(28 days)
No
The summary describes a physical medical device (oxygenator) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on biocompatibility and functional equivalence to a predicate device.
Yes
The device is described as a cardiopulmonary bypass blood oxygenator for extracorporeal gas exchange support, which is a therapeutic intervention to treat a patient's condition.
No
This device is an oxygenator used for extracorporeal gas exchange and blood temperature control during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger," which are hardware components. The performance studies also focus on biocompatibility, sterility, and functional parameters of a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "extracorporeal gas exchange support and blood temperature control" during surgery. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description confirms it's a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger." This is a device that directly interacts with the patient's blood flow to perform a physiological function (oxygenation and temperature control).
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the APEX HP M Adult Hollow Fiber Membrane Oxygenator is a medical device used for therapeutic support during surgery, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Apex HP M 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 of up to 6 hours.
Product codes
DTZ
Device Description
The Apex HP M Adult Hollow Fiber Membrane 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)
NON CLINICAL 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. No new materials are used in the APEX HP M oxygenator compared to the unmodified device except the lack of the coating material, as a result of the modifications. Therefore, this 510(k) cross references biocompatibility data for the APEX M predicate device (#K014080). 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 testing met established specifications.
Similarly, the package integrity testing has not been performed since the packaging is unchanged from unmodified device. For this reason this 510(k) cross references packaging data previously submitted for the unmodified device (#K083021).
IN VITRO TEST RESULTS:
The functional parameters exhibited by APEX HP M Ph.I.S.I.O. apply also to APEX HP M as no technical modifications were introduced into the device.
CONCLUSION:
Test results show that the APEX HP M performs in a manner substantially equivalent to the unmodified 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 APEX HP M is sterile and nonpvrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hollow Fiber Membrane APEX M Adult Oxygenator (#K014080)
Reference Device(s)
APEX HP M. Ph.I.S.I.O. Adult Hollow Fiber Oxygenator (#K083021)
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
. *
092895
Special 510(k) September 18, 2009
OCT 1 9 2009
.
APPENDIX I
s
510(K) Summary
CONFIDENTIAL
1
510(k) Summary
SUBMITTER:
Sorin Group Italia S.r.I. 86, Via Statale 12 Nord 41037 Mirandola (MO) Italy
CONTACT PERSON:
Luigi Vecchi Phone: 39 0535 29811 Fax: 39 0535 25229
September 18, 2009
Hollow Fiber Oxygenator
Cardiopulmonary Bypass Oxygenator
Membrane Oxygenator (#K083021)
Oxygenator
DATE PREPARED:
DEVICE TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
LEGALLY UNMODIFIED DEVICE:
PREDICATE DEVICE:
Hollow Fiber Membrane APEX M Adult Oxygenator (#K014080)
APEX HP M. Ph.I.S.I.O. Adult Hollow Fiber
APEX HP M Adult Hollow Fiber Membrane
DEVICE DESCRIPTION:
The Apex HP M Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
INDICATION FOR USE:
The Apex HP M 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 of up to 6 hours.
2
TECHNOLOGICAL CHARACTERISTICS:
The Apex HP M Adult Hollow Fiber Membrane Oxygenator is identical in design, materials, operating principles and control mechanisms to the Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, unmodified device. The changes consist of: the lack of the coating material on the blood contact surfaces, a general reviewing of the labeling, and the updating of the labeling as a consequence of these minor modifications. The fundamental scientific technology is unchanged. The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
NON CLINICAL 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. No new materials are used in the APEX HP M oxygenator compared to the unmodified device except the lack of the coating material, as a result of the modifications. Therefore, this 510(k) cross references biocompatibility data for the APEX M predicate device (#K014080). 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 testing met established specifications.
Similarly, the package integrity testing has not been performed since the packaging is unchanged from unmodified device. For this reason this 510(k) cross references packaging data previously submitted for the unmodified device (#K083021).
IN VITRO TEST RESULTS:
The functional parameters exhibited by APEX HP M Ph.I.S.I.O. apply also to APEX HP M as no technical modifications were introduced into the device.
CONCLUSION:
Test results show that the APEX HP M performs in a manner substantially equivalent to the unmodified 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 APEX HP M is sterile and nonpvrogenic.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 1 9 2009
Sorin Group Italia S.R.L. c/o Mr. Barry Sall Principal Consultant 195 West Street Waltham, MA 02451
Re: K092895
APEX HP M Adult Hollow Fiber Membrane Oxygenator Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTZ Dated: September 18, 2009 Received: September 21, 2009
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 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.
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
4
Page 2 - Mr. Barry Sall
comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
R. Vachner
Image /page/4/Picture/8 description: The image shows a handwritten symbol or character that resembles a stylized letter or a mathematical symbol. The symbol is drawn with thick, dark lines, suggesting it was created with a pen or marker. The symbol is abstract and does not immediately correspond to any standard letter or number.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: APEX HP M Adult Hollow Fiber Membrane Oxygenator.
Ko92895
Indication for Use:
The APEX HP M 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 of up to 6 hours.
Prescription Use (Part 21CFR 801 Subpart D)
Over-the- Counter Use AND/OR (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)
sumner R. VeLunes
(Division Sig. Off) (Division Sig. On)
Division of Cardiovascular Devices
510(k) Number. K092895