D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR

K020351 · Dideco S.P.A. · DTZ · Feb 26, 2002 · Cardiovascular

Device Facts

• Record ID: K020351
• Device Name: D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
• Applicant: Dideco S.P.A.
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.

Device Story

Hollow fiber membrane oxygenator with integral heat exchanger and hardshell cardiotomy venous reservoir; used in cardiopulmonary bypass surgery. Device receives venous blood input; performs gas exchange (oxygenation/CO2 removal) and temperature control via heat exchanger; collects aspirated blood via venous reservoir/cardiotomy filter. Operated by perfusionists/surgeons in OR. Output is oxygenated blood returned to patient. Benefits include maintenance of normothermia or induction of hypothermia and blood collection/oxygenation during extracorporeal circulation.

Clinical Evidence

Bench testing only. Testing performed per ISO 10993-1:1995 for biocompatibility (hemolysis, cytotoxicity, irritation, acute systemic toxicity, mutagenicity) and ISO 7199 (1996) for in vitro performance (gas transfer, heat exchanger performance, mechanical integrity, leaking/flaking). Results met all established specifications and were comparable to the predicate device.

Technological Characteristics

Hollow fiber membrane oxygenator with integral heat exchanger and hardshell venous reservoir. Features phosphorylcholine coating. Ethylene oxide sterilized; single-use. Nonpyrogenic fluid path. Compliant with ISO 10993-1 and ISO 7199 standards.

Indications for Use

Indicated for adults undergoing cardiopulmonary bypass surgery requiring extracorporeal circulation for 6 hours or less.

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

• Dideco D 903 AVANT Adult Hollow Fiber Oxygenator (K980600)
• D 901 Lilliput Ph.I.S.I.O. Infant Hollow Fiber Oxygenator (K010478)
• Monolyth Mimesys Hollow Fiber Oxygenator (K004001)

Submission Summary (Full Text)

{0}------------------------------------------------

| FEB 2 6 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: | February 21, 2002 |
| DEVICE TRADE NAME: | D 903 AVANT 2 Ph.I.S.I.O<br>(Phospholipidic Inert Surface In<br>Oxygenation) Adult Hollow Fiber<br>Oxygenator |
| COMMON NAME: | Hollow Fiber Oxygenator/Reservoir |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator |

### PREDICATE DEVICES:

Dideco D 903 AVANT Adult Hollow Fiber Oxygenator (K980600)

D 901 Lilliput Ph.I.S.I.O. Infant Hollow Fiber Oxygenator (K010478)

Monolyth Mimesys Hollow Fiber Oxygenator (K004001)

### DEVICE DESCRIPTION:

The D 903 AVANT Ph.I.S.I.O is a hollow fiber membrane oxygenator with integral heat exchanger and a hardshell cardiotomy venous reservoir.

### INDICATION FOR USE:

The D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.

{1}------------------------------------------------

## TECHNOLOGICAL CHARACTERISTICS:

The D 903 AVANT Ph.I.S.I.O. hollow fiber oxygenator is identical in design, operating principles The D 903 AVANT FIT... ST.O. nollow fiber oxygenator predicate device. The and control mechanisms to the D 000 NVR. Faction nellow phosphorylcholine coating treatment only modified to the dones is the coating is identical to the phosphorylcholine coating used on the D 901 Lilliput Ph.l.S.l.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 1.1990 and the I DA May 1, 1980 memerials. Testing was performed on the D 903 AVANT Ph.L.S.I.O. The device was aged up to 2 years and was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Sterility, Pyrogenicity, ETO residuals and In neation, Acate Oyotomio Yoxlory and mentige. The results of the testing met established specifications.

#### IN VITRO TEST RESULTS:

In vitro testing were carried out in accordance with the requirements of "Guidance for m Viro testing World Cathird Sather 510(k) submissions - Final Guidance for Industry and FDA Staff' issued on November 13, 2000 and when applicable, following the ISO 7199 (1996) standard for "Cardiovascular Implants and Artificial Organs - Extra Corporeal Blood-Gas Standard 10 - Oaranovator for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness oquirements. The device was aged up to 2 years and was tested for gas transfer characteristics, requirements. The do not has age 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. For comparative purposes, the same testing, when applicable, has been conducted also on the D 903 AVANT predicate device.

The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable.

### MARKETING HISTORY:

Currently the Dideco D 903 AVANT Adult Hollow Fiber Oxygenator is in commercial distribution in Europe since 1999 and currently about 8800 units have been sold. No reports of adverse events involving patient safety due to malfunctioning have been received.

### CONCLUSIONS:

The results of in vitro gas transfer studies demonstrate that the D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the nredicate device. Biocompatibility studies demonstrate that the phosphorylcholine coating is biocompatible, and functional tests demonstrate that the D 903 AVANT Ph.I.S.I.O. is equivalent to the 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

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

Re: K020351

Trade Name: D903 AVANT 2 Ph.I.S.I.O. Hollow Fiber Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator. Regulatory Class: Class II (two) Product Code: DTZ Dated: February 1, 2002 Received: February 4, 2002

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device w for to ro rowe and have determined the device is substantially equivalent (for the indications for referenced are over and and to legally marketed predicate devices marketed in interstate commerce ass butted in also encreated of the Medical Device Amendments, or to devices that provision in the Provision 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

{3}------------------------------------------------

Page 2 - Mr. Barry Sall, RAC

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. obliable (10 view to begin marketing your device as described in your Section 510(k) I mis letter will and w you've ough finding of substantial equivalence of your device to a legally premaince notification - river 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 11 you desire specific arras 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 11 Sections of the questions on the promotion and advertising of Compilance at [phone]. 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,

N. Dak Tull

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

Enclosure

{4}------------------------------------------------

Dideco S.p.A.

Special 510(k) - K020351

D903 AVANT Ph.I.S.I.O. Hollow Fiber OxygenatorFebruary 14, 2002

510(k) Number (if known): K020351

Device Name: Dideco D 903 Avant 2 Adult Hollow Fiber Oxygenator with Ph.I.S.I.O. coating

Indications For Use:

The Dideco D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator with Integral Hardshell Venous The Bidood B 600 Rtan use in adults who undergo cardiopulmonary bypass surgery requiring resorver in interiation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or integration hour exchanger promothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood intention to to veins during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020351

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use __