(141 days)
Not Found
Not Found
No
The summary describes a mechanical device (cannulae, introducer) for cardiopulmonary bypass and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an arterial cannula and introducer used during cardiopulmonary bypass to deliver oxygenated blood and assist with the introduction and removal of catheters; it does not provide therapy but rather facilitates a medical procedure.
No
Explanation: The device is an arterial cannula and related kits intended to deliver oxygenated blood during cardiopulmonary bypass and to facilitate the introduction and removal of an aortic catheter. Its function is to provide blood flow and access for other medical devices, not to diagnose a condition.
No
The device description clearly indicates it is a "kit" including "arterial cannulae" and an "AutoIncisor introducer," which are physical hardware components used in surgical procedures.
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 for delivering oxygenated blood during cardiopulmonary bypass and facilitating the introduction/removal of a catheter. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the physical components and their function in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta
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
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 demonstrated that the subject device meets established specifications.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
APPENDIX B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
The assigned 510(k) number is: _____________________
Applicant Information:
| Date Prepared: | December 15, 1999 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 700 Bay Road |
| Redwood City, CA 94063 | |
| Contact Person: | Marianne C. Drennan |
| Phone Number: | (650) 482-4405 |
| Fax Number: | (650) 482-4346 |
Device Information:
| Trade Names: | Heartport® DirectFlow™ Kit, DirectFlow™ Cannula
Heartport SoftClamp™ Kit, SoftClamp™ Cannula
Heartport StraightShot™ Kit, StraightShot™ Cannula
Heartport AutoIncisor™ Introducer |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Cardiovascular Surgical Devices - Cardiopulmonary bypass
vascular cannula |
Equivalent Devices:
The subject device is substantially equivalent in intended use, technological characteristics, and materials to currently marketed Heartport arterial kits.
Intended Use:
The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and Straints of erial cannulae are intended to deliver oxygenated blood for cardionulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostation in and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.
Comparison to Predicate Devices:
This device has the same intended use, technological characteristics, and materials as the predicate device.
Non-clinical Test Results:
Performance testing demonstrated that the subject device meets established specifications.
1
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.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2000
Ms. Marianne C. Drennan Senior Manager, Regulatory Affairs HeartPort 700 Bay Road Redwood City, CA 94063
K994243/S2 Re: Heartport® arterial cannulae Regulatory Class: II (two) Product Code: DWF Dated: April 17, 2000 . Received: April 18, 2000
Dear Ms. Drennan:
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 Regulations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
3
Page 2 - Ms. Marianne C. Drennan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your of your device to a legally marketed predicate device equits 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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,
Brian E. Haney Jr.
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX D. INDICATIONS FOR USE STATEMENT
Indications for Use
1.994243 510(k) Number (if known):
Device Name: DirectFlow™ Kit, SoftClamp™ Kit, StraightShot™ Kit
Indications for Use:
The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | OR | Over- The Counter Use
(Optional Format 1-2-96) |
|------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------|
| | Division of Cardiovascular, Respiratory,
and Neurological Devices | |
| | 510(k) Number _ | |