The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

Device Description

The Heartport Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

AI/ML Overview

The provided 510(k) notification for the Heartport® Endoaortic Clamp™ Catheter does not include specific acceptance criteria or a study that proves the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. The key statement regarding device performance is:

"Based on the equivalence in design to the predicate device, performance testing was not warranted for this device. The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter."

Therefore, most of the requested information cannot be extracted from this document as no new performance study was conducted.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in this document for the new device submission.	No new performance data presented for this submission.
Assumed to be the same criteria as the predicate device: Heartport® Endoaortic Clamp™ catheter.	Assumed to meet the same criteria as the predicate device.

The subsequent questions relate to a performance study, which was explicitly stated as "not warranted" for this device due to its substantial equivalence to a predicate device. Therefore, the answers to these questions are generally "Not applicable" or "Not specified in this document."

2. Sample size used for the test set and the data provenance

Not applicable. No new performance testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new performance testing was conducted for this submission.

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

Not applicable. No new performance testing was conducted for this 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

Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool, and no performance study was conducted.

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

Not applicable. This device is a medical catheter, not an algorithm. No standalone performance study was done for this submission.

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

Not applicable. No new performance testing requiring ground truth was conducted for this submission. The device's "ground truth" for regulatory purposes is its substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.

8. The sample size for the training set

Not applicable. This device is a medical catheter, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As above, no training set for a machine learning model is relevant here.

Summary

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510(k) Notification

K974175

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

This summary of 510(k) 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:

DEC I 6 1997

Date Prepared:	November 5, 1997
----------------	------------------

Heartport, Inc. Name: Address: 200 Chesapeake Drive Redwood City, CA 94063
Marianne C. Drennan Contact Person: (650) 482-4405 Phone Number: Fax Number: (650) 482-4346

Device Information:

Trade Name:	Heartport® Endoaortic Clamp™ Catheter
Classification Name:	Vascular Clamp, 21 CFR 870.4450

Equivalent Devices:

The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport® Endoaortic Clamp™ catheter and the Medi-tech Occlusion Balloon catheter.

Intended Use:

Comparison to Predicate Devices:

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

Non-clinical Test Results:

Based on the equivalence in design to the predicate device, performance testing was not warranted for this device, The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Rockville MD 20857

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

DEC 1 6 1997

Re : K974175 Heartport® Endoaortic Clamp™ Catheter Regulatory Class: II (Two) Product Code: DWZ Dated: November 5, 1997 Received: November 6, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 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 requlation (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/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahai 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-DWF II
CPB Vascular Catheters, Cannula, or Tubing

Indications for Use

ﻳﺪ 974175 510(k) Number (if known):

Device Name:

Heartport® Endoaortic Clamp™ Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lori R. Lamberti

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

510(k) Number K974175

Prescription Use
(Per 21 CFR 801.109)

Over- The Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4075 Endomyocardial biopsy device.

(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).