(70 days)
Not Found
No
The summary describes a system of physical catheters and cannulae for cardiopulmonary bypass and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to maintain cardiopulmonary bypass and arrest the heart during cardiac surgery, which are therapeutic interventions.
No
Explanation: The device description states its use is to maintain a patient on cardiopulmonary bypass during cardiac surgery, and its components are bypass catheters, cannulae, and accessories. There is no mention of it being used to diagnose a condition or disease.
No
The device description explicitly lists physical components (catheters, cannulae, accessories) that are part of the system, indicating it is a hardware-based medical 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 system used during cardiac surgery to maintain cardiopulmonary bypass and arrest the heart. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description lists catheters, cannulae, and accessories used for bypass procedures. These are instruments used directly on the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient's heart to be arrested without the need for a median sternotomy.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955132, K961245, K955121, K875353, K961270
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
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:
July 19, 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: | Endovascular Cardiopulmonary Bypass Systems |
|---|---|
| Common Name: | Cardiopulmonary bypass catheter kits |
| Classification Name: | Cardiopulmonary bypass vascular catheter |
Equivalent Devices:
The Heartport Endovascular Antegrade Cardiopulmonary Bypass System is composed of the following commercially available bypass catheters, cannulae and accessories:
Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent Heartport manufactured device
The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to:
Heartport Endosinus Catheter (K961270)
1
Intended Use:
The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient's heart to be arrested without the need for a median sternotomy.
Comparison To Predicate Devices:
There are no changes from the predicate devices other than the shelf packaging and its label.