PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K050447 · Dideco S.R.L. · DTZ · Mar 8, 2005 · Cardiovascular

Device Facts

• Record ID: K050447
• Device Name: PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Applicant: Dideco S.R.L.
• Product Code: DTZ · Cardiovascular
• Decision Date: Mar 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Performa 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 up to 6 hours.

Device Story

Performa Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass device with an integral heat exchanger. It facilitates extracorporeal gas exchange and blood temperature regulation during adult surgical procedures. The device is a modified version of the Apex Ph.I.S.I.O. oxygenator, featuring a reduced size and ergonomic/aesthetic updates while maintaining the same fundamental scientific technology. It is intended for single use in clinical settings. The device is ethylene oxide sterilized and features a nonpyrogenic fluid path. It supports patient safety by providing controlled gas exchange and thermal management during bypass, with performance validated through in vitro testing for gas transfer, pressure drop, plasma leakage, heat exchanger efficiency, and hemolysis/cell depletion.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vitro performance evaluation. Testing included gas transfer characteristics, pressure drop, plasma leakage, heat exchanger performance, hemolysis/cell depletion, operating blood volume, and mechanical integrity per ISO 7199 and FDA guidance. Biocompatibility testing performed per ISO 10993-1. All tests conducted on devices subjected to 3-year accelerated aging; results met all established specifications.

Technological Characteristics

Hollow fiber membrane oxygenator with integral heat exchanger. Materials: nonpyrogenic fluid path. Sterilization: Ethylene oxide. Single-use. Design is a size-reduced version of the predicate. Connectivity: None. Software: None.

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 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator

Submission Summary (Full Text)

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Performa Adult Hollow Fiber Membrane Oxygenator Dideco S.r.l.

# MAR 8 - 2005

# 510(k) SUMMARY

| SUBMITTER: | Dideco S.r.l.<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------|------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | February 21, 2005 |
| DEVICE TRADE NAME: | Performa Adult Hollow Fiber Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Oxygenator |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator. |
| PREDICATE DEVICE: | Apex Ph.I.S.I.O. Adult Hollow Fiber Oxygenator |

DEVICE DESCRIPTION:

The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

#### INDICATION FOR USE:

The Performa Adult Hollow Fiber Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

# TECHNOLOGICAL CHARACTERISTICS:

The Performa adult hollow fiber oxygenator is identical in design to the Apex Ph.1.S.I.O. adult hollow The Forformal adult heller modifications made to the device consist of an overall reduction in the size of the device, updating of the instructions for use reflecting this modification and changes in format, ergonomic and aesthetic variations that do not change the function of the device. The fundamental scientific technology is unchanged from the predicate device.

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

### 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 three years real time aging. Sterility, pyrogenicity, EO 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 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 Performa Oxygenator aged to 3 years was tested for gas transfer characteristics, pressure drop and plasma leakage, heat exchanger performance, hemolysis/ cell depletion, operating blood volume and mechanical integrity. The results The modifications being made to the Performa of these tests met established specifications.

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Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility Oxygenator us not anoot the Ph.I.S.I.O. apply only to the Performa Oxygenator.

#### CONCLUSION:

The Performa membrane oxygenator is substantially equivalent to the Apex P.h.l.S.l.O predicate The Penomia Thembrane Oxygenator 15 Gabocandary - Sce is biocompatible according to its intended device. Biocompanility studies demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 - 2005

Dideco S.r.I. c/o Mr. Barry Sall Senior Consultant Parexel International Corporation 195 West Street Waltham, MA 02451-1163

Re: K050447

> Performa 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: February 21, 2005 Received: February 22, 2005

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 classificd (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 Please be advised that FDA's issuance of a substanted activation of the requirements of the Act
that FDA has made a determination that your device on plier Federal agencies. that FDA has made a determination that your device compines with one oncess. You must
or any Federal statutes and regulations administered by other Federal on and listi or any Federal statutes and regulations administration application and listing (21
comply with all the Act's requirements, including, but not limited to: reguirements as set comply with all the Act 's requirements, including, but not minted novelse requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice, the ele CFR Part 807); labeling (21 CFR Pat 801); good manufacturing practice liqueded, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (QS) regulation (2) CFR 1 at 620), and 21 (2FR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 31-342 of the 100), 21 0100
This letter will allow you to begin marketing your device of your Section 510(k)
This letter will a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inning of substantial equir device to a premarket notification. The FDA finding of substanial equivalence of your device and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the If you desire specific advice for your device on our adocting included to the specificals on the contact the Office of Compliance at (501) 394-40-1 could office of Compliance at
promotion and advertising of your device, please contact the Office of Compliance promotion and advertising of your device, please contact, "Misbranding by reference to
[phone]. Also, please note the regulation entitled, "Misbranding of [phone]. Also, please note the regulation entitler, "WilsOthers. Policy on your
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responsibilities under the Act may be obt its toll from the Division of Small or (301) 44 responsibilities under the Act may be obtained from the Roll of Sames of Sames of Sames of Same of Constitutions of American Property of Constitutions of Constitutions of Con International and Consumer Assistance at the results of the main.html

Sincerely yours,

Vitina R. Vichner

(V)_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): Kのら0447

Device Name: Performa Adult Hollow Fiber Membrane Oxygenator

Indications For Use:

The Performa 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 up to 6 hours.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

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AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divire D. Vordone1

(Division Sign-Off) Jivision of Cardiovascular Devices

510(k) Number_k (25447