(28 days)
D 903
Not Found
No
The document describes a physical medical device (oxygenator) and its performance testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device, an oxygenator with an integral heat exchanger, is used to provide extracorporeal gas exchange and temperature control, directly treating a physiological function.
No
The device is described as an oxygenator used for extracorporeal gas exchange, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger," which are hardware components. The performance studies also describe testing of physical properties like gas transfer, pressure drop, and mechanical integrity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "extracorporeal gas used in addre basgerature control for periods up to 6 hours." This indicates a direct interaction with the patient's blood outside the body for gas exchange and temperature control, which is a therapeutic procedure, not a diagnostic test performed on a sample.
- Device Description: The description clearly states it's a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger." This further confirms its role in supporting physiological functions during surgery, not in diagnosing a condition.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
The device is clearly intended for use in a surgical setting to support a patient's physiological needs during a procedure.
N/A
Intended Use / Indications for Use
The Apex 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.
Product codes
DTZ
Device Description
The Apex 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 five 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 to 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 D903 Avant Oxygenator aged to 5 years was tested for gas transfer characteristics, pressure drop, mechanical integrity, hemolysis, cell depletion and device integrity. The results of these tests met established specifications. The modifications being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant apply to the Apex Oxygenator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dideco D 903 Avant Adult Hollow Fiber Oxygenator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 8 2002 | K014080 | |
|---|---|---|
| 510(k) SUMMARY | ||
| 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: | December 10, 2001 | |
| DEVICE TRADE NAME: | Apex Adult Hollow Fiber Oxygenator | |
| COMMON NAME: | Hollow Fiber Oxygenator | |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator. |
PREDICATE DEVICE:
Dideco D 903 Avant Adult Hollow Fiber Oxygenator
DEVICE DESCRIPTION:
The Apex Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
INDICATION FOR USE:
The Apex 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 Apex hollow fiber oxygenator is identical in design to the D 903 Avant adult hollow fiber oxygenator. The only modifications made to the device consist of using a different temperature probe, relocation of the gas connectors, 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 five 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 D903 Avant Oxygenator aged to 5 years was tested for gas transfer characteristics, pressure drop, mechanical integrity, hemolysis, cell depletion and device integrity. The results of these tests met established specifications. The modifications
1
being made to the Apex Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant apply to the Apex Oxygenator.
CONCLUSION:
The Apex membrane oxygenator is substantially equivalent to the predicate device. Biocompatibility studies demonstrate that the device is biocompatible 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.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 JAN
Dideco S.p.A. c/o Mr. Barry S. Sall, RAC Senior Regulatory Consultant PAREXEL International West Corporation 195 West Street Waltham, MA 02451-1163
Re: K014080
Trade Name: Apex 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: December 10, 2001 Received: December 11, 2001
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.
3
Page 2 - Mr. Barry S. Sall, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
L. Danta Tiller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K014080
Device Name: Apex Hollow fiber membrane oxygenator
Indications For Use:
The Apex Hollow fiber membrane oxygenator is intended to be the Apex norrow riber procedures requiring extracorporeal gas used in addre basgerature control for periods up to 6 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014080
Prescription Use Use (Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional format 1-2-96)