The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Device Description

The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device.

A. 24 Fr Venous Cannula
The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable length measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.

B. Introducer
The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque PVC material for visualization under fluoroscopy.

AI/ML Overview

Below is the information regarding the acceptance criteria and study for the Protek Solo 24 Fr Venous Cannula Set, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from "Conclusion" or "Acceptance criterion was identical to that of the predicate and was met in all tests.")	Reported Device Performance
Comparative Hemolysis	No difference in hemolysis levels between test articles and predicate controls over 6 hours.	No difference in hemolysis levels between test articles and predicate controls.
Pressure-Flow	Measured flow rates to exceed the smaller predicate at all levels of pressure difference across the cannula. Design specifications were 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.	Met in all tests.
Pathway Integrity	Identical to that of the predicate.	Met in all tests.
Kink Radius	Identical to that of the predicate.	Met in all tests.
Stiffness	Established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury.	The cannula, the introducer, and the cannula/introducer assembly met acceptance criteria.

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

The document does not specify the exact sample sizes (number of devices) used for each individual test. It consistently refers to "all tests" or testing of "the cannula, the introducer, and the cannula/introducer assembly," implying that a sufficient number of units were tested to draw conclusions.

The data provenance is from bench-top testing conducted by Cardiac Assist, Inc. The document does not specify the country of origin of the data beyond the company's location in Pittsburgh, Pennsylvania, USA. The studies are retrospective in the sense that they are assessing conformance against predetermined criteria, rather than a prospective clinical trial.

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

This section is not applicable as the document describes bench-top engineering and performance testing for a medical device (venous cannula and introducer), not a diagnostic or AI-assisted device that requires human expert review for ground truth establishment. The "ground truth" here is defined by engineering specifications and comparative performance against a predicate device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. The tests performed are objective physical and performance measurements, not subjective evaluations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging interpretation or other scenarios where human reader performance is being evaluated and compared, typically in the context of AI assistance. The described tests are for the physical and functional characteristics of a medical device.

Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device or study.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument (venous cannula and introducer), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for these tests was based on:

Engineering specifications and design requirements for the new device.
Comparative performance against legally marketed predicate devices (TandemHeart 21 Fr Venous Cannula and Protek Duo Veno-Venous Cannula Introducer), which serve as the established benchmark for safety and effectiveness for similar devices.

8. The Sample Size for the Training Set

This section is not applicable. The document describes the testing of a physical medical device, not an AI or machine learning model that would require a training set.

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

This section is not applicable for the reasons stated above. There was no training set, as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 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 symbol featuring three abstract human profiles facing to the right, stacked one behind the other. The profiles are depicted with flowing lines, creating a sense of movement and unity.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Cardiac Assist, Inc. Greg Johnson VP Regulatory Affairs and Quality Assurance 240 Alpha Dr. Pittsburgh, Pennsylvania 15238

Re: K162214

Trade/Device Name: Protek Solo 24 Fr 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: August 5, 2016 Received: August 8, 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

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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.

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,

M.R. Hilleman

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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Indications for Use

510(k) Number (if known)

Device Name Protek Solo 24 Fr Venous Cannula Set

Indications for Use (Describe)

、、

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic to the left of the company name. The graphic contains four arrows pointing in different directions. The company name is written in a bold, sans-serif font.

Date: 8/5/2016

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 Solo 24 Fr Venous Cannula Set
Common Name:	Venous Cannula and Introducer
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, ortubing. (21 CFR 870.4210, Product Code DWF)

Predicate Device

TandemHeart 21 Fr Venous Cannula (K133236)

Protek Duo Veno-Venous Cannula Introducer (K140999)

Device Description

Image /page/3/Figure/14 description: The image shows a diagram of a medical device with several labeled components. The device features a 'Barbed Connector' at one end, followed by a 'Clamping Area' and a 'Suture Wing'. Along the length of the device, there are 'Insertion Depth Markers' labeled with numbers ranging from 60 to 10, and the area is marked as 'Wire Reinforced Area'. The opposite end has 'Distal Holes (16)'.

Image /page/3/Figure/15 description: The image shows the title of a figure, which is "Figure 1. Protek 24 Fr Venous Cannula". The title is written in a clear, bold font, making it easily readable. The title indicates that the figure is the first one in a series or document. The figure likely depicts or discusses the Protek 24 Fr Venous Cannula, which is a medical device used for venous access.

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Image /page/4/Picture/0 description: The image contains 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.

A. 24 Fr Venous Cannula

The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable length measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.

Image /page/4/Figure/4 description: The image shows a medical instrument labeled as an introducer. The introducer has a long, thin shaft that tapers to a point at one end. At the opposite end, there is an introducer hub and a hemostasis cap. The text in the image labels the introducer hub and hemostasis cap.

Image /page/4/Figure/5 description: The image shows the text "Figure 2: 21 Fr. Introducer". The text is in bold font and is likely a figure caption. The figure number is 2, and the figure is about a 21 Fr. Introducer.

B. Introducer
The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque PVC material for visualization under fluoroscopy.

Indications for Use

The Protek Solo 24 Fr. Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Comparison of Technological Characteristics

The Protek Solo 24 Fr Venous Cannula is substantially equivalent to the TandemHeart 21 Fr. Venous Cannula (Catalog Number 5140-2163) in design characteristics, performance, and

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Image /page/5/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic with arrows pointing in different directions, followed by the text "CardiacAssist, Inc." The text is in a bold, sans-serif font and is a dark blue color. The logo appears to be for a medical or healthcare-related company.

intended use. The two cannula products differ in diameter (24 Fr vs 21 Fr), length (24 Fr is 2 cm longer than the predicate), and the number and precise location of side holes. All materials and methods of manufacture are identical. The Protek Solo 24 Fr Venous Cannula Introducer is substantially equivalent in design characteristics and intended use to the Protek Duo Veno-Venous Cannula Set Introducers. The two components differ only in length and diameter. All materials and methods of manufacture are identical.

Summary of Non-clinical Testing

Testing of the Protek Solo 24 Fr Venous Cannula Set included comparative hemolysis, pressureflow 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

Conclusion

The Protek Solo 24 Fr Venous Cannula is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate TandemHeart 21 Fr Venous Cannula. Testing demonstrated that hemolysis, tensile strength, pathway integrity, and kink radius are identical to the predicate. Stiffness and pressure-flow properties differed as

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Image /page/6/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic to the left of the company name. The graphic contains arrows pointing in different directions. The text "CardiacAssist, Inc." is written in a sans-serif font.

expected for the larger diameter cannula and met established acceptance criteria. The Protek Solo 24 Fr Venous Cannula Introducer is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate Protek Duo Veno-Venous Cannula Introducer. Stiffness differed as expected for the larger diameter introducer and met established acceptance criteria. The Protek Solo 24 Fr Venous Cannula Set is determined to be substantially equivalent to the predicates.

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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).