HEARTPORT ENDOARTERIAL RETURN CANNULA

K971291 · Heartport, Inc. · DWF · Jun 17, 1997 · Cardiovascular

Device Facts

• Record ID: K971291
• Device Name: HEARTPORT ENDOARTERIAL RETURN CANNULA
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoarterial Return Cannula, with or without hemostasis valve, is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.

Device Story

Endoarterial Return Cannula functions as vascular access device for cardiopulmonary bypass; delivers oxygenated blood to patient during surgery. Version with integrated hemostasis valve enables introduction/removal of secondary vascular catheters (e.g., Endoaortic Clamp Catheter) while maintaining hemostasis. Used in surgical setting by clinicians; provides conduit for extracorporeal circulation. Biocompatible materials ensure safety during bypass procedure.

Clinical Evidence

Bench testing only; no clinical data provided. Performance testing demonstrated compliance with established specifications and biocompatibility requirements.

Technological Characteristics

Cardiopulmonary bypass vascular cannula; Class II device. Features include optional hemostasis valve for catheter introduction. Materials are biocompatible. Device is a mechanical conduit for blood flow.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring delivery of oxygenated blood. Version with hemostasis valve indicated for hemostatic introduction/removal of vascular catheters (e.g., Endoaortic Clamp Catheter).

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™ Endoarterial Return™ Cannula (K971291)
• BioMedicus® Cannula

Submission Summary (Full Text)

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Heartport™ Endoarterial Return™ Cannula
K971291
510(k) Notification

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: _________________________

## Applicant Information:

JUN 17 1997

Date Prepared: April 4, 1997
Name: Heartport, Inc.
Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Marianne C. Drennan
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Classification: Class II
Trade Name: Heartport™ Endoarterial Return™ Cannula
Classification Name: Cardiovascular Surgical Devices - Cardiopulmonary bypass vascular cannula
21 CFR 870.4210

## Equivalent Devices:

The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.

## Intended Use:

The Endoarterial Return Cannula, with or without hemostasis valve, is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.

## Non-Clinical Test Results:

Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications. The materials used in the Heartport Endoarterial Return 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.

Heartport Confidential
Page 26

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 17 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Marianne C. Drennan
Regulatory Affairs Specialist
HeartPort, Inc.
200 Chesapeake Drive
Redwood City, California 94063

Re: K971291
HeartPort™ Endoarterial Return™ Cannula
Regulatory Class: II (Two)
Product Code: 74 DWF
Dated: April 4, 1997
Received: April 7, 1997

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 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 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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.

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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" (21 CFR 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 "[e-mail]."

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

Enclosure

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870.4210 - CPB Yascular Catheter, Cannula
Dwf II

# Indications for Use

510(k) Number (if known): K971291

Device Name: Heartport™ Endoarterial Return™ Cannula

Indications for Use:

The Endoarterial Return Cannula with and without a hemostasis valve is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K971291

Prescription Use ☑ (Per 21 CFR 801.109)

OR

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