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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator". This is a regulatory submission for a device, not a study of an AI algorithm, therefore the requested information fields related to AI, ground truth, expert review, and sample sizes for training/test sets are not applicable.

Here's the relevant information extracted from the provided text:

Device: Apex HP M Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator

Indications for Use: Intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Predicate Device: Apex M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (K020997) and Dideco D 903 Avant 2 Ph.I.S.I.O Adult Hollow Fiber Oxygenator (K020351)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to compliance with established standards and specifications. The "reported device performance" is described in terms of meeting these specifications and being substantially equivalent to the predicate device.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meets ISO 10993-1:1997 and FDA May 1, 1995 Memorandum requirements; no new materials used.	Substantially equivalent to unmodified/predicate device; biocompatible according to intended use.
Sterility	Meets established specifications.	Met established specifications; production techniques effective.
Pyrogenicity	Meets established specifications.	Met established specifications; production techniques effective; non-pyrogenic.
EO Residuals	Meets established specifications.	Met established specifications.
Package Integrity	Meets established specifications.	Met established specifications.
Gas Transfer Characteristics	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Pressure Drop	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Plasma Leakage Data	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Operating Blood Volume	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Heat Exchanger Performance	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Hemolysis/Cell Depletion	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Mechanical Integrity	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Leaking Test	Meets ISO 7199 and FDA Guidance requirements; meets established specifications.	Met established specifications for 3-year aged devices.
Overall Performance	Substantially equivalent to predicate devices.	Performs in a manner substantially equivalent to the unmodified device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "in vitro testing" and "applicable tests" being carried out. It does not provide specific sample sizes (e.g., number of devices tested) for these nonclinical tests. The tests were performed on devices aged to an equivalent of three years real-time aging. The data provenance is implied to be from internal testing conducted by the manufacturer (Sorin Group Italia S.r.I. in Italy), but no explicit country of origin for the data is mentioned, nor is it specified as retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study using expert-derived ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a medical device 510(k) submission focusing on nonclinical and in vitro performance, not an AI algorithm study involving human adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a medical device 510(k) submission for a physical medical device (oxygenator), not an AI-assisted diagnostic or clinical decision support system. No human reader studies with or without AI assistance were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a medical device 510(k) submission for a physical medical device (oxygenator), not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the nonclinical and in vitro tests, the "ground truth" (or basis for evaluation) was established by recognized industry standards (ISO 10993-1:1997, ISO 7199) and FDA guidance documents (FDA May 1, 1995 Memorandum on biocompatibility, Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - November 13, 2000). The device's performance was compared against the "established specifications" derived from these standards and the performance of the legally marketed predicate device.

8. The sample size for the training set

Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires training data.

9. How the ground truth for the training set was established

Not Applicable. This is a medical device 510(k) submission for a physical medical device, not an AI algorithm that requires ground truth for a training set.

Summary

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K083021

APPENDIX I: 510(K) Summary

OCT 2 9 2008

SUBMITTER:	Sorin group Italia S.r.I.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	October 8, 2008
DEVICE TRADE NAME:	Apex HP M Ph.I.S.I.O Adult HollowFiberMembrane Oxygenator
COMMON NAME:	Hollow Fiber Oxygenator
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator
LEGALLY UNMODIFIED DEVICE:	Apex M Ph.I.S.I.O. Adult Hollow Fiber MembraneOxygenator (K020997)
PREDICATE DEVICE:	Dideco D 903 Avant 2 Ph.I.S.I.O Adult HollowFiber 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.

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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.

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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.

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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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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:

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

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.”