The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Device Description

The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

AI/ML Overview

This document is a 510(k) Summary for the MC3 Crescent™ Jugular Dual Lumen Catheter. It outlines the device's indications for use, description, comparison to a predicate device, and how it conforms to Class II Special Controls.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the way one might expect for diagnostic accuracy or clinical outcomes. Instead, it discusses conformance to "Special Controls" and mentions various types of testing to demonstrate "substantial equivalence."

Based on the information provided, the "acceptance criteria" can be inferred from the "Class II Special Controls" and the general requirements for substantial equivalence. The "device performance" is described qualitatively as meeting these controls.

Acceptance Criteria (Inferred from Special Controls and Substantial Equivalence)	Reported Device Performance
Technological Characteristics: Geometry/design consistent with intended use in ECLS. Compatible with other ECLS circuit devices.	Demonstrated conformance. Design scaled to include additional sizes. Optional blunt tipped introducer and assembly stylet added to smallest diameter catheters. All materials and methods of manufacture are identical to predicate.
Biocompatibility: Demonstrated as a prolonged use device in accordance with ISO 10993-1:2009 and GLP (21 CFR 58), and FDA guidance.	Demonstrated conformance.
Sterility and Shelf-life: Sterility of device as provided, and maintenance of sterility, integrity, durability, and reliability over stated shelf-life.	Demonstrated conformance.
Non-clinical Performance: Substantial equivalence demonstrated by performance characteristics on the bench, mechanical integrity, 30-day durability, and reliability for long-term use.	Demonstrated conformance.
In vivo Evaluation: 7-day in vivo thrombogenicity evaluation demonstrates performance over a long-term duration of use in a biologic test system.	Demonstrated conformance.
Labeling: Detailed summary of non-clinical and in vivo evaluations. Adequate instructions for anticoagulation, circuit setup, maintenance, and compatibility.	Demonstrated conformance. Instructions for use (IFU) includes detailed summary.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (Jugular Dual Lumen Catheter K180151) rather than proving novel clinical efficacy or diagnostic accuracy as might be seen for AI-driven diagnostic devices. The performance metrics are related to safety, material compatibility, and engineering design rather than clinical outcome improvements attributable to the device itself beyond its function in ECMO.

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

The document describes various types of testing but does not provide specific sample sizes for each test mentioned (e.g., "non-clinical performance," "in vivo evaluation," "biocompatibility").

Non-clinical Performance: Mentions "bench" testing, "mechanical integrity," and "30-day durability." No specific sample size is given.
In vivo Evaluation: Mentions "7-day in vivo thrombogenicity evaluation." No specific sample size is given, nor is the species used.
Biocompatibility: Refers to ISO 10993-1:2009 and GLP (21 CFR 58). These are standards for testing, but they don't specify the sample size used in this particular submission.

Data Provenance: The data is generated from various tests (bench, in vivo, etc.) conducted by the manufacturer (MC3 Incorporated). The document does not specify the country of origin for the data or if it's retrospective or prospective, as these are typically controlled laboratory and animal studies, not patient data in the context of this device.

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

This information is not provided in the document. The tests described are laboratory and animal studies, not typically involving human expert adjudication for "ground truth" in the way a diagnostic AI would.

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

This information is not provided and is not applicable to the types of engineering and biocompatibility tests described for this medical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, not for a physical medical device like a catheter.

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

This question is not applicable as the device is a physical catheter, not an algorithm or AI system.

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

The concept of "ground truth" in the context of diagnostic accuracy is not directly applicable here. For the various tests performed, the "truth" is established through:

Bench Test Results: Measured physical and mechanical properties against pre-defined specifications.
Biocompatibility Standards: Adherence to established ISO and GLP guidelines.
In vivo Evaluation: Biological responses (e.g., thrombogenicity) observed in an animal model, measured against expected safety profiles.

8. The sample size for the training set

This is not applicable. The MC3 Crescent™ Jugular Dual Lumen Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2021

MC3, Inc. Martha Rumford VP Regulatory 2555 Bishop Circle West Dexter, Michigan 48130

Re: K203409

Trade/Device Name: MC3 Crescent™ Jugular Dual Lumen Catheter Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: PZS Dated: March 26, 2021 Received: March 29, 2021

Dear Martha Rumford:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette for Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203409

Device Name

MC3 Crescent™ Jugular Dual Lumen Catheter

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the letters "MC3" in dark blue. Below the letters, the word "Cardiopulmonary" is written in a smaller, lighter blue font. The logo is simple and modern, with a focus on the company's name and area of expertise.

510(k) Summary MC3 Jugular Dual Lumen Catheter

Date Prepared:	May 3, 2021
Sponsor Information:
Owner/Applicant/Submitter:	MC3 Incorporated2555 Bishop Circle WestDexter, MI 481301-734-995-9089Registration number: 3011468686
Contact Person:	Martha RumfordVP Regulatory2555 Bishop Circle WestDexter, MI 48130734.995.9089
Device Names/Classification:
Device Trade Name:	MC3 Crescent™ Jugular Dual Lumen Catheter
Device Common Name:	Dual Lumen ECMO Cannula
Regulation Name:	Extracorporeal circuit and accessories for long-termrespiratory/cardiopulmonary failure
Regulation Number:	21 CFR 870.4100
Product Code:	PZS
Predicate Device:	Jugular Dual Lumen Catheter (K180151)
Reference Devices:	Origen Reinforced Dual Lumen Cannula (K113869)
	Avalon Elite Bi-Caval Dual Lumen Catheter (K081820)

Indications for Use:

The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring Venous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Indications for use of the dual lumen catheters remains the same as the predicate device.

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the text "MC3" in dark blue. Below "MC3" is the word "Cardiopulmonary" in a smaller font, also in dark blue. The logo appears to be for a medical or healthcare-related organization specializing in cardiopulmonary services.

for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).

Comparison of Technological Characteristics to Predicate Device:

The MC3 Dual Lumen Catheter product line is extended by scaling the design to include additional sizes. An optional blunt tipped introducer (obturator) and assembly stylet are added to the smallest diameter catheters. All materials and methods of manufacture are identical.

Class II Special Controls

The subject MC3 Crescent™ Jugular Dual Lumen Catheter has demonstrated conformance to the Special Controls outlined in 21 CFR 870.4100 in a manner equivalent to the Predicate Device. The following information outlines how we conform. Because this product is a line-extension, a risk assessment determined when previous testing is applicable to the new design. Special Controls met are:

. Technological Characteristics: Geometry and design parameters are consistent with the devices intended use in extracorporeal life support procedures. The subject device is designed to be compatible with other extracorporeal circuit devices and accessories.
. Biocompatibility: The subject device is demonstrated to be biocompatible as a prolonged use device in accordance with ISO 10993-1:2009 and GLP (21 CFR 58), and pursuant to FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
. Sterility and Shelf-life: Testing demonstrates the sterility of the subject device as provided and that it maintains its sterility, integrity, durability, and reliability over the stated Shelf-life of the device.
. Non-clinical Performance: Substantial equivalence is demonstrated by performance characteristics on the bench, mechanical integrity, 30-day durability, and reliability for a longterm duration of use.
. In vivo Evaluation: 7-day in vivo thrombogenicity evaluation demonstrates the subject device's performance over a long-term duration of use in a biologic test system.
. Labeling: The instructions for use includes a detailed summary of the non-clinical and in vivo evaluations pertinent to the device's use in an extracorporeal circuit. Adequate instructions are also included with respect to anticoagulation, circuit setup, maintenance during a procedure, and performance characteristics relevant to compatibility among different devices and accessories in the circuit.

Conclusion: The information and data included in this 510(k) Notification demonstrate that the subject MC3 Crescent™ Jugular Dual Lumen Catheter is substantially equivalent to the Predicate Device for both venous drainage and reinfusion of blood via the jugular vein during extracorporeal life support procedures in patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Regulation Number and Section

§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.