The Dideco D 903 Avant 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 on other 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 to tient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

Device Description

The D 903 AVANT and D 903 AVANT 2 Ph.I.S.I.O, hereafter referred to as the AVANT, are hollow fiber membrane oxygenators with integral heat exchanger and a hardshell cardiotomy/venous reservoir. The D 903 AVANT 2 Ph.I.S.I.O. is the phosphorylcholine coated version of the same AVANT oxygenator. The change covered by this submission is limited to extending the intended use of the AVANT (uncoated and coated versions) in order to allow the use of active venous drainage with vacuum. No modifications are being made to the devices themselves except an addition to the indications for use and instructions for use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the D 903 AVANT Adult Hollow Fiber Oxygenator. These notifications are about demonstrating substantial equivalence to a predicate device, not necessarily defining or proving new acceptance criteria through a clinical study in the way an AI/ML device submission would. Therefore, many of the requested categories for AI/ML study details (like sample size for test sets, number of experts, MRMC studies, training set details) are not applicable here.

Here's a breakdown of the available information in the context of your request:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate devices and the relevant standards. The "reported device performance" is a demonstration of substantial equivalence to these predicate devices.

Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance
Material Biocompatibility	"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 biocompatibility testing on the raw materials." These tests included: Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, and material characterization. "The results of the testing met established specifications."
Sterility & Pyrogenicity	Tested for Sterility, Pyrogenicity, ETO residuals, and package integrity. "The results of the testing met established specifications." "Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic."
Functional Performance (In Vitro)	In vitro testing was performed according to "Guidance for Cardiopulmonary Bypass Oxygenators 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 Exchangers (Oxygenator)'". This included: - Performance characterization- Physical effectiveness characterization/integrity
Blood Compatibility (for coated version)	"Blood compatibility characterization and stability of the coating were performed on the AVANT Ph.I.S.I.O. predicate device (K020351)." This included "hemolysis/cell depletion characterization, microembolic activity characterization, and reservoir housing integrity during active venous drainage." "The results of these tests met established specifications."
Intended Use with Vacuum Drainage	The submission specifically addresses the extension of intended use to include active venous drainage with vacuum. The above tests (e.g., reservoir housing integrity during active venous drainage) would cover this. "functional tests demonstrate that the AVANT is equivalent to the predicate devices, with respect to its intended use with vacuum drainage."
Equivalence to Predicate Devices	"The results of the study showed the device characteristics of the modified AVANT and predicate devices are comparable." "The results of in vitro studies demonstrate that the AVANT Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the predicate device."

Study Details (as applicable to a 510(k) for a non-AI/ML device)

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. This submission focuses on in vitro and biocompatibility testing of a physical medical device. The "test set" would refer to the physical samples of the oxygenator or its materials subjected to various tests. The provenance is the manufacturer's testing facilities (Dideco S.p.A., Italy).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by standardized laboratory measurements and compliance with ISO standards, not expert consensus in the diagnostic sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for subjective assessments or discrepancies in diagnostic interpretations, not for objective measurements of physical device performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a physical medical device, not an AI/ML diagnostic algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international standards (ISO 10993-1:1995, ISO 7199 (1996)) and FDA guidance documents, as well as objective measurements of physical and chemical properties of the device and its materials.
The sample size for the training set: Not applicable. This is for a physical medical device, not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) premarket notification demonstrates substantial equivalence for a physical medical device based on in vitro performance data and biocompatibility testing, not an AI/ML diagnostic product, so many of the requested AI/ML-specific details are not present.

Summary

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JAN 1 3 2004

SUBMITTER:	Dideco S.p.A.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	October 14, 2003
DEVICE TRADE NAME:	D 903 AVANT Adult Hollow Fiber Oxygenator (K980600)D 903 AVANT 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenatorwith Ph.I.S.I.O coating (K020351)
COMMON NAME:	Hollow Fiber Oxygenator/Reservoir
CLASSIFICATION NAME:	Cardiopulmonary Bypass OxygenatorCardiopulmonary Bypass Heat ExchangerCardiopulmonary Bypass Blood ReservoirCardiopulmonary Bypass Defoamer
PREDICATE DEVICES:	D 903 AVANT Adult Hollow Fiber Oxygenator (K980600)D 903 AVANT 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenatorwith Ph.I.S.I.O coating (K020351)Monolyth Mimesys Adult Hollow Fiber Oxygenator (K004001)

510(k) SUMMARY

DEVICE DESCRIPTION:

INDICATION FOR USE:

The previous indications for use has been modified as follows: "The Dideco D 903 AVANT 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 (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device is intended to be used for six hours or less."

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TECHNOLOGICAL CHARACTERISTICS:

The AVANT hollow fiber oxygenator is identical in design, operating principles, control mechanisms, manufacturing process and biocompatibility of the PmMl2 coating to the AVANT predicate devices. The only mantiacioning process and breended use of the AVANT (uncoated and coated version) to allow the mountation is the extention owith vacuum. The fundamental scientific technology of the modified device is not changed as a result of the extension of the intended use described in this submission.

The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fiuid 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 biocompatibility testing on the raw materials. The AVANT was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and fall materity. Biocompatibility testing performed on AVANT Ph.I.S.I.O. predicate devices have been taken as reference for the AVANT as the raw materials used in manufacturing process are identical to those used in the predicate devices. Sterlity, Pyrogenicity, ETO residuals and package integrity testing were also conducted. 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 Cardiopulmonary Bypass Oxygenators 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 Exchangers (Oxygenator)" for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. As the device is unchanged with respect to the predicate device safety and characterization is based upon the performance characterization, physical effectiveness characterization/integrity performed on AVANT (K980600) and AVANT Ph.I.S.I.O. (K020351) predicate device validation. Blood compatibility characterization and stability of the coating were performed on the AVANT Ph.I.S.I.O. predicate device (K020351). The device was aged up to 5 years (considered as worst case) and tested for hemolysis/cell depletion characterization, microembolic activity characterization, and reservoir housing integrity during active venous drainage. The results of these tests met established specifications.

The results of the study showed the device characteristics of the modified AVANT and predicate devices are comparable.

CONCLUSIONS:

The results of in vitro studies demonstrate that the AVANT Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the predicate device. Biocompatibility studies demonstrate that the phosphoryicholine coating is biocompatible, and functional tests demonstrate that the AVANT is equivalent to the predicate devices, with respect to its intended use with vacuum drainage. Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Image /page/2/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three thick, curved lines. The seal is black and white.

JAN 1 3 2004

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: K033323

D 908 AVANT Adult Hollow Fiber Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: October 14, 2003 Received: October 15, 2003

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in ad 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 conimoted provision in accordance with the provisions of the Federal Food, Drug, devices mat intro been room require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, diererers, hans 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back as back as 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 Please be advised that I DA 3 issualled of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that TDA has made a decemination that your instered by other Federal agencies. You must or any Pederal statutes and regulations daministered or registration and listing (21 comply with an the Act 3 requirements, n.c. and 801); good manufacturing practice requirements as set and CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions your device as described in your Section 5110(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification: "The PDF miding of castion 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 If you desire specific advice for your ac (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misblanding by receive to promantonibilities under the Act from the Division of Small other general information on your respenses at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address.

Sincerely yours,

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "dideco" in a bold, stylized font. The letters are connected, giving the word a fluid and continuous appearance. The overall design is simple yet eye-catching, making it easily recognizable.

DIDECO S.p.A.

K033323

510(k) Number (if known):

Device Name: Dideco D 903 Avant Adult Hollow Fiber Oxygenator

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

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K053323

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”