The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Device Description

The CentriMag™ Blood pump for use with CentriMag™ Acute Circulatory Support System (hereafter referred to as the CentriMag System) is designed to provide assisted extracorporeal circulation and physiologic gas exchange of patients' blood for adult patients with acute respiratory and/or acute cardiopulmonary failure. The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The system includes: CentriMag 2nd Generation Primary Console, CentriMag Motor, CentriMag Blood Pump, Flow Probe, and Mag Monitor (optional). The CentriMag System features a centrifugal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology). The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

AI/ML Overview

The provided text describes the CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System. While it details extensive performance testing and claims substantial equivalence, it does not present acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that would apply to an AI/ML device, nor does it provide a study that explicitly demonstrates the device meets these types of criteria using methods common for AI/ML performance evaluation (like those involving expert consensus for ground truth).

Instead, the document focuses on the engineering and clinical performance of a mechanical circulatory support system. The "acceptance criteria" appear to be implicit in meeting the special controls outlined in 21 CFR 870.4100(b) and demonstrating substantial equivalence to a predicate device through various non-clinical and clinical evaluations.

Here's a breakdown of the information that is present, interpreted in the context of the prompt, and highlighting what is not present but would be typical for AI/ML device evaluation:

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

The document does not provide a table with explicit acceptance criteria (e.g., target percentages for accuracy, sensitivity, specificity) and corresponding reported device performance for an AI/ML component. The "acceptance criteria" for this device seem to be implicitly tied to meeting regulatory requirements for extracorporeal circuits and accessories, and demonstrating performance comparable to a predicate device through a range of engineering and clinical tests.

Reported Device Performance (based on the provided text):

The performance of the CentriMag System was demonstrated through a comprehensive set of tests:

Component	Test	Outcome (Implicitly met for Substantial Equivalence)
System (console, monitor, pump, motor)	30-day reliability	Demonstrated reliability over the intended duration.
	In Vivo Animal Testing	Demonstrated performance in an in-vivo setting.
	Water Ingress Resistance	Verified resistance to water ingress.
	Electrical Safety & EMC	Complied with electrical safety and electromagnetic compatibility standards.
Motor	Thermal Operating conditions	Demonstrated safe thermal operating conditions.
	Fluid Intrusion	Verified resistance to fluid intrusion.
Console & Monitor	Battery life / run time	Verified specified battery performance.
Blood Pump	Rough Handling (Shock/Drop/Vibration)	Demonstrated mechanical durability.
	Environmental Test	Performed as expected under various environmental conditions.
	Software validation	Software functions validated.
	H-Q performance (Pressure/Flow)	Demonstrated appropriate pressure-flow characteristics.
	In Vitro Hemolysis, Platelet count, WBC, RBC, hematocrit, thrombus	Demonstrated acceptable blood compatibility, minimizing hemolysis, and adverse effects on blood components.
	Air handling	Demonstrated effective handling of air.
	Priming volume	Verified appropriate priming volume.
	Leak and burst pressure testing	Demonstrated structural integrity under pressure.
	Sterilization	Validated sterilization process and sterility assurance level (SAL).
	Transportation distribution / simulation	Demonstrated integrity after transportation simulations.
	Shelf life	Validated performance over stated shelf life.
	Biocompatibility	Demonstrated to be biocompatible in accordance with ISO 10993-1.
Clinical Study (ELSO Registry analysis)	Propensity matched analysis on seven ECMO-related complications and outcomes	Result: Did not identify any statistically significant or clinically meaningful differences between the CentriMag System and a comparator group in terms of ECMO-related complications and outcomes. This supports the claim of substantial equivalence for its indicated use.

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

Sample Size for Test Set: Not explicitly stated as a test set in the traditional AI/ML sense. The "clinical summary" refers to a "pre-specified statistical analysis plan from the ELSO Registry," which is a real-world clinical data source. The number of patients included in this propensity-matched analysis is not provided.
Data Provenance: The data comes from the ELSO Registry, which is a registry for Extracorporeal Life Support Organization, suggesting a multi-center, international scope. The analysis was retrospective (utilizing existing registry data).

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

Not applicable in the typical AI/ML context. The clinical study used the ELSO Registry, which records actual clinical outcomes and complications. The "ground truth" here is the aggregated, documented patient outcomes from the registry, not an expert-annotated dataset for an algorithm.

4. Adjudication method for the test set

Not applicable. As the "ground truth" is derived from a clinical registry of patient outcomes, there's no mention of an adjudication method used by experts for a test set. The registry likely has its own data entry and validation protocols.

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 such study was conducted or mentioned, as the device is a mechanical circulatory support system, not an AI-assisted diagnostic or decision support tool for human readers.

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

This question is not applicable to the CentriMag Blood Pump, as it is a mechanical device, not an algorithm.

7. The type of ground truth used

For the clinical evaluation, the "ground truth" consists of outcomes data from the ELSO Registry, specifically ECMO-related clinical complications and other patient outcomes.

8. The sample size for the training set

Not applicable. The CentriMag Blood Pump is a hardware device; it does not involve a training set for an AI/ML algorithm.

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

Not applicable. There is no training set mentioned for this device.

Summary

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December 8, 2022

Abbott (formerly Thoratec Corporation) Meera Mehta Project Manager, Regulatory Affairs 6035 Stoneridge Drive Pleasanton, California 94588

Re: K222038

Trade/Device Name: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure Regulatory Class: Class II Product Code: QNR Dated: November 21, 2022 Received: November 21, 2022

Dear Meera Mehta:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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) K222038

Device Name

CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

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/1 description: The image shows the Abbott logo, which is a stylized blue letter 'a' with a rounded design. Below the logo, the word "Abbott" is written in bold, black font. Underneath "Abbott", the text "CentriMag Pre-connected Pack" is written in a smaller, regular font.

6. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.

SUMBITTER l.

II.

Date Prepared:	July 8, 2022
Submitter's Name & Address:	Abbott6035 Stoneridge DrivePleasanton, CA 94588
Establishment Registration No.	2916596
Contact Person:	Meera Mehta6035 Stoneridge Dr,Pleasanton, CA-94588Project Manager, Regulatory AffairsPh: 925-315-6483
DEVICE
Trade or Proprietary Name:	CentriMag™ Blood Pump for use withCentriMag™ Acute Circulatory SupportSystem
Common or Usual Name:	CentriMag System
Classification Name:	Extracorporeal circuit and accessories forlong-term respiratory/cardiopulmonaryfailure
Regulation Number:	21 CFR 870.4100

Class II (special controls)

QNR

Product Code:

Regulatory Class:

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Image /page/4/Picture/1 description: The image shows the Abbott logo, which consists of a stylized blue "A" shape above the word "Abbott" in bold, black font. Below the word "Abbott" is the text "CentriMag Pre-connected Pack" in a smaller, regular font. The logo is clean and modern, with a focus on the company name and a product line.

III. PREDICATE DEVICE

Predicate device: FDA final order for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure (21 CFR 870.4100, section (b) Class II (special controls)).

Secondary/Reference device: Medtronic BPX-80 Centrifugal Pump (K973011)

IV. DEVICE DESCRIPTION

The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

CentriMag 2nd Generation Primary Console
CentriMag Motor
. CentriMag Blood Pump
Flow Probe
. Mag Monitor (optional)

The CentriMag System features a centrifygal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology).

The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

Note: The CentriMag Drainage (Venous) and Return (Arterial) Cannula Kits (K200306) are not part of this 510(k) premarket notification seeking clearance per 21 CFR 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, section (b) Class II (special controls).

V. INDICATION FOR USE

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Image /page/5/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo features a stylized letter "A" in blue, positioned above the company name "Abbott" in bold, black font. Below the company name is the text "CentriMag Pre-connected P" in a smaller font size.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Substantial equivalence of the CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System was demonstrated by meeting the special controls in FDA Final Order, 21 CFR 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, section (b) Class II (special controls) and through bench testing, mechanical testing, electrical safety and electromagnetic compatibility testing, usability, and software testing.

. Technological Characteristics: Geometry and design parameters of the subject device are consistent with devices intended for 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 (CentriMag blood pump) is demonstrated to be biocompatible in accordance with FDA biocompatibility 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: The CentriMag blood pump has been validated over the stated shelf life of the device to ensure a minimum sterility assurance level (SAL) of 10th as described in ANSI/AAMI/ISO 11135, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
. Non-clinical Performance: Substantial equivalence has been demonstrated by performance testing (bench), mechanical integrity, durability, and reliability.
. In vivo Evaluation: In vivo evaluation demonstrates the subject device's performance over an intended duration of use.
. Labeling: The labeling summarizes non-clinical performance of the CentriMag System and provides 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.

VII. PERFORMANCE DATA

The CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System performance characteristics were demonstrated through bench testing, mechanical testing, electrical safety and electromagnetic compatibility testing, usability, and software testing to support the determination of substantial equivalence.

Component	Test
System (console,monitor, pump,motor)	30-day reliability
	In Vivo Animal Testing
	Water Ingress Resistance
	Electrical Safety & EMC
Motor	Thermal Operating conditions
	Fluid Intrusion
Console &Monitor	Battery life
	Battery run time

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Image /page/6/Picture/1 description: The image shows the logo for Abbott CentriMag Pre-connected Pack. The logo features a stylized letter "a" in blue, followed by the word "Abbott" in bold, black font. Below "Abbott" is the text "CentriMag Pre-connected Pack" in a smaller, regular font.

Blood Pump	Rough Handling (Shock/Drop/Vibration)
	Environmental Test
	Software validation
	HQ performance
	In Vitro Hemolysis, Platelet count, WBC,
	RBC, hematocrit and thrombus
	Air handling
	Priming volume
	Leak and burst pressure testing
	Sterilization
	Transportation distribution / simulation
	Shelf life
	Biocompatibility

VIII. CLINICAL SUMMARY

This submission included a pre-specified statistical analysis plan from the ELSO Registry. The propensity matched analysis demonstrates the safety and effectiveness of the CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System as part of an ECMO circuit to provide longterm assisted extracorporeal circulation and physiologic gas exchange of the blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure. This pre-specified analysis focused on seven ECMO-related clinical complications and outcomes.

The results of the propensity analysis did not identify any statistically significant or clinically meaningful differences in the seven ECMO-related clinical outcomes between the CentriMag System and the comparator group. This analysis demonstrated the CentriMag Blood pump for use with CentriMag System as part of an ECMO circuit is substantially equivalent to other devices used in the same manner.

IX. CONCLUSION

The CentriMag Blood Pump along with CentriMag Acute Circulatory Support System met the special controls in 21 CFR 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, section (b) Class II (special controls) and are substantially equivalent to the predicate device. The information and data in this 510(k) premarket notification demonstrate that the CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System are substantially equivalent to the predicate to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/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.