(77 days)
No
The summary describes a simple vascular catheter for mechanical functions and pressure monitoring, with no mention of AI/ML terms or capabilities.
No
The device is used for occlusion, delivery, and monitoring, which are functional purposes during a medical procedure, not for treating a disease or disorder.
No
The device is primarily used for occlusion, delivery of cardioplegia, and monitoring pressure, which are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly identifies it as a "Catheter," which is a physical medical device, not software. The intended use also describes a physical action (occlusion, delivery) performed by a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during a medical procedure (cardiopulmonary bypass) to interact directly with the patient's anatomy (coronary sinus) for purposes like occlusion, delivery of substances, and monitoring pressure.
- Device Description: The device is described as a "Cardiopulmonary bypass vascular catheter," which is a device used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status. The provided information does not mention any interaction with patient specimens or analysis performed outside the body.
Therefore, this device is a medical device used in vivo (within the body) during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during 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
coronary sinus
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 Endosinus Catheter will meet or exceed Heartport's performance standards. Performance testing has demonstrated that the Endosinus Catheter will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
Key Metrics
Not Found
Predicate Device(s)
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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Image /page/0/Picture/2 description: The image shows the text "K961270" in a handwritten style. Below this text, the word "Appendices" is printed in a smaller, serif font. The text is black against a white background.
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: | Heartport Endosinus Catheter |
|---|---|
| Common Name: | Sinus Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Devices:
| Name: | Coronary Sinus Perfusion & Pressure Monitoring Cannula |
|---|---|
| Manufacturer: | Research Medical, Inc. |
| Status: | Post-enactment |
| 510(k) # | K897137 |
| Name: | Baim Coronary Sinus Flow Catheter |
| Manufacturer: | Electro-Catheter Corporation |
| Status: | Post-enactment |
| 510(k) # | K810360 |
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അവലംബം
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
This device has the same intended use and technological characteristics as the predicate devices.
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the Endosinus Catheter will meet or exceed Heartport's performance standards.
Test Conclusions:
Performance testing has demonstrated that the Endosinus Catheter will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
Heartport, Inc.