SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800

K033641 · Cobe Cardiovascular, Inc. · DTN · Dec 11, 2003 · Cardiovascular

Device Facts

• Record ID: K033641
• Device Name: SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Dec 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE Cardiovascular® SMARxT® VVR™ 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

Device Story

Sealed hardshell venous reservoir; includes defoamer and integral cardiotomy filter. Collects venous blood during cardiopulmonary bypass; filters blood; removes air/bubbles via defoamer. Used in clinical surgical settings; operated by perfusionists or surgical staff. Features surface-modifying material on blood-contact surfaces to reduce platelet adhesion. Output is processed blood returned to patient circulation or collected drainage for autotransfusion. Benefits include improved blood compatibility and reduced platelet activation during bypass procedures.

Clinical Evidence

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

Technological Characteristics

Sealed hardshell venous reservoir; includes defoamer and integral cardiotomy filter. Features surface-modifying material for improved blood compatibility. Sterile, non-pyrogenic fluid pathways. Single-use. No electronic components or software.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring cardiopulmonary bypass (up to 6 hours) and for postoperative chest drainage collection and autotransfusion.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• COBE Cardiovascular® VVR™ 4000 Filtered Hardshell Venous Reservoir

Submission Summary (Full Text)

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DEC 1 1 2003

## SPECIAL 510(K) NOTIFICATION COBE Cardiovascular Inc. SMAR,T VVR4000i Plus Filtered Hardshell Venous Reservoir

#### IX. 510(k) SUMMARY

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 West 65th Way<br>Arvada, CO 80004 USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>Regulatory Affairs, Submissions<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | November 6, 2003 |
| DEVICE TRADE<br>NAME: | COBE Cardiovascular® SMARxT® VVR™ 4000i Plus Filtered<br>Hardshell Venous Reservoir |
| COMMON/USUAL<br>NAME: | Hardshell Venous Reservoir with Integral Cardiotomy Filter |
| CLASSIFICATION<br>NAME: | Cardiopulmonary Bypass Blood Reservoir with Defoamer<br>and Cardiotomy Suction Line Blood Filter |
| PREDICATE DEVICE: | COBE Cardiovascular® VVR™ 4000 Filtered Hardshell Venous<br>Reservoir |

#### DEVICE DESCRIPTION:

The COBE SMARxT VVR4000i Plus is a sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter. It is a sterile device with non-pyrogenic fluid pathways, for single use micgrar cardroionly micer. ilized by the user. Certain blood contact surfaces of the oxygenator only, and is not to be resterined by and dified to improve blood compatibility, resulting in reduced platelet adhesion on the treated surfaces.

## INDICATIONS FOR USE:

The COBE SMARxT VVR4000i Plus Sealed Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods up to six hours, and for postoperative chest drainage collection and autotransfusion.

K033641

p112

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### SPECIAL 510(K) NOTIFICATION COBE Cardiovascular Inc. SMAR,T VVR4000i Plus Filtered Hardshell Venous Rescrvoir

# STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The COBE SMARxT VVR4000i Plus Venous Reservoir described in this submission is substantially equivalent to the unmodified version, the COBE VVR4000 Venous Reservoir. 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 deviods up to six hours, and for postoperative chest drainage collection and autotransfusion. The portodo ap to the the COBE SMARxT VVR4000i Plus Venous Reservoir contains a surfacemodifying material that improves the blood compatibility of the device.

# TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:

In-vitro tests were performed to demonstrate that the COBE Cardiovascular SMARxT VVR4000i m vide were were portionscribed in this submission is substantially equivalent to the unmodified version, the COBE VVR4000 Venous Reservoir.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling waves or curves, stacked on top of each other.

DEC 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033641

COBE Cardiovascular® SMAR,T VVR™ 4000i Plus Filtered Hardshell Venous Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Venous Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: November 7, 2003 Received: November 20, 2003

Dear Ms. Leonard:

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 – Ms. Lynne Leonard

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the simplies as a subsites semplies with other requirements Please be advised that FDA's issuance of a substantial complies with other requirements of the Act
that FDA has made a determination that your device Federal avencies. You that FDA has made a determination inal your development of ederal agencies. You must
or any Federal statutes and regulations administered by registration and listi or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not hirements as set comply with all the Act s requirements, Mc.ian.ing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god in and 800); and if annlicable, the clection CFR Part 807); labeling (21 CFR Patl 601); good manufactaring phone if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if appli forth in the quality systems (QS) regulation (2 - CFR of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections - ver decries on decribed in vour Section product radiation control provisions (Sections 31 care as described in your Section 510(k)
This letter will allow you to begin marketing your device as your device to a legal This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equiralevice of your device premarket notification. The FDA inding of subsantal equivalence of .
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
rst the register and and 1904 - 114 - Also, masses note the regulation en If you desire specific advice for your device on but nacements (* (* ) = ) = (* )
contact the Office of Compliance at [phone]. Also, please noto the regulation contact the Office of Comphalice at (301) 571 101 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification (21CFR Part 807.97). "Misbranding by reference to prematics nonification " (2) be Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 63 other general information on your responsibilities and the reveal and the received or [phone] or at its Internet address.

Sincerely yours,

CML

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

Enclosure

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# Indications for Use Statement

:

:

| 510(k)<br>Number<br>(if known) | K033641 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | COBE Cardiovascular ^® SMAR _x T ^® VVR ^™ 4000i Plus Filtered<br>Hardshell Venous Reservoir |
| Indications<br>for Use | The COBE Cardiovascular ^® SMAR _x T ^® VVR ^™ 4000i Plus Filtered<br>Hardshell Venous Reservoir is intended to be used in adult surgical<br>procedures requiring cardiopulmonary bypass for periods of up to six<br>hours, and for postoperative chest drainage collection and<br>autotransfusion. |

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED :

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801. 109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number: k033641