APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K020997 · Dideco S.P.A. · DTZ · Apr 4, 2002 · Cardiovascular

Device Facts

• Record ID: K020997
• Device Name: APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Applicant: Dideco S.P.A.
• Product Code: DTZ · Cardiovascular
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Device Story

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass device with an integrated heat exchanger. It facilitates extracorporeal gas exchange and blood temperature regulation during adult surgical procedures. The device is operated by clinical staff in a surgical setting. The primary modification from the predicate is the addition of a biocompatible phosphorylcholine coating to all blood-contacting surfaces to improve hemocompatibility. The device is intended for single use and is ethylene oxide sterilized. It functions as a passive component of the extracorporeal circuit, supporting patient physiological needs during surgery.

Clinical Evidence

No clinical data. Bench testing only. Testing performed in accordance with ISO 10993-1:1997 and ISO 7199. Evaluations included biocompatibility, sterility, pyrogenicity, EO residuals, package integrity, gas transfer characteristics, pressure drop, plasma leakage, operating blood volume, heat exchanger performance, hemolysis/cell depletion, and mechanical integrity. All results met established specifications.

Technological Characteristics

Hollow fiber membrane oxygenator with integrated heat exchanger. Features phosphorylcholine coating on blood-contacting surfaces. Ethylene oxide sterilized; single-use. Design, operating principles, and control mechanisms are identical to the predicate device. Complies with ISO 10993-1 and ISO 7199 standards.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control for up to 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

• Apex Adult Hollow Fiber Membrane Oxygenator (K014080)
• Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)

Submission Summary (Full Text)

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Special 510(k) March 27, 2002

| | APR - 4 2002 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 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: | March 27, 2002 |
| DEVICE TRADE NAME: | Apex Ph.I.S.I.O Adult Hollow Fiber<br>Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Oxyenator |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator. |
| PREDICATE DEVICE: | Apex Adult Hollow Fiber Membrane<br>Oxygenator (K014080)<br>Dideco D 903 Avant 2 Ph.I.S.I.O Adult<br>Hollow Fiber Oxygenator (K020351) |

# DEVICE DESCRIPTION:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

#### INDICATION FOR USE:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

# TECHNOLOGICAL CHARACTERISTICS:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is identical in design, operating principles and control mechanisms to the Apex Adult Hollow Fiber Membrane Oxygenator predicate device. The only modification made to the device is the biocompatible phosphorylcholine coating treatment added to all blood contact surfaces. The fundamental scientific technology is unchanged from the predicate device. The coating is identical to the phosphorylcholine coating used on the D 903 Avant 2 Ph.I.S.I.O. predicate device. The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

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### NONCLINICAL TEST RESULTS:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of two years real time aging. Sterility, pyrogenicity, EO residuals and package integrity testing were also conducted. The results of testing met established specifications.

### IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the requirements of ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff November 13, 2000 to provide the data necessary to demonstrate compliance of the predicate device with safety and effectiveness requirements. The D 903 Avant 2 Ph.I.S.I.O. Oxygenator was aged to 2 years and tested for gas transfer characteristics, pressure drop, plasma leakage data, operating blood volume, heat exchanger performance evaluation, hemolysis/cell depletion, mechanical integrity and leaking/flaking test. The results of these tests met established specifications. The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant 2 Ph.I.S.I.O. apply to Apex Ph.I.S.I.O.

#### CONCLUSION:

The Apex Ph.I.S.I.O. is substantially equivalent to the predicate device. Biocompatibility studies demonstrate that the device is biocompatible according to its intended use. Additional testing has also demonstrated the effectiveness of production techniques to assure that Apex Ph.I.S.I.O. is sterile and non-pyrogenic.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR - 4 2002

Mr. Barry Sall, RAC Senior Regulatory Consultant DIDECO S.R.A. c/o Parexel International Corporation 195 West Street Waltham, MA 02451-1163

K020997 Re:

Trade Name: APEX PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator. Regulatory Class: Class II (two) Product Code: DTZ Dated: March 27, 2002 Received: March 28, 2002

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Barry Sall, RAC

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 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,

signature

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

Enclosure

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510(k) Number (if known): - KOZO997

Device Name: APEX Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator.

Indications For Use:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascula
510(k) Number K020997
Devices

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional format 1-2-96)