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.

Device Description

The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Heartport® DirectFlow™ arterial cannula. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the context of device accuracy or efficacy.

Therefore, the requested information elements such as device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, and detailed ground truth establishment are not present in the provided document. The document states that "Performance testing demonstrated that the subject device meets established specifications," but it does not elaborate on what those specifications are, nor does it provide a table of acceptance criteria and reported performance.

Below is a table reflecting the information that can be extracted (or is explicitly absent) based on the provided text:

Acceptance Criteria and Device Performance

There is no specific table of acceptance criteria or detailed device performance metrics provided in the document. The statement "Performance testing demonstrated that the subject device meets established specifications" is a high-level summary without specifics.

Study Information Table

Information Element	Details from Provided Text
1. Acceptance Criteria and Reported Device Performance	Acceptance Criteria: Not explicitly stated or detailed in the document. The document only mentions "meets established specifications." Reported Device Performance: Not provided in quantitative terms. The document only states "Performance testing demonstrated that the subject device meets established specifications."
2. Sample size and Data Provenance (test set)	Sample Size: Not specified. Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is referred to as "Non-clinical Test Results."
3. Number of experts and qualifications (ground truth for test set)	Number of Experts: Not specified. Qualifications of Experts: Not specified. The document does not describe the establishment of a "ground truth" using human experts for the non-clinical performance tests mentioned.
4. Adjudication method (test set)	Not applicable/Not specified. There is no mention of a clinical study or expert review process that would require adjudication.
5. MRMC Comparative Effectiveness Study	Not performed or reported. The document focuses on substantial equivalence based on intended use and technological characteristics, not on comparative effectiveness with human readers.
6. Standalone (algorithm only) performance study	Not performed or reported. This device is a physical medical device (arterial cannula), not an algorithm.
7. Type of ground truth used	Not applicable/Not specified in the sense of analytical ground truth for accuracy. For "Non-clinical Test Results," the "ground truth" would be the established engineering specifications or benchmarks against which the device was tested. The document does not detail these.
8. Sample size for the training set	Not applicable/Not specified. This is a hardware medical device, not a machine learning algorithm that requires a training set.
9. How ground truth for the training set was established	Not applicable/Not specified. As this is a hardware device, there is no "training set" in the context of AI/ML.

Summary of Study (as described in the 510(k) Summary):

The "study" mentioned in the document is "Performance testing" which demonstrated that the device "meets established specifications." This is described under "Non-clinical Test Results." The primary purpose of this 510(k) submission is to demonstrate "substantial equivalence" to a predicate device based on intended use, technological characteristics, and biocompatibility, rather than providing detailed clinical or algorithm performance data.

Summary

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3/23/99
Heartport® DirectFlow™ arterial cannula

K990772

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 RoadRedwood 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:

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.

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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.

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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

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APPENDIX D. INDICATIONS FOR USE STATEMENT

and the same of the same of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

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.

.��

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(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)

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).