(78 days)
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 |
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Phone Number: | (415) 306-7900 |
Fax Number: | (415) 306-7905 |
Device Information:
Trade Name: | Endopulmonary Vent |
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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
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