(20 days)
Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)
No
The summary describes a physical medical device (oxygenator) and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is described as an "Adult Hollow Fiber Membrane Oxygenator" used for "extracorporeal gas exchange support and blood temperature control" in surgical procedures, which are therapeutic functions.
No
Explanation: The device, an oxygenator, is intended for extracorporeal gas exchange and blood temperature control during surgical procedures, which are therapeutic functions, not diagnostic ones.
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 the patient's blood outside the body to perform a physiological function (oxygenation and temperature regulation).
- Device Description: It's described as a "cardiopulmonary bypass blood oxygenator with an integral heat exchanger." This further confirms its role in supporting the patient's circulation and gas exchange during bypass.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any diagnostic testing on specimens. It's a therapeutic device used to support a patient's physiological functions.
Therefore, the Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Apex HP M Ph.I.S.I.O. 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 Ph.I.S.I.O 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)
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. As no new materials are used in the APEX HP M Ph.I.S.I.O. oxygenator compared to the unmodified and predicate device as a result of the modifications, this 510(k) cross references biocompatibility data previously submitted. 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.
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 unmodified device with safety and effectiveseas requirements. The Apex HP M Ph.I.S.I.O. Oxygenator was aged to 3 years and tested for gas transfer characteristics, pressure drop, plasma leakage data, operating blood volume, heat exchanger performance evaluation, hemolysis/cell depletion, mechanical integrity and leaking test. The results of these tests met established specifications. For comparative purposes all tests, where applicable, were carried out on sterilized aged devices comparing the Apex HP M Ph.I.S.I.O. and the Apex M Ph.I.S.I.O. unmodified device. In addition, the functional and biocompatibility parameters exhibited by Apex M Ph.I.S.I.O. apply to Apex HP M Ph.I.S.I.O.
CONCLUSION: Test results show that the Apex HP M Ph.I.S.I.O. 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 Ph.I.S.I.O. is sterile and non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)
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.”
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APPENDIX I: 510(K) Summary
OCT 2 9 2008
| SUBMITTER: | Sorin group Italia S.r.I.
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 8, 2008 |
| DEVICE TRADE NAME: | Apex HP M Ph.I.S.I.O Adult Hollow
Fiber
Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Oxygenator |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator |
| LEGALLY UNMODIFIED DEVICE: | Apex M Ph.I.S.I.O. Adult Hollow Fiber Membrane
Oxygenator (K020997) |
| PREDICATE DEVICE: | Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow
Fiber Oxygenator (K020351) |
| DEVICE DESCRIPTION: | |
The Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
INDICATION FOR USE:
The Apex HP M Ph.I.S.I.O 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.
1
TECHNOLOGICAL CHARACTERISTICS:
The Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is identical in design, materials, operating principles and control mechanisms to the Apex M Adult Hollow Fiber Membrane Oxygenator predicate device. The only modifications made lo the device consist of an overall reduction in the size of the device, optimization of the heat exchanger water path, updating of the instructions for use reflecting this modification and change in Ph.I.S.I.O. trade name. The fundamental scientific technology is unchanged from the predicate device. The coating is identical to the phosphorylchine coating used on the Apex M Ph.I.S.I.O. unmodified and D 903 Avant 2 Ph.I.I.I.O. 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. As no new materials are used in the APEX HP M Ph.I.S.I.O. oxygenator compared to the unmodified and predicate device as a result of the modifications, this 510(k) cross references biocompatibility data previously submitted. 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.
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 unmodified device with safety and effectiveseas requirements. The Apex HP M Ph.I.S.I.O. Oxygenator was aged to 3 years and tested for gas transfer characteristics, pressure drop, plasma leakage data, operating blood volume, heat exchanger performance evaluation, hemolysis/cell depletion, mechanical integrity and leaking test. The results of these tests met established specifications. For comparative purposes all tests, where applicable, were carried out on sterilized aged devices comparing the Apex HP M Ph.I.S.I.O. and the Apex M Ph.I.S.I.O. unmodified device. In addition, the functional and biocompatibility parameters exhibited by Apex M Ph.I.S.I.O. apply to Apex HP M Ph.I.S.I.O.
2
CONCLUSION:
Test results show that the Apex HP M Ph.I.S.I.O. 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 Ph.I.S.I.O. is sterile and non-pyrogenic.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2008
Sorin Group Italia S.r.1. c/o Mr. Barry Sall Principal Consultant 200 West Street Waltham, MA 02451
Re: K083021
Apcx HP M Ph.I.S.I.O. 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: October 8, 2008 Received: October 9, 2008
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.
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Page 2 - Mr. Barry Sall
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 requircments 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Holmes
^ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Sorin Group. The logo consists of a stylized graphic to the left of the company name. Below the company name is the text "AT THE HEART OF MEDICAL TECHNOLOGY".
Sorin Group Italia S.r.l.
510(k) Number (if known): _ K0 8302
Device Name: Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator Indications for Use:
The Apex HP M Ph.I.S.I.O. 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 uploa 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)
Nuna R. James
Division of Cardiovascular Devices
510(k) Number_408 302