Story

Ultra High Pressure Injector Lines are PVC tubing (10" to 48" length) used as connecting lines during coronary angiography. Device facilitates delivery of radio-opaque dye or saline from an injector to a catheter. Designed to withstand up to 3 injections at a maximum pressure of 1200 psi. Used in clinical settings by medical professionals. Disposable device provided sterile or non-sterile; available as bulk, single units, or within procedure kits.

Clinical Evidence

Bench testing only. Device tested to withstand up to 3 injections at a limiting pressure of 1200 psi.

Technological Characteristics

PVC tubing; 10" to 48" length; 1200 psi pressure rating; flexible; disposable; sterile or non-sterile; manual operation.

Indications for Use

Indicated for patients undergoing coronary angiography procedures requiring the injection of radio-opaque dye or saline.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: | [phone] |
|----------|--------------------------|----------------------|----------------|
| 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 Catheter<br>Class 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

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.

#### 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 a<br>component in trays or kits | Bulk, single put ups or as a<br>component 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 [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 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 [phone] or [phone] 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)

OR

Over-The-Counter Use_

Vola Th

**510(k) Number** K023591