JOSTRA MECC SYSTEM

K023132 · Jostra AG · KFM · Dec 17, 2002 · Cardiovascular

Device Facts

• Record ID: K023132
• Device Name: JOSTRA MECC SYSTEM
• Applicant: Jostra AG
• Product Code: KFM · Cardiovascular
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

Device Story

Jostra Mecc System is a sterile, single-use extracorporeal circuit for cardiopulmonary bypass. System integrates circulatory and gas exchange support components, including pump, oxygenator, reservoir, filter, and tubing. Unlike custom tubing packs, components are pre-assembled to manufacturer specifications. Used in surgical settings for procedures requiring extracorporeal circulation up to 6 hours. Operates as a closed-loop circuit to provide gas exchange and blood circulation. Healthcare providers manage the system during surgery to support patient physiological function. Benefits include integrated, validated assembly for extracorporeal support.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench validation of the assembly of previously cleared components into a closed-loop extracorporeal circuit.

Technological Characteristics

Extracorporeal circuit comprising pump, oxygenator, reservoir, filter, and tubing. Closed-loop configuration. Sterile, single-use. Components are pre-assembled to manufacturer specifications. No specific materials or ASTM standards cited in the provided text.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal circulation and gas exchange support for durations of 6 hours or less.

Regulatory Classification

Identification

A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability; (ii) The patient-contacting components of the device must be demonstrated to be biocompatible; (iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and (iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device. (b) *Nonroller-type temporary ventricular support blood pump* —(1)*Identification.* A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2) *Classification.* Class III (premarket approval).(c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Bentley Duraflo Treated Extracorporeal Circuit

Submission Summary (Full Text)

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

# DEC 1 7 2002

#### 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: | September 16, 2002 |
| Device Trade Name: | Jostra Mecc System |
| Common/Usual Name: | Extracorporeal Circuit |
| Classification Names: | Cardiopulmonary bypass vascular catheter, cannula, or<br>tubing<br>Cardiopulmonary bypass adaptor, stopcock, manifold, or<br>fitting<br>Cardiopulmonary bypass blood reservoir<br>Non-roller-type cardiopulmonary bypass blood pump<br>Cardiopulmonary bypass pump speed control<br>Cardiopulmonary bypass oxygenator<br>Cardiopulmonary bypass arterial line blood filter |
| Predicate Device: | Bentley Duraflo Treated Extracorporeal Circuit |

Device Description:

The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.

Indications for use:

The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

Statement of Technical Characteristics Comparison:

The Bentley Duraflo Extracorporeal circuit provides a user defined tubing circuit and may provide other user specified components such as pump, gas exchange device, reservoir and filter packaged together as a "custom tubing pack". The Jostra Mecc

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

System provides the same components assembled to the manufacturer's specifications.

All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit. The instructions for the Jostra Mecc System address safety issues regarding the use of a closed loop extracorporeal circuit.

### Conclusion:

The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2002

Jostra AG c/o Ms. Kathleen Johnson Jostra-Bentley Corp. 2828 N. Crescent Ridge Drive The Woodlands, TX 77381

Re: K023132

Jostra Mecc System Regulation Number: 870.4360 Regulation Name: Non-roller type CPB pump Regulatory Class: Class III (three) Product Code: KFM Dated: September 16, 2002 Received: September 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.

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

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

### Page 2 - Ms. Kathleen Johnson

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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kallstrom

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

510(k) Number:

Device Name: JOSTRA MECC SYSTEM

#### Indications for Use

Indications for ose THE - oosta - MOSC - Systems gas exchange support 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)

(Optional Format 3-10-98)

X Prescription Use

Odetten

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K023132

003