The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult 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 VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

Device Description

The VitalFlow Centrifugal Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump.

The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.

AI/ML Overview

The provided document is a 510(k) Summary for the VitalFlow™ Centrifugal Pump, a Class II medical device. It details the device's indications for use, description, and studies conducted to demonstrate its substantial equivalence to predicate and reference devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets in the way one might expect for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the acceptance criteria are framed within the context of demonstrating substantial equivalence to predicate devices and meeting specific "Special Controls" outlined in 21 CFR 870.4100. The performance is assessed through various bench, animal, and real-world clinical data.

Therefore, the table below summarizes the Special Controls as acceptance criteria and how the device's performance, as reported, addresses them.

Acceptance Criteria (Special Controls from 21 CFR 870.4100)	Reported Device Performance and Evidence
Technological Characteristics	Geometry and design parameters are consistent with the intended use in extracorporeal life support procedures. Device is designed to be compatible with other extracorporeal circuit devices and accessories. (Implies meeting functional specifications for flow, pressure, etc.)
Biocompatibility	Demonstrated to be biocompatible in accordance with ISO 10993-1:2018 and GLP (21 CFR 58).
Sterility and Shelf-life	Testing demonstrates sterility and maintenance of sterility, integrity, durability, and reliability over the stated shelf-life.
Non-clinical Performance	Demonstrated substantial equivalence through performance characteristics on the bench, mechanical integrity, durability, and reliability. Bench studies demonstrated a blood pump use duration of 14 days, with mechanical stability and critical flow performance attributes maintained. High flow blood trauma testing and hydraulic performance were also conducted.
In vivo Evaluation	A 96-hour animal study (13 sheep) to evaluate safety and performance for long-term ECMO use (target ACT 180-220 sec). Sustained high (5 L/min) and low (2 L/min) blood flow rates for 96 hours with no clots in any location in the device and confirmed blood pump functionality.
Clinical Evidence of Performance	A summary of real-world evidence (1048 reports) from ELSO.org (Extracorporeal Life Support Organization registry) on the Affinity CP Centrifugal Blood Pump (which the VitalFlow Centrifugal Pump is stated to be "the same as"). This demonstrated acceptable long-term performance in ECMO patients over 200,000 hours of ECMO time, averaging 225.6 hours per adult patient. The overall complication rate (34.7%) and specific mechanical complication rate (1.2%) for the AP40 group were comparable to or better than "All Other Pumps" (Non-AP40 group) in the registry, with a notably lower moderate or severe hemolysis rate (1.1% vs 4.6%). The pump failure rate (per 1000 hours) was 0.06 for VitalFlow (AP40) vs 0.03 for other pumps.
Labeling	Instructions for use include detailed summary of non-clinical evaluations, installation, circuit setup, maintenance, adverse effects, and performance characteristics relevant to compatibility.

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

The document describes several types of studies:

Bench Performance Evaluations: No specific sample size is given for individual tests, but it states "Design verification studies were performed by the original manufacturer... and supplemented by MC3 bench performance testing, including long-term characterization." This implies multiple samples were tested for each characteristic.
Animal Studies (In vivo evaluation): A sample size of 13 sheep was used for the 96-hour study. The data provenance is a controlled research environment.
Clinical Performance (Real-world evidence): This utilized 1048 reports from the ELSO.org registry for the Affinity CP Centrifugal Blood Pump (AP40 group). The document states this is a "summary of real-world evidence," implying retrospective data extraction from an international registry. The country of origin for the data isn't explicitly stated but the ELSO registry collects data internationally. The comparison group ("All Other Pumps") involved 51,032 reports.

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

This device is not an AI diagnostic device that relies on expert interpretation of images or signals to establish a "ground truth" in the traditional sense. The "ground truth" for its performance is established through objective measures in bench testing (e.g., flow, pressure, mechanical integrity), physiological parameters in animal studies (e.g., presence/absence of clots, functionality), and reported clinical outcomes in the ELSO registry.

Therefore, there is no mention of "experts" establishing ground truth in the context of adjudication for a test set. Design verification and animal study results would be assessed by engineers, veterinarians, and researchers involved in those studies. Clinical outcomes in the ELSO registry are reported data.

4. Adjudication Method for the Test Set

Given that this is not an AI diagnostic device evaluating, for example, medical images requiring consensus on findings, there is no adjudication method (e.g., 2+1, 3+1) mentioned or applicable for the test sets described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance for tasks like diagnosis or detection. The VitalFlow™ Centrifugal Pump is a mechanical device, not an AI diagnostic tool, so such a study is not relevant.

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, as the VitalFlow™ Centrifugal Pump is a physical medical device. The "standalone" performance here would refer to the device's function outside of a human-in-the-loop context, which is effectively what the bench and animal studies demonstrate regarding its mechanical integrity and ability to pump blood.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the VitalFlow™ Centrifugal Pump's performance is multi-faceted:

Bench Testing: Engineering specifications and performance metrics (e.g., pressure-flow curves, durability, wear, integrity, blood trauma data).
Animal Studies: Direct observation of device functionality, physiological parameters, and absence of adverse events like clot formation in a living system over a defined period (96 hours).
Clinical Performance (Real-world evidence): Reported clinical outcomes and complication rates from a large patient registry (ELSO.org), providing real-world data on pump failure, hemolysis, circuit changes, and other adverse events. This relies on the accuracy of data submitted to the registry.

8. The Sample Size for the Training Set

The document is for a traditional medical device (centrifugal pump), not an AI/Machine Learning device. Therefore, there is no "training set" in the context of AI model development that would typically have a distinct sample size. The design verification, bench testing, and animal studies serve as part of the overall development and validation process.

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

As there is no AI training set, this question is not applicable. The "ground truth" for the device's design and engineering would be based on established medical and engineering principles, material science, and regulatory requirements, which are then verified through rigorous testing, as mentioned above.

Summary

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August 25, 2023

Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) Martha Rumford VP Regulatory Affairs 2555 Bishop Circle West Dexter, Michigan 48130

Re: K223898

Trade/Device Name: VitalFlowTM Centrifugal Pump Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: ONR Dated: August 11, 2023 Received: August 11, 2023

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

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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 M. Gillette -S

Nicole Gillette Assistant Director 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

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Indications for Use

510(k) Number (if known)

Device Name VitalFlow™ Centrifugal Pump

Indications for Use (Describe)

The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

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 contains the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the text "MC3" in a dark blue, bold font. Below "MC3" is the word "Cardiopulmonary" in a smaller, lighter font. The overall design is clean and professional.

Date Prepared:

510(k) Summary VitalFlow™ Centrifugal Pump

August 11, 2023

Sponsor Information:
Owner/Applicant/Submitter:	Michigan Critical Care Consultants, Inc(dba MC3, Inc.)2555 Bishop Circle West Dexter, MI 481301-734-995-9089Registration number: 3011468686
Contact Person:	Martha RumfordVice President of Regulatory Affairs2555 Bishop Circle WestDexter, MI 48130734.995.9089
Device Names/Classification:
Device Trade Name:	VitalFlow™ Centrifugal Pump
Device Common Name:	Blood Pump For ECMO, Long-Term (> 6 Hours) Use
Regulation Name:	Extracorporeal circuit and accessories for long-termrespiratory/cardiopulmonary failure
Regulation Number:	21 CFR 870.4100
Product Code:	QNR
Predicate:	TandemHeart Pump (K202751)
Reference Device 1:	Affinity CP Centrifugal Blood Pump BBAP40(K111657)
Reference Device 2:	Maquet Rotaflow Centrifugal Pump (K991864)

Indications for Use:

The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

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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 large, bold, dark blue letters. Below "MC3" is the word "Cardiopulmonary" in a smaller, lighter blue font. The logo is clean and professional, suggesting a medical or healthcare-related organization.

Device Description:

The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.

Bench and Animal Performance Evaluations:

Design verification studies were performed by the original manufacturer of the subject device and supplemented by MC3 bench performance testing, including long-term characterization. This data is coupled with animal studies to support a finding of substantial equivalence to the Predicate with respect to the Special Controls described by 21CFR 870.4100. The following testing demonstrated the pump's duration of use:

Bearing wear
Coating coverage ●
Mechanical integrity
Pressure integrity
. Hydraulic performance
High flow blood trauma testing
In-vivo performance testing ●
Magnetic coupling
Port and Pull strength
Prime volume

Substantial Equivalence:

Substantial equivalence analysis includes both comparison to the predicate device and clinically relevant Reference Devices. The VitalFlow Centrifugal Pump is the same as the Affinity TM CP Centrifugal Blood Pump with Balance™ Biosurface in design, principles of operation, materials of construction, performance, and fundamental scientific technology. The design, principles of operation, materials of construction, performance, and fundamental scientific technology are substantially equivalent to the TandemHeart Pump.

Comparison of Technological Characteristics with the Predicate Device

The subject and predicate devices are centrifugal pumps that are designed to move blood through the extracorporeal circuit. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump is the disposable portion of the pumping system that is electromagnetically coupled to an instrument that monitors and displays the blood flow.

At a high level, the subject and predicate devices are based on the following same technological elements:

. Principle of operation

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Image /page/5/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 text "MC3" in blue. Below "MC3" is the word "Cardiopulmonary" in a smaller font size, also in blue. The red symbol appears to be composed of three curved shapes arranged in a circular pattern.

. Design characteristics
. Coupled to a motor for control via a pump console
Connection to extracorporeal circuit via 3/8" inlet and outlet connectors
. Sterilization method

The following technological differences exist between the subject and predicate devices:

. The subject device has a shaft seal around the bearing, whereas the predicate device has a hydrodynamic bearing with an infusate line included in the device.
. The capacity of the pump of the Predicate (prime volume 10 ml) is lower compared to the Subject pumping system (prime volume 40 ml) because TandemHeart pump head is smaller in diameter and volume. As a result, the predicate pump requires a higher RPM to achieve similar flows with output pressure of 450 mmHg at pump speed of 7500 RPM. The maximum RPM for Subject device is 3800 RPM with an output pressure of 680 mmHg.
. Maximum flow rate of Subject device is 7 L/min, maximum flow rate of Predicate device is 5 L/min (percutaneous connection) or 8 L/min (surgical connection).

The VitalFlow Centrifugal Pump meets all special controls required by 21 CFR 870.4100. 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 in accordance with ISO 10993-1:2018 and in accordance with GLP (21 CFR 58).
. 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, durability, and reliability.
In vivo Evaluation: Animal testing demonstrates the subject device's performance over a longterm duration of use in a biologic test system.
Clinical Evidence of Performance: A summary of real-world evidence of the clinical experience with this pump was prepared by ELSO.org and presented which demonstrated acceptable longterm performance of the device in ECMO patients.
. Labeling: The instructions for use includes a detailed summary of the non-clinical evaluations pertinent to the device's use in an extracorporeal circuit. Adequate instructions are also included with respect to installation, circuit setup, maintenance during a procedure, adverse effects, and performance characteristics relevant to compatibility among different devices and accessories in the circuit.

ECMO Performance Evidence

. Bench studies demonstrating a blood pump use duration of 14 days were performed, including a bench durability study at 37° C in blood analog to assure mechanical stability with a substantial

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Image /page/6/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 text "MC3" in large, bold, dark blue letters. Below "MC3" is the word "Cardiopulmonary" in a smaller, lighter blue font. The abstract symbol appears to be four stylized, curved shapes arranged in a circular pattern.

margin of safety. The device was mounted in the orientation as described by these instructions and met all critical flow performance attributes after this study, including pressure-flow performance and product integrity.

. A 96-hour animal study was conducted to evaluate the safety and performance of the VitalFlow Centrifugal Pump used for extracorporeal membrane oxygenation (ECMO) when used for long term use with a target ACT of 180-220 sec. The study was conducted on a total of 13 sheep. High (5 L/min) and low (2 L/min) blood flow rates were sustained for 96 hours and there were no clots in any location in the device and blood pump functionality was confirmed.
. Clinical Performance

A summary of real-world evidence (1048 reports) of the clinical experience with this pump was presented which demonstrated acceptable long-term performance of the device in ECMO patients. The performance of the pump was shown to be excellent with the data representing over 200,000 hours of ECMO time with this device, with the ECMO duration averaging 225.6 hours in the adult group.

Complications on ECMO (adult): For the complications that were specified to be of interest to pump performance, the overall complication rate in the adult ECMO population was 34.7% [364/1048] in the AP40 group versus 35.0% [17852/51032] in the non-AP40 group. For specific mechanical complications, the proportion of runs with a pump complication was 1.2% [13/1048] in the AP40 group versus 0.7 [355/51032] in the non-AP40 group, and the proportion of runs with at least one hemolysis complication was 1.1% [12/1048] in the AP40 group, lower than the corresponding percentage of 4.6% [2322/51032] in the non-AP40 group. The proportion of runs with the neurologic complication CNS infarction by US/ CT/MRI was 2.8% [29/1048] in the AP40 group versus 2.3% [1199/51032] in the non-AP40 group.

Complication	VitalFlow Pump(AP40)(n=1048)	All Other Pumps(Non-AP40)(n=51032)
≥ 1 of any	34.7% (364)	35.0% (17852)
Mechanical
Oxygenator Failure	5.1%(53)	7.1%(3632)
Pump failure (Prevalence)ª	1.2% (13)	0.7% (355)
Pump failure (Rate per 1000 hrs)b	0.06	0.03
Heat Exchanger Malfunction	0.1%(1)	0.0% (22)
Air in circuit	1.3% (14)	0.9% (444)
Circuit change	7.8% (82)	5.6% (2851)
Emboli (clots or air)	0.2% (2)	0.2% (94)
Thrombosis/Clots in circuit	2.9% (30)	2.8% (1429)
Hemorrhagic
Cannulation site bleeding	9.4%(98)	8.1%(4157)
Surgical site bleeding	10.8%(113)	7.9%(4019)
Neurologic
CNS infarction (US/CT/MRI)	2.8% (29)	2.3% (1199)
CNS Hemorrhage (US/CT/MRI)	3.6%(38)	3.7%(1875)
CNS Diffuse Ischemia (CT/MRI)	1.5%(16)	1.6%(801)
Hemolysis
Moderate Hemolysis	0.7%(7)	2.4%(1242)
Severe Hemolysis	0.4%(4)	1.8%(925)
Moderate or Severe Hemolysis	1.1% (12)	4.6% (2322)

b: Rate of failures per 1000 hours corresponding to the initial pur

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Image /page/7/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 a dark blue, bold font. Below the letters, the word "Cardiopulmonary" is written in a smaller, lighter blue font.

Conclusion:

The VitalFlow Centrifugal Pump device is substantially equivalent to the predicate device and the clinically used reference extracorporeal blood pump devices. The risks of this device are mitigated by meeting the Special Controls required by the regulation, 21 CFR 870.4100.

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.