(203 days)
Not Found
Not Found
No
The summary describes a physical medical device (cannula) used for draining blood during surgery and mentions performance testing related to flow rates, with no indication of software, image processing, or AI/ML terms.
Yes
The device is used to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery, which directly addresses a physiological condition and is thus a therapeutic function.
No
The device is described as a drainage cannula used to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery. This is a therapeutic function, not a diagnostic one.
No
The device is described as a "Heartport Endovenous Drainage Cannula," which is a physical medical device used for draining blood. The summary discusses flow rates and predicate devices that are also physical cannulas, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery." This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used during a medical procedure.
N/A
Intended Use / Indications for Use
Use of the Heartport Endovenous Drainage Cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The Heartport Endovenous Drainage Cannula serves to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery.
Product codes
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Device Description
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula provides comparable flow rates to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
10 1997
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: July 18, 1996
Heartport, Inc. Name: 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 Endovenous Drainage Cannula |
|---|---|
| Common Name: | Venous Cannula |
| Classification Name: | Cardiopulmonary bypass vascular cannula |
Equivalent Devices:
Medtronic DLP, Inc. - Femoral Venous Cannula Research Medical, Inc. - Fem-flex Femoral Access Cannulae
Intended Use:
Use of the Heartport Endovenous Drainage Cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The Heartport Endovenous Drainage Cannula serves to drain non-oxygenated blood for cardiopulmonary bypass during cardiac surgery.
Comparison To Predicate Devices:
The Heartport Endovenous Drainage Cannula is not significantly different from the identified predicates. The only difference is the addition of a surface coating to enhance lubricity during insertion of the cannula.
1
510(k) Summary of Safety and Effectiveness (continued)
Non-clinical Test Results:
Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula provides comparable flow rates to the identified predicate devices.
Test Conclusions:
Performance testing has demonstrated that the Heartport Endovenous Drainage Cannula will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
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