JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA

K020515 · Jostra AG · DWF · Apr 24, 2002 · Cardiovascular

Device Facts

• Record ID: K020515
• Device Name: JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 6 hours or less.

Device Story

Jostra Antegrade Cardioplegia Cannula; single-use, sterile device for infusion of blood/cardioplegia solution into aortic root during cardiopulmonary bypass. Constructed from polyurethane (PUR); available in 7 Fr., 9 Fr., and 11 Fr. sizes; optional vent lines and needle safety system. Used by clinicians in surgical settings during extracorporeal circulation. Device facilitates myocardial protection by delivering cardioplegic agents. Benefits include controlled delivery of solutions to myocardium during bypass procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (flow-pressure, kink resistance, bond strength, leakage) and in-vitro testing regarding effects on cellular components.

Technological Characteristics

Polyurethane (PUR) construction; 7 Fr., 9 Fr., 11 Fr. sizes; optional vent lines and needle safety system; single-use; sterile. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring antegrade infusion of blood or cardioplegia solution via the aortic root for durations 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 Antegrade Cardioplegia Cannula

Submission Summary (Full Text)

{0}------------------------------------------------

K020515

## APR 2 4 2002

### 510 (K) Summary

| Submitter: | Jostra AG<br>Hechinger Straße 38<br>72145 Hirrlingen<br>Germany |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Johnson |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | January 25, 2002 |
| Device Trade Name: | Jostra Antegrade Cardioplegia Cannula |
| Common/Usual Name: | Antegrade Cardioplegia Cannula |
| Classification Names: | Cardiopulmonary Bypass Vascular Cannula<br>Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or<br>Fitting<br>Trocar |
| Predicate Device: | Medtronic DLP Antegrade Cardioplegia Cannula |

Device Description:

The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.

Indications for use:

The Jostra Antegrade Cardioplegia Cannulas are designed to infuse blood and/or cardioplegia solution antegrade via the aortic root during cardiopulmonary bypass up to 6 hours or less.

Statement of Technical Characteristics Comparison:

The Jostra Antegrade Cardioplegia Cannulas have the same intended use as the Medtronic DLP Antegrade Aortic Root Cannulas. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.

{1}------------------------------------------------

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.

#### Concluïsion:

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

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen Johnson Regulatory Affairs, Submission Manager Jostra® AG Hechinger Straße 38 72145 Hirrlingen Germany

Re: K020515

Trade/Device Name: Jostra Antegrade Cardioplegia Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II Product Code: DWF Dated: January 25, 2002 Received: February 15, 2002

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreases of 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 I ou may, aterere, mains 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 or any I 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

{3}------------------------------------------------

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 vou 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,

Deb Tull

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# 510(k) Number: HD20515

Device Name: Jostra Antegrade Cardioplegia Cannulas

#### Indications for Use

. 184 2017

The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020515

· (Optional Format 3-10-98)

**Prescription Use**
**(Per 21 CFR 801.109)**