The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.

Device Description

The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the CTS Voyager Quad Cannula. It focuses on establishing substantial equivalence to existing predicate devices and does NOT include a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI algorithm or diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of submission. Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance for CTS Voyager Quad Cannula

This 510(k) submission is for a physical medical device (a cannula), not an AI/ML algorithm or a diagnostic test with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are related to functional performance and safety as demonstrated through bench and animal testing. The "device performance" reported is that the device "performs as designed and is suitable for its intended use."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Functional Performance	Ability to perfuse and occlude the ascending aorta during cardiopulmonary bypass.	"The results of the testing verified that the Voyager Quad Cannula performs as designed and is suitable for its intended use." Mentions specific functions: balloon inflation for occlusion, main lumen for arterial perfusion, side lumen for cardioplegia delivery and venting.
Safety	No new issues of safety compared to predicate devices.	"Any differences between the Voyager Quad Cannula and its predicate devices do not raise any new issues of safety or effectiveness."
Biocompatibility	Suitable for contact with human tissue and blood (implied for medical devices of this nature).	Not explicitly detailed in this summary, but would be part of standard device testing ensuring "suitability for its intended use" and "no new issues of safety."
Durability/Integrity	Maintaining structural integrity and function during intended use (implied from "performs as designed").	Not explicitly detailed, but integral to "performs as designed."
Occlusion Range	Compliant balloon expands to occlude a range of aorta sizes.	"The compliant balloon expands to occlude a range of aorta sizes." (This implicitly confirms it meets the design intent for occlusion range).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in terms of numerical count for bench or animal testing.
Data Provenance: The text states, "Functional bench testing and animal testing has been conducted." The country of origin for the data is not specified but would presumably be conducted by CardioThoracic Systems, Inc. in the USA.
Retrospective or Prospective: These types of tests (bench and animal) are inherently prospective studies designed to evaluate the device's performance under controlled conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable (N/A): This is a submission for a physical medical device. The "ground truth" is established by direct physical measurement and observation during bench and animal testing, evaluated by engineers, scientists, and veterinary staff, rather than by human expert interpretation of data points for an AI algorithm.

4. Adjudication Method for the Test Set

Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among human readers agreeing on a "ground truth" for diagnostic or AI studies. For physical device testing, results are typically determined by direct measurement, observation, and established acceptance criteria for functional performance and safety, with no "adjudication" in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No: An MRMC comparative effectiveness study is not applicable to a physical medical device like a cannula. These studies are used for evaluating diagnostic performance, often for AI systems compared to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable (N/A): This is for a physical device, not an algorithm.

7. The Type of Ground Truth Used

Physical Performance and Safety Data: The "ground truth" for this device is derived from direct measurements and observations during functional bench testing and animal studies. This includes confirming the physical capabilities of the cannula (e.g., balloon inflation, fluid delivery/venting) and its safety profile by observing its effect on biological systems in animal models. It's essentially the verifiable physical and biological responses to the device's operation.

8. The Sample Size for the Training Set

Not Applicable (N/A): This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A): This is not an AI/ML device, so there is no "training set" or ground truth establishment for it.

Summary

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JUL 28 1999

2983270

510(k) Premarket Notification CTS Voyager Quad Cannula

SECTION 2

510(k) SUMMARY of SAFETY and EFFECTIVENESS

This summary of the 510(k) premarket notification for the CTS Voyager Quad Cannula is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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510(k) Premarket Notification CTS Voyager Quad Cannula

510(k) Summary CardioThoracic Systems, Inc. Voyager Quad Cannula 510(k) Notification K_

GENERAL INFORMATION

Manufacturer:	CardioThoracicSystems, Inc.10600 North Tantau AvenueCupertino, California(408) 342-1700(408) 342-1717 FAXEst. Reg. No. 9027735
Contact Person:	Michael J. BilligVice President, Regulatory, Quality, and ClinicalResearch
Date Prepared:	September 16, 1998
DEVICE DESCRIPTION
Classification:	Cardiopulmonary Bypass Vascular Cannula, 21CFR 870.4210
Trade Name:	CTS Voyager Quad Cannula
Generic/Common Name:	Cardiopulmonary Bypass Vascular Cannula

PREDICATE DEVICES

Cardiopulmonary bypass cannulae manufactured by Medtronic and Sarns.

INTENDED USE

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PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The CTS Voyager Quad Cannula is substantially equivalent to other cannulae and catheters currently on the market for use in cardiopulmonary bypass procedures, manufactured by companies such as Research Medical, Inc, (RMI), DLP (Medtronic) and Sarns. The Voyager Quad Cannula is substantially equivalent to these predicate devices in regards to device design, intended use, patient population and anatomical site. Any differences between the Voyager Quad Cannula and its predicate devices do not raise any new issues of safety or effectiveness.

Functional bench testing and animal testing has been conducted and the results of the testing verified that the Voyager Quad Cannula performs as designed and is suitable for its intended use.

SUMMARY

As contained in this 510(k) summary, the CTS Voyager Quad Cannula is substantially equivalent to the predicate device identified in that the Voyager Quad Cannula is substantially equivalent in regards to device design, intended use, patient population and anatomical site.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1999 Mr. Michael Billig Vice President, Regulatory, Ouality and Clinical Research CardioThoracic Systems, Inc. 10600 N. Tantau Avenue Cupertino, CA 95014-0739

Re: K983270 CTS Voyager™ Quad Cannula Requlatory Class: II (Two) Product Code: DWF Dated: June 18, 1999 Received: June 21, 1999

Dear Mr. Billig:

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 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 requlations.

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Page 2 - Mr. Michael Billig

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 leqally 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 requlation 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. Callahon

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CardioThoracic Systems, Inc. CTS Voyager™ Quad Cannula 510(k) Premarket Notification

STATEMENT OF INDICATIONS FOR USE

Mr. Rugh

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number

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).