COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

K984456 · Cobe Cardiovascular, Inc. · DTN · Jan 11, 1999 · Cardiovascular

Device Facts

• Record ID: K984456
• Device Name: COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

Device Story

Sterile, single-use open venous blood reservoir with integral cardiotomy filter; used in cardiopulmonary bypass circuits during adult cardiac surgery. Device collects venous blood and filters cardiotomy suction blood; functions as a reservoir for blood during bypass. Operated by perfusionists in clinical surgical settings. Provides blood storage and filtration; supports maintenance of extracorporeal circulation during surgery.

Clinical Evidence

Bench testing only. In-vitro testing included venous blood flow, defoaming capacity, filtration efficiency, operating volume, breakthrough volume, unrecoverable volume, filter loading, blood trauma, and minimum/maximum operating volumes.

Technological Characteristics

Open venous blood reservoir with integral cardiotomy filter. Sterile, non-pyrogenic, single-use. Materials modified in defoamer and cardiotomy filter compared to predicate. No software or electronic components.

Indications for Use

Indicated for adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass for up to six hours.

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® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669)

Submission Summary (Full Text)

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Special 510(k)-Device Modification: COBE® HVR® 4000 Filtered Hardshell Venous Reservoir

JAN 1 1 1999

K984456

# 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|----------------------|--------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>Phone: [phone]<br>Fax:<br>[phone] |
| DATE PREPARED: | December 14, 1998 |
| DEVICE TRADE NAME: | COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir |
| COMMON/USUAL NAME: | Hardshell Venous Reservoir with Integral Cardiotomy Filter |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Blood Reservoir with Defoamer<br>and Cardiotomy Suction Line Blood Filter |
| PREDICATE DEVICE: | COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669) |

## DEVICE DESCRIPTION:

The COBE® HVR" 4000 Fittered Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is an open venous blood reservoir with integral cardiotomy filter.

### INDICATIONS FOR USE

The COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.

### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669). The modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir is identical to the original, unmodified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669) in intended use, specifications, features, method of operation, and fundamental scientific technology. The two devices differ in the materials used in the defoamer and cardiotomy filter.

### TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE

In-vitro tests were performed to demonstrate that the modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR® 4000 Filtered Hardshell Venous Reservoir (K971669). In-vitro testing consisted of venous blood flow, defoaming capacity, filtration efficiency, operating volume, breakthrough volume, unrecoverable volume, filter loading, blood trauma, and minimum/maximum operating volumes.

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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three wavy lines extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 1999

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re : K984456 COBE® HVR® 4000 Filtered Hardshell Venous Reservoir Requlatory Class: II (Two) and III (Three) Product Code: DTN/DTP Dated: December 14, 1998 December 15, 1998 Received:

Dear Ms. Leonard:

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 aqainst 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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#### Page 2 - Ms. Lynne Leonard

This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, `Misbranding by reference to premarket notification' (21 Other general information on your responsibilities CFR 807.97) . 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, Ph.D. 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):

COBE® HVR® 4000 Filtered Hardshell Venous Reservoir Device Names:

Indications For Use:

The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Numbe

Over-The-Counter Use

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Prescription Use (Per 21 CFR 801.109) OR