QUICKDRAW VENOUS CANNULA

K981995 · Heartport, Inc. · DWF · Apr 20, 1999 · Cardiovascular

Device Facts

• Record ID: K981995
• Device Name: QUICKDRAW VENOUS CANNULA
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.

Device Story

QuickDraw venous cannula; used during cardiopulmonary bypass procedures. Device functions to drain non-oxygenated blood from venae cavae and/or right atrium. Used in clinical settings by medical professionals. Mechanical device; no software or electronic components.

Clinical Evidence

Bench testing only; no clinical data provided. Performance testing demonstrated device meets established specifications and materials possess proven biocompatibility.

Technological Characteristics

Cardiopulmonary bypass cannula. Materials are biocompatible. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring drainage of non-oxygenated blood from the venae cavae and/or right atrium.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Heartport Endovenous Drainage™ Cannula
• Research Medical, Inc. (RMI) Venous Drainage Cannula
• Heartport Endoarterial Return™ Cannula

Submission Summary (Full Text)

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

# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K981995

### Applicant Information:

| Date Prepared: | October 22, 1998 |
|----------------|------------------------------------------------|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive<br>Redwood City, CA 94063 |

Marianne C. Drennan, Requlatory Affairs Manager Contact Person: [phone] Phone Number: Fax Number: [phone]

### Device Information:

| Classification | Class II |
|----------------------|--------------------------------------|
| Trade Name: | Heartport® QuickDraw™ venous cannula |
| Classification Name: | Cardiopulmonary Bypass Cannula |
| | 21 CFR §870.4210 |

### Equivalent Devices:

The subject device is substantially equivalent in intended use, method of operation and/or materials to the currently marketed Heartport Endovenous Drainage™ Cannula, Baxter Healthcare Corporation- Cardiovascular Group [Research Medical, Inc. (RMI)] RMI Venous Drainage Cannula, and the Heartport Endoarterial Return™ Cannula

### Intended Use:

The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.

### Non-Clinical Test Results:

Performance testing demonstrated that the subject device meets established specifications. The materials used in the Heartport QuickDraw venous cannula have proven biocompatibility.

### Summary:

Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three overlapping wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 1999

Ms. Marianne C. Drennan Regulatory Affairs Manager HeartPort, Inc. 700 Bay Road Redwood City, CA 94063

Re: K981995 HeartPort™ QuickDraw™ Venous Cannula Regulatory Class: II (Two) Product Code: 74 DWF Dated: January 27, 1999 Received: January 28, 1999

Dear Ms. Drennan:

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 Druq 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 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.

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

#### Page 2 - Ms. Marianne C. Drennan

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 [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, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): __ 8 98 1995

Heartport® QuickDraw™ venous cannula Device Name:

Indications for Use:

The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bypass.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dove L. Simpson

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 981994 510(k) Number _

Prescription Use レ (Per 21 CFR 801.109)

OR

Over- The Counter Use (Optional Format 1-2-96)