DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP

K994243 · Heartport, Inc. · DWF · May 5, 2000 · Cardiovascular

Device Facts

• Record ID: K994243
• Device Name: DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 5, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Device Story

DirectFlow, SoftClamp, and StraightShot kits consist of arterial cannulae and an AutoIncisor introducer; used during cardiopulmonary bypass procedures. Cannulae deliver oxygenated blood to patient; DirectFlow and SoftClamp models facilitate hemostatic introduction and removal of Heartport EndoClamp aortic catheter. DirectFlow cannula designed for thoracic trocar or incision access. AutoIncisor performs aortic incision and cannula placement. Used in surgical settings by cardiovascular surgeons. Devices provide mechanical access and perfusion support during cardiac surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cardiovascular surgical cannulae and aortic incisor/introducer. Materials and design characteristics are identical to previously marketed Heartport arterial kits. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring delivery of oxygenated blood. DirectFlow and SoftClamp cannulae also indicated for hemostatic introduction/removal of Heartport EndoClamp aortic catheter. AutoIncisor indicated for aortic incision and cannula introduction.

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.

Reference Devices

• Heartport EndoClamp aortic catheter

Submission Summary (Full Text)

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# APPENDIX B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

The assigned 510(k) number is: _____________________

### Applicant Information:

| Date Prepared: | December 15, 1999 |
|-----------------|----------------------------------------|
| Name: | Heartport, Inc. |
| Address: | 700 Bay Road<br>Redwood City, CA 94063 |
| Contact Person: | Marianne C. Drennan |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

### Device Information:

| Trade Names: | Heartport® DirectFlow™ Kit, DirectFlow™ Cannula<br>Heartport SoftClamp™ Kit, SoftClamp™ Cannula<br>Heartport StraightShot™ Kit, StraightShot™ Cannula<br>Heartport AutoIncisor™ Introducer |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Cardiovascular Surgical Devices - Cardiopulmonary bypass<br>vascular cannula |

### Equivalent Devices:

The subject device is substantially equivalent in intended use, technological characteristics, and materials to currently marketed Heartport arterial kits.

### Intended Use:

The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and Straints of erial cannulae are intended to deliver oxygenated blood for cardionulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostation in and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

### Comparison to Predicate Devices:

This device has the same intended use, technological characteristics, and materials as the predicate device.

### Non-clinical Test Results:

Performance testing demonstrated that the subject device meets established specifications.

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# 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.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2000

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

K994243/S2 Re: Heartport® arterial cannulae Regulatory Class: II (two) Product Code: DWF Dated: April 17, 2000 . Received: April 18, 2000

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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 in your of your device to a legally marketed predicate device equits 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 requlation (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 Also, please note the regulation entitled, [phone]. "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,

Brian E. Haney Jr.

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### APPENDIX D. INDICATIONS FOR USE STATEMENT

### Indications for Use

1.994243 510(k) Number (if known):

Device Name: DirectFlow™ Kit, SoftClamp™ Kit, StraightShot™ Kit

Indications for Use:

The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over- The Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------|
| | Division of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| | 510(k) Number _ | |