JOSTRA DUAL STAGE VENOUS RETURN CANNULAE

K013944 · Jostra AG · DWF · Feb 11, 2002 · Cardiovascular

Device Facts

• Record ID: K013944
• Device Name: JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Two-Stage Venous Cannulae are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.

Device Story

Jostra Two-Stage Venous Cannulae are single-use, sterile perfusion devices designed for extracorporeal circulation during surgery. The cannulae divert venous blood from the patient to an extracorporeal circuit by simultaneously draining blood from the right atrium and inferior vena cava. Used in surgical settings by clinical staff, the device facilitates venous return to support cardiopulmonary bypass. The cannulae are constructed from polyvinyl chloride (PVC) and are available in various sizes (32/40Fr to 36/51Fr) with optional tip configurations and connectors. The device is intended for short-term use (up to 6 hours).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and in-vitro testing, including flow-pressure curves, kink resistance, bond strength, leakage tests, and evaluation of effects on cellular components.

Technological Characteristics

Single-use venous cannulae constructed from polyvinyl chloride (PVC). Sizes range from 32/40Fr to 36/51Fr. Features include multi-stage tips and optional connectors. Principle of operation is passive venous drainage for extracorporeal circulation. Sterilized for single use.

Indications for Use

Indicated for patients undergoing surgery requiring extracorporeal circulation for up to 6 hours, where venous blood diversion is necessary.

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 Two-Stage Venous Cannulae

Submission Summary (Full Text)

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## 510 (K) Summary

Submitter:

Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany

Contact Person:

Kathleen Johnson P. O. Box 218 Oxford, PA 19363 Phone: [phone] [phone] Fax:

Date Prepared:

Device Trade Name: Jostra Dual-stage Venous Cannulae

November 21, 2001

Common/Usual Name: Two-Stage Venous Cannulae

Cardiopulmonary Bypass Vascular Cannula Classification Names: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting

Medtronic DLP Two-Stage Venous Cannulae Predicate Device:

Device Description:

The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.

Indications for use:

The Jostra Two-Stage Venous Cannulae are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.

Statement of Technical Characteristics Comparison:

The Jostra Two-Stage Venous Cannula have the same intended use and design as the Medtronic DLP Two-Stage Venous Cannula. The Jostra Two-Stage Venous Cannula are available in sizes 32/40Fr to 36/51Fr. The Medtronic DLP Two-stage Venous cannula range in sizes from 28/36Fr. to 36/51Fr. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.

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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 Two-Stage Venous Cannulae 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

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

Re: K013944

Trade Name: Jostra Dual Stage Venous Return Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF, DTL Dated: November 21, 2001 Received: November 29, 2001

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, 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 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

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Page 2 - Ms. Kathleen Johnson

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 and additionally 21 CFR Part 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Danle Teth
la Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K01394L

Page 1 of 1

510(k) Number:

Device Name: Jostra Two-Stage Venous Cannulas

## Indications for Use

The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Optional Format 3-10-98)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013944