ECC.O SYSTEM

K050890 · Dideco S.R.L. · KFM · May 5, 2005 · Cardiovascular

Device Facts

• Record ID: K050890
• Device Name: ECC.O SYSTEM
• Applicant: Dideco S.R.L.
• Product Code: KFM · Cardiovascular
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

Device Story

ECC.O is an extracorporeal hemodynamic and gas exchange support system for perfusion. It integrates a hollow fiber membrane oxygenator, heat exchanger, venous air removal device (defoamer), centrifugal blood pump, and pump bracket. The system connects to a Stockert Centrifugal Pump Console. The centrifugal pump moves blood through the cardiopulmonary bypass circuit via centrifugal force; the oxygenator/heat exchanger module provides gas exchange and temperature control; the integrated defoamer separates gaseous emboli from venous blood. Used in clinical settings during surgical procedures requiring cardiopulmonary bypass. The integration of components reduces operating blood volumes during priming. Healthcare providers operate the system to maintain patient hemodynamics and gas exchange during surgery.

Clinical Evidence

Bench testing only. Testing included biocompatibility (hemolysis, cytotoxicity, irritation, acute systemic toxicity, mutagenicity) per ISO 10993-1:1995, sterility, pyrogenicity, ETO residuals, and package integrity. In vitro performance testing followed ISO 7199 and FDA guidance for oxygenators and defoamers, evaluating hemolysis/cell depletion, operating blood volume, mechanical integrity, flaking/leaching, and air handling. Results met established specifications and demonstrated equivalence to predicate devices.

Technological Characteristics

System comprises a hollow fiber oxygenator, integrated heat exchanger, venous defoamer, and centrifugal pump. Materials are identical to predicates (D 905 EOS and Ideal Mimesys). Features phosphorylcholine coating. Sterilized via ethylene oxide; nonpyrogenic fluid path; single-use. Operates via centrifugal force for blood propulsion. Designed for integration with Stockert Centrifugal Pump Console.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control, with a maximum blood flow rate of 5 L/min. Contraindicated for use longer than 6 hours.

Regulatory Classification

Identification

A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability; (ii) The patient-contacting components of the device must be demonstrated to be biocompatible; (iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and (iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device. (b) *Nonroller-type temporary ventricular support blood pump* —(1)*Identification.* A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2) *Classification.* Class III (premarket approval).(c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (K043323)
• Ideal Mimesys' Centrifugal Pump (K032040)
• Cobe Cardiovascular Revolution Centrifugal Blood Pump with PC coating (K030462)
• Ideal Mimesys' Venous Air Removal Device (K032040)
• Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter (K032040)

Submission Summary (Full Text)

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

# MAY - 5 2005

Special 510(k) April 7, 2005

## 510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

COMMON NAMES:

DEVICE TRADE NAME:

Dideco S.r.l. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy

Luigi Vecchi Phone: [phone] Fax: [phone]

April 7, 2005

ECC.O: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Hollow Fiber Oxygenator and Heat Exchanger

Hollow Fiber Oxygenator with Integrated Heat Exchanger Venous Defoamer Centrifugal Blood Pump

Cardiopulmonary Bypass Oxygenator. Cardiopulmonary Bypass Heat Exchanger Cardiopulmonary Bypass Defoamer Non-Roller Type cardiopulmonary Bypass Blood Pump

UNMODIFIED DEVICE

CLASSIFICATION NAMES:

PREDICATE DEVICE:

D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (K043323)

Ideal Mimesys' Centrifugal Pump (K032040) cleared also independently as Cobe Cardiovascular Revolution Centrifugal Blood Pump with PC coating (K030462)

Ideal Mimesys' Venous Air Removal Device (K 032040)

Ideal Mimesys (K032040) System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter (K032040), with phosphorylcholine coating.

#### DEVICE DESCRIPTION:

The ECC.O System with Integrated Venous Air Removal Device, Centrifugal Blood Pump, Pump Bracket. Hollow Fiber Oxygenator and Heat Exchanger is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. ECC.O consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger connected to a venous air removal device (defoamer) (Ideal Mimesys' Venous Air Removal Device, K032040), a centrifugal pump (Ideal Mimesys' Centrifugal Pump, K032040) and a pump bracket.

7 2

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

### INDICATION FOR USE:

The ECC.O System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Hollow Fiber Oxygenator and Heat Exchanger The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

### TECHNOLOGICAL CHARACTERISTICS:

The ECC.O is comprised of a hollow fiber oxygenator with an integrated heat exchanger identical to the D 905 EOS unmodified device. The only modifications made to the device consist of a combination of the Ideal Mirnesys' Bubble Trap and Centrifugal Pump to the oxygenating module of the D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (K043323), updating of the product specifications in the IFUs and change in the Ph.I.S.I.O. trade name. The basic function of all integrated defoamer/oxygenators is the same. The function is a combination blood gas exchange device with a dedicated active venous air removal section (defoamer). The basic function of all centrifugal pumps is the same, that is, moving blood through the cardiopulmonary bypass circuit by centrifugal force. The operating principles and fundamental scientific technology is unchanged from the unmodified The ECC.O duplicates the functionality of the separate predicate devices and the indications for use is unchanged as a result of the combination. The coating is identical to the phosphoryicholine coating used on the D 905 EOS unmodified and Ideal Mimesys' Bubble Trap and Centrifugal Pump predicate devices.

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 10993-1:1995 and the FDA May 1, 1995 Memorandum on 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 .- The D 905 EOS device was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. The Ideal Mimesys was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Biocompatibility testing performed on D 905 EOS and Ideal Mirnesys predicate devices have been taken as reference for the ECC.O system as the raw materials used in the manufacturing process are identical to those used in both predicate devices. Sterility, Pyrogenicity, ETO 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 the "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 and when applicable, following the ISO 7199 standard for "cardiovascular Implants and Artificial Organs – Extra Corporeal Blood gas Exchangers (Oxygenator)" for providing the data necessary to demonstrate both the substantial equivalence with the unmodified/predicate devices and compliance with safety and effectiveness requirements. The ECC.O aged up to 3 years was tested for hemolysis/cell depletion, operating blood volume, mechanical integrity, flaking and leaching study characterization and air handling characterization. The results of these tests met established specifications. For comparative purposes the same testing, when applicable, has been conducted also on the D 905 EOS assembled in a circuit with the Ideal Mimesys' Bubble Trap and Centrifugal Pump. The modifications being made to the ECC.O do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 905 EOS apply to the ECC.O.

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

### CONCLUSION:

The ECC.O system is substantially equivalent to the unmodified device. Additional testing has also demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

Previous in-vitro data showed that the ECC.O performs in a manner substantially equivalent to the D 905 EOS with respect to the expected main performance parameters associated with ordinary oxygenators with integrated heat exchanger that is transfer of oxygen and removal of carbon dioxide, blood temperature control.

Furthermore, the ECC.O performs in a manner substantially identical to the Ideal Mimesys' Centrifuqal Pump predicate device with respect to the basic function of an ordinary centrifugal pump that is propulsion of blood through the cardiopulmonary bypass circuit by centrifugal force. In addition the ECC.O air removal system (defoamer) replaces the air removal function of ordinary venous reservoirs in a way substantially equivalent to the Ideal Mimesys' Bubble Trap with respect to the main functions of an ordinary bubble trap that is separation of gaseous emboli form the venous blood.

Data collected show that integration of the venous air removal device (defoamer) and of the centrifugal pump to the oxygenating module is advantageous in terms of lower operating blood volumes during priming procedures.

Therefore it can be concluded that ECC.O system duplicates the functionality of the separated predicate devices. 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 the device is sterile and non-pyrogenic.

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

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

#### K050890 Re:

K050890
ECC.O. System with Integrated Venous Air Removal, Centrifical Blood Pump, Pump O, System Wall mogenator and Heat Exchanger Regulation Number: 21 CFR 870.4360 Regulation Number. 21 CFR 076. 1500
Regulation Name: Nonroller-type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: April 7, 2005 Received: April 8, 2005

## Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQC ) prematics is substantially equivalent (for the indications
referenced above and have determined the devices and estable referenced above and have delemined the devices marketed in interstate for use stated in the enclosure) to regally manced tecal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval applications of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general connus provisions of t You may, therefore, market the device, stole general of on mal registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende roquilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regula may be subject to such additional controlist. Listing indicts 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regarations, Fride of the Federal Register.

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

Page 2 - Mr. Barry Sall

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607); adoming (21 CFR Part 820); and if applicable, the electronic form in the quality of telems (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction control pro here... (2) (2) = 1) = (2) = (2) = 1) = (2) = 1) = (10) = 10(k) This letter will and w yourse out finding of substantial equivalence of your device to a legally prematication. The PDF and 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 11 you desire 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 (2017 27 1057. Theo) processor and 807.97) you may obtain. Other general information on your premative houriedion > ( 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,

onna R. Willines

Image /page/4/Picture/5 description: The image contains a signature. The signature is illegible, but appears to be a stylized set of lines and curves. The signature is in black ink and is on a white background.

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

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Dideco, which is a company that is part of the Sorin Group. The logo is black and has a stylized font. The words "A. SORIN GROUP COMPANY" are printed in a smaller font below the logo.

### DIDECO S.r.I.

K050890 510(k) Number (if known): __

Device Name: ECC.O System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Hollow Fiber Oxygenator and Heat Exchanger

Indications For Use:

The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

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)

Duna R. Varlines
(Division Sign-Off)

Division of Cardiovascular Devices

510(K) Number_Ko