(170 days)
There are no K/DEN numbers mentioned in the "Predicate Device(s)" section.
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on equivalence to a previously marketed device without mentioning advanced algorithms.
No
The device is described as assisting in decompressing the heart and removing blood, which are supportive functions during cardiopulmonary bypass rather than directly treating a disease or medical condition.
No
Explanation: The device is intended to remove blood and decompress the heart during cardiopulmonary bypass, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly refers to a "catheter," which is a physical, hardware component. The summary describes a medical device that is a physical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in patients undergoing cardiopulmonary bypass to remove blood and assist in decompressing the heart. This is a direct intervention on a living patient.
- Device Description: The description focuses on the physical characteristics and equivalence to a marketed catheter, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and interventional.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The Heartport® Endopulmonary Vent™ catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.
Product codes
DWF
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)
Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications. The materials used in the Heartport® Endopulmonary Vent™ catheter have proven biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.
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
4 1698 SEP
Heartport® Endopulmonary Vent™ Catheter
APPENDIX B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of 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 17, 1998 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 |
| Contact Person: | Marianne C. Drennan |
|---|---|
| Phone Number: | (650) 482-4405 |
| Fax Number: | (650) 482-4346 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport® Endopulmonary Vent™ catheter |
| Classification Name: | Cardiopulmonary bypass catheter |
Equivalent Devices:
The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.
Intended Use:
The Heartport® Endopulmonary Vent™ catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.
Non-Clinical Test Results:
Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications. The materials used in the Heartport® Endopulmonary Vent™ catheter have proven biocompatibility.
Summary:
Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 4 1998
Ms. Lisa McGrath Sr. Regulatory Affairs Specialist HeartPort, Inc. 200 Chesapeake Drive Redwood City, CA 94063
Re : K981009 HeartPort® Endopulmonary Vent™ Catheter Regulatory Class: ı i Product Code: DWF Dated: July 16, 1998 Received: July 17, 1998
Dear Ms. McGrath:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
2
Page 2 - Ms. Lisa McGrath
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."
Sincerely yours,
sincerely years,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
K 981009 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Heartport® Endopulmonary Vent™ catheter
Indications for Use:
The Heartport Endopulmonary Vent Catheter is indicated for use in The Heartport Endopulmonary vonments bypass. It is intended to
patients undergoing cardiopulmonary bypass. It is intended to patients undergoing caraloponary artery and assist in decompressing the heart.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bere R. Cooper Se
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use (Optional Format 1-2-96)