(76 days)
01055
Not Found
No
The summary describes a mechanical clamp and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device's function is to occlude the aorta, deliver cardioplegic solution, and monitor pressure during cardiopulmonary bypass. These actions are performed on the body but are not in themselves therapeutic treatment of a disease or condition; rather, they are instrumental to a surgical procedure.
No
The device physically occludes the aorta, delivers solution, and monitors pressure, none of which are diagnostic functions. While monitoring pressure involves data collection, its primary purpose here is not to diagnose a condition but to guide a procedure.
No
The device description explicitly states "Endoaortic Clamp (Catalog Number 02055)", which is a physical medical device used for surgical procedures, not a software-only product.
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 in vivo (within the body) for surgical procedures (occlusion of the aorta, delivery of cardioplegic solution, monitoring of aortic root pressure).
- Device Description: The description is of a physical clamp used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root 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
aorta
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 Endoaortic Clamp will meet or exceed Heartport, Inc. performance standards.
Key Metrics
Not Found
Predicate Device(s)
Heartport Endoaortic Clamp (Catalog Number 01055)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Drive |
| Redwood City, CA 94063 |
| Contact Person: | Robert J. Chin |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
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.