(90 days)
No
The summary describes a mechanical device for cardiopulmonary bypass and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an oxygenator that provides oxygenation and carbon dioxide removal from venous blood, and also allows blood temperature control, which are therapeutic functions for patients undergoing cardiopulmonary bypass surgery.
No
Explanation: The device, an oxygenator, is intended for oxygenation and carbon dioxide removal during cardiopulmonary bypass surgery, and blood collection/temperature control. These are therapeutic and assistive functions, not diagnostic ones.
No
The device description clearly states it is a hollow fiber membrane oxygenator with integral heat exchanger and a hardshell cardiotomy/venous reservoir, which are physical hardware components. The submission is for an extended intended use, not a software-only device.
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 undergoing cardiopulmonary bypass surgery, providing oxygenation and carbon dioxide removal from venous blood during the procedure. This is a direct intervention on the patient's blood flow, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details a hollow fiber membrane oxygenator with an integral heat exchanger and a hardshell cardiotomy/venous reservoir. These are components designed for extracorporeal circulation and blood management during surgery, not for analyzing a sample to provide diagnostic information.
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) to detect a disease or condition.
- Providing diagnostic information.
- Using reagents or assays.
- Performing tests in a laboratory setting.
The device is a therapeutic device used to support a patient's physiological function during surgery.
N/A
Intended Use / Indications for Use
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. The device is intended to be used for six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
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.
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 Testing: Carried out in accordance with "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff issued on November 13, 2000" and ISO 7199 (1996) standard. The device was unchanged from the predicate device in terms of design, operating principles, and manufacturing. Performance characterization, physical effectiveness characterization/integrity were based on validation of AVANT (K980600) and AVANT Ph.I.S.I.O. (K020351) predicate devices. 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 worst case) and tested for hemolysis/cell depletion, microembolic activity, and reservoir housing integrity during active venous drainage. Results met established specifications.
Results: The study showed that the device characteristics of the modified AVANT and predicate devices are comparable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
D 903 AVANT Adult Hollow Fiber Oxygenator (K980600), D 903 AVANT 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator with Ph.I.S.I.O coating (K020351), Monolyth Mimesys Adult Hollow Fiber Oxygenator (K004001)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
JAN 1 3 2004
| SUBMITTER: | Dideco S.p.A.
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 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 Oxygenator
with Ph.I.S.I.O coating (K020351) |
| COMMON NAME: | Hollow Fiber Oxygenator/Reservoir |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator
Cardiopulmonary Bypass Heat Exchanger
Cardiopulmonary Bypass Blood Reservoir
Cardiopulmonary Bypass Defoamer |
| PREDICATE DEVICES: | D 903 AVANT Adult Hollow Fiber Oxygenator (K980600)
D 903 AVANT 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator
with Ph.I.S.I.O coating (K020351)
Monolyth Mimesys Adult Hollow Fiber Oxygenator (K004001) |
510(k) SUMMARY
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.
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."
1
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,
R
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.
510(k) Number (if known):
Device Name: Dideco D 903 Avant Adult Hollow Fiber Oxygenator
Indications For Use:
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.
(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