The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

Device Description

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual lumen Veno-Venous Cannula and a 15.5 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.

The PROTEK Duo 31 Fr. Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels. The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.

The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the PROTEK Duo 31 Fr. Veno-Venous Cannula Set. This document is a regulatory submission to the FDA, not a study publication. Therefore, it does not describe an AI/ML-based device or a clinical study in the typical sense for AI/ML validation.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) tests performed to demonstrate the substantial equivalence of the new device (PROTEK Duo 31 Fr.) to a legally marketed predicate device (PROTEK Duo 29 Fr.). The device in question is a physical medical device (cannula), not a software algorithm.

Based on the provided information, here's a breakdown of the requested points as they apply to this document:

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

Test	Acceptance Criteria (Implicitly compared to Predicate or Design Specifications)	Reported Device Performance
Comparative Hemolysis	No difference in hemolysis levels compared to the predicate device.	No difference in hemolysis levels between test articles and predicate controls.
Pressure-Flow	Measured flow rates must exceed the smaller predicate at all levels of pressure difference across the cannula, and design specifications must be met.	Measured flow rates exceed the smaller predicate at all levels of pressure difference across the cannula. Design specifications were met.
Tensile Strength	Identical to those of the predicate device (specific values not provided).	Acceptance criteria were identical to those of the predicate and were met in all tests.
Pathway Integrity	Identical to that of the predicate device (specific values not provided).	Acceptance criterion was identical to that of the predicate and was met in all tests.
Kink Radius	Identical to that of the predicate device (specific values not provided).	Acceptance criterion was identical to that of the predicate and was met in all tests.
Stiffness	Sufficiently stiff for insertion while remaining flexible enough to avoid vessel injury (specific values not provided).	The cannula, the introducer, and the cannula/introducer assembly met acceptance criteria established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury.

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

Sample Size: The document does not specify exact sample sizes for each benchtop test (e.g., how many cannulas were tested for hemolysis, tensile strength, etc.). It generally refers to "tests" and "all tests," implying multiple units were tested.
Data Provenance: The tests are non-clinical, benchtop tests performed by the manufacturer, CardiacAssist, Inc., located in Pittsburgh, PA, USA. Therefore, the data provenance is from internal laboratory testing within the USA. It is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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)

This question is not applicable to this document. The "ground truth" for these non-clinical tests is based on objective physical measurements and engineering specifications, not expert interpretation or clinical outcomes. For example, hemolysis is measured by laboratory methods, tensile strength by force gauges, and flow rates by fluid dynamics measurements. No human experts are used to establish ground truth in this context.

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

This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers or experts interpret data (e.g., medical images) and their disagreements need resolution. For physical benchtop tests, results are typically quantitative and objectively measured, not subject to subjective adjudication.

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

This question is not applicable to this document. This submission is for a physical medical device (cannula), not an AI/ML-based medical device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This question is not applicable to this document. As stated, this is a physical medical device, not an algorithm.

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

As explained in point 3, the "ground truth" here refers to the actual physical properties and performance of the device under controlled benchtop conditions, measured objectively using established engineering and laboratory test methods. It's based on physical measurements against established specifications and comparison to a predicate device's performance, not clinical ground truth types like pathology or outcomes data.

8. The sample size for the training set

This question is not applicable. This submission is for a physical medical device. There is no AI/ML algorithm that requires a "training set." The device itself is manufactured; it does not "learn."

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

This question is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to be established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2016

Cardiac Assist, Inc. Greg Johnson, PhD Director of Regulatory Affairs 240 Alpha Drive Pittsburgh, PA 15238

Re: K160257

Trade/Device Name: PROTEK Duo 31 Fr. Veno-Venous Cannula Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: January 27, 2016 Received: February 1, 2016

Dear Greg Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICEFood and Drug Administration	orm Approved: OMB No. 0910-0120piration Date: January 31, 201
Indications for Use	See PRA Statement below
510(k) Number (if known)K160257
PROTEK Duo 31 Fr. Veno-Venous Cannula SetDevice Name
Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage andreinfusion of blood via an internal jugular vein during extracorporeal life support procedures.Indications for Use (Describe) The PROTEK Duo 31 Fr. '






or both, as applicable)Type of Use (Select one
🇿 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.This section applies only to requirements of the Paperwork Reduction Act of 1995
The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and complete and review the collection of information. Send comments regarding this burden estimate or any o
Department of Health and Human ServicesPaperwork Reduction Act (PRA) StaffOffice of Chief Information Officerood and Drug AdministrationPRAStaff@fda.hhs.gov
An agency may not conduct or sponsor, and a person is not respond to, a collection
Page 1 of 1FORM FDA 3881 (8/14)	PSC Publishing Services (301) 443-6740

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Image /page/3/Picture/0 description: The image contains the logo for CardiacAssist, Inc. The logo features a circular graphic with arrows pointing in different directions, followed by the company name in a bold, blue font. The text "CardiacAssist, Inc." is written in a clear, sans-serif typeface, making it easily readable. The overall design is clean and professional, conveying a sense of reliability and innovation.

Date: 3/3/2016

Applicant

CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800

Contact person

Greg Johnson, PhD Title: Director of Regulatory Affairs Phone: 412-963-7770 x266 e-mail: gjohnson@tandemheart.com

Device

Trade/Proprietary Name:	PROTEK Duo 31 Fr. Veno-Venous Cannula Set
Common Name:	Veno-Venous Cannula and Introducer
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, ortubing. (21 CFR 870.4210, Product Code DWF)

Predicate Device

PROTEK Duo 29 Fr. Veno-Venous Cannula (K140999)

Reference Device

Avalon Elite 31 Fr. Veno-Venous Cannula (K081820)

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo features a circular graphic with arrows pointing in different directions. The text "CardiacAssist, Inc." is written in a bold, sans-serif font to the right of the graphic.

Image /page/4/Figure/2 description: This image shows a medical device with several labeled components. The device features barbed connectors at one end and tantalum markers along its length. Insertion depth markers are visible, labeled with numbers 52, 50, and 48, and a wire-reinforced area is indicated in the middle section of the device.

Figure 1. PROTEK Duo 31 Fr. Veno-Venous Cannula

The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.

The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula The hemostasis cap minimizes blood loss when the within the target vessel. cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.

Image /page/4/Figure/7 description: The image shows a medical device, specifically an introducer needle. The device has a long, thin needle with a sharp tip on the right side of the image. On the left side of the image, there is an introducer hub and hemostasis cap, which are labeled with arrows pointing to them.

Figure 2: 15.5 Fr. Introducer

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Image /page/5/Picture/0 description: The image contains the logo for CardiacAssist, Inc. The logo features a stylized graphic to the left of the company name. The graphic consists of a circle with arrows pointing in different directions, suggesting circulation or assistance. The text "CardiacAssist, Inc." is written in a bold, sans-serif font, with the company name in a dark blue color.

Indications for Use

Comparison of Technological Characteristics

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is identical to the predicate PROTEK Duo 29 Fr. Veno-Venous Cannula Set, with the exception that it is two French larger in diameter along the proximal length, 2.5 Fr larger in diameter along the distal portion of the device, and approximately 1.97 inches (5.0 cm) longer. It is designed for the same intended use as the PROTEK Duo 29 Fr. Veno-Venous Cannula Set, but in larger patients and/or those who require additional blood flow. All materials and methods of manufacture are identical.

Summary of Non-clinical Testing

Testing of the PROTEK Duo 31 Fr. Veno-Venous Cannula Set included comparative hemolysis, pressure-flow testing, tensile strength, pathway integrity, kink radius, and stiffness.

Test	Method	Conclusion
ComparativeHemolysis	Side-by-side comparison withpredicate of bench tophemolysis levels over 6 hours.	No difference in hemolysis levelsbetween test articles and predicatecontrols.
Pressure-Flow	Measure pressure losses acrosscannula at different flow rates.	Measured flow rates exceed thesmaller predicate at all levels ofpressure difference across thecannula. Design specificationswere met.
Tensile Strength	Pull testing of both cannula andintroducer	Acceptance criteria were identicalto those of the predicate and weremet in all tests.
Pathway Integrity	Pressure testing	Acceptance criterion was identicalto that of the predicate and was metin all tests.
Kink Radius	Flow rate reduction caused byspecified minimum bend radiuswas measured	Acceptance criterion was identicalto that of the predicate and was metin all tests.
Stiffness	Deflection testing to measureforce required to bend cannulaa specified distance	The cannula, the introducer, and thecannula/introducer assembly metacceptance criteria established toensure the cannula is stiff enough toinsert while remaining flexibleenough to avoid vessel injury.

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Image /page/6/Picture/0 description: The image features the logo of CardiacAssist, Inc. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a circular design with internal elements, possibly representing a heart or circulatory system. The text "CardiacAssist, Inc." is written in a bold, sans-serif font, with the company name clearly emphasized.

Conclusion

The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate device. Testing demonstrated that hemolysis, tensile strength, pathway integrity, and kink radius are identical to the predicate. Stiffness and pressure-flow properties differed as expected for the larger diameter cannula and met established acceptance criteria. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is determined to be substantially equivalent to the predicate PROTEK Duo 29 Fr. Veno-Venous Cannula Set.

{End of Section}

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).