HEARTPORT ENDOAORTIC CLAMP

• K Number: K962510
• Device Name: HEARTPORT ENDOAORTIC CLAMP
• Manufacturer: HEARTPORT, INC.
• Date Cleared: 1996-09-11 ( 76 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K964161 , K980631

Intended Use

Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Device Description

Endoaortic Clamp (Catalog Number 02055)

AI/ML Overview

This document does not describe acceptance criteria or a study that proves a device meets them. Instead, it is a 510(k) summary for a medical device (Endoaortic Clamp) and contains the following information:

• Applicant Information: Heartport, Inc.
• Device Information:
  • Trade Name: Endoaortic Clamp (Catalog Number 02055)
  • Common Name: Endoaortic Clamp Catheter
  • Classification Name: Cardiopulmonary bypass vascular catheter
• Equivalent Devices: Heartport Endoaortic Clamp (Catalog Number 01055)
• Intended Use: Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
• Comparison To Predicate Devices: The new device is a preassembled version of the predicate device with necessary accessories in one sterile package.
• Non-clinical Test Results: States that performance testing demonstrated with 95% confidence that the device meets or exceeds Heartport, Inc. performance standards.
• Test Conclusions: States that performance testing demonstrated the device will function safely and efficaciously, meeting anticipated clinical requirements.

The document does not provide the detailed information requested in your prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement. It is a high-level summary.

Summary

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Image /page/0/Picture/2 description: The image shows the word "Appendices" and a series of numbers and a letter above it. The numbers and letter are K962510. The text is in black and white.

Appendix A. 510(k) Summary of Safety and Effectiveness

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:

June 26, 1996 Date Prepared:

Name:	Heartport, Inc.
Address:	200 Chesapeake DriveRedwood City, CA 94063

Contact Person:	Robert J. Chin
Phone Number:	[phone]
Fax Number:	[phone]

Device Information:

Trade Name:	Endoaortic Clamp (Catalog Number 02055
Common Name:	Endoaortic Clamp Catheter
Classification Name:	Cardiopulmonary bypass vascular catheter

Equivalent Devices:

Heartport Endoaortic Clamp (Catalog Number 01055)

Intended Use:

Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Comparison To Predicate Devices:

The modifications to the predicate device provides the surgeon with an endoaortic clamp already preassembled with the necessary accessories in one sterile package.

Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the Endoaortic Clamp will meet or exceed Heartport, Inc. performance standards.

Test Conclusions:

Performance testing has demonstrated that the Endoaortic Clamp will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).