K Number
K961245
Device Name
HEARTPORT ENDOPULMONARY VENT
Manufacturer
Date Cleared
1996-06-18

(78 days)

Product Code
Regulation Number
870.4210
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.
Device Description
Not Found
More Information

No
The summary does not contain any keywords or descriptions related to AI or ML technology. The focus is on a mechanical device for blood removal and decompression.

Yes
The device is intended for the removal of blood from the pulmonary artery and decompression of the heart, which are therapeutic interventions.

No
The device is used for the removal of blood and decompression of the heart, which are therapeutic actions, not diagnostic.

No

The intended use describes a device for the removal of blood and decompression of the heart, which strongly implies a physical, invasive device (like a catheter or vent) rather than software alone. The predicate devices listed are also physical catheters.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass." This describes a surgical or interventional procedure performed directly on the patient's body.
  • Anatomical Site: The anatomical site is the "pulmonary artery," which is an internal organ within the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in biological samples to diagnose, monitor, or predict disease or conditions.

The device appears to be a surgical or interventional tool used during a medical procedure, not a diagnostic test performed on a sample.

N/A

Intended Use / Indications for Use

Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

Product codes

Not Found

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pulmonary Artery

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Performance testing has demonstrated with 95% confidence that the Endopulmonary Vent will meet or exceed Heartport's performance standards. Performance testing has demonstrated that the Endopulmonary Vent will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.

Key Metrics

Not Found

Predicate Device(s)

K845046, not applicable, K811411

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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Appendices

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:

Date Prepared: March 29, 1996

Name:Heartport, Inc.
Address:200 Chesapeake Drive
Redwood City, CA 94063
Contact Person:Robert J. Chin
Phone Number:(415) 306-7900
Fax Number:(415) 306-7905

Device Information:

Trade Name:Endopulmonary Vent
Common Name:Pulmonary Vent Catheter
Classification Name:Cardiopulmonary bypass catheter

Equivalent Devices:

Name:Pulmonary Artery Vent Catheter
Manufacturer:DLP
Status:Post-enactment
510(k) #K845046
Name:Edslab Pulmonary Artery Catheter
Manufacturer:Baxter Healthcare Corporation
Status:Pre-enactment
510(k) #not applicable
Name:Swan-Ganz® Heparin Coated, Pulmonary Artery Catheter
Manufacturer:Baxter Healthcare Corporation
Status:Post-enactment
510(k) #K811411

1

510(k) Summary of Safety and Effectiveness (continued)

Intended Use:

Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

Comparison To Predicate Devices:

This device has the same intended use as the DLP Pulmonary Artery Vent Catheter and uses a combination of the technological characteristics of the identified predicate devices.

Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the Endopulmonary Vent will meet or exceed Heartport's performance standards.

Test Conclusions:

Performance testing has demonstrated that the Endopulmonary Vent will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.

Heartport, Inc.

CONFIDENTIAL