The Heartport® Endopulmonary Vent™ catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.

Device Description

The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.

AI/ML Overview

The provided text describes a 510(k) summary for the Heartport® Endopulmonary Vent™ Catheter. It discusses the device's intended use and non-clinical test results, but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the way you've outlined.

The document states that:

"Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications."
"The materials used in the Heartport® Endopulmonary Vent™ catheter have proven biocompatibility."

However, it does not provide details on what those "established specifications" are, what the "performance testing" entailed, or any specific numerical results. It also does not mention any clinical studies involving human readers, AI, or ground truth establishment in the context of device performance.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

Here's how I would attempt to answer based on the lack of information in the document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Specific criteria are not detailed in the provided document. The document generally states that the device must meet "established specifications" for performance and biocompatibility.	The Heartport® Endopulmonary Vent™ catheter "meets established specifications" for performance. The materials used "have proven biocompatibility." No specific numerical performance metrics are provided.

Study Details (Based on available information in the document):

Sample size used for the test set and the data provenance: Not specified. The document only mentions "performance testing" and "biocompatibility" but does not detail sample sizes, types of data (e.g., in-vitro, ex-vivo), or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. This document describes a non-clinical device (catheter) and discusses performance and biocompatibility testing, not an AI or diagnostic device requiring expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not specified.
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: Not applicable. This is for a physical medical catheter, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not specified. The testing described appears to be engineering performance and biocompatibility rather than diagnostic accuracy against a "ground truth" as typically defined for algorithms or diagnostic tests.
The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Conclusion from the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, non-clinical test results (performance and biocompatibility), and materials. It does not provide the detailed information about specific acceptance criteria or the methodology of performance studies (e.g., sample sizes, expert involvement, ground truth establishment) common for diagnostic devices or AI algorithms. The "performance testing" mentioned is likely in-vitro or bench testing verifying physical characteristics and functionality of the catheter, not a clinical trial involving patients and expert interpretation.

Summary

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4 1698 SEP

Heartport® Endopulmonary Vent™ Catheter

APPENDIX B. 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: _______________________________________________________________________________________________________________________________________________

Applicant Information:

Date Prepared:	March 17, 1998
Name:	Heartport, Inc.
Address:	200 Chesapeake Drive
	Redwood City, CA 94063

Contact Person:	Marianne C. Drennan
Phone Number:	(650) 482-4405
Fax Number:	(650) 482-4346

Device Information:

Classification	Class II
Trade Name:	Heartport® Endopulmonary Vent™ catheter
Classification Name:	Cardiopulmonary bypass catheter

Equivalent Devices:

The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.

Intended Use:

Non-Clinical Test Results:

Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications. The materials used in the Heartport® Endopulmonary Vent™ catheter 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 4 1998

Ms. Lisa McGrath Sr. Regulatory Affairs Specialist HeartPort, Inc. 200 Chesapeake Drive Redwood City, CA 94063

Re : K981009 HeartPort® Endopulmonary Vent™ Catheter Regulatory Class: ı i Product Code: DWF Dated: July 16, 1998 Received: July 17, 1998

Dear Ms. McGrath:

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 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 Failure to comply with the GMP regulation may result in assumptions. 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.

Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

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Page 2 - Ms. Lisa McGrath

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

sincerely years,

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

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Indications for Use

K 981009 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Heartport® Endopulmonary Vent™ catheter

Indications for Use:

The Heartport Endopulmonary Vent Catheter is indicated for use in The Heartport Endopulmonary vonments bypass. It is intended to
patients undergoing cardiopulmonary bypass. It is intended to patients undergoing caraloponary artery and assist in decompressing the heart.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bere R. Cooper Se

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

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

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).