(14 days)
Not Found
Not Found
No
The summary describes a mechanical device (oxygenator with heat exchanger) and the performance studies focus on biocompatibility, gas transfer, pressure drop, and mechanical integrity, with no mention of AI/ML or related concepts.
Yes.
The device is used in extracorporeal gas exchange support, which is a therapeutic intervention for patients requiring cardiopulmonary bypass.
No
Explanation: The device is an oxygenator and heat exchanger used for extracorporeal gas exchange and blood temperature control during surgery, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly states it is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "extracorporeal gas exchange support and blood temperature control" during surgery. This describes a device that interacts directly with blood outside the body for therapeutic purposes (oxygenation and temperature regulation), not for diagnostic testing of samples.
- Device Description: It's described as a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger." This further confirms its role in supporting physiological functions during surgery, not in analyzing biological samples for diagnostic information.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to support the body's functions during surgery.
N/A
Intended Use / Indications for Use
The Performa Adult Hollow Fiber Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Performa Adult Hollow Fiber Membrane oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
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
Adult
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)
NONCLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of three years real time aging. Sterility, pyrogenicity, EO 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 ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions -- Final Guidance for industry and FDA Staff November 13, 2000 to provide the data necessary to demonstrate compliance of the predicate device with safety and effectiveness requirements. The Performa Oxygenator aged to 3 years was tested for gas transfer characteristics, pressure drop and plasma leakage, heat exchanger performance, hemolysis/ cell depletion, operating blood volume and mechanical integrity. The results The modifications being made to the Performa of these tests met established specifications.
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.
Apex Ph.I.S.I.O. Adult Hollow Fiber Oxygenator
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
Performa Adult Hollow Fiber Membrane Oxygenator Dideco S.r.l.
MAR 8 - 2005
510(k) SUMMARY
| SUBMITTER: | Dideco S.r.l.
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: | February 21, 2005 |
| DEVICE TRADE NAME: | Performa Adult Hollow Fiber Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Oxygenator |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator. |
| PREDICATE DEVICE: | Apex Ph.I.S.I.O. Adult Hollow Fiber Oxygenator |
DEVICE DESCRIPTION:
The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
INDICATION FOR USE:
The Performa Adult Hollow Fiber Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
TECHNOLOGICAL CHARACTERISTICS:
The Performa adult hollow fiber oxygenator is identical in design to the Apex Ph.1.S.I.O. adult hollow The Forformal adult heller modifications made to the device consist of an overall reduction in the size of the device, updating of the instructions for use reflecting this modification and changes in format, ergonomic and aesthetic variations that do not change the function of the device. The fundamental scientific technology is unchanged from the predicate device.
The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
NONCLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of three years real time aging. Sterility, pyrogenicity, EO 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 ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions -- Final Guidance for industry and FDA Staff November 13, 2000 to provide the data necessary to demonstrate compliance of the predicate device with safety and effectiveness requirements. The Performa Oxygenator aged to 3 years was tested for gas transfer characteristics, pressure drop and plasma leakage, heat exchanger performance, hemolysis/ cell depletion, operating blood volume and mechanical integrity. The results The modifications being made to the Performa of these tests met established specifications.
1
Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility Oxygenator us not anoot the Ph.I.S.I.O. apply only to the Performa Oxygenator.
CONCLUSION:
The Performa membrane oxygenator is substantially equivalent to the Apex P.h.l.S.l.O predicate The Penomia Thembrane Oxygenator 15 Gabocandary - Sce is biocompatible according to its intended device. Biocompanility studies demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 - 2005
Dideco S.r.I. c/o Mr. Barry Sall Senior Consultant Parexel International Corporation 195 West Street Waltham, MA 02451-1163
Re: K050447
Performa Adult Hollow Fiber Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: February 21, 2005 Received: February 22, 2005
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 classificd (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.
3
Page 2 - Mr. Barry Sall
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted activation of the requirements of the Act
that FDA has made a determination that your device on plier Federal agencies. that FDA has made a determination that your device compines with one oncess. You must
or any Federal statutes and regulations administered by other Federal on and listi or any Federal statutes and regulations administration application and listing (21
comply with all the Act's requirements, including, but not limited to: reguirements as set comply with all the Act 's requirements, including, but not minted novelse requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice, the ele CFR Part 807); labeling (21 CFR Pat 801); good manufacturing practice liqueded, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (QS) regulation (2) CFR 1 at 620), and 21 (2FR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 31-342 of the 100), 21 0100
This letter will allow you to begin marketing your device of your Section 510(k)
This letter will a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inning of substantial equir device to a premarket notification. The FDA finding of substanial equivalence of your device and thus, permits your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the If you desire specific advice for your device on our adocting included to the specificals on the contact the Office of Compliance at (501) 394-40-1 could office of Compliance at
promotion and advertising of your device, please contact the Office of Compliance promotion and advertising of your device, please contact, "Misbranding by reference to
(301) 594-4639. Also, please note the regulation entitled, "Misbranding of (301) 594-4639. Also, please note the regulation entitler, "WilsOthers. Policy on your
premarket notification" (21CFR Part 807.97) you may obtain. Other general information premarket notification" (21CFR Pat 80 /.97) you may bivision of Small Manufacturers,
responsibilities under the Act may be obt its toll from the Division of Small or (301) 44 responsibilities under the Act may be obtained from the Roll of Sames of Sames of Sames of Same of Constitutions of American Property of Constitutions of Constitutions of Con International and Consumer Assistance at the results of the main.html
Sincerely yours,
Vitina R. Vichner
(V)_Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Kのら0447
Device Name: Performa Adult Hollow Fiber Membrane Oxygenator
Indications For Use:
The Performa Adult Hollow Fiber Membrane oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
Prescription Use __ X (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)
Divire D. Vordone1
(Division Sign-Off) Jivision of Cardiovascular Devices
510(k) Number_k (25447