SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

K031223 · Dideco S.P.A. · DTZ · May 2, 2003 · Cardiovascular

Device Facts

• Record ID: K031223
• Device Name: SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
• Applicant: Dideco S.P.A.
• Product Code: DTZ · Cardiovascular
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

Device Story

Device is a high-efficiency microporous hollow fiber membrane oxygenator with integrated heat exchanger, arterial filter, and hardshell venous/cardiotomy reservoir. Used in cardiopulmonary bypass circuits to substitute for lung function (O2/CO2 exchange) and regulate blood temperature. Operates by circulating venous blood through the oxygenator module; gas exchange occurs across hollow fibers; integrated filter removes gas emboli and aggregates >40µm. Device features a phosphorylcholine (PC) coating to improve biocompatibility. Used in clinical settings (e.g., OR) by perfusionists/surgeons. Output is oxygenated, temperature-controlled, filtered blood returned to the patient. Benefits include reduced gas emboli and improved blood-material interface via PC coating. Single-use, sterile, nonpyrogenic.

Clinical Evidence

Bench testing only. No clinical data. Testing included hemolysis, cytotoxicity, irritation, acute systemic toxicity, mutagenicity, sterility, pyrogenicity, ETO residuals, package integrity, operating blood volume, mechanical integrity, pressure drop, arterial filter characterization, and microembolic activity. Results met established specifications and were comparable to predicate devices.

Technological Characteristics

Microporous hollow fiber membrane oxygenator with integrated heat exchanger, arterial filter, and hardshell venous/cardiotomy reservoir. Features phosphorylcholine (PC) coating. Ethylene oxide sterilized. Single-use. Compliant with ISO 10993-1:1995 and ISO 7199 (1996).

Indications for Use

Indicated for adult patients undergoing cardiopulmonary bypass surgery requiring extracorporeal gas exchange, temperature control, venous blood storage, and filtration of gas emboli and aggregates >40µm. Contraindicated for use exceeding 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• SYNTHESIS Adult Membrane Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated
• MONOLYTH C 1200 Hollow Fiber Membrane Lung Integrated Softshell Venous Reservoir, CVR 600 and 1200 (K990103)
• D 903 AVANT 2 Ph.I.S.I.O. Hollow Fiber Oxygenator (K030351)
• SYNTHESIS Adult Membrane Oxygenator (K020351)
• MONOLYTH MIMESYS Hollow Fiber Oxygenator (K004001)

Submission Summary (Full Text)

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Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator

| Synthesis Mimesys Hollow Fiber Oxygenator | April 17, 2003 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) SUMMARY |
| SUBMITTER: | Dideco S.p.A.<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | April 17, 2003 |
| DEVICE TRADE NAME: | SYNTHESIS MIMESYS Adult Membrane<br>Oxygenator with Integrated Arterial Filter<br>and Hardshell Venous Cardiotomy<br>Reservoir Mimesys Treated<br>(Phosphorylcholine coating hereinafter<br>called PC coating) |
| COMMON NAME: | Hollow Fiber Membrane<br>Oxygenator/Integrated Arterial<br>Filter/Reservoir |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator/<br>Cardiopulmonary Bypass Heat<br>Exchanger/ Cardiopulmonary Bypass<br>Blood Reservoir/ Cardiopulmonary<br>Bypass Defoamer/ Cardiopulmonary<br>Bypass Arterial Line Blood Filter |
| PREDICATE DEVICES: | SYNTHESIS Adult Membrane<br>Oxygenator with Integrated Arterial Filter<br>and Hardshell Venous/Cardiotomy<br>Reservoir Mimesys treated<br>MONOLYTH C 1200 Hollow Fiber<br>Membrane Lung Integrated Softshell<br>Venous Reservoir, CVR 600 and 1200<br>Sotfshell Venous Reservoir (reservoir<br>only) (K990103),<br>D 903 AVANT 2 Ph.I.S.I.O. Hollow Fiber<br>Oxygenator (K030351) |

Oxygenator (K020351),

MONOLYTH MIMESYS Hollow Fiber Oxygenator (K004001).

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### DEVICE DESCRIPTION:

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.

#### INDICATION FOR USE:

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated (PC coating) hereinafter called the SYNTHESIS MIMESYS is a sterile, nonpyrogenic device intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40µm. SYNTHESIS MIMESYS is an adult oxygenator intended for use in operations on adult patients. SYNTHESIS MIMESYS must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

# TECHNOLOGICAL CHARACTERISTICS:

The SYNTHESIS MIMESYS Adult Membrane Oxygenator with Integrated Hardshell Venous/Reservoir, Heat Exchanger and Arterial Filter Mimesys treated (PC coating), is essentially identical to the SYNTHESIS predicate device with respect to operating principles, control mechanisms and biocompatibility of the PC coating. The softshell venous reservoir present in both SYNTHESIS C MIMESYS and MONOLYTH C 1200 predicate device share the same technological characteristics, operating principles and materials. The only modification made to the SYNTHESIS MIMESYS (and other modified version) is the extension of the coating already present on the whole oxygenating module and hardshell venous reservoir (except the filtering media of the reservoir) to the integrated arterial filter and softshell venous reservoir. The coating is identical to the phosphorycholine coating used on the SYNTHESIS, D 903 AVANT 2 Ph.1.S.I.O. and MONOLYTH MIMESYS predicate devices.

The oxygenator 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 carried 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. Testing was performed on the SYNTHESIS (accelerated aging). The device aged up to three years was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.

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#### IN VITRO TEST RESULTS:

In vitro testing were 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 the ISO 7199 (1996) standard for "Cardiovascular Implants and Artificial Organs - Extra Corporeal Blood-Gas Exchangers (Oxygenator)" when applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. The device was aged up to 3 years and was tested for operating blood volume, mechanical integrity, connection testing, pressure drop, arterial filter characterization, hemolysis/cell depletion, softshell venous reservoir microembolic activity and filtration efficiency, uniformity test and flaking/leaching of the results of these tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the SYNTHESIS and SYNTHESIS C predicate device. This 510(k) crosses reference performance data previously submitted in the SYNTHESIS 510k (K022450) for the gas transfer studies, heat exchanger performance evaluation and venous cardiotomy characterization and in the MONOLYTH C1200 510(k) (K990103) for the aspects of the softshell venous reservoir characterization as the above mentioned aspects are not affected by the modification.

The results of the study showed the device characteristics between SYNTHESIS MIMESYS and SYNTHESIS were comparable.

#### CONCLUSIONS:

The results of in vitro studies demonstrate that the SYNTHESIS MIMESYS devices perform in a manner substantially equivalent to the predicate devices. Biocompatibility studies demonstrate that the phosphorylcholine coating is biocompatible and functional tests demonstrate that its performance are equivalent to the SYNTHESIS predicate device, according to its intended use. Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a central symbol. The symbol consists of a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines extending below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Dideco S.P.A. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International 195 West Street Waltham, MA 02451-1163

Re: K031223

Synthesis Mimesys Adult Membrane Oxygenator with Integrated Arterial Filter, Mimesys Treated Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: April 17, 2003 Received: April 18, 2003

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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]. 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 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.

KoleTtu

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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510(k) Number (if known): -

K031223

Device Name: Synthesis Mimesys Adult Membrane Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys Treated

#### Indications For Use:

Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescritption Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Otional format 1-2-96)

V. Deletta

510(k) Numbe