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

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Heartport QuickDraw venous cannula. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer most of the requested questions about acceptance criteria and a specific study proving the device meets them.

Here's a breakdown of what can be gleaned and what is missing based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Established specifications	Meets established specifications (details not provided)
Biocompatibility	Materials have proven biocompatibility (details not provided)

Missing Information: The document states that performance testing demonstrated the device meets "established specifications" and that its materials have "proven biocompatibility," but it does not detail what those specific criteria or specifications are, nor does it provide quantitative performance data against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document refers to "performance testing" but does not provide any details about the sample size used for the test set, the country of origin, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information: This information is not present in the provided text. The device is a physical medical device (venous cannula), not an AI/diagnostic tool that would typically require expert-established ground truth for its performance evaluation in the way implied by this question.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: This information is not present. As above, this type of adjudication is usually relevant for diagnostic assessments, not for the physical performance of a cannula.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing Information: This is completely inapplicable to the device described. The Heartport QuickDraw venous cannula is a physical device used in cardiopulmonary bypass, not an AI or imaging diagnostic tool that would be evaluated with an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing Information: This question is not applicable to the device described. It is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing Information: Not explicitly stated as the device's performance is likely measured against engineering specifications and relevant ISO standards for medical devices, rather than a diagnostic "ground truth."

8. The sample size for the training set

Missing Information: This is not applicable to the device described, which is a physical medical device and not an AI model requiring a training set.

9. How the ground truth for the training set was established

Missing Information: Not applicable to the device described.

Summary of Study Information Provided in the Text:

The document states:

"Performance testing demonstrated that the subject device meets established specifications."
"The materials used in the Heartport QuickDraw venous cannula have proven biocompatibility."
The overall conclusion is based on "intended use, product performance and biocompatibility information" and establishes "substantial equivalence to currently marketed predicate devices."

However, the 510(k) summary itself (the provided text) does not detail the specifics of this performance testing or biocompatibility assessment, nor does it include information about clinical studies with human subjects or detailed expert evaluations that would be typical for many AI-based or diagnostic devices. The acceptance criteria it refers to are internal "established specifications" and "proven biocompatibility," the details of which are not disclosed in this public summary. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than a de novo detailed clinical efficacy study with specific expert-adjudicated ground truth.

Summary

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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 DriveRedwood City, CA 94063

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

Device Information:

Classification	Class 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:

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.

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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.

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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 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

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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)

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

Regulation Number and Section

§ 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).