Ideal is intended to be used in surgical procedures requiring extracorporeal gas exchange support. Ideal is intended for use in operations on adult patients. Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal is intended for use with the Stöckert Centrifugal Pump Console.

Device Description

The Ideal, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The Ideal consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifuqal pump (Cobe Revolution Centrifyial Blood Pump. K011835) and a pump bracket.

AI/ML Overview

The provided text describes the Dideco S.p.A. IDEAL System, an extracorporeal hemodynamic and gas exchange support system, seeking 510(k) clearance. The submission focuses on demonstrating substantial equivalence to predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump) rather than establishing new performance criteria or conducting a standalone effectiveness study.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't define explicit acceptance criteria in terms of specific thresholds for the IDEAL system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices across several characteristics. The reported device performance is primarily a statement of comparability.

Characteristic/Test Category	Acceptance Criteria (Implicit from Substantial Equivalence to Predicate)	Reported Device Performance
Material Biocompatibility	Identical raw materials to predicate devices (Synthesis and Revolution)	Biocompatibility testing on Synthesis and Revolution predicate devices was taken as reference, as raw materials are identical. Sterility, Pyrogenicity, ETO residuals, and package integrity met established specifications.
Operating Blood Volumes	Comparable to predicate devices	Testing conducted; results met established specifications. Integration of defoamer and centrifugal pump to oxygenating module is "advantageous in terms of lower operating blood volumes."
Hemolysis/Cell Depletion	Comparable to predicate devices	Testing conducted; results met established specifications.
Mechanical Integrity	Comparable to predicate devices	Testing conducted; results met established specifications.
Air Handling Characterization (Venous Air Removal)	Substantially equivalent to Synthesis predicate's defoaming system	Testing conducted; results met established specifications. Air bubbles are "equally well handled and purged from venous blood" by the IDEAL's integrated device compared to traditional systems.
Oxygen Transfer	Substantially equivalent to Synthesis predicate	Previous in-vitro data showed substantial equivalence to Synthesis for "transfer of oxygen."
Carbon Dioxide Removal	Substantially equivalent to Synthesis predicate	Previous in-vitro data showed substantial equivalence to Synthesis for "removal of carbon dioxide."
Blood Temperature Control	Substantially equivalent to Synthesis predicate	Previous in-vitro data showed substantial equivalence to Synthesis for "blood temperature control."
Arterial Filter Performance	Substantially equivalent to Synthesis predicate	Previous in-vitro data showed substantial equivalence to Synthesis for "removal of arterial blood components aggregates larger than 40 u."
Blood Propulsion (Centrifugal Pump)	Substantially identical to Revolution predicate	Performs in a "substantially identical" manner to the Revolution predicate for propulsion of blood.

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

Sample Size: The document does not explicitly state numerical sample sizes for the "in vitro test results." It mentions that "the device aged up to 3 years was tested for operating blood volumes, hemolysis/cell depletion, mechanical integrity and air handling characterization." It also states "the same testing, when applicable, has been conducted also on the Synthesis and Revolution predicate" for comparative purposes. This implies tests were performed on at least one IDEAL device and comparable predicate devices, but exact numbers of units tested are not provided.
Data Provenance: The testing was carried out in vitro, following FDA guidance documents and ISO standards. The country of origin of the data is not specified beyond the manufacturer being Dideco S.p.A. (Italy). The data is presumably prospective for the IDEAL system tests performed for this submission, although some reference is made to "previous in-vitro data" for the Synthesis predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is not applicable to this submission. The "ground truth" for this device is based on physical and chemical performance measurements (e.g., blood volumes, hemolysis, air removal) against established engineering specifications and comparison to predicate devices, not on expert interpretations of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" concept is typically used in clinical studies or studies involving human readers, where discrepancies in interpretation need to be resolved. This submission describes in-vitro performance testing, which does not involve human readers for ground truth establishment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant for a device like the IDEAL system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study (in vitro testing) was done. The entire "In Vitro Test Results" section describes the performance of the IDEAL device itself (without human intervention in its function) against specific standards and in comparison to predicate devices. This testing evaluated the device's functional performance directly.

7. The Type of Ground Truth Used

The ground truth for the in-vitro performance tests was based on:

Established specifications derived from relevant FDA guidance documents ("Guidance for Cardiopulmonary Bypass Oxygenators," "Guidance for Blood Extracorporeal Blood Circuit Defoamer," "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter") and ISO 7199 (1996) standard.
Performance data from the legally marketed predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump), which served as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This device is a medical mechanical/biological system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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K030154

MAR 3 1 2003

510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAMES:

CLASSIFICATION NAMES:

PREDICATE DEVICES:

Dideco S.p.A. 86. Via Statale 12 Nord 41037 Mirandola (MO) Italy

Luigi Vecchi Phone: 011 39 0535 29811 Fax: 011 39 0535 25229

January 15, 2003

IDEAL: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter

Hollow Fiber Membrane Oxygenator with Integrated Arterial Filter and Heat Exchanger Venous Defoamer Centrifugal Blood Pump

Cardiopulmonary Bypass Oxygenator Cardiopulmonary Bypass Heat Exchanger Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Defoamer Cardiopulmonary Bypass Arterial Line Blood Filter Non-Roller Type Cardiopulmonary Bypass Blood Pump

Membrane Oxygenator With SYNTHESIS: Adult Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated (Phosphorylcholine coating hereinafter called PC coating) (K022450)

Cobe Revolution Centrifugal Blood Pump, (K011835)

DEVICE DESCRIPTION:

INDICATION FOR USE:

The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter hereinafter called the IDEAL is a sterile, nonpyrogenic device intended to be used in surgical procedures requiring extracorporeal gas

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The IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Fitter hereinafter called the IDEAL is a sterile, nonpyrogenic device intended to be used in surgical procedures requiring extracorporeal gas exchange support. The Ideal is intended for use in operations on adult patients. The Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. The ldeal is intended for use with Stockert Centrifugal Pump Console

TECHNOLOGICAL CHARACTERISTICS:

The Ideal is comprised of an adult membrane oxygenator with an integrated heat exchanger and arterial filter identical to the Synthesis predicate device. The coating is identical to the phosphoryline coating used on the Synthesis predicate device. The Ideal design has been completely reviewed with reference to the defoaming system as compared to the Synthesis' predicate device defoaming system.

The air removal system (defoamer) of the Ideal replaces the air removal function of ordinary venous reservoirs by centralizing venous line air and effectively removing it in a way substantially equivalent to the Synthesis hardshell venous/cardiotomy reservoir. The basic function of all integrated defoamer/oxygenators is the same. That is, a combination blood-gas exchange device with a separate active venous air removal section (defoamer).

The Ideal with reference to the integrated centrifugal blood pump is also identical to the Revolution Pump predicate device. The basic function of all centrifugal pumps is the same, that is, moving blood through the cardiopulmonary bypass circuit by centrifugal force.

Therefore the Ideal duplicates the functionality of the separate predicate devices.

The Ideal 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 carned 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 biocompatibility testing on the raw materials. The Synthesis device was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. The Revolution device was tested for Hemolysis. Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Biocompatibility testing performed on Synthesis and Revolution predicate devices have been taken as reference for the Ideal 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 "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 -"Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000 and when applicable, following the ISO 7199 (1996) standard for "Cardiovascular Implants and Articial Organs - Extra Corporeal Blood-Gas Exchangers (Oxygenator)" for providing the data necessary to demonstrate both the substantial equivalence with the predicate devices and also complying with safety and effectiveness requirements. The device aged up to 3 years was tested for operating blood volumes, hemolysis/cell deplation, mechanical integrity and air handling characterization of the integrated venous air removal device. The results of this tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the Synthesis and Revolution predicate.

The result of the study showed that the device is comparable to the predicate devices concerning with all characteristics.

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CONCLUSIONS:

The results of in vitro studies demonstrate that the Ideal performs in a manner substantially equivalent to the Synthesis with respect to the main function of ordinary venous reservoirs (defoamers) that is separation and evacuation of gaseous emboli form the venous blood. Previous in-vitro data showed that the Ideal performs in a manner substantially equivalent to the Synthesis with respect to the expected main performance parameters associated with ordinary oxygenators with integrated heat exchanger and arterial filter that is transfer of oxygen and removal of carbon dioxide, blood temperature control, removal of arterial blood components aggregates larger than 40 u. Furthermore, the Ideal performs in a manner substantially identical to the centrifying pump Revolution predicate device with respect to the basic function of an ordinary centrifygal pump that is propulsion of blood through the cardiopulmonary bypass circuit by centrifugal force.

Data collected show that integration of the active venous air removal device (defoamer) and of the centrifugal pump to the oxygenating module is advantageous in terms of lower operating blood volumes during procedures. Moreover air handling test results indicate that air bubbles are equally well handled and purged from venous blood by the Ideal integrated venous air removal device with respect to traditional extracorporeal cardiopulmonary bypass reservoirs.

Therefore it can be concluded that Ideal integrated system duplicates the functionality of the separated predicate devices. Biocompatibility and functional performances of phosphorylcholine coated devices, proved for the Synthesis predicate device, have been taken as reference for the ldeal. Additional testing has also demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

MAR 31 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dideco S.p.A. c/o Mr. Barry Sall Parexel International Corp. 195 West Street Waltham, MA 02451-1163

Re: K030154

IDEAL, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller Type CPB Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: January 15, 2003 Received: January 16, 2003

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 requirements 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 (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 premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Ana Hlusherfor
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 word "dideco" in a stylized, bold, sans-serif font. The letters are connected, with the "d" and "i" forming a single shape, and the "e" and "c" similarly joined. The overall design is compact and visually unified, with a slightly rounded appearance.

DIDECO S.p.A.

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: IDEAL System with Integrated Venous Air Removal, Centrifygal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

Dva Hlulu

510

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.