The Dideco D 903 Avant 2 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 six hours or less.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the D 903 AVANT Ph.I.S.I.O. Adult Hollow Fiber Oxygenator:

This document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study report describing novel performance claims. Therefore, the device is not demonstrating performance against acceptance criteria in the way an AI/ML device would. Instead, it is demonstrating substantial equivalence to existing devices through a series of tests. Many of the requested categories are not directly applicable to this type of submission.

The "acceptance criteria" here are implicitly that the D 903 AVANT Ph.I.S.I.O. performs equivalently or within acceptable ranges compared to its predicate devices for relevant characteristics. The "study" proving this is a series of in vitro and biocompatibility tests.

1. Table of "Acceptance Criteria" and Reported Device Performance

"Acceptance Criteria" (Implicit)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1:1995 standards for medical devices and FDA May 1, 1995 Memorandum.	Testing Performed: Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals. Result: "The results of the testing met established specifications." The phosphorylcholine coating "is biocompatible."
Gas Transfer Characteristics: Comparable to predicate device (D 903 AVANT).	Testing Performed: In vitro gas transfer studies (following "Guidance for in Vitro Testing World Cardiac Sustained 510(k) submissions - Final Guidance" and ISO 7199 (1996)). Result: "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 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."
Operating Blood Volume: Comparable to predicate device.	Testing Performed: In vitro testing. Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable."
Heat Exchanger Performance Evaluation: Comparable to predicate device.	Testing Performed: In vitro testing. Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable."
Hemolysis/Cell Depletion: Comparable to predicate device.	Testing Performed: In vitro testing. Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable."
Mechanical Integrity: Comparable to predicate device.	Testing Performed: In vitro testing. Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable."
Leaking/Flaking Test: Comparable to predicate device.	Testing Performed: In vitro testing. Result: Included in general statement: "The results of these tests met established specifications." Also inferred from "The results of the study showed the device characteristics between D 903 AVANT Ph.J.S.I.O. and D 903 AVANT were comparable."
Sterility: Achieve and maintain sterility.	Testing Performed: Sterilization validation, ETO residuals. Result: "Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic."
Pyrogenicity: Be non-pyrogenic.	Testing Performed: Pyrogenicity test. Result: "Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic."
Shelf Life (Durability): Maintain performance characteristics for the specified shelf life (up to 2 years).	Testing Performed: Biocompatibility and in vitro tests were conducted on the device "aged up to 2 years." Result: Implied that results met specifications for aged devices.

The following points are mostly not applicable to this type of device submission (a traditional 510(k) for an oxygenator, not an AI/ML diagnostic system):

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in terms of number of devices or "cases." The "tests" here refer to laboratory evaluations on physical devices (e.g., a certain number of oxygenator units were subjected to gas transfer, heat exchange, etc., tests). The specific number of units isn't detailed in this summary.
Data Provenance: The tests were conducted internally by Dideco S.p.A. (Italy) as part of their submission to the FDA. The data is prospective in the sense that the tests were specifically performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic interpretations. For this device, "ground truth" refers to established physical and chemical measurement standards (e.g., for gas exchange, blood compatibility), which are measured by laboratory technicians according to specified protocols.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers/experts in diagnostic tasks. This device is evaluated by objective physical and chemical tests against predefined specifications.

5. 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 not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware medical device, not an algorithm. Performance is inherent to the device's physical function.

7. The type of ground truth used

Physical and Chemical Measurement Standards / Predicate Device Performance: The "ground truth" is based on established engineering and biocompatibility standards (e.g., ISO 10993, ISO 7199, FDA guidance) and the performance characteristics of the legally marketed predicate devices (D 903 AVANT, D 901 Lilliput Ph.I.S.I.O., Monolyth Mimesys). The device is considered "substantially equivalent" if it meets the same functional performance levels.

8. The sample size for the training set

Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, but not "trained" with data.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question does not apply.

Summary

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FEB 2 6 2002	510(k) SUMMARY
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:	February 21, 2002
DEVICE TRADE NAME:	D 903 AVANT 2 Ph.I.S.I.O(Phospholipidic Inert Surface InOxygenation) Adult Hollow FiberOxygenator
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.

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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.

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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

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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 (301) 594-1010. Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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 __

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.”