IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR

K030154 · Dideco S.P.A. · KFM · Mar 31, 2003 · Cardiovascular

Device Facts

• Record ID: K030154
• Device Name: IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
• Applicant: Dideco S.P.A.
• Product Code: KFM · Cardiovascular
• Decision Date: Mar 31, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Fitter hereinafter called the IDEAL is a sterile, nonpyrogenic device intended to be used in surgical procedures requiring extracorporeal gas exchange support. The Ideal is intended for use in operations on adult patients. The Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. The ldeal is intended for use with Stockert Centrifugal Pump Console

Device Story

The IDEAL is an extracorporeal hemodynamic and gas exchange support system for cardiopulmonary bypass. It integrates a hollow fiber membrane oxygenator, heat exchanger, arterial filter, active venous air removal device (defoamer), and a centrifugal blood pump. The system is designed for use in adult surgical procedures requiring extracorporeal support, operated by clinical staff in conjunction with a Stöckert Centrifugal Pump Console. The device functions by circulating blood through the circuit via centrifugal force, providing gas exchange, temperature control, and filtration of gaseous emboli and aggregates. Integration of the venous air removal and pump modules into the oxygenator assembly reduces operating blood volumes compared to traditional setups. The device is for single-use only and limited to a maximum duration of 6 hours.

Clinical Evidence

Bench testing only. In vitro studies evaluated operating blood volumes, hemolysis/cell depletion, mechanical integrity, and air handling characterization. Testing followed ISO 7199 and FDA guidance for oxygenators, defoamers, and arterial filters. Results confirmed performance comparable to predicate devices.

Technological Characteristics

Integrated extracorporeal system; hollow fiber membrane oxygenator; heat exchanger; arterial filter; centrifugal blood pump; active venous air removal (defoamer). Materials identical to Synthesis and Revolution predicates; phosphorylcholine coating. Ethylene oxide sterilized; single-use. Complies with ISO 10993-1:1995 for biocompatibility and ISO 7199 for oxygenators.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal gas exchange support. Contraindicated for use longer than 6 hours.

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

• Synthesis Adult Membrane Oxygenator (K022450)
• Cobe Revolution Centrifugal Blood Pump (K011835)

Submission Summary (Full Text)

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K030154

MAR 3 1 2003

### 510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAMES:

CLASSIFICATION NAMES:

PREDICATE DEVICES:

Dideco S.p.A. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy

Luigi Vecchi Phone: [phone] Fax: [phone]

January 15, 2003

IDEAL: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter

Hollow Fiber Membrane Oxygenator with Integrated Arterial Filter and Heat Exchanger Venous Defoamer Centrifugal Blood Pump

Cardiopulmonary Bypass Oxygenator Cardiopulmonary Bypass Heat Exchanger Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Defoamer Cardiopulmonary Bypass Arterial Line Blood Filter Non-Roller Type Cardiopulmonary Bypass Blood Pump

Membrane Oxygenator With SYNTHESIS: Adult Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated (Phosphorylcholine coating hereinafter called PC coating) (k022450)

Cobe Revolution Centrifugal Blood Pump, (K011835)

### DEVICE DESCRIPTION:

The Ideal, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The Ideal consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifuqal pump (Cobe Revolution Centrifyial Blood Pump. K011835) and a pump bracket.

## INDICATION FOR USE:

The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter hereinafter called the IDEAL is a sterile, nonpyrogenic device intended to be used in surgical procedures requiring extracorporeal gas

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The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Fitter hereinafter called the IDEAL is a sterile, nonpyrogenic device intended to be used in surgical procedures requiring extracorporeal gas exchange support. The Ideal is intended for use in operations on adult patients. The Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. The ldeal is intended for use with Stockert Centrifugal Pump Console

#### TECHNOLOGICAL CHARACTERISTICS:

The Ideal is comprised of an adult membrane oxygenator with an integrated heat exchanger and arterial filter identical to the Synthesis predicate device. The coating is identical to the phosphoryline coating used on the Synthesis predicate device. The Ideal design has been completely reviewed with reference to the defoaming system as compared to the Synthesis' predicate device defoaming system.

The air removal system (defoamer) of the Ideal replaces the air removal function of ordinary venous reservoirs by centralizing venous line air and effectively removing it in a way substantially equivalent to the Synthesis hardshell venous/cardiotomy reservoir. The basic function of all integrated defoamer/oxygenators is the same. That is, a combination blood-gas exchange device with a separate active venous air removal section (defoamer).

The Ideal with reference to the integrated centrifugal blood pump is also identical to the Revolution Pump predicate device. The basic function of all centrifugal pumps is the same, that is, moving blood through the cardiopulmonary bypass circuit by centrifugal force.

Therefore the Ideal duplicates the functionality of the separate predicate devices.

The Ideal is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

#### BIOCOMPATIBILITY TEST RESULTS:

A complete battery of tests were carned out in accordance with the requirements of ISO 10993-1:1995 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. The Synthesis device was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. The Revolution device was tested for Hemolysis. Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Biocompatibility testing performed on Synthesis and Revolution predicate devices have been taken as reference for the Ideal system as the raw materials used in the manufacturing process are identical to those used in both predicate devices. Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of this testing met established specifications.

#### IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff" issued on November 13, 2000 - "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000 -"Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000 and when applicable, following the ISO 7199 (1996) standard for "Cardiovascular Implants and Articial Organs - Extra Corporeal Blood-Gas Exchangers (Oxygenator)" for providing the data necessary to demonstrate both the substantial equivalence with the predicate devices and also complying with safety and effectiveness requirements. The device aged up to 3 years was tested for operating blood volumes, hemolysis/cell deplation, mechanical integrity and air handling characterization of the integrated venous air removal device. The results of this tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the Synthesis and Revolution predicate.

The result of the study showed that the device is comparable to the predicate devices concerning with all characteristics.

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#### CONCLUSIONS:

The results of in vitro studies demonstrate that the Ideal performs in a manner substantially equivalent to the Synthesis with respect to the main function of ordinary venous reservoirs (defoamers) that is separation and evacuation of gaseous emboli form the venous blood. Previous in-vitro data showed that the Ideal performs in a manner substantially equivalent to the Synthesis with respect to the expected main performance parameters associated with ordinary oxygenators with integrated heat exchanger and arterial filter that is transfer of oxygen and removal of carbon dioxide, blood temperature control, removal of arterial blood components aggregates larger than 40 u. Furthermore, the Ideal performs in a manner substantially identical to the centrifying pump Revolution predicate device with respect to the basic function of an ordinary centrifygal pump that is propulsion of blood through the cardiopulmonary bypass circuit by centrifugal force.

Data collected show that integration of the active venous air removal device (defoamer) and of the centrifugal pump to the oxygenating module is advantageous in terms of lower operating blood volumes during procedures. Moreover air handling test results indicate that air bubbles are equally well handled and purged from venous blood by the Ideal integrated venous air removal device with respect to traditional extracorporeal cardiopulmonary bypass reservoirs.

Therefore it can be concluded that Ideal integrated system duplicates the functionality of the separated predicate devices. Biocompatibility and functional performances of phosphorylcholine coated devices, proved for the Synthesis predicate device, have been taken as reference for the ldeal. Additional testing has also demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

MAR 31 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dideco S.p.A. c/o Mr. Barry Sall Parexel International Corp. 195 West Street Waltham, MA 02451-1163

# Re: K030154

IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller Type CPB Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: January 15, 2003 Received: January 16, 2003

# Dear Mr. Sall:

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 -- Mr. Barry Sall

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), 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 vours.

Ana Hlusherfor
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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DIDECO S.p.A.

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: IDEAL System with Integrated Venous Air Removal, Centrifygal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter

Indications For Use:

Ideal is intended to be used in surgical procedures requiring extracorporeal gas exchange support. Ideal is intended for use in operations on adult patients. Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal is intended for use with the Stöckert Centrifugal Pump Console.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

Dva Hlulu

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