The Apex 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.

Device Description

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, formatted to address your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a typical detailed clinical study report or a "device performance" section as one might find in a peer-reviewed publication or a PMA submission. Therefore, some of your requested information (e.g., specific performance metrics with numerical values, sample sizes for test/training sets, expert qualifications, and detailed ground truth establishment for AI/diagnostic devices) is not present in this type of regulatory document concerning a mechanical, non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from predicate device standards)	Reported Device Performance (as demonstrated by predicate)
Biocompatibility	Compliance with ISO 10993-1:1997 and FDA May 1, 1995 Memorandum for biocompatibility testing of raw materials. (Studies performed on devices aged to 2 years real-time equivalent.)	"The results of testing met established specifications." (Implied: The device is biocompatible according to its intended use, based on the D 903 Avant 2 Ph.I.S.I.O predicate device's performance, as the modification (coating) does not affect performance).
Sterility	Established specifications for sterility.	"Sterility... testing were also conducted. The results of testing met established specifications." "Additional testing has also demonstrated the effectiveness of production techniques to assure that Apex Ph.I.S.I.O. is sterile..."
Pyrogenicity	Established specifications for pyrogenicity.	"Pyrogenicity... testing were also conducted. The results of testing met established specifications." "...Additional testing has also demonstrated the effectiveness of production techniques to assure that Apex Ph.I.S.I.O. is... non-pyrogenic."
Ethylene Oxide (EO) Residuals	Established specifications for EO residuals.	"EO residuals... testing were also conducted. The results of testing met established specifications."
Package Integrity	Established specifications for package integrity.	"Package integrity testing were also conducted. The results of testing met established specifications."
In Vitro Performance	Compliance with ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff November 13, 2000. This includes: - Gas transfer characteristics - Pressure drop - Plasma leakage data - Operating blood volume - Heat exchanger performance evaluation - Hemolysis/cell depletion - Mechanical integrity - Leaking/flaking test	"The D 903 Avant 2 Ph.I.S.I.O. Oxygenator was aged to 2 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/flaking test. The results of these tests met established specifications. The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant 2 Ph.I.S.I.O. apply to Apex Ph.I.S.I.O." (Performance for the predicate device, which is considered equivalent to the new device).

Information Not Applicable to this Document Type / Not Provided:

The provided document is a 510(k) summary for a mechanical medical device (oxygenator), not an AI/diagnostic software. Therefore, the following AI-specific questions are not relevant and the information is not present:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Study Design of the Device for Substantial Equivalence:

The core of the "study" for this 510(k) submission is to demonstrate substantial equivalence to an existing legally marketed device (predicate device).

The approach taken is:

Identify Changes: The new device (Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator) is "identical in design, operating principles and control mechanisms" to the predicate device (Apex Adult Hollow Fiber Membrane Oxygenator), with the only modification being the addition of a phosphorylcholine coating to all blood contact surfaces.
Leverage Predicate Data: The phosphorylcholine coating itself is identical to one used on another predicate device (D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator).
Prove Non-Inferiority/Equivalence of Coating: The claim is that "The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device."
Testing Strategy:
- Biocompatibility: Tests were carried out on the new device (accelerated aged to 2 years) to ensure the integrated system with the new coating met ISO 10993-1:1997 standards.
- Sterility, Pyrogenicity, EO Residuals, Package Integrity: These were conducted on the new device to ensure manufacturing processes were adequate.
- In Vitro Performance (Functional Testing): Instead of re-testing all functional parameters on the new Apex Ph.I.S.I.O. device, the document states that the D 903 Avant 2 Ph.I.S.I.O. Oxygenator (the predicate with the same coating) was tested for all key performance metrics (gas transfer, pressure drop, plasma leakage, blood volume, heat exchanger, hemolysis, mechanical integrity, leaking/flaking). The results of these tests on the D 903 Avant 2 Ph.I.S.I.O. were then deemed applicable to the Apex Ph.I.S.I.O. because the modifications in the Apex Ph.I.S.I.O. (the addition of the coating) were judged not to affect these performance parameters.

In essence, the study primarily relies on the existing performance data of two predicate devices and the demonstration that the minor change (the coating) in the new device does not negatively impact its safety and effectiveness, nor introduce new questions of safety or effectiveness.

Summary

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Special 510(k) March 27, 2002

	APR - 4 2002
510(k) SUMMARY
SUBMITTER:	Dideco S.p.A.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	March 27, 2002
DEVICE TRADE NAME:	Apex Ph.I.S.I.O Adult Hollow FiberMembrane Oxygenator
COMMON NAME:	Hollow Fiber Oxyenator
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator.
PREDICATE DEVICE:	Apex Adult Hollow Fiber MembraneOxygenator (K014080)Dideco D 903 Avant 2 Ph.I.S.I.O AdultHollow Fiber Oxygenator (K020351)

DEVICE DESCRIPTION:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

INDICATION FOR USE:

TECHNOLOGICAL CHARACTERISTICS:

The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is identical in design, operating principles and control mechanisms to the Apex Adult Hollow Fiber Membrane Oxygenator predicate device. The only modification made to the device is the biocompatible phosphorylcholine coating treatment added to all blood contact surfaces. The fundamental scientific technology is unchanged from the predicate device. The coating is identical to the phosphorylcholine coating used on the D 903 Avant 2 Ph.I.S.I.O. predicate device. The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

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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 two 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 predicate device with safety and effectiveness requirements. The D 903 Avant 2 Ph.I.S.I.O. Oxygenator was aged to 2 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/flaking test. The results of these tests met established specifications. The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant 2 Ph.I.S.I.O. apply to Apex Ph.I.S.I.O.

CONCLUSION:

The Apex Ph.I.S.I.O. 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 Apex Ph.I.S.I.O. is sterile and non-pyrogenic.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2002

Mr. Barry Sall, RAC Senior Regulatory Consultant DIDECO S.R.A. c/o Parexel International Corporation 195 West Street Waltham, MA 02451-1163

K020997 Re:

Trade Name: APEX PH.I.S.I.O. 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: March 27, 2002 Received: March 28, 2002

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.

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 (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.

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Page 2 - Mr. Barry Sall, RAC

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,

signature

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): - KOZO997

Device Name: APEX Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator.

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascula
510(k) Number K020997
Devices

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional format 1-2-96)

Regulation Number and Section

§ 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.”