DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER

K040184 · Cobe Cardiovascular, Inc. · DTM · Feb 26, 2004 · Cardiovascular

Device Facts

• Record ID: K040184
• Device Name: DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTM · Cardiovascular
• Decision Date: Feb 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

Intended Use

The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

Device Story

Arterial blood filter with 40 µm screen; used in extracorporeal circuits during cardiopulmonary bypass procedures. Device traps and removes gaseous emboli and particulate debris from arterial blood flow. Operated by perfusionists or clinical staff in surgical settings. Subject device incorporates a surface coating (Ph.I.S.I.O.) to enhance blood compatibility compared to the predicate. Mechanical filtration principle; no electronic or software components.

Clinical Evidence

Bench testing only; in-vitro studies performed to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Arterial blood filter; 40 µm screen; surface-modified for improved blood compatibility. Mechanical filtration principle. No energy source, connectivity, or software.

Indications for Use

Indicated for adult patients undergoing procedures requiring cardiopulmonary bypass for up to six hours; used in the arterial line of an extracorporeal circuit to trap and remove gaseous emboli and particulate debris.

Regulatory Classification

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

• Dideco Micro 40 Adult Arterial Filter

Submission Summary (Full Text)

{0}------------------------------------------------

K040184
Pg 1 OF 2

# FEB 26 2004

#### X. 510(k) SUMMARY

| SUBMITTER: | COBE Cardiovascular<br>14401 W 65th Way<br>Arvada, CO 80004. USA |
|-------------------------|------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>E-mail: [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| DATE PREPARED: | January 23, 2004 |
| DEVICE TRADE<br>NAME: | Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter |
| COMMON/USUAL<br>NAME: | Arterial Filter |
| CLASSIFICATION<br>NAME: | Cardiopulmonary Bypass Arterial Line Blood Filter |
| PREDICATE DEVICE: | Dideco Micro 40 Adult Arterial Filter |

## DEVICE DESCRIPTION:

The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.

### INDICATIONS FOR USE:

The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

{1}------------------------------------------------

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter. The devices are identical in design, method of operation, and fundamental scientific technology. Both devices are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods up to six hours. The devices differ in that the Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter contains a surface coating that improves the blood compatibility of the device.

#### TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:

In-vitro tests were performed to demonstrate that the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2004

COBE Cardiovascular, Inc. c/o Ms. Lynne Leonard Regulatory Affairs, Submission 14401 W. 65th Way Arvada. CO 80004-3599

Re: K040184

Dideco Micro 40 Adult Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: January 23, 2004 Received: January 27, 2004

Dear Ms. Leonard:

Wc 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.

{3}------------------------------------------------

Page 2 – Ms. Lynne Leonard

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), 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 Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmar R. Lochner

ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter Device Name:

Indications For Use: The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DQ NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna D. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

Page 1 of _1_

510(k) Number KU40184