The Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. 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. The device is intended to be used for 6 hours or less.

Device Description

The D 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir (hereafter referred to as the D 905 EOS) is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir. The device is a modified version of the currently marketed D 903 Avant 2 Ph.I.S.I.O (K033323) predicate device (hereafter referred to as the Avant Ph.1.S.I.O.). The modification is limited to an overall reduction in the size of the device. The reduction in size enables the device to be better suited for the pediatric and small adult patient population.

AI/ML Overview

Here's an analysis of the provided text regarding the D 905 EOS Oxygenator, extracting information relevant to acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it states that the test results "met established specifications" and that the device is "substantially equivalent" to predicate devices. The performance is reported in relation to these comparisons.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meets ISO 10993-1:1995 and FDA guidelines; Sterility; Non-pyrogenicity; ETO residuals; Package Integrity	Met established specifications for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals, and Package Integrity.
Gas Transfer Characteristics	Comparable to predicate devices (Avant Ph.I.S.I.O. and Cobe Optimin)	Showed substantial equivalence to Cobe Optimin and comparable to Avant Ph.I.S.I.O.
Pressure Drop	Comparable to predicate devices	Showed substantial equivalence to Cobe Optimin and comparable to Avant Ph.I.S.I.O.
Plasma Leakage Data	Met established specifications	Met established specifications.
Operating Blood Volumes	Met established specifications	Met established specifications.
Heat Exchanger Performance	Met established specifications	Met established specifications.
Hemolysis/Cell Depletion	Met established specifications	Met established specifications.
Mechanical Integrity	Met established specifications	Met established specifications.
Venous Cardiotomy Reservoir Characterization	Comparable to predicate devices (Avant Ph.I.S.I.O.) and met established specifications for various parameters.	Showed substantial equivalence to Avant Ph.I.S.I.O. for breakthrough times, volumes, graduated scale accuracy, residual blood volume, defoaming capacity, filtration efficiency, and reservoir housing integrity.
Leaching Studies	Met established specifications	Met established specifications.
Clinical Performance (Post-Market)	No reports of adverse events due to malfunctioning.	In commercial distribution in Europe since March 2003 with no reported adverse events.

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

The document does not specify a distinct "test set" sample size for each performance characteristic. Instead, it refers to in-vitro testing performed on the "D 905 EOS" (the device itself) and, "for comparative purposes," on the "D 903 Avant 2 Ph.I.S.I.O." and the "Cobe Optimin predicate device."

Sample Size: Not explicitly stated as a number of devices or data points for the in-vitro tests. It refers to testing the device and predicate devices.
Data Provenance: Retrospective for the predicate devices as they are "legally marketed." Prospective for the D 905 EOS, as the testing was conducted to support its 510(k) submission. There is no mention of country of origin for the data collection, but the submitter is Italian (Dideco S.r.l.).

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

This information is not provided in the document. The studies described are in-vitro tests, which typically rely on standardized laboratory measurements and comparison to objective specifications and predicate device performance, rather than expert judgment for "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies are in-vitro tests with objective measurements, not studies requiring expert adjudication.

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 device is a medical oxygenator, not an AI-based diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the context of imaging or similar interpretation tasks.

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

Not applicable. The device itself is a standalone medical device. The "standalone" concept typically applies to software or AI algorithms operating independently of human intervention. Here, the device's performance was evaluated in various standalone in-vitro tests.

7. The Type of Ground Truth Used

The "ground truth" for the in-vitro performance characteristics was established by:

Established Specifications: These would be pre-defined numerical or qualitative criteria based on regulatory guidelines, engineering principles, and clinical requirements for oxygenators.
Predicate Device Performance: The functional parameters of the D 903 Avant 2 Ph.I.S.I.O. and Cobe Optimin served as benchmarks for demonstrating substantial equivalence.

There is no mention of pathology, outcomes data, or expert consensus (in the context of clinical interpretation) as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a software algorithm that would require a "training set" in the context of machine learning. The term "training set" refers to data used to train an AI model.

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

Not applicable, for the same reasons as point 8.

Summary

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Abbreviated 510(k) December 1, 2004

ber 1, 2004

510(k) SUMMARY

SUBMITTER:	Dideco S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	December 1, 2004
DEVICE TRADE NAME:	D 905 EOS: Hollow Fiber Oxygenator With IntegratedHardshell Venous/Cardiotomy Reservoir
COMMON NAMES:	Hollow Fiber Oxygenator with HardshellVenous/Cardiotomy ReservoirHollow Fiber OxygenatorHardshell Venous/Cardiotomy Reservoir
CLASSIFICATION NAMES:	Cardiopulmonary Bypass OxygenatorCardiopulmonary Bypass Heat ExchangerCardiopulmonary Bypass Blood ReservoirCardiopulmonary Bypass Defoamer
PREDICATE DEVICES:	D 903 Avant 2 Ph.I.S.I.O. Adult Hollow FiberOxygenator with Integral Hardshell Cardiotomy /Venous Reservoir with Biocompatible TreatmentSurface (Ph.I.S.I.O.) (K033323)Cobe Optimin Hollow Fiber Membrane Oxygenator(K991452)

DEVICE DESCRIPTION:

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INDICATION FOR USE:

The D 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir hereinafter called the D 905 EOS, is a sterile, nonpyrogenic device intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters/minute. The device provides oxygenation and carbon dioxide removal from venous or suctioned 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 the patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. Following intraoperative use, the reservoir is used for the collection and autotransfusion of shed blood and/or chest drainage. The device is intended to be used for 6 hours or less. Contact with blood for longer periods is inadvisable.

TECHNOLOGICAL CHARACTERISTICS:

The D 905 EOS is essentially identical to the Avant Ph.I.S.I.O. predicate device with respect to design, materials, biocompatibility of the PmM2 coating, operating principles, technological characteristics and manufacturing process. The hardshell cardiotomy/venous reservoir present in both D 905 EOS and Avant Ph.I.S.I.O. share the same technological characteristics, operating principles, materials and basic design of the Avant Ph.I.S.I.O. except for a reduction of its dimensions. The D 905 EOS oxygenating module shares the same basic design, operating principles and control mechanisms of the Avant Ph.I.S.I.O. module. The only modifications consist of a reduction of its dimensions and consequently in less hollow fiber membrane material with respect to the Avant Ph.I.S.I.O. predicate device. These differences make the D 905 EOS more suited for smaller adult and pediatric patients like the Cobe Optimin predicate device. The D 905 EOS is substantially equivalent to the Cobe Optimin predicate device in intended use, patient population and performance specifications.

The coating of the oxygenating module is identical to the phosphorycholine coating used on the Avant Ph.I.S.I.O. predicate device.

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 biocompatibility testing on the raw materials. Testing were performed on the D 905 EOS. (accelerated aging). The device aged up to three years was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Sterlity, 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 Cardiopylmonary Bypass Oxygenalors 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 Cardiopylmonary 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 Artificial 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 gas transfer characteristics, pressure drop, plasma leakage data, operating blood volumes, heat exchanger performance evaluation, hemolysis/cell depletion, mechanical integrity, venous cardiotomy reservoir characterization (including breakthrough times and volumes, reservoir graduated scale accuracy, residual blood volume, defoaming capacity, filtration efficiency and reservoir housing integrity) and leaching studies characterization. The results of these tests met established

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specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the D 903 Avant 2 Ph.1.S.I.O. and on the Cobe Optimin predicate device. The result of the study showed that the device is comparable to the predicate devices concerning with all characteristics.

MARKETING HISTORY:

Up to now the D 905 EOS is in commercial distribution in Europe since March 2003. No reports of adverse events involving patient safety due to malfunctioning have been received.

CONCLUSIONS:

The results of in vitro studies demonstrate that the D 905 EOS performs in a manner substantially equivalent to the Cobe Optimin hollow fiber oxygenator with respect to the relevant functional parameters. Furthermore, the D 905 EOS performs in a manner substantially equivalent to the Avant Ph.I.S.I.O. predicate device with respect to the venous reservoir characterization. Biocompatibility studies demonstrate that the phosphorycholine coating is biocompatible and functional tests demonstrate that its performance is equivalent to the Cobe Optimin predicate device, according to its intended use. Additional testing has also demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2005

Dideco S.R.L. c/o Mr. Barry Sall Parexel International Corporation 195 West Street Waltham, MA 02451

Re: K043323

D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir Regulation Number: 21 CFR 868.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: December 1, 2004 Received: December 2, 2004

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 yours,

Dwana R. Lochner

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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510(k) Number (if known): 上の4ろ323

Device Name: Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir

Indications For Use:

Prescription Use (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)

Mina P. Lacher

Division Sian-C Division of Cardiovascular Devices

510(k) Number K043323

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.”