The Dideco D903 Avant Hollow Fiber Oxygenator 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 patients' veins during normal operation to assure the proper oxygenation capability of the device. The D903 Avant is intended to be used for six hours or less.

Device Description

The Dideco D903 Avant membrane oxygenator is a high efficiency membrane oxygenator of hollow fiber design with an integral heat exchanger and an attached hardshell cardiotomy/venous reservoir. The device will be available both as an integrated device and as separate devices; a single sterile oxygenator module and the venous/cardiotomy reservoir. The fiber bundle within the oxygenator consists of a polycarbonate core wound with microporous polypropylene hollow fibers. The core is encapsulated on both ends with polyurethane and contained within a polycarbonate housing. Two versions of the oxygenator will be offered in two configurations having different affective gas exchange surface. The first has an effective gas exchange surface of 1.6 m², while the latter has an effective gas exchange surface of 2.0 m². The integral heat exchanger is comprised of a grooved and plated stainless steel sheet. The hardshell cardiotomy/venous reservoir of the integrated version is attached to the top of the oxygenator by means of a molded fitted joint and is comprised of a rigid polycarbonate housing with an internal support. The filtering system surrounds the internal support. Suctioned blood enters the cardiotomy section by two rotatable turrets equipped with %" and 1/2" connectors. The blood enters the reservoir by gravity drainage from the cardiotomy, through the venous inlet placed in the bottom of the reservoir or by means of a recirculation line (allowing oxygenated blood to be recirculated and purged back to the reservoir). A self-purging four-way stopcock located beside the oxygenation module of the D903 Avant allows for arterial and venous blood sampling. The blood sampling system consists of three coiled PVC tubes connected to a four-way stopcock. The tubes allow for either sampling or purging of arterial and venous blood or delivery of drugs into the venous line. The D903 Avant includes arterial and venous temperature probe sites for monitoring of blood temperature. A holder is available for use with the oxygenator. The holder is comprised of a stainless steel rotating arm secured to the IV pole by means of a knob. This allows for independent rotation of the device. On the bottom of the holder are two integrated Hansen water connectors securing the Oxygenator in a locked position.

AI/ML Overview

Acceptance Criteria and Study for D903 Avant Hollow Fiber Oxygenator

The D903 Avant Hollow Fiber Oxygenator underwent a series of in vitro and clinical studies to demonstrate its performance and substantial equivalence to a predicate device (MONOLYTH Oxygenator). The acceptance criteria were largely based on comparison to this predicate device and conformance with the proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
In Vitro Studies
Oxygen Transfer Rates (at 4, 6, 8 LPM blood flow)	Compared favorably with the predicate device.
Carbon Dioxide Transfer Rates (at 4, 6, 8 LPM blood flow)	Similar to the predicate device.
Operating Blood Volumes (static prime, post-use recovered, retained volume)	Compared favorably to the predicate device. D903 Avant showed a reduced retained volume (desirable for less hemodilution and decreased risk of donor-transmitted disease) and lower priming volume.
Blood Side Pressure Drop (at T=0 and T=6 hours during gas transfer testing)	No significant change in blood path pressure drop.
Heat Exchange Performance	Compares favorably to other oxygenators on the market.
Hemolysis/Cell Depletion (plasma hemoglobin, index of hemolysis, WBC, RBC, platelet counts)	No statistically significant differences (p > 0.05) in cell depletion and hemolytic characteristics between the D903 Avant and the predicate device.
Mechanical Integrity (leakage, pressure decay)	No signs of leakage or pressure decay throughout the test periods for either the blood path or the heat exchanger water path.
Breakthrough Time and Volume (cardiotomy screen at 1 LPM)	Statistically significant differences (p < 0.05) with D903 Avant showing a lower apparition time and volume than the predicate device (desirable for lower fluid losses during priming and perfusion).
Filter Pressurization and Residual Volumes (cardiotomy reservoir)	Comparable to the Monolyth reservoir.
Filtration Efficiency (cardiotomy reservoir for 40-micron particles)	Both devices satisfy the requirements of ANSI/AAMI BF7 - 1982 (80% particle removal at 40 microns).
Reservoir Venous Inlet Flow Capacity and Venous Backpressure	Comparable to the Monolyth reservoir.
Clinical Studies (n=10 patients)
Arterial and Venous PO2, PCO2, pH during CPB	Satisfactorily maintained for all study patients.
Venous pO2	Ranged from 32.3 to 66.9 mmHg (average 43 mmHg).
Arterial pO2	Adequately maintained, ranging from 111 to 657 mmHg (average 324.1 mmHg).
Plasma free hemoglobin at end of CPB	Average of approximately 40.6 mg/dl.
Platelet concentration	Followed normal CPB levels (decreasing during surgery, increasing post-operatively).
Red blood cell count	Decreased on average to 20-30% below normal at 60 minutes into the procedure, then rebounded to ~75% of normal at 72 hours post-bypass.
White blood cell count	Dropped during surgery, then rebounded to normal or slightly greater than normal values.

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

In vitro studies: The sample sizes for individual in vitro tests are not explicitly stated. However, the studies were performed by Dideco S.p.A. in Italy, indicating a European origin for the data. These were laboratory-based tests comparing the D903 Avant to the predicate device.
Clinical studies: A total of ten patients were used. The country of origin for the clinical data is not explicitly stated, but given that Dideco S.p.A. is based in Italy, it is highly probable the clinical studies were conducted there. The data is prospective, as it involved patients undergoing cardiopulmonary bypass surgery using the D903 Avant.

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

This information is not provided in the summary. For the in vitro studies, specific expert consensus is less relevant as performance metrics are often objective and measurable against standards or predicate devices. For the clinical studies, patient outcomes represent the "ground truth" for safety and efficacy in a clinical setting, which would be evaluated by treating physicians and medical teams, but no formal "expert panel" is mentioned for establishing ground truth for the test set itself.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessments, especially in imaging or diagnostic device evaluations where multiple readers might interpret results. This type of adjudication method is not applicable and therefore not mentioned for this device, which focuses on objective physiological measurements, gas exchange capabilities, and mechanical integrity as compared to a predicate device and existing standards.

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

An MRMC comparative effectiveness study was not conducted, nor is it relevant given the nature of the device (oxygenator) and the types of performance metrics evaluated. The device is not an AI-assisted diagnostic tool where human readers' performance would be compared with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (in vitro performance and clinical studies on patients) was performed.

The in vitro studies directly evaluated the algorithm/device's performance (gas transfer, pressure drops, hemolysis, etc.) against established benchmarks and the predicate device.
The clinical studies assessed the device's performance in humans without explicit mention of human-in-the-loop interaction for performance correction beyond the standard operation of an oxygenator by a perfusionist.

7. Type of Ground Truth Used

In vitro studies: The ground truth was established by objective measurements compared to:
- Proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators.
- Performance characteristics of a legally marketed predicate device (MONOLYTH oxygenator).
Clinical studies: The ground truth was based on patient physiological parameters and outcomes (e.g., arterial and venous blood gas levels, hematological data) during and after cardiopulmonary bypass, as monitored by standard clinical practice.

8. Sample Size for the Training Set

The concept of a "training set" with ground truth is primarily relevant for machine learning or AI-based devices. This medical device is a physical product (oxygenator), not an AI algorithm. Therefore, no distinct "training set" in the machine learning sense was used or reported. Device design and optimization would have relied on engineering principles, material science, and iterative testing, rather than an AI training set.

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

As noted above, there was no "training set" in the context of an AI algorithm. The device's design and optimization were based on:

Engineering specifications and principles for cardiopulmonary bypass equipment.
Knowledge of physiological requirements for blood oxygenation and CO2 removal.
Comparison with existing predicate devices to understand desirable performance characteristics.
Internal testing and refinement processes during product development, guided by standards like the AAMI-ISO Draft Standard.

Summary

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K980600

AUG 1 2 1998

510(k) Summary Dideco S.p.A. D903 Avant Hollow Fiber Oxygenator

1. SUBMITTER

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

Contact Person: Mr. Marco Mantovani Quality Director 011 535 29 811 Telephone: 011 535 25 229 Facsimile:

Date Summary Prepared: February 13, 1998

NAME OF DEVICE 2.

Trade Name: D903 Avant Hollow fiber oxygenator Common Name:

3. DEVICE CLASSIFICATION

Cardiopulmonary bypass oxygenator 21 CFR 870.4350 Class III: 21 CFR 870.4230 Cardiopulmonary bypass defoamer Class III: Cardiopulmonary bypass blood reservoir 21 CFR 870.4400 Class II:

DEVICE INTENDED USE AND DESCRIPTION 4.

The D903 Avant is intended for use in an extracorporeal bypass circuit. The device provides oxygenation and removal of carbon dioxide from venous or suctioned blood. The integral heat exchanger provides blood temperature control, allows for use of hypothermia, or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect the blood aspirated from the operating field during surgical procedures and the blood

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from patients' veins during normal operation, to always assure the proper oxygenation capability of the device.

The fiber bundle within the oxygenator consists of a polycarbonate core wound with microporous polypropylene hollow fibers. The core is encapsulated on both ends with polyurethane and contained within a polycarbonate housing.

Two versions of the oxygenator will be offered in two configurations having different affective gas exchange surface. The first has an effective gas exchange surface of 1.6 m², while the latter has an effective gas exchange surface of 2.0 m².

The integral heat exchanger is comprised of a grooved and plated stainless steel sheet. The hardshell cardiotomy/venous reservoir of the integrated version is attached to the top of the oxygenator by means of a molded fitted joint and is comprised of a rigid polycarbonate housing with an internal support. The filtering system surrounds the internal support. Suctioned blood enters the cardiotomy section by two rotatable turrets equipped with %" and 1/2" connectors. The blood enters the reservoir by gravity drainage from the cardiotomy, through the venous inlet placed in the bottom of the reservoir or by means of a recirculation line (allowing oxygenated blood to be recirculated and purged back to the reservoir).

A self-purging four-way stopcock located beside the oxygenation module of the D903 Avant allows for arterial and venous blood sampling. The blood sampling system consists of three coiled PVC tubes connected to a four-way stopcock. The tubes allow for either sampling or purging of arterial and venous blood or delivery of drugs into the venous line.

The D903 Avant includes arterial and venous temperature probe sites for monitoring of blood temperature. A holder is available for use with the oxygenator. The holder is comprised of a stainless steel rotating arm secured to the IV pole by means of a knob. This allows for independent rotation of the device. On the bottom of the holder are two integrated Hansen water connectors securing the Oxygenator in a locked position.

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Venous blood flows into the hardshell venous reservoir where the air is constantly evacuated through the integrated filter. The blood volume into the reservoir is monitored by a graduation on the hardshell. The suctioned blood flows into the cardiotomy reservoir mechanically separated from the venous reservoir. The separate cardiotomy section of the Avant allows the suctioned blood from the operating field to spontaneously debubble before it enters into the venous reservoir section.

Blood is pumped out of the venous reservoir through tubing in a pump head and pumped into the bottom of the heat exchanger (blood side) of the oxygenator module. The blood then flows in an upward direction through the stainless steel heat exchanger, where the blood temperature is easily controlled by adjusting the temperature of the circulating water. After the rewarming or cooling, venous blood flows from the inside of the hollow fiber bundle in a downward direction and towards the outside of the bundle core. The oxygenated blood exits the bundle core through the arterial outlet. Gas flows through the interior of the hollow fiber s and blood flows over the exterior. Gas exchange occurs with blood flow outside the polypropylene hollow fibers. As the gas and the blood flow in opposite directions, oxygen and carbon dioxide will diffuse across the membrane. By regulating the concentration of oxygen and controlling the gas flow, the amount of oxygen and carbon dioxide transfer can be controlled.

ನೆ. SUBSTANTIAL EQUIVALENCE

The D903 Avant is substantially equivalent to the following currently marketed integrated oxygenators/reservoirs in commercial distribution (cleared on 5/11/93 -510(k) K922933):

Device Name	Device Designation	Manufacturer
MONOLYTH	MONOLYTH	Sorin Biomedical Inc.17600 Gillette AvenueP.O. Box 19503Irvine, CA 92713-9503U.S.A.

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The claim of substantial equivalence is based on the following criteria:

The D903 Avant is an adult Hollow Fiber Oxygenator with integral hardshell venous reservoir and heat exchanger, like the predicate device. The basic function of all integrated reservoir oxygenators is the same. That is, a combination bloodgas exchange device with a separate reservoir section. Blood is drawn from the venous reservoir and pushed through the heat exchanger and gas modules via an external pump. This flow is referred to as 'post-pump' and is the same for both D903 Avant and Monolyth.

The operating principles and control mechanisms are exactly the same for both the D903 Avant and the Monolyth. The gas exchange module of both devices is comprised of microporous polypropylene fibers with blood flow around the outside of the fibers and oxygen flows within the bundle of the fibers. The D903 Avant utilizes the same fiber material type and blood flow path as the Monolyth and both the oxygenators contain an integrated heat exchanger comprised of corrugated stainless steel sheet.

The indications for use are the same for both D903 Avant and Monolyth. Both devices are intended for the adult population who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation.

The same probes are used for all devices. A bayonet fitting blood temperature port is placed in both the arterial and venous lines. Temperature probe sites are compatible with YSI 400 series monitoring systems.

TESTING SUMMARY 6.

In vitro studies of the Dideco D903 Avant Membrane Oxygenator were performed by Dideco to evaluate the performance characteristics and mechanical integrity of the D903 Avant oxygenator. Product testing included gas transfer, operating and residual volumes, blood-side pressure drop, gas-side pressure drop, hemolysis/cell changes, mechanical integrity, filtration and defoaming efficiency, reservoir venous inlet flow capacity and backpressure, breakthrough time and volume, filter pressurization and residual volumes. The Dideco in vitro protocols used were based on the proposed 1991 AAMI-ISO Draft Standard for blood-gas oxygenators, where applicable.

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Clinical studies were also performed on a total of ten patients using the Avant D903 Hollow Fiber Oxygenator. Satisfactory arterial and venous PO2, PCO2, and pH were reported during CPB for all study patients. The blood flow rates ranged from 2.9 1/min to 5 1/min. The gas flow rates during CPB ranged from 1.8 1/min to 4.0 1/min with an average of 2.72 l/min at all time points.

Gas composition (FiO2) ranged between 35 and 100% and averaged 60%. Venous pO2 ranged from 32.3 to 66.9 with the average being 43 for all time points. Arterial pO2 was adequately maintained throughout the procedure ranging from 111 to 657 mmHg. The average arterial pO2 was 324.1 mmHg.

Hematological data were collected for evaluation of blood trauma. Increases of plasma free hemoglobin and changes of formed elements such as platelets, Overall general results showed that the average plasma free hemoglobin was about 40.6 mg/dl at the end of cardiopulmonary bypass. Platelet concentration followed normal cardiopulmonary bypass levels, decreasing during surgery and increasing post-operatively. A similar pattern was demonstrated for red blood cells which decreased on average to about 20% to 30% below normal at 60 minutes into the procedure and then rebounded back to about 75% of normal at 72 hours post-bypass. The white blood cell count dropped during surgery and then rebounded back up to normal or slightly greater than normal values.

Test Results and Conclusions

Test Results	Conclusions
Oxygen transfer	The oxygen transfer rates were evaluated at blood flowrates of 4, 6 and 8 LPM. The results compare favorablywith the predicate device.
Carbon DioxideTransfer	The carbon dioxide transfer rates were evaluated at bloodflow rates of 4, 6, and 8 LPM. The results are similar tothe predicate device.
Test Results	Conclusions
Operating BloodVolumes	The operating blood volumes for the D903 Avant,including static prime, post-use recovered and retainedvolume were evaluated. Results compares favorably to thepredicate device. The D903 Avant has a reduced retainedvolume respect the predicate device, a lower primingvolume is desirable in that it results in less haemodilutionto the patient and decreased risk of donor transmitteddisease.
Blood Side PressureDrop	The blood path pressure drop data were recorded duringgas transfer testing at T=0 hours and T=6 hours. Theresults indicated no significant change in blood pathpressure drop.
Heat Exchange Study	Heat exchange performance compares favorably to otheroxygenators on the market.
Hemolysis/CellDepletion	The hemolysis and cell change results were characterizedby comparing the D903 Avant to the predicate device forplasma hemoglobin, index of hemolysis, white blood cellcounts/percent depletion, red blood cell counts/percentdepletion and platelet counts/percent depletion. Therewere no statistically significant differences ( $p>0.05$ ) incell depletion and haemolytic characteristics between theD903 Avant and the predicate device.
Mechanical IntegrityStudy	There were no signs of leakage or pressure decaythroughout the test periods for either the blood path or theheat exchanger water path.
Breakthrough Timeand Volume	Time and volumes of blood required to breakthrough thecardiotomy screen of the D903 Avant cardiotomy reservoirat 1 LPM were carried out. The results were compared todata obtained for the Monolyth reservoir. There werestatistically significant differences ( $p<0.05$ ) both time andvolume requested to breakthrough the cardiotomy screen,the D903 Avant showed a lower apparition time andvolume than the predicate device. A reduced breakthroughtime and volume is desirable as it results in lower fluidlosses during priming and perfusion phases.
Test Results	Conclusions
Filter Pressurizationand Residual Volumes	The filter pressurization and residual volume characteristicsof the D903 Avant cardiotomy reservoir were evaluated.The results were compared to data obtained for theMonolyth reservoir. The results of this study indicate thatthe filter pressurization and residual volume of the D903Avant are comparable to the Monolyth's one.
Filtration Efficiency	The filtration efficiency characteristics of the D903 Avantcardiotomy reservoir was evaluated. The results werecompared to data obtained for the Monolyth reservoir. Theresults of this study indicate that the filtration efficiency ofboth devices satisfy the requirements of ANSI/AAMI BF7 -1982 (80% particles removal at 40 microns).
Reservoir Venous InletFlow Capacity andVenous Backpressure	The amount of flow attained by the venous inlet of the unitwhile maintaining 2 litres reservoir volume at various headheights above the reservoir inlets and the pressure exertedin the venous return line of the D903 Avant cardiotomyreservoir were evaluated. The results were compared todata obtained fro the Monolyth reservoir. The results ofthis study indicate that the venous inlet flow capacity andbackpressure of the D903 Avant are comparable to theMonolyth's one.
Conclusions	Based on the above information and the clinical studies,Dideco S.p.A. concludes that the D903 Avant demonstratesequivalence to other legally marketed devices.

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Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a minimalist design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

AUG 1 2 1998

DIDECO S.P.A. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re : K980600 Dideco D903 Avant Hollow Fiber Oxygenator Requlatory Class: II Product Code: JOW Dated: May 13, 1998 Received: May 14, 1998

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Mary McNamara-Cullinane

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): K980600

Device Name: Dideco D903 Avant 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)

Bote L. Ruyzerle
Division Sign Off

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).