(71 days)
None
Not Found
No
The summary describes a physical medical device (cannula) and its intended use in cardiopulmonary bypass. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The focus is on the device's function and material biocompatibility.
Yes.
The device is used to deliver oxygenated blood for cardiopulmonary bypass during surgery, which is a therapeutic intervention aimed at maintaining a patient's life functions during heart surgery.
No
The device is described as a cannula used to deliver oxygenated blood during cardiopulmonary bypass, and to allow the introduction and removal of vascular catheters. Its function is to facilitate a medical procedure, not to diagnose a condition.
No
The device description clearly indicates a physical cannula, which is a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering oxygenated blood during cardiopulmonary bypass and for introducing/removing vascular catheters. This is a direct interaction with the patient's circulatory system during surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such testing on specimens.
- Device Description: The description focuses on its function within the circulatory system during surgery, not on analyzing biological samples.
The device is a surgical tool used in vivo (within the living body), not in vitro (in glass/outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Endoarterial Return Cannula, with or without hemostasis valve, is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
Product codes
74 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
Non-Clinical Test Results: Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications. The materials used in the Heartport Endoarterial Return Cannula have proven biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Heartport™ Endoarterial Return™ Cannula, BioMedicus® Cannula
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
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:
JUN 17 1997
| Date Prepared: | April 4, 1997 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 |
| Contact Person: | Marianne C. Drennan |
|---|---|
| Phone Number: | (415) 482-4405 |
| Fax Number: | (415) 482-4346 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport™ Endoarterial Return™ Cannula |
| Classification Name: | Cardiovascular Surgical Devices - Cardiopulmonary bypass vascular |
| cannula | |
| 21 CFR 870.4210 |
Equivalent Devices:
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.
Intended Use:
The Endoarterial Return Cannula, with or without hemostasis valve, is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
Non-Clinical Test Results:
Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications. The materials used in the Heartport Endoarterial Return Cannula 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
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Image /page/1/Picture/2 description: The image shows a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the left side of the seal. To the right of the text is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The symbol is black and the text is in a sans-serif font.
JUN 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marianne C. Drennan Requlatory Affairs Specialist HeartPort, Inc. 200 Chesapeake Drive Redwood City, California 94063
Re: K971291 - Novaro----------------------------------------------------------------------------------------------------------------------------------------------------------------------Requlatory Class: II (Two) Product Code: 74 DWF Dated: April 4, 1997 Received: April 7, 1997
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 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, Druq, 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 Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP 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.
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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 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 requlation 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"dsmo@fdadr.cdrh.fda.qov."
Sincerely yours,
Thomas J. Callahon, Ph.D.
Thomas J. Callad Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 870.4210 | - CPB Vascular Catheter, Cannula |
|---|---|
| or Tubing | |
| DWF II |
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The Endoarterial Return Cannula with and without a hemostasis valve is , indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette R. Gemperle
(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)