← Product Code [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM) · K994208

# AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 (K994208)

_Medtronic Perfusion Systems · DTM · Jan 13, 2000 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K994208

## Device Facts

- **Applicant:** Medtronic Perfusion Systems
- **Product Code:** [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM.md)
- **Decision Date:** Jan 13, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.4260
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Intended Use

The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

## Device Story

Single-use arterial blood filter; used during cardiopulmonary bypass surgery. Device filters blood in extracorporeal circuits to remove particulate and gaseous microemboli. Operates via physical filtration through a 20-micron pore size screen. Used in clinical settings by perfusionists or surgical staff. Output is filtered blood returned to the patient. Benefits include reduction of microemboli-related complications during bypass.

## Clinical Evidence

Bench testing only. In vitro analysis performed on prime volume, pressure integrity, pressure drop, ease of prime, filtration efficiency, microemboli removal, bolus air management, and blood trauma. Results demonstrate performance equivalent to predicate devices.

## Technological Characteristics

Single-use arterial blood filter; 20-micron pore size screen. Mechanical filtration principle. Designed for integration into extracorporeal cardiopulmonary bypass circuits.

## Regulatory Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

## Predicate Devices

- AFFINITY® 38 u Arterial Blood Filter ([K952532](/device/K952532.md))
- INTERSEPT® 20 µ Arterial Blood Filter ([K926413](/device/K926413.md))

## Submission Summary (Full Text)

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K 994208

# SUMMARY OF SAFETY AND EFFECTIVENESS

## COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: 612-391-9000 FAX: 612-391-9603

Marie Holm, Associate Product Regulations Manager, Regulatory/Clinical Affairs Debra Kridner, Director of Regulatory/Clinical Affairs

# DEVICE NAME

AFFINITY® 20u Arterial Blood Filter

# NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

AFFINITY® 38 u Arterial Blood Filter (K952532) INTERSEPT® 20 µ Arterial Blood Filter (K926413)

# DESCRIPTION OF DEVICE

The 20 u arterial blood filter is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.

# STATEMENT OF INTENDED USE

The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

# STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

The INTERSEPT® and Medtronic arterial blood filter is indicated for use in all cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli from the arterial line.

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# STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics 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® Arterial Blood Filter. The modification is to change only the filter pore size and market both a 38 u and 20 u Arterial Blood Filter.

The AFFINITY® 20 u Arterial Blood Filter is being "compared to the following Marketed Devices":

- · AFFINITY® 38 µ Arterial Blood Filter (K952532)
- INTERSEPT® 20 µ Arterial Blood Filter (K926413) .

The AFFINITY® 20 u Arterial Blood Filter has the "same indications statement and intended uses" as the:

- AFFINITY® 38 µ Arterial Blood Filter (K952532) .
- INTERSEPT® 20 µ Arterial Blood Filter (K926413) .

The AFFINITY® 20 u Arterial Blood Filter has "new technological characteristics (e.g., design)" from the AFFINITY" 38 u Arterial Blood Filter. The new technological characteristic is solely the pore size of the micron filter:

- . 20 μ
The technological characteristic of the 20 u screen is common to other arterial blood filters currently in commercial distribution as follows:

- · INTERSEPT® 20 µ Arterial Blood Filter (K926413)
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.

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the AFFINITY® 20 u Arterial Blood Filter is substantially equivalent to other marketed arterial filters.

| SPECIAL 510(k) Notification<br>Medtronic, Inc.<br>Medtronic Perfusion Systems | AFFINITY® 20μ Arterial Blood Filter<br>December 13, 1999 | Confidential<br>Appendix II<br>Page 3 |
|-------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------|
|-------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------|

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The in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 u Arterial Blood Filter does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters. The in vitro bench testing included analysis of:

#### I. Physical Characteristics

- a. Prime volume
- b. Pressure integrity

#### II. Performance Characteristics

- a. Pressure drop
- b. Ease of prime
- c. Filtration efficiency
- d. Microemboli removal
- Bolus air management e.
- ﻧﺖ Blood trauma

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol consisting of three curved lines that resemble a person. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters.

# 'JAN 1 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie Holm Associate Product Regulation Manager Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

Re: K994208 AFFINITY® 20 Micron Arterial Blood Filter Regulatory Class: III Product Code: DTM Dated: December 13, 1999 Received: December 14, 1999

Dear Ms. Holm:

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 general controls provisions of the Act include the Act. 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. 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.

This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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### Page 2 - Ms. Marie Holm

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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number if known: メタウイコ0 8

Device Name: AFFINITY® 20 µ Arterial Blood Filter

Indications for Use:

The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sate L. Campbell

Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-The-Counter use

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