JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS

K020784 · Jostra AG · DWF · Jan 9, 2003 · Cardiovascular

Device Facts

• Record ID: K020784
• Device Name: JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.

Device Story

Single-use, sterile venous return catheter; diverts blood from patient to extracorporeal circuit during cardiopulmonary bypass. Input: venous blood from superior and inferior vena cava. Output: blood flow to bypass circuit. Used in surgical settings by clinicians. Device facilitates extracorporeal circulation, supporting patient during cardiac procedures.

Clinical Evidence

Bench testing only. Performance testing included flow-pressure curves, kink resistance, bond strength, and leakage tests. In-vitro testing evaluated effects on cellular components.

Technological Characteristics

Material: Polyvinyl chloride (PVC). Sizes: 12 Fr. – 40 Fr. Design: Single stage catheter with various tip configurations and optional connectors. Sterilization: Single use, non-resterilizable.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous blood collection from the superior and inferior vena cava for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Medtronic DLP Single Stage Venous Cannulae

Submission Summary (Full Text)

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K020784

## 510 (K) Summary

JAN 0 9 2003

| Submitter: | Jostra AG<br>Hechinger Straße 38<br>72145 Hirrlingen<br>Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Johnson<br>P. O. Box 218<br>Oxford, PA 19363<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | March 08, 2002 |
| Device Trade Name: | Jostra Single Stage Venous Return Catheters |
| Common/Usual Name: | Single Stage Venous Catheters |
| Classification Names: | Cardiopulmonary Bypass Vascular Catheter, Cannula and<br>Tubing<br>Cariopulmonary Bypass Adaptor, Stopcock, Manifold, or<br>Fitting |
| Predicate Device: | Medtronic DLP Single Stage Venous Cannulae |

Device Description:

The Jostra Single Stage Venous Catheters are single, sterile devices for single use only and not to be resterilized by the user. The catheters are to be used to divert blood from the patient to the extracorporeal circuit by draining blood from the Inferior Vena Caya and the Superior Vena Cava. The catheters are made from polyvinyl chloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips and with or without attached connectors.

Indications for use:

The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.

Statement of Technical Characteristics Comparison:

The Jostra Single Stage Venous Cannulas have the same intended use and design as the Medtronic DLP Single Stage Venous Cannulas. The Jostra Single Stage Venous Cannulas are available in sizes 12 Fr. – 40 Fr. The Medtronic DLP Single Stage Venous Cannulas range in sizes from 12 Fr. - 40 Fr. Comparative tesling has demonstrated that the differences do not effect safety and effectiveness.

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Non-Clinical Testing:

Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.

Performance testing included:

Flow-Pressure curves Kink Resistance Bond Strength Leakage Test

Additionally, in-vitro testing was performed to determine the effects on cellular components.

## Conclusion:

Performance, and in-vitro testing demonstrate that the Jostra Single Stage Venous Return Cannulas are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Jostra AG c/o Ms. Kathleen Johnson Jostra-Bentley Corp. 478 Media Road Oxford, PA 19363

Re: K020784

Trade Name: Jostra Single Stage Venous Return Catheters Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 20, 2002 Received: November 22, 2002

Dear Ms. Johnson:

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. Iisting 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). 11 may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FI> \ max publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Kathleen Johnson

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 vou 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. R. D. Ziderman, M.P.

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

Enclosure

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Ka20784

Page 1 of 1

510(k) Number:

Device Name: Jostra Single Stage Venous Return Catheters

## Indications for Use

The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.

## (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)

(Optional Format 3-10-98)

Dedra Tiller

**510(k) Number** K020784