(169 days)
No
The summary describes a mechanical device (catheter) and its intended use, with no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on meeting performance standards and safety/effectiveness, not on the performance of an AI/ML algorithm.
Yes
The device states its intended use is for "Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass," all of which are direct medical interventions or monitoring functions, fitting the definition of a therapeutic device.
No
The device's description focuses on therapeutic actions (occlusion, delivery) and monitoring, rather than diagnosing a condition or disease. The monitoring of aortic root pressure is for guiding the therapeutic procedure, not for diagnostic purposes.
No
The device description explicitly states "Endoaortic Clamp Catheter," which is a physical medical device, not software.
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 procedures like aortic occlusion, delivery of solutions, and pressure monitoring during cardiopulmonary bypass. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: The device is described as an "Endoaortic Clamp Catheter," which is consistent with an in vivo medical device used within the aorta.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or performing tests on samples outside the body, which are hallmarks of IVDs.
Therefore, this device falls under the category of an in vivo medical device, not an IVD.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has demonstrated with 95% confidence that the Heartport Endoaortic ClampTM will meet or exceed Heartport, Inc. performance standards. Performance testing has demonstrated that the Endoaortic Clamp will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Endoaortic Clamp
APR - 4 1997
64161
510(k) Notification
and the same of the same of the same of the same of
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:
October 16, 1996 Date Prepared:
| Name: | Heartport, Inc. |
|---|---|
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 | |
| Contact Person: | Kevin F. MacDonald |
| Phone Number: | (415) 306-7900 |
Device Information:
Fax Number:
| Trade Name: | Heartport Endoaortic ClampTM |
|---|---|
| Common Name: | Endoaortic Clamp Catheter |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
(415) 306-7905
Equivalent Devices:
Heartport Endoaortic Clamp - K962510 Heartport Endoaortic Clamp - K955132
Intended Use:
Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
Comparison To Predicate Devices:
and the same of the same of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the stat
This device has the same intended use and technological characteristics as the predicate device.
1
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the Heartport Endoaortic Clamp™ will meet or exceed Heartport, Inc. performance standards.
Test Conclusions:
Performance testing has demonstrated that the Endoaortic Clamp will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.