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.

Device Description

The Apex Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

AI/ML Overview

Acceptance Criteria and Study for Apex Adult Hollow Fiber Oxygenator

This report details the acceptance criteria and the study used to demonstrate the performance of the Apex Adult Hollow Fiber Oxygenator, as described in the provided 510(k) summary.

Key takeaway: The study demonstrating the device meets the acceptance criteria is based on the equivalence of the modified device to a predicate device, rather than a standalone clinical AI study. The modified device's performance is inferred from the extensive testing of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Apex Adult Hollow Fiber Oxygenator are primarily based on established specifications for similar devices, particularly the predicate device (Dideco D 903 Avant Adult Hollow Fiber Oxygenator), and adherence to relevant international standards.

Acceptance Criteria Category	Specific Criteria (Based on ISO 7199 and FDA Guidance)	Reported Device Performance
Biocompatibility	Meets ISO 10993-1:1997 requirements for raw materials.	"The results of this testing met established specifications." (Implied: The Apex device inherits this, as modifications do not affect function).
Sterility	Meets or exceeds sterility standards (method: Ethylene Oxide sterilization).	"Sterility... testing were also conducted. The results of this testing met established specifications."
Non-pyrogenicity	Meets non-pyrogenicity standards.	"Pyrogenicity... testing were also conducted. The results of this testing met established specifications."
EO Residuals	Levels below established maximums.	"EO residuals... testing were also conducted. The results of this testing met established specifications."
Package Integrity	Maintain sterility during storage and handling.	"Package integrity testing were also conducted. The results of this testing met established specifications."
Gas Transfer Characteristics	Meets performance specifications (e.g., oxygenating/CO2 removal efficiency).	"The D903 Avant Oxygenator aged to 5 years was tested for gas transfer characteristics... 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."
Pressure Drop	Meets specified limits across the device.	"The D903 Avant Oxygenator aged to 5 years was tested for... pressure drop... 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."
Mechanical Integrity	Withstands operational stresses without failure.	"The D903 Avant Oxygenator aged to 5 years was tested for... mechanical 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."
Hemolysis	Within acceptable limits for blood damage.	"The D903 Avant Oxygenator aged to 5 years was tested for... hemolysis... 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."
Cell Depletion	Within acceptable limits for cell loss.	"The D903 Avant Oxygenator aged to 5 years was tested for... cell depletion... 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."
Device Integrity	Maintains structural and functional integrity.	"The D903 Avant Oxygenator aged to 5 years was tested for... 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... parameters exhibited by D 903 Avant apply to the Apex Oxygenator."

Study Demonstrating Acceptance Criteria Met

The study demonstrating the Apex Adult Hollow Fiber Oxygenator meets the acceptance criteria is primarily an equivalence study to its predicate device, the Dideco D 903 Avant Adult Hollow Fiber Oxygenator.

Key Principle: The core argument is that 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."

Therefore, the performance characteristics of the D 903 Avant are directly transferable to the Apex device because the modifications are deemed to not affect critical function or safety.

Additional Breakdown of Study Information:

2. Sample Size Used for the Test Set and Data Provenance:

Test Set: The document does not specify a distinct "test set" in the context of an AI device. Instead, the "test set" is the D903 Avant Oxygenator aged to 5 years that underwent comprehensive in vitro testing. There is no mention of a sample size (e.g., number of units tested) for these in vitro evaluations within the provided text.
Data Provenance: The data is from in vitro testing of the Dideco D 903 Avant Oxygenator and is retrospective in relation to the Apex device's submission, as the D903 Avant was already an established device. The country of origin for the testing would likely be Italy, given the submitter's location (Dideco S.p.A., Mirandola, Italy).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable to this type of device and study. The ground truth for in vitro performance is established by objective measurements against engineering specifications and validated standards (ISO 7199 and FDA Guidance), not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As the "test set" involves objective laboratory measurements against defined standards, there is no need for expert adjudication in the manner typically seen with AI algorithms interpreting subjective data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic or interpretive device, but rather a medical device with direct physiological function. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a hollow fiber oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, measured through in vitro tests.

7. The Type of Ground Truth Used:

The ground truth used for the D903 Avant (and by extension, the Apex) is based on established specifications and validated international standards (ISO 7199 for in vitro testing, ISO 10993-1:1997 for biocompatibility, and FDA Guidance for Cardiopulmonary Bypass Oxygenators). This represents a form of objective, performance-based ground truth rather than subjective expert consensus, pathology, or outcomes data in the typical sense of AI/image analysis.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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JAN 8 2002	K014080
	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:	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

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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.

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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.

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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

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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)

Over-The-Counter

(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.”