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 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.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to compliance with established specifications and guidance documents. The reported device performance is presented as meeting these specifications.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met established specifications (ISO 10993-1:1995 and FDA May 1, 1995 Memorandum).
Sterility	Met established specifications.
Pyrogenicity	Met established specifications.
ETO Residuals	Met established specifications.
Package Integrity	Met established specifications.
Hemolysis/Cell Depletion	Met established specifications.
Operating Blood Volume	Met established specifications.
Mechanical Integrity	Met established specifications.
Flaking and Leaching	Met established specifications.
Air Handling Characterization	Met established specifications.
Functional Equivalence	Performed in a manner substantially equivalent to predicate devices for gas exchange, blood temperature control, blood propulsion, and air removal.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a sample size for the test set in terms of number of devices or data points used for each specific in vitro test. It generally states that "Applicable tests were carried out" and "In vitro testing was carried out."

Regarding data provenance:

Country of Origin: Not specified for the test data, but the submitter (Dideco S.r.l.) is based in Mirandola (MO), Italy.
Retrospective or Prospective: The testing described appears to be prospective as it involves new in vitro tests on the ECC.O system, as well as comparative testing with the D 905 EOS assembled with predicate devices. The biocompatibility data from predicate devices are used as a reference, which could be considered retrospective in a way, as it leverages prior testing. The ECC.O devices were "accelerated aged to an equivalent of three years real time aging" for some tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable in this context. This submission describes non-clinical (in vitro) testing and substantial equivalence to predicate devices, not studies involving human interpretation or clinical outcomes where expert ground truth would be established.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical evaluation based on laboratory testing against established specifications and comparative performance with predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for a medical device (extracorporeal circulation system), not an AI-powered diagnostic or imaging interpretation tool where such studies would be relevant.

6. Standalone Performance:

Yes, a standalone performance evaluation was conducted in the sense that the ECC.O system was subjected to various in vitro tests to assess its algorithm-only equivalent performance (i.e., the device's functional and safety performance without human intervention during the test itself). The results were then compared to established specifications and the performance of predicate devices.

7. Type of Ground Truth Used:

The "ground truth" for this device evaluation is primarily based on:

Established Specifications: Predetermined performance targets and safety limits derived from regulatory standards (e.g., ISO 10993-1, ISO 7199), FDA guidance documents (e.g., for Cardiopulmonary Bypass Oxygenators, Blood Extracorporeal Blood Circuit Defoamers), and internal validated engineering and design specifications.
Predicate Device Performance: The functional performance of the predicate devices (D 905 EOS, Ideal Mimesys' Centrifugal Pump, Ideal Mimesys' Venous Air Removal Device) served as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a "training set." The testing described is for a physical medical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this type of device.

Summary

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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: 011 39 0535 29811 Fax: 011 39 0535 25229

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:

7 2

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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.

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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.

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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.

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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:

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

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)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.
(2)
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.