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

K083021 · Sorin Group Italia S.R.L. · DTZ · Oct 29, 2008 · Cardiovascular

Device Facts

• Record ID: K083021
• Device Name: APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DTZ · Cardiovascular
• Decision Date: Oct 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex HP M 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

Cardiopulmonary bypass oxygenator with integral heat exchanger; provides extracorporeal gas exchange and blood temperature control. Used in adult surgical procedures; operated by clinical staff. Device receives venous blood flow; facilitates gas exchange via hollow fiber membrane; regulates temperature via heat exchanger; returns oxygenated blood to patient. Modifications from predicate include reduced device size and optimized heat exchanger water path. Phosphorylcholine coating used for biocompatibility. Single-use device; ethylene oxide sterilized.

Clinical Evidence

Bench testing only. In vitro testing performed per ISO 7199 and FDA guidance for cardiopulmonary bypass oxygenators. Evaluated gas transfer, pressure drop, plasma leakage, operating blood volume, heat exchanger performance, hemolysis/cell depletion, and mechanical integrity on aged devices (3-year equivalent). Biocompatibility testing performed per ISO 10993-1:1997. Results met all established specifications.

Technological Characteristics

Hollow fiber membrane oxygenator with integral heat exchanger. Materials identical to predicate; phosphorylcholine coating. Ethylene oxide sterilized; nonpyrogenic fluid path. Single-use. Design features reduced size and optimized heat exchanger water path compared to predicate. Complies with ISO 10993-1:1997 and ISO 7199.

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 M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (K020997)
• Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)

Submission Summary (Full Text)

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K083021

## APPENDIX I: 510(K) Summary

OCT 2 9 2008

| SUBMITTER: | Sorin group Italia S.r.I.<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | October 8, 2008 |
| DEVICE TRADE NAME: | Apex HP M Ph.I.S.I.O Adult Hollow<br>Fiber<br>Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Oxygenator |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator |
| LEGALLY UNMODIFIED DEVICE: | Apex M Ph.I.S.I.O. Adult Hollow Fiber Membrane<br>Oxygenator (K020997) |
| PREDICATE DEVICE: | Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow<br>Fiber Oxygenator (K020351) |
| DEVICE DESCRIPTION: | |

The Apex HP M 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 HP M 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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#### TECHNOLOGICAL CHARACTERISTICS:

The Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is identical in design, materials, operating principles and control mechanisms to the Apex M Adult Hollow Fiber Membrane Oxygenator predicate device. The only modifications made lo the device consist of an overall reduction in the size of the device, optimization of the heat exchanger water path, updating of the instructions for use reflecting this modification and change in Ph.I.S.I.O. trade name. The fundamental scientific technology is unchanged from the predicate device. The coating is identical to the phosphorylchine coating used on the Apex M Ph.I.S.I.O. unmodified and D 903 Avant 2 Ph.I.I.I.O. 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. As no new materials are used in the APEX HP M Ph.I.S.I.O. oxygenator compared to the unmodified and predicate device as a result of the modifications, this 510(k) cross references biocompatibility data previously submitted. 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 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 unmodified device with safety and effectiveseas requirements. The Apex HP M Ph.I.S.I.O. Oxygenator was aged to 3 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 test. The results of these tests met established specifications. For comparative purposes all tests, where applicable, were carried out on sterilized aged devices comparing the Apex HP M Ph.I.S.I.O. and the Apex M Ph.I.S.I.O. unmodified device. In addition, the functional and biocompatibility parameters exhibited by Apex M Ph.I.S.I.O. apply to Apex HP M Ph.I.S.I.O.

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#### CONCLUSION:

Test results show that the Apex HP M Ph.I.S.I.O. performs in a manner substantially equivalent to the unmodified 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 HP M Ph.I.S.I.O. is sterile and non-pyrogenic.

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Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

# OCT 2 9 2008

Sorin Group Italia S.r.1. c/o Mr. Barry Sall Principal Consultant 200 West Street Waltham, MA 02451

Re: K083021

> Apcx HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTZ Dated: October 8, 2008 Received: October 9, 2008

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 requircments 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/industry/support/index.html.

Sincerely yours,

Duna R. Holmes

^ 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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Sorin Group Italia S.r.l.

510(k) Number (if known): _ K0 8302

Device Name: Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator Indications for Use:

The Apex HP M 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 uploa to 6 hours.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Nuna R. James

Division of Cardiovascular Devices

510(k) Number_408 302