The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava The CentriMag™ Blood Pump for use with the 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™ Acute Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours), it is also indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - · Mag Monitor The CentriMag Motor is a reusable, non-sterile component of the CentriMag System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

AI/ML Overview

The provided documents describe a 510(k) submission for the Abbott CentriMag™ Acute Circulatory Support System. This submission is a "Special 510(k)," which means it addresses a modification to an already cleared device. The primary change is an update to the CentriMag Motor, specifically a new "snap-in motor locking feature" replacing a "screw locking feature."

Therefore, the acceptance criteria and performance study described are focused on demonstrating that this change does not negatively impact the safety and effectiveness of the device and that the new design is substantially equivalent to the predicate device.

Here's the breakdown of the requested information based on the provided text:

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

Since this is a Special 510(k) for a design change (motor locking mechanism), the "performance" is about demonstrating that the new design is as safe and effective as the previous one, and that it conforms to requirements for its intended use. The document doesn't list specific numerical acceptance criteria (e.g., a "failure rate must be less than X%"). Instead, it describes categories of testing performed to ensure the new design performs adequately.

Acceptance Criteria Category (Implicit via testing)	Reported Device Performance (Summary of results)
Mechanical Integrity & Robustness: The new snap-in locking feature can withstand physical stresses (drop, shock, vibration).	Environmental Testing: Drop, shock, and vibration testing was executed. (Implies satisfactory performance, as no issues were raised).
Durability: The new locking feature maintains its function over a prolonged period of use.	Durability Testing: Performed. (Implies satisfactory performance, as no issues were raised).
Cleanability: The new motor design can be adequately cleaned.	Cleaning Testing: Performed for the CentriMag Motor. (Implies satisfactory performance, as no issues were raised).
Manual Usability & Accuracy: The operating manual accurately reflects the device's function and can be followed by users.	Operating Manual Verification Testing: Performed. (Implies satisfactory performance, as no issues were raised).
Human Factors & Usability: The changes in the user interface (due to the snap-in feature) are safe and effective for users.	Summative Human Factors Validation Testing: Performed for the changes in user interface. (Implies satisfactory performance, as no issues were raised).
No New Safety or Performance Issues: The design change does not introduce new hazards or reduce performance.	Overall Conclusion: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for any of the verification or validation tests (e.g., number of motors subjected to durability testing, number of users in human factors testing).
The testing described (Mechanical, Durability, Cleaning, Operating Manual Verification, Human Factors Validation) are typically prospective engineering and usability tests conducted by the manufacturer, not retrospective studies on patient data. The provenance for such tests would be the manufacturer's testing facilities, likely in the US (given the submitter's address in California).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable in the context of this 510(k) submission. The "ground truth" concept, often associated with clinical diagnostic studies requiring expert review of medical images or patient outcomes, is not relevant here. The studies described are hardware and human factors engineering tests. For human factors, users (not necessarily "experts" in the medical sense, but representative users of the device) would participate to validate the user interface changes. Their qualifications are not specified but would typically align with the intended users (e.g., perfusionists, surgeons, nurses).

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

This is not applicable to the type of engineering and human factors testing described. Adjudication methods like "2+1" are used in clinical studies where multiple experts independently review cases and discrepancies are resolved by a third party.

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

This is not applicable. The device is a mechanical circulatory support system (pump, motor, console, flow probe), not an AI-assisted diagnostic or clinical decision support tool that would involve human readers interpreting data.

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

This is not applicable. The device is a physical medical device (mechanical support system), not a software algorithm or AI. Its operation inherently involves a human in the loop (a clinician operating the system).

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

"Ground truth" as traditionally understood in clinical validation studies (e.g., pathology for cancer detection, long-term outcomes for treatment efficacy) is not directly applicable here. For the engineering tests, the "ground truth" is simply the documented design specifications and functional requirements of the device. For human factors, the "ground truth" or success criteria would be based on validated usability principles and the ability of representative users to safely and effectively operate the device with the new feature.

8. The sample size for the training set

This is not applicable. This is a hardware modification to an existing device, not a machine learning or AI 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 a hardware modification.

Summary

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January 26, 2024

Abbott Medical Manas Lele Senior Manager 6035 Stoneridge Drive Pleasanton Pleasanton, California 94588

Re: K234118

Trade/Device Name: 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, DWA Dated: December 27, 2023 Received: December 28, 2023

Dear Manas Lele:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Eric E. Richardson -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

Submission Number (if known)

K234118

Device Name

CentriMag™ Acute Circulatory Support System

Indications for Use (Describe)

i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or

ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

The CentriMag™ Blood Pump for use with the 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.

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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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.

1. SUBMITTER'S NAME	Abbott Medical
2. SUBMITTER'S ADDRESS	6035 Stoneridge Drive, Pleasanton CA94588
3. CONTACT PERSON	Manas Lele, Senior Manager RegulatoryAffairs (925) 460-7086
4. ALTERNATE CONTACT PERSON	Lucy Tan, Senior Director Regulatory Affairs(925) 416-9778
5. DATE PREPARED	January 26, 2024
6. DEVICE TRADE NAME	CentriMag™ Acute Circulatory SupportSystem
	CentriMag™ Blood Pump for use withCentriMag™ Acute Circulatory SupportSystem
7. DEVICE COMMON NAME	CentriMag Extracorporeal Blood PumpingSystem
8. DEVICE CLASSIFICATION NAME	Class II, DWA, 21 CFR 870.4380 Control,Pump Speed, Cardiopulmonary Bypass
	Class II, QNR, 21 CFR 870.4100Extracorporeal circuit and accessories forlong-term respiratory/cardiopulmonaryfailure
9. ASSOCIATED PRODUCT CODES:	DWA, QNR

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10. PREDICATE DEVICE NAME

CentriMag™ Acute Circulatory Support System (K200306)

CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038)

Note: The CentriMag Drainage (Venous) and Return (Arterial) Cannula Kits (K200306) are not part of this Special 510(k) premarket notification.

11. DEVICE DESCRIPTION

The CentriMag System is composed of:

CentriMag Primary Console
CentriMag Motor
CentriMag Blood Pump
CentriMag Flow Probe
· Mag Monitor

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Image /page/5/Picture/2 description: The image shows four different components of the CentriMag system. The first component is the CentriMag blood pump, which is a clear plastic device with a circular impeller inside. The second component is the CentriMag console and Mag monitor, which includes a monitor displaying numerical data such as "2500" and "6.17". The third component is the CentriMag motor, which is a silver cylindrical device with a black cable attached. The fourth component is the flow probe, which is a small black device with a gray cable attached and is designed to fit standard 3/8" tubing.

The CentriMag Motor is a reusable, non-sterile component of the CentriMag System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

12. INDICATIONS FOR USE

This Special 510k does not include changes to the cleared indications for use. The FDA 510k cleared indications are as follows:

1. The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
  i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or

ii. Temporary circulatory bypass for diversion of flow around a planned

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disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

1. The CentriMag™ Blood Pump for use with the 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.

13. SUBSTANTIAL EQUIVALENCE

The subject device CentriMag Acute Circulatory Support System ( CentriMag Motor with snap in motor locking feature) has an intended use, technological characteristics, and performance characteristics which are substantially equivalent to the predicate CentriMag Acute Circulatory Support System (CentriMag Motor with screw locking feature).

No other components of the CentriMag System are affected by the design change proposed in this Special 510(k) premarket notification.

14. PERFORMANCE DATA

The CentriMag Motor for use with CentriMag System performance characteristics were demonstrated through the following verification testing and usability validation testing to support the determination of substantial equivalence.

Following Verification Testing was performed to support the Motor Locking Feature with snap in levers:

. Mechanical Testing was executed that included Environmental testing for drop, shock and vibration.
Durability Testing
Cleaning testing for the CentriMag Motor. ●
Operating Manual Verification Testing

Following Validation Testing was performed to support the Motor Locking Feature with snap in levers:

Summative Human Factors Validation Testing was executed for the changes in user interface.

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The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate device.

15. CLINICAL PERFORMANCE

Clinical testing was not performed on the redesigned motor locking feature, as this design change did not impact the clinical performance of the device.

16. CONCLUSION

Given that the intended use and the technological characteristics of the subject device CentriMag Acute Circulatory Support System (CentriMag Motor with snap in locking feature) are the same to the predicate device CentriMag Acute Circulatory Support System (CentriMag Motor with screw locking feature) and the results of the performance testing demonstrate no differences in safety and effectiveness of the subject device when compared to the predicate device, CentriMag Motor with Snap in Motor Locking Feature is substantially equivalent to the Abbott's predicate device .

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.