(14 days)
The provided text does not contain any K/DEN numbers for predicate devices. It states: "The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula."
Not Found
No
The summary describes a physical medical device (arterial cannula) and its intended use in cardiopulmonary bypass. There is no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is an arterial cannula used to deliver oxygenated blood during cardiopulmonary bypass. While it assists during a therapeutic procedure (surgery), it is not, in itself, a device that treats or prevents a disease or condition; it is a surgical accessory.
No
The device is an arterial cannula intended to deliver oxygenated blood and allow insertion/removal of another catheter during cardiopulmonary bypass, which are therapeutic and interventional functions, not diagnostic.
No
The device description explicitly states it is an "arterial cannula," which is a physical medical device used for delivering oxygenated blood. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver oxygenated blood for cardiopulmonary bypass during surgery" and to "allow the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter." This describes a device used in vivo (within the body) during a surgical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described does not perform such tests.
- Device Description: The description focuses on its function in delivering blood and facilitating the use of another catheter, consistent with an in vivo surgical device.
- Lack of IVD-related information: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the DirectFlow™ arterial cannula is a surgical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DirectFlow™ arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.
Product codes (comma separated list FDA assigned to the subject device)
74 DWF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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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 subject device meets established specifications. The materials used in the Heartport DirectFlow™ arterial cannula have proven biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula.
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.
Not Found
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).
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
3/23/99
Heartport® DirectFlow™ arterial cannula
APPENDIX A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
The assigned 510(k) number is: __
Applicant Information:
| Date Prepared: | March 5, 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:
Fax Number:
| Trade Names: | Heartport® DirectFlow™ arterial cannula |
|---|---|
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
.
Equivalent Devices:
The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula.
Intended Use:
The DirectFlow™ arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.
Comparison to Predicate Devices:
This device has the same intended use and technological characteristics as the predicate device.
Non-clinical Test Results:
Performance testing demonstrated that the subject device meets established specifications. The materials used in the Heartport DirectFlow™ arterial 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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures.
Public Health Service
MAR 2 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marianne C. Drennan Regulatory Affairs Manager HeartPort, Inc. 700 Bay Road 94063 Redwood City, CA
K990772 Re : K990772
HeartPort® DirectFlow™ Arterial Cannula Regulatory Class: II (Two) 74 DWF Product Code: March 5, 1999 Dated: Received: March 9, 1999
Dear Ms. Drennan:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceen above and we have determined the market the device referenced above and indications for use device is subscanciarly equiresally marketed predicate devices
stated in the enclosure) to legally marketed as 1976, the stated in the cherobate, or acy may 28, 1976, the marketed in Interstate Common Device Amendments, or to devices enactment date of the Medical Devocation with the provisions of that have been fectassified in actic Act (Act (Act). You may, the rederal rood, brag, and combject to the general controls therefore, market the device, Basjocontrols provisions of the provisions of the Act. The genoual registration, listing of Act incrude requirements for and the labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II II your device is crabbility (200 million (200 million of the may be (Special Controls) or Grabb controls. Existing major regulations subject to such addressional of found in the Code of Federal arrecting your device camber on to 895. A substantially Requiralent determination assumes compliance with the Current Good equivalent decermination as set forth in the Quality
Manufacturing Practice requirements, as set forth in the publication Manufacturing Fracese Foque Medical Devices: General regulation System Regulacion (20) Lot, through periodic QS inspections, the (21 CFR Part 620) and chae, childer will verify such assumptions. Food and Brag nammith the GMP regulation may result in In addition, FDA may publish further regulatory action. regulatory accion. "In address, see in the Federal Register. announcements consentions to your premarket notification Flease note. Chro respense any obligation you might have under sections 531 through 542 of the Act for devices under the sections 531 childgi 312 can 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 This lected will arrow you co began manocaming. The FDA finding described in your 510\x) premarker hevice to a legally marketed of substantial equivalence on your deication for your device and produce and predicate device rebares in a conceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in vitro regulation (21 crk rail ase contact the Office of Compliance at diagnostic devices), proaze y, for questions on the promotion and (301) 594-4640. Addressma, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639_ entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (21crk 607.97). Ocher genead may be obtained from the Division responsibilities under the stars 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,
Thomas J. Callahson
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
APPENDIX D. INDICATIONS FOR USE STATEMENT
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Indications for Use
| 510(k) Number (if known): | K990772 |
|---|---|
| --------------------------- | --------- |
DirectFlow™ arterial cannula Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The DirectFlow™ arterial cannula is indicated for patients undergoing The Directif fow " artenal cannula is interestial cannula is intended to deliver Cardiopulmonary bypass. The Birning surgery. The DirectFlow oxygenated blood for ourdlopation and removal of vascular catheters Cannula also allows the nomostalic catheter. The DirectFlow cannula is Such as the Fleatport EndoClump though a thoracic trocar or incision.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |
| Prescription Use | OR | Over- The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |