(90 days)
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No
The summary describes a physical catheter for delivering solutions and monitoring pressure, with no mention of AI/ML, image processing, or data analysis that would typically involve such technologies.
Yes
The device is described as delivering cardioplegic solution to the coronary sinus and monitoring pressure, which indicates a direct therapeutic action or support during a medical procedure.
No
The device is described as delivering cardioplegic solution and monitoring pressure, which are therapeutic and monitoring functions, not diagnostic.
No
The device is described as a "catheter" and "Endocoronary Sinus Catheter," which are physical medical devices used for delivering solutions and monitoring pressure. The summary does not mention any software component as the primary or sole function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter designed for:
- Occlusion of the coronary sinus.
- Delivery of cardioplegic solution.
- Monitoring coronary sinus pressure.
These are all in vivo procedures, meaning they are performed directly within the living body. The device is not analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
coronary sinus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport's performance standards.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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: October 22, 1996
| Name: | Heartport, Inc. |
|---|---|
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 |
| Contact Person: | Kevin F. MacDonald |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Trade Name: | Heartport Endocoronary Sinus Catheter |
|---|---|
| Common Name: | Sinus Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Device:
| Name: | Endosinus Catheter |
|---|---|
| Manufacturer: | Heartport, Inc. |
| Status: | Post-enactment |
| 510(k) # | K961270 |
| Cleared: June 18, 1996 |
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
This device has the same intended use and technological characteristics as the predicate device.
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport's performance standards.
Test Conclusions:
Performance testing has demonstrated that the Endocoronary Sinus Catheter will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.