(40 days)
Not Found
Not Found
No
The document describes a mechanical device for occluding and venting the aorta, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
Yes
The device is used in patients undergoing cardiopulmonary bypass to occlude and vent the ascending aorta, deliver cardioplegia to arrest the heart, and monitor aortic root pressure, all of which are therapeutic interventions aimed at altering the patient's condition for treatment during surgery.
No
The device is used to occlude and vent the ascending aorta, deliver cardioplegia, and monitor aortic root pressure during cardiopulmonary bypass. While it monitors pressure, its primary function is therapeutic (occlusion, venting, drug delivery) rather than diagnostic.
No
The device description clearly outlines a physical catheter with lumens, a balloon, and the function of occluding and venting the aorta, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a catheter used in vivo (within the body) to occlude and vent the ascending aorta, deliver cardioplegia, and monitor aortic root pressure during cardiopulmonary bypass. These are all direct interventions and measurements within the patient's body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, the Heartport Endoaortic Clamp catheter is a medical device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
Product codes
DWZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta, aortic root
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:
Based on the equivalence in design to the predicate device, performance testing was not warranted for this device, The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter.
Key Metrics
Not Found
Predicate Device(s)
Heartport® Endoaortic Clamp™ catheter, Medi-tech Occlusion Balloon catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).
0
510(k) Notification
APPENDIX A. 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:
DEC I 6 1997
| Date Prepared: | November 5, 1997 |
|---|---|
| ---------------- | ------------------ |
- Heartport, Inc. Name: Address: 200 Chesapeake Drive Redwood City, CA 94063
Marianne C. Drennan Contact Person: (650) 482-4405 Phone Number: Fax Number: (650) 482-4346
Device Information:
| Trade Name: | Heartport® Endoaortic Clamp™ Catheter |
|---|---|
| Classification Name: | Vascular Clamp, 21 CFR 870.4450 |
Equivalent Devices:
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport® Endoaortic Clamp™ catheter and the Medi-tech Occlusion Balloon catheter.
Intended Use:
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
Comparison to Predicate Devices:
This device has the same intended use and technological characteristics as the predicate devices.
Non-clinical Test Results:
i
Based on the equivalence in design to the predicate device, performance testing was not warranted for this device, The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Rockville MD 20857
Ms. Marianne C. Drennan Senior Regulatory Affairs Specialist HeartPort, Inc. 200 Chesapeake Drive Redwood City, CA 94063
DEC 1 6 1997
Re : K974175 Heartport® Endoaortic Clamp™ Catheter Regulatory Class: II (Two) Product Code: DWZ Dated: November 5, 1997 Received: November 6, 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, 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 A substantially equivalent determination assumes compliance with 895. 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 assumptions. Failure to comply with the GMP regulation may result in 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.
2
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 requlation (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/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahai Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
870.4210-DWF II
CPB Vascular Catheters, Cannula, or Tubing
Indications for Use
ﻳﺪ 974175 510(k) Number (if known):
Device Name:
Heartport® Endoaortic Clamp™ Catheter
Indications for Use:
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori R. Lamberti
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K974175
Prescription Use
(Per 21 CFR 801.109)
OR
Over- The Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)