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 Description

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

AI/ML Overview

This document is a 510(k) summary for a medical device submitted to the FDA in 1999. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a more modern AI/ML device submission.

Therefore, many of the requested sections below either cannot be answered or can only be addressed by stating that the information is not provided in this context.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Device meets established specifications.	"Performance testing demonstrated that the subject device meets established specifications."
Substantially equivalent in intended use.	"The subject device is substantially equivalent in intended use... to currently marketed Heartport arterial kits."
Substantially equivalent in technological characteristics.	"The subject device is substantially equivalent in... technological characteristics... to currently marketed Heartport arterial kits."
Substantially equivalent in materials.	"The subject device is substantially equivalent in... materials to currently marketed Heartport arterial kits."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical test results" and "performance testing" but does not detail the sample size or data provenance for these tests. Given the nature of a 1999 510(k) for a physical medical device (cannulae), the "testing" likely involved engineering and biocompatibility tests rather than clinical data sets as would be relevant for AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As this is a physical medical device from 1999, the concept of "ground truth" derived from expert consensus on a test set (like for an imaging AI) is not applicable here. The "ground truth" for this device would be its ability to physically perform its function (e.g., deliver blood, allow introduction/removal of catheters) as per engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for human-led assessments of complex data, which isn't the focus of this device's submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-driven clinical decision support tools or imaging analysis, which this device (surgical cannulae) is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical surgical tool and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" would be related to its physical and functional performance according to engineering and biocompatibility standards. For example, testing for tensile strength, flow rates, biocompatibility, and ability to house the designated catheter. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.

8. The sample size for the training set

This information is not provided. This concept of a "training set" is not applicable to the development and testing of this physical medical device.

9. How the ground truth for the training set was established

This information is not provided. Similarly, the concept of a "training set" and associated ground truth is not applicable here.

Summary

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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 RoadRedwood City, CA 94063
Contact Person:	Marianne C. Drennan
Phone Number:	(650) 482-4405
Fax Number:	(650) 482-4346

Device Information:

Trade Names:	Heartport® DirectFlow™ Kit, DirectFlow™ CannulaHeartport SoftClamp™ Kit, SoftClamp™ CannulaHeartport StraightShot™ Kit, StraightShot™ CannulaHeartport AutoIncisor™ Introducer
Classification Name:	Cardiovascular Surgical Devices - Cardiopulmonary bypassvascular 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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 (800) 638-2041 or (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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).