AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)

K992910 · Medtronic Vascular · DTZ · Sep 15, 1999 · Cardiovascular

Device Facts

• Record ID: K992910
• Device Name: AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
• Applicant: Medtronic Vascular
• Product Code: DTZ · Cardiovascular
• Decision Date: Sep 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Single-use, sterile, disposable extracorporeal perfusion device; consists of microporous polypropylene hollow fibers wound around core, encased in plastic shell, with integrated stainless steel heat exchanger. Operates by circulating blood around hollow fibers while oxygen flows through fibers; gas exchange occurs via diffusion. Used in clinical settings (e.g., OR) by perfusionists during cardiopulmonary bypass. Provides oxygenation, CO2 removal, and thermal regulation. Modification involves application of non-leaching, biocompatible polydimethylsiloxane coating (Balance™) to primary blood contact surfaces to improve hemocompatibility. Output is oxygenated, temperature-regulated blood returned to patient circulation. Benefits include reduced blood-material interaction during bypass procedures.

Clinical Evidence

Bench testing only. Evaluation included biocompatibility testing, leaching analysis, and in vitro performance testing. Performance metrics assessed: oxygen/CO2 transfer rates, heat exchanger performance, pressure drop (blood and gas side), blood pathway integrity, and blood cell damage. Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

Microporous polypropylene hollow fibers; stainless steel heat exchanger; polydimethylsiloxane (Balance™) biocompatible coating. Standards: ISO/DIS 7199, BG7199-1996, ISO 10993-1. Single-use, disposable, sterile, nonpyrogenic. No software or electronic components.

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass procedures requiring extracorporeal oxygenation, carbon dioxide removal, and blood temperature regulation for up to 6 hours.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

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

Submission Summary (Full Text)

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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 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™).

# 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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)

OR

Over-The Counter Use