The Medtronic AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Device Description

The Medtronic AFFINITY Oxygenator with Balance" Biocompatible Surface is a single-use, disposable, sterile, nonpyrogenic fluid path, gas exchange device with a self contained, venous-side heat exchanger for regulating blood temperature. The microporous polypropylene hollow fibers are wound around a core and encased in a plastic outer shell. Oxygen flows through the hollow fibers and blood flows from the stainless steel heat exchanger around the hollow fibers. Gas exchange occurs by diffusion across the hollow fiber membrane. A gas outlet is provided for scavenging, and a gas vent prevents over pressurization. The modification to the currently marketed AFFINITY® Hollow Fiber Oxygenator is to coat the primary blood contact surfaces with a non-leaching, biocompatible coating (Balance™).

AI/ML Overview

The provided text is a 510(k) submission for a medical device, specifically an oxygenator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of quantitative acceptance criteria through a standalone clinical study. Therefore, general acceptance criteria and performance data are discussed in the context of comparison to the predicate devices.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating that the new device, the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface, does not raise new safety or effectiveness concerns compared to its predicate devices and performs comparably. The "reported device performance" refers to the results of in vitro bench testing and biocompatibility testing.

Acceptance Criteria Category	Specific Test/Characteristic	Implied Acceptance Criterion (Performance is comparable to predicate)	Reported Device Performance (as stated in the document)
Biocompatibility	Biocompatibility testing	No significant impact on safety/effectiveness compared to predicate.	"Biocompatibility testing... demonstrated that when compared to the predicate device the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface does not significantly affect safety and effectiveness."
Coating Characteristics	Leaching	Acceptable leaching levels.	Analyzed; results demonstrate substantial equivalence.
	Coverage	Adequate and consistent coating coverage.	Analyzed; results demonstrate substantial equivalence.
Physical Characteristics	Blood Pathway Integrity	Maintain integrity during use.	Analyzed; results demonstrate substantial equivalence.
	Heat Exchanger Fluid Pathway Integrity	Maintain integrity during use.	Analyzed; results demonstrate substantial equivalence.
	Blood Volumes	Comparable to predicate.	Analyzed; results demonstrate substantial equivalence.
	Connectors	Functionality and sealing.	Analyzed; results demonstrate substantial equivalence.
Performance Characteristics	Oxygen Transfer Rates	Comparable to predicate.	Analyzed; results demonstrate substantial equivalence.
	Carbon Dioxide Transfer Rates	Comparable to predicate.	Analyzed; results demonstrate substantial equivalence.
	Time Dependent Performance Changes	Maintain performance over intended use duration.	Analyzed; results demonstrate substantial equivalence.
	Heat Exchanger Performance Factor	Comparable to predicate.	Analyzed; results demonstrate substantial equivalence.
	Pressure Drop	Acceptable pressure drop across the device.	Analyzed; results demonstrate substantial equivalence.
	Gas Side Pressure Drop	Acceptable gas side pressure drop.	Analyzed; results demonstrate substantial equivalence.
	Priming Evaluation	Effective priming.	Analyzed; results demonstrate substantial equivalence.
	Blood Cell Damage	Acceptable levels of blood cell damage.	Analyzed; results demonstrate substantial equivalence.

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

The document does not specify a "test set" in the sense of a clinical trial patient cohort. The evaluation was done through in vitro bench testing and biocompatibility testing.

Sample Size: Not explicitly stated for each test. The testing would involve a certain number of device units or components subjected to standardized laboratory tests.
Data Provenance: The testing was conducted by Medtronic Perfusion Systems. The provenance is internal company testing, likely done in a lab setting, rather than from a specific country of origin or being retrospective/prospective clinical data. It is retrospective in the sense that the data was collected for the purpose of this 510(k) submission.

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

This information is not applicable to this type of submission. Ground truth, in the context of expert review, is typically associated with diagnostic devices where expert interpretation of images or other data is compared against device output. Here, the "ground truth" for the bench tests would be the established scientific methods and engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical trials or studies involving expert consensus, which are not described here. The "adjudication" for the bench testing would be the interpretation of the test results against predefined engineering and performance standards by qualified engineers and scientists.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates how human readers' performance (e.g., diagnostic accuracy) changes with or without the assistance of an AI algorithm. The device in question is an oxygenator, which is a therapeutic device, not a diagnostic one that would typically involve human "readers" interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a medical apparatus (oxygenator), not an AI algorithm. It functions autonomously in terms of gas exchange and heat regulation within the extracorporeal circuit.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the performance evaluation was established through:

Established scientific methods and engineering standards: Referenced standards include ISO/DIS 7199, BG7199-1996, and ISO 10993-1. These standards define the acceptable performance and safety parameters for blood-gas exchangers and biocompatibility.
Comparison to predicate devices: The "ground truth" for demonstrating substantial equivalence is the known safety and effectiveness of the legally marketed predicate devices (AFFINITY® Hollow Fiber Oxygenator and MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface). The new device's performance data was compared against the expected performance of these predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data. The device's design and manufacturing are based on engineering principles and established medical device development processes.

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

This is not applicable as there is no training set mentioned or implied for this device.

Summary

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K 9929/0

SEB 1 5 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 4633 E. La Palma Avenue Anaheim, CA 92807 714-779-3650

Debra Kridner, Director of Regulatory/Clinical Affairs

DEVICE NAME

AFFINITY®NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

AFFINITY® Hollow Fiber Oxygenator (K932252) ●
MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with Plasma . Resistant Fiber (K984271)

DESCRIPTION OF DEVICE

The modification to the currently marketed AFFINITY® Hollow Fiber Oxygenator is to coat the primary blood contact surfaces with a non-leaching, biocompatible coating (Balance™).

STATEMENT OF INTENDED USE

The Medtronic AFFINITY No Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

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STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

The Medtronic AFFINITY® Hollow Fiber Oxygenator is intended for use in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Medtronic MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristic comparison is provided in the following section, "Determination of Substantial Equivalence".

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "Special 510(k)" is being submitted for a modification to the AFFINITY® Hollow Fiber Oxygenator. The modification to the current AFFINITY NT Hollow Fiber Oxygenator is to coat the primary blood contact surfaces with a non-leaching, biocompatible coating (Balance™). In determining substantial equivalence of the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface the decision-making process follows the 510(k) "Substantial Equivalence" flow diagram and is presented as follows:

The AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface is being "compared to the following Marketed Devices":

. AFFINITY® Hollow Fiber Oxygenator (K932252)
. MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with Plasma Resistant Fiber (K984271)

AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface has the "same indications statement and intended uses" as the:

. AFFINITY® Hollow Fiber Oxygenator (K932252)
AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface has "new technological characteristics (e.g.,materials and manufacturing processes)" from the current Medtronic AFFINITY® Hollow Fiber Oxygenator. The new technological characteristic is solely the coating material of the blood pathway:
. Polydimethylsiloxane coating
The technological characteristic of Balance" Biocompatible Surface coating the blood path is common to other adult oxygenators currently in commercial distribution as follows;
MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface with . Plasma Resistant Fiber (K984271)

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This technological characteristic "could affect the safety and effectiveness of the device". However these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are accepted scientific methods which exist for assessing effects of these new technological characteristics". These scientific methods are provided in the following oxygenator standards;

ISO/DIS 7199 (ISO/TC 150/SC 2) International Standard titled "Cardiovascular implants . and artificial organs - Blood-gas exchangers"
BG7199-1996 (proposed new American National Standard) titled, "Cardiovascular implants . and artificial organs - Blood-gas exchangers (oxygenators)"
ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Guidance on selection of . tests; First Edition, 1992-04-15.
. Leaching Analysis

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the AFFINITY NT Oxygenator with Balance" Biocompatible Surface is substantially equivalent to other marketed hollow fiber oxygenators.

The biocompatibility testing and in vitro bench testing demonstrated that when compared to the predicate device the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed hollow fiber oxygenators. The in vitro bench testing included analysis of:

. Coating Characteristics

Leaching ●
Coverage ●

Physical Characteristics .

Blood Pathway Integrity ●
Heat Exchanger Fluid Pathway Integrity ●
. Blood Volumes
Connectors .

. Performance Characteristics

Oxygen and Carbon Dioxide Transfer Rates ●
Time Dependent Performance Changes .
. Heat Exchanger Performance Factor
Pressure Drop .
. Gas Side Pressure Drop
. Priming Evaluation
Blood Cell Damage .

)

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1999

Ms. Debra Kridner Director Requlatory/Clinical Affairs Medtronic, Inc. Cardiopulmonary Division 4633 East La Palma Avenue Anaheim, CA 92807

K992910 Re: Affinity® NT Hollow Fiber Oxygenator Regulatory Class: III (three) Product Code: 74DTZ Dated: August 27, 1999 Received: Auqust 30, 1999

Dear Ms. Kridner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Debra Kridner

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known): _ K992 910

Device Name:

AFFINITY®NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bace Cooperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number 992910

Prescription Use L (Per 21 CFR 801.109)

Over-The Counter Use

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.”