The Direct Aortic Return Cannula is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Direct Aortic Return Cannula also allows the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ catheter. The cannula may be introduced through a 12mm or larger trocar or incision.

The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Heartport® Direct Aortic Return Cannula with Introducer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantifiable acceptance criteria such as "minimum flow rate of X mL/min" or "burst pressure of Y psi." Instead, it uses a more general statement.

Acceptance Criteria Category	Acceptance Criteria (as stated in document)	Reported Device Performance (as stated in document)
Overall Performance	"meets established specifications"	"Performance testing demonstrated that the Heartport Direct Aortic Return Cannula with Introducer meets established specifications."
Biocompatibility	(Implied: safe for biological contact)	"The materials used in the Heartport Direct Aortic Return Cannula with Introducer have proven biocompatibility."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Non-Clinical Test Results" section is very brief and refers generally to "Performance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the document describes a medical device (cannula and introducer) that is evaluated through non-clinical performance and biocompatibility testing, not through diagnostic accuracy studies requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool where human reader performance would be assessed.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as this is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

For a physical device like this, the "ground truth" for performance testing is typically defined by engineering specifications, material science standards, and accepted physiological parameters relevant to its intended use (e.g., flow rates, pressure resistance, material strength, sterility, biocompatibility). The document vaguely states "established specifications." For biocompatibility, the ground truth is established through in vitro and in vivo biocompatibility testing against recognized standards.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set with established ground truth. It is likely that the "specifications" for this device were established through engineering design, material selection, and existing industry standards for similar devices.

Summary

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K974736

510(k) Notification

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

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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: _______________________________________________________________________________________________________________________________________________

(650) 482-4346

Applicant Information:

Date Prepared:	December 18, 1997
Name:	Heartport, Inc.
Address:	200 Chesapeake DriveRedwood City, CA 94063
Contact Person:	Marianne C. Drennan
Phone Number:	(650) 482-4405

Device Information:

Fax Number:

Classification	Class II
Trade Name:	Heartport® Direct Aortic Return Cannula with Introducer
Classification Name:	Cardiovascular Surgical Devices - Cardiopulmonary bypass vascularcannula (21 CFR 870.4210); Catheter introducer (21 CFR 870.1340)

Equivalent Devices:

The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport® Direct Aortic Return Cannula, the Heartport® Endoarterial Return™ Cannula and the Cardiovascular Research, Inc. Cannula Introducer.

Intended Use:

The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.

Non-Clinical Test Results:

Performance testing demonstrated that the Heartport Direct Aortic Return Cannula with Introducer meets established specifications. The materials used in the Heartport Direct Aortic Return Cannula with Introducer 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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

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

Re : K974736 HeartPort® Direct™ Aortic Return Cannula with Introducer Regulatory Class: II (Two) Product Code: DWF Dated: May 22, 1998 May 26, 1998 Received:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. requirements for annual reqistration, 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 Requlations, 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 regulatory In addition, FDA may publish further announcements action. 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 described in your stority promazion nevice to a legally marketed or babbuantana 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97) . . the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, 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 Division Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _ K 97 4736

Heartport® Direct Aortic Return Cannula with Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bore L. Spencer
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K974736

Prescription Use V (Per 21 CFR 801.109),

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

Heartport Confidential

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
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.(b)
Classification. Class II (performance standards).