JOSTRA VENT CATHETERS, MODELS LV & HKV

K022022 · Jostra AG · DWF · Sep 11, 2002 · Cardiovascular

Device Facts

• Record ID: K022022
• Device Name: JOSTRA VENT CATHETERS, MODELS LV & HKV
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.

Device Story

Jostra Vent Catheter is a sterile, single-use device for venting the left ventricle during cardiopulmonary bypass surgery. Inserted into the left ventricle via pulmonary vein, cardiac auricle, or cardiac apex. Available in various configurations: straight or bent tip, wire-reinforced or non-reinforced, with or without integrated stylet, with or without vacuum valve, malleable or non-malleable. Sizes range from 8 to 18 French; lengths from 23 to 40 cm. Operated by surgeons in an OR setting. Device facilitates blood/fluid drainage to assist cardiac bypass procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including kink stability, leak testing, tensile strength, and in-vitro testing to determine effects on cellular components.

Technological Characteristics

Constructed of polyvinyl chloride. Available in sizes 8-18 French and lengths 23-40 cm. Configurations include straight/bent tips, wire reinforcement, integrated stylets, and vacuum valves. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring drainage of blood or fluid from the left ventricle for a duration of 6 hours or less.

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 Left Heart Vent Catheters
• Edwards Lifesciences Research Medical Vent Catheters

Submission Summary (Full Text)

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KO22022

# 510 (K) Summary

| Submitter: | Jostra AG<br>Hechinger Straße 38<br>72145 Hirrlingen<br>Germany | SEP 11 2002 |
|-----------------------|-------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Kathleen Johnson<br>P. O. Box 218<br>Oxford, PA 19363<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared: | May 29, 2002 | |
| Device Trade Name: | Jostra Vent Catheter | |
| Common/Usual Name: | Cardiac Vent Catheter | |
| Classification Names: | Cardiopulmonary Bypass Vascular Catheter, Cannula and<br>Tubing | |
| Predicate Device: | Medtronic DLP Left Heart Vent Catheters<br>Edwards Lifesciences Research Medical Vent Catheters | |

Device Description:

The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.

Indications for use:

The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.

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Statement of Technical Characteristics Comparison:

The Jostra Vent Catheters have the same intended use and similar design as the Medtronic DLP and Edwards Lifesciences Research Medical Vent Catheters. The Jostra Vent Catheters range from 8 to 18 French and are 23 to 40 cm in length. The Medtronic DLP Vent Catheters range from 10 to 20 French and are 33 and 41 cm in length. The Edwards Lifesciences Research Medical device is a 20Fr. O.D. and 36.8 cm long. Comparative testing has demonstrated that the differences do not affect safety and effectiveness.

Non-Clinical Testing:

::

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

Performance testing of the smallest and largest models included:

Kink stability Leak testing Tensile strength testing

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

Conclusion:

Performance and in-vitro testing demonstrate that the Jostra Vent Catheters are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling an abstract bird or a symbol representing health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SFP 1 1 2002

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

Re: K022022

Trade Name: Vent Catheters Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF and DRA Dated: May 29, 2002 Received: June 20, 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, 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.

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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 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,

Dria Plenhu for
Bram D. Zuckerman, M.D.

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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510(k) Number:

Device Name: Vent Catheters

### Indications for Use

The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle 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)

| FDA/CDRH/ODE/DMC |
|--------------------|
| JUN 205 3 25 PM 02 |
| RECEIVED |

(Optional Format 3-10-98)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022022

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR 801.109)