JOSTRA SUCKERS, MODEL JS

K020983 · Jostra AG · DWF · Jan 30, 2004 · Cardiovascular

Device Facts

• Record ID: K020983
• Device Name: JOSTRA SUCKERS, MODEL JS
• Applicant: Jostra AG
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 hours or less.

Device Story

Jostra Suction Devices are single-use, sterile instruments used during open-heart surgery. The device line includes rigid, flexible, and pericardial suckers. The device functions by aspirating blood and fluids from the surgical field and returning them to the extracorporeal circuit. It is operated by surgical staff in an operating room environment. The device aids in maintaining a clear operative field and blood conservation. Performance is validated through bond strength, leakage, and in-vitro cellular component testing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including bond strength and leakage tests, and in-vitro testing to evaluate effects on cellular components.

Technological Characteristics

Single-use, sterile suction devices (rigid, flexible, and pericardial configurations). Materials and design are consistent with predicate suction devices used in cardiopulmonary bypass. No energy source or software components.

Indications for Use

Indicated for aspiration of blood and fluids from the operative field for return to the extracorporeal circuit during open-heart surgery procedures lasting 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 Suction Devices

Submission Summary (Full Text)

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| 510 (K) Summary | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Jostra AG<br>Hechinger Straße 38<br>72145 Hirrlingen<br>Germany |
| Contact Person: | Kathleen Johnson<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | March 11, 2002 |
| Device Trade Name: | Jostra Suction Devices |
| Common/Usual Name: | Suction Devices |
| Classification Names: | Cardiopulmonary Bypass Vascular Cannula<br>Cardiopulmonary-Bypass Cardiotomy Return Sucker<br>Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or<br>Fitting |
| Predicate Device: | Medtronic DLP Suction Devices |

Device Description:

The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.

Indications for use:

The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery lasting 6 hours or less.

Statement of Technical Characteristics Comparison;

The Jostra Suction Devices have the same intended use as the Medtronic DLP Suction Devices. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.

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Non-Clinical Testing:

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

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Performance testing included:

Bond Strength Leakage Test

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

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Conclusion:

Section of the couple

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Performance, and in-vitro testing demonstrate that the Jostra Suction Devices 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

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 3 0 2004

Jostra AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Hechinger Strasse 38 72145 Hirrlingen Germany

Re: K020983

Suction Devices Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 11, 2003 Received: November 14, 2003

Dear Ms. Schwenkglenks:

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. Katrin Schwenkglenks

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 Of It 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 prarketed 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), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Willines

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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# 020983

Page 1 of 1

510(k) Number:

1988 - 1999

. . .

Device Name: Suction Devices

### Indications for Use

The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 · hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription use X

Dolma, R. builting Division of Cardiovascular & Respiratory Devices 510(k) Number K620983