The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula 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 15 French TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1: a 15 Fr. Femoral Arterial Cannula and a 10 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device.

The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip.

The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process.

The 10 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer body is also constructed of a radiopaque material for visualization under fluoroscopy.

The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.

AI/ML Overview

This submission K133293 describes a medical device, the 15 French TandemHeart Femoral Arterial Cannula Set, and its substantial equivalence to predicate devices, but it does not include a study that defines or demonstrates acceptance criteria in the manner requested (e.g., using performance metrics like sensitivity, specificity, or accuracy based on human-AI comparison).

The document details non-clinical performance testing conducted to show substantial equivalence for a physical medical device (cannula), not a diagnostic algorithm or AI-powered system that would typically have acceptance criteria presented as performance metrics against ground truth.

Therefore, for your specified questions, I can only provide information based on the type of testing described in the document, which focuses on physical and functional characteristics of the cannula.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that "All performance tests were conducted on both the 15 French TandemHeart Femoral Arterial Cannula Set and the applicable control device... Based on the performance test results, the TandemHeart Femoral Arterial Cannula Set was found to meet the established design input requirements as well as to perform comparably to the predicate devices."

The acceptance criteria are implicitly defined by "established design input requirements" and "perform comparably to the predicate devices." No numerical targets or specific performance metrics are provided in the document for these tests, nor are the detailed results.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Meet established design input requirements	Met established design input requirements
Perform comparably to the 17 French TandemHeart Femoral Arterial Cannula Set (for size-independent characteristics)	Performed comparably to the 17 French TandemHeart Femoral Arterial Cannula Set
Perform comparably to the 15 Fr Bio-Medicus Femoral Arterial Cannula (for size-dependent characteristics like flow rate)	Performed comparably to the 15 Fr Bio-Medicus Femoral Arterial Cannula, with a slightly lower maximum achievable flow rate than the 17 Fr TandemHeart due to smaller diameter, but equivalent to the 15 Fr Bio-Medicus.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the document. The testing involved "in-vitro" (laboratory) conditions not patient data.
Data Provenance: In-vitro non-clinical testing. Not applicable for country of origin or retrospective/prospective as it's not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the "ground truth" for this type of device (cannula) is based on engineering specifications and physical performance measurements (e.g., flow rate, kink resistance, leak proofing) in a laboratory setting, not expert clinical interpretation of data.

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

Not applicable. This concept applies to expert consensus on clinical findings, not to in-vitro engineering tests.

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:

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device like a cannula.

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

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device.

7. The type of ground truth used:

The "ground truth" (or reference standard) would be the established engineering specifications for flow rates, material properties, and mechanical integrity tests (e.g., kink resistance, hemolysis limits, leak limits).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device design and manufacturing processes are developed based on engineering principles and prior device experience, not a data training set.

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

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/machine learning device.

Summary

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K133293

Image /page/0/Picture/1 description: The image shows the logo for CardiacAssist, Inc. The logo features a stylized graphic to the left of the company name. The graphic appears to be a circle with arrows pointing in different directions. The text "CardiacAssist, Inc." is written in a bold, sans-serif font.

Section 8 510(k) Summary FEB 12 2014

Date: 2/11/14

Applicant

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

Contact Person

Greg Johnson Title: Director of Regulatory Affairs Phone: 412-963-7770 x226 e-mail: gjohnson@tandemheart.com

Device

Trade/Proprietary Name:	15 French TandemHeart Femoral Arterial Cannula Set
Common Name:	Femoral Arterial Cannula and Introducer
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
	(21 CFR 870.4210, Product Code DWF)

Predicate Devices

17 French TandemHeart Femoral Arterial Cannula Set (K120543) Medtronic Bio-Medicus Femoral Cannula and Introducer (K924642)

Device Description

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Image /page/1/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. The logo is simple and professional, and it is likely used to represent the company's brand.

Image /page/1/Figure/4 description: The image shows a TandemHeart Femoral Arterial Cannula and a 10 Fr Introducer. The cannula is labeled with several parts including the clamp area, vented barbed connector, suture wing, stop, insertion depth markers, and wire-reinforced area. The introducer is labeled with the introducer hub w/luer and the hemostasis cap. The cannula tip has radiopaque discs.

Figure 1: TandemHeart Femoral Arterial Cannula Set

Intended Use

The 15 French TandemHeart Femoral Arterial Cannula Set is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula 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.

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Image /page/2/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. The logo is simple and professional, and it is likely used to represent the company's brand.

Comparison of Technological Characteristics

The 15 French TandemHeart Femoral Arterial Cannula Set is identical to the predicate 17 French TandemHeart Femoral Arterial Cannula Set, with the exception that it is two French smaller in diameter along the working length of the device. It is designed for the same intended use as the 17 French Femoral Arterial cannula, but in smaller patients and/or those who require less blood flow. Both products consist of a wire-reinforced, polyurethane arterial cannula and a polyurethane introducer. All materials and methods of manufacture are identical.

Performance Data

The 15 French TandemHeart Femoral Arterial Cannula Set has a slightly lower maximum achievable flow rate compared to the 17 French TandemHeart Arterial Cannula Set, due to the smaller diameter. However, the maximum achievable flow rate is equivalent to that of the 15 Fr Bio-Medicus Femoral Arterial Cannula.

Non-clinical performance testing was performed to demonstrate substantial equivalence between the 15 French TandemHeart Femoral Arterial Cannula Set and the predicate 17 French TandemHeart Femoral Arterial Cannula Set. For size-dependent performance characteristics, the 15 Fr Bio-Medicus Femoral Arterial Cannula was used for comparison.

The performance testing included in-vitro hemolysis testing, in-vitro system capacity testing, kink testing, leak testing, and deflection testing. All performance tests were conducted on both the 15 French TandemHeart Femoral Arterial Cannula Set and the applicable control device (either the 17 French TandemHeart Femoral Arterial Cannula Set or the 15 Fr Bio-Medicus Femoral Arterial Cannula). Based on the performance test results, the TandemHeart Femoral Arterial Cannula Set was found to meet the established design input requirements as well as to perform comparably to the predicate devices.

Conclusions

The 15 French TandemHeart Femoral Arterial Cannula Set is substantially equivalent to the 17 French TandemHeart Femoral Arterial Cannula Set in design characteristics, performance, and intended use. For size-dependent performance characteristics such as flow rate, the 15 French TandemHeart Femoral Arterial Cannula Set is substantially equivalent to the 15 French Bio-Medicus Femoral Arterial Cannula.

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

February 12, 2014

CardiacAssist, Inc. Greg Johnson 240 Alpha Drive Pittsburgh, PA 15238

Re: K133293

Trade/Device Name: 15 French TandemHeart Femoral Arterial 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 10, 2014 Received: January 13, 2014

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 device-related 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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Page 2 - Greg Johnson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aftilleman

for 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:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

M.A. Hillerman

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).