K Number
K981995
Device Name
QUICKDRAW VENOUS CANNULA
Manufacturer
Date Cleared
1999-04-20

(316 days)

Product Code
Regulation Number
870.4210
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.
Device Description
Not Found
More Information

Heartport Endovenous Drainage™ Cannula, Baxter Healthcare Corporation- Cardiovascular Group [Research Medical, Inc. (RMI)] RMI Venous Drainage Cannula, Heartport Endoarterial Return™ Cannula

N/A

No
The summary describes a physical venous cannula used for draining blood during cardiopulmonary bypass and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.

Yes
The device is used to drain blood during cardiopulmonary bypass, which is a medical procedure aimed at treating a patient's condition. While it doesn't directly treat, it plays a vital role in a therapeutic process.

No
Explanation: The device is a venous cannula used to drain blood during cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one. It is used to facilitate a medical procedure, not to identify a disease or condition.

No

The device is described as a "venous cannula," which is a physical medical device used to drain blood. The description of its function and intended use clearly indicates a hardware component.

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 drain nonoxygenated blood from the venae cavae and/or right atrium. This describes a device used in vivo (within the body) for a surgical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
  • Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
  • Other Sections: The absence of information related to image processing, AI/ML, input imaging modality, training/test sets, performance metrics like sensitivity/specificity, and the nature of the predicate devices (which are also surgical cannulas) further supports that this is not an IVD.

IVDs are typically used to analyze samples like blood, urine, tissue, etc., to provide information about a patient's health status. This device is a surgical tool used directly on the patient during a procedure.

N/A

Intended Use / Indications for Use

The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.

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

vena cavae and/or right atrium

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 subject device meets established specifications. The materials used in the Heartport QuickDraw venous cannula have proven biocompatibility.

Key Metrics

Not Found

Predicate Device(s)

Heartport Endovenous Drainage™ Cannula, Baxter Healthcare Corporation- Cardiovascular Group [Research Medical, Inc. (RMI)] RMI Venous Drainage Cannula, Heartport Endoarterial Return™ 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

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: K981995

Applicant Information:

Date Prepared:October 22, 1998
Name:Heartport, Inc.
Address:200 Chesapeake Drive
Redwood City, CA 94063

Marianne C. Drennan, Requlatory Affairs Manager Contact Person: (650) 482-4405 Phone Number: Fax Number: (650) 482-4346

Device Information:

ClassificationClass II
Trade Name:Heartport® QuickDraw™ venous cannula
Classification Name:Cardiopulmonary Bypass Cannula
21 CFR §870.4210

Equivalent Devices:

The subject device is substantially equivalent in intended use, method of operation and/or materials to the currently marketed Heartport Endovenous Drainage™ Cannula, Baxter Healthcare Corporation- Cardiovascular Group [Research Medical, Inc. (RMI)] RMI Venous Drainage Cannula, and the Heartport Endoarterial Return™ Cannula

Intended Use:

The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.

Non-Clinical Test Results:

Performance testing demonstrated that the subject device meets established specifications. The materials used in the Heartport QuickDraw venous 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 seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three overlapping wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 1999

Ms. Marianne C. Drennan Regulatory Affairs Manager HeartPort, Inc. 700 Bay Road Redwood City, CA 94063

Re: K981995 HeartPort™ QuickDraw™ Venous Cannula Regulatory Class: II (Two) Product Code: 74 DWF Dated: January 27, 1999 Received: January 28, 1999

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 aqainst 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 Reqister. 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 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" (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,

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

Enclosure

3

Indications for Use

510(k) Number (if known): __ 8 98 1995

Heartport® QuickDraw™ venous cannula Device Name:

Indications for Use:

The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bypass.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dove L. Simpson

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 981994 510(k) Number _

Prescription Use レ (Per 21 CFR 801.109)

OR

Over- The Counter Use (Optional Format 1-2-96)