(176 days)
Not Found
No
The device description and performance studies focus on the physical components and in vitro/clinical performance related to gas exchange and blood handling, with no mention of AI or ML.
Yes
The device is described as an oxygenator and heat exchanger used during cardiopulmonary bypass surgery to provide oxygenation and carbon dioxide removal from venous blood, and to control blood temperature. These functions directly address physiological needs and support recovery or maintenance of health during a medical procedure, classifying it as a therapeutic device.
No
This device, the Dideco D903 Avant Hollow Fiber Oxygenator, is described as an oxygenator for cardiopulmonary bypass surgery. Its function is to provide oxygenation and carbon dioxide removal from venous blood, and to control blood temperature. It does not analyze patient data or provide a diagnosis of a medical condition.
No
The device description clearly details a physical medical device with hardware components such as hollow fibers, a heat exchanger, a reservoir, filters, and connectors. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation." It focuses on oxygenating and removing carbon dioxide from blood during a surgical procedure, and controlling blood temperature. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the physical components and how they facilitate blood flow, gas exchange, and temperature control. There is no mention of analyzing blood or other biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to perform its intended function (gas transfer, pressure drop, hemolysis, etc.) and its clinical performance during bypass surgery (maintaining blood gas levels, hematological changes). These are evaluations of the device's therapeutic efficacy and safety, not its diagnostic accuracy.
IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such analysis. It is a medical device used in a surgical procedure to support physiological function.
N/A
Intended Use / Indications for Use
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 from patients' veins during normal operation, to always assure the proper oxygenation capability of the device.
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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 ³⁄₈" and ½" 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 l/min to 5 l/min. The gas flow rates during CPB ranged from 1.8 l/min to 4.0 l/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:
Oxygen transfer: The oxygen transfer rates were evaluated at blood flow rates of 4, 6 and 8 LPM. The results compare favorably with the predicate device.
Carbon Dioxide Transfer: The carbon dioxide transfer rates were evaluated at blood flow rates of 4, 6, and 8 LPM. The results are similar to the predicate device.
Operating Blood Volumes: The operating blood volumes for the D903 Avant, including static prime, post-use recovered and retained volume were evaluated. Results compares favorably to the predicate device. The D903 Avant has a reduced retained volume respect the predicate device, a lower priming volume is desirable in that it results in less haemodilution to the patient and decreased risk of donor transmitted disease.
Blood Side Pressure Drop: The blood path pressure drop data were recorded during gas transfer testing at T=0 hours and T=6 hours. The results indicated no significant change in blood path pressure drop.
Heat Exchange Study: Heat exchange performance compares favorably to other oxygenators on the market.
Hemolysis/Cell Depletion: The hemolysis and cell change results were characterized by comparing the D903 Avant to the predicate device for plasma hemoglobin, index of hemolysis, white blood cell counts/percent depletion, red blood cell counts/percent depletion and platelet counts/percent depletion. There were no statistically significant differences (p>0.05) in cell depletion and haemolytic characteristics between the D903 Avant and the predicate device.
Mechanical Integrity Study: There were 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: Time and volumes of blood required to breakthrough the cardiotomy screen of the D903 Avant cardiotomy reservoir at 1 LPM were carried out. The results were compared to data obtained for the Monolyth reservoir. There were statistically significant differences (p
§ 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).
0
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
1
from patients' veins during normal operation, to always assure the proper oxygenation capability of the device.
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.
2
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 Avenue | ||
| P.O. Box 19503 | ||
| Irvine, CA 92713-9503 | ||
| U.S.A. |
3
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.
4
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 flow |
| rates of 4, 6 and 8 LPM. The results compare favorably | |
| with the predicate device. | |
| Carbon Dioxide | |
| Transfer | The carbon dioxide transfer rates were evaluated at blood |
| flow rates of 4, 6, and 8 LPM. The results are similar to | |
| the predicate device. | |
| Test Results | Conclusions |
| Operating Blood | |
| Volumes | The operating blood volumes for the D903 Avant, |
| including static prime, post-use recovered and retained | |
| volume were evaluated. Results compares favorably to the | |
| predicate device. The D903 Avant has a reduced retained | |
| volume respect the predicate device, a lower priming | |
| volume is desirable in that it results in less haemodilution | |
| to the patient and decreased risk of donor transmitted | |
| disease. | |
| Blood Side Pressure | |
| Drop | The blood path pressure drop data were recorded during |
| gas transfer testing at T=0 hours and T=6 hours. The | |
| results indicated no significant change in blood path | |
| pressure drop. | |
| Heat Exchange Study | Heat exchange performance compares favorably to other |
| oxygenators on the market. | |
| Hemolysis/Cell | |
| Depletion | The hemolysis and cell change results were characterized |
| by comparing the D903 Avant to the predicate device for | |
| plasma hemoglobin, index of hemolysis, white blood cell | |
| counts/percent depletion, red blood cell counts/percent | |
| depletion and platelet counts/percent depletion. There | |
| were no statistically significant differences ( $p>0.05$ ) in | |
| cell depletion and haemolytic characteristics between the | |
| D903 Avant and the predicate device. | |
| Mechanical Integrity | |
| Study | There were 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 | Time and volumes of blood required to breakthrough the |
| cardiotomy screen of the D903 Avant cardiotomy reservoir | |
| at 1 LPM were carried out. The results were compared to | |
| data obtained for the Monolyth reservoir. There were | |
| statistically significant differences ( $p |