JOSTRA ARTERIAL PERFUSION CANNULAE

K012774 · Jostra AG · DWF · Nov 16, 2001 · Cardiovascular

Device Facts

• Record ID: K012774
• Device Name: JOSTRA ARTERIAL PERFUSION CANNULAE
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.

Device Story

Jostra Adult Arterial Cannulae are single-use, sterile perfusion devices; used to return arterial blood to patient via aortic root or large artery during cardiopulmonary bypass. Constructed from polyvinyl chloride (PVC); available in 20fr to 24fr sizes; features include curved or straight tips and vent plug for de-airing. Operated by clinical staff in surgical settings. Device facilitates extracorporeal circulation for up to 6 hours; supports blood flow requirements exceeding 3L/min. Output is the physical return of oxygenated blood to the patient's circulatory system.

Clinical Evidence

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

Technological Characteristics

Materials: Polyvinyl chloride (PVC). Sizes: 20fr to 24fr. Length: 23cm. Features: Curved or straight tip options, integrated vent plug for de-airing. Sterilization: Single-use, sterile. Energy source: None (passive).

Indications for Use

Indicated for adult patients requiring cardiopulmonary bypass during extracorporeal circulation for procedures lasting 6 hours or less, specifically for those requiring blood flow rates greater than 3L/min.

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 Adult Arterial Cannulae

Submission Summary (Full Text)

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NOV 1 6 2001

K012774

510 (K) Summary

| 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: | July, 27 2001 |
| Device Trade Name: | Jostra Adult Arterial Cannulae |
| Common/Usual Name: | Adult Arterial Cannulae |
| Classification Names: | Cardiopulmonary Bypass Vascular Cannula<br>Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or<br>Fitting |
| Predicate Device: | Medtronic DLP Adult Arterial Cannulae |

Device Description:

The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.

Indications for use:

The Jostra Adult Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.

Statement of Technical Characteristics Comparison:

The Jostra Arterial Cannulae have the same intended use as the Medtronic DLP Cannulae Both the Jostra Arterial Cannulae and the Medtronic-DLP lines provide the user with the option of a curved or straight tip. The Jostra Arterial Cannulae come with a vent plug for safe de-airing and are available in 23cm length only. The Medtronic-DLP Arterial Cannula have an optional vent plug on models without a

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connector and range in length from 18cm to 33cm. Comparative testing has demonstrated that these 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 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 Adult Arterial Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Kathleen Johnson Jostra AG C/O Jostra-Bentlye Corporation 478 Media road Oxford, PA 19363

Re: K012774

Device Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulatory Class: Class II (two) Product Code: DWF Dated: July 25, 2001 Received: August 20, 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

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Page 2 - Ms. Kathleen Johnson

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 O insion 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,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## NOV 1 6 2001

Page 1 of 1

510(k) Number: K012774

Device Name: Arterial Cannulae (adults)

## Indications for Use

The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012774

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