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

K222038 · Abbott (Formerly Thoratec Corporation) · QNR · Dec 8, 2022 · Cardiovascular

Device Facts

• Record ID: K222038
• Device Name: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
• Applicant: Abbott (Formerly Thoratec Corporation)
• Product Code: QNR · Cardiovascular
• Decision Date: Dec 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

CentriMag System provides temporary mechanical circulatory support for adult patients in acute hemodynamic compromise. System components include primary console, motor, blood pump, flow probe, and optional monitor. Centrifugal flow pump utilizes magnetically levitated (Full MagLev™) impeller; eliminates need for mechanical seals, bearings, or shafts; reduces friction, heat, and wear. Motor drives impeller via electromagnetic levitation. Console controls pump speed and resultant blood flow; monitors system operation. Used in clinical settings by healthcare providers to manage ECMO circuits. Provides assisted extracorporeal circulation and physiologic gas exchange. Benefits include temporary support for patients with failing treatment options and imminent risk of death.

Clinical Evidence

Included propensity-matched analysis from ELSO Registry comparing CentriMag System to a comparator group. Analysis focused on seven ECMO-related clinical complications and outcomes. Results showed no statistically significant or clinically meaningful differences between the CentriMag System and the comparator, supporting safety and effectiveness for long-term assisted extracorporeal circulation.

Technological Characteristics

Centrifugal flow pump with magnetically levitated impeller (Full MagLev™). Components: console, motor, pump, flow probe, monitor. Biocompatibility per ISO 10993-1. Sterilization via ethylene oxide (ANSI/AAMI/ISO 11135). Electrical safety/EMC testing performed. System is designed for extracorporeal circuit integration.

Indications for Use

Indicated for adult patients with acute respiratory failure and/or acute cardiopulmonary failure requiring extracorporeal membrane oxygenation (ECMO) support when other treatments have failed and clinical deterioration is expected or death is imminent.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

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

Reference Devices

• Medtronic BPX-80 Centrifugal Pump (K973011)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

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 ([e-mail]) or phone [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm1.5 0a.5.5 0 0 0-.5.5v12a.5.5 0 0 0 .5.5h12a.5.5 0 0 0 .5-.5V2.5a.5.5 0 0 0-.5-.5H1.5z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: | Abbott<br>6035 Stoneridge Drive<br>Pleasanton, CA 94588 |
| Establishment Registration No. | 2916596 |
| Contact Person: | Meera Mehta<br>6035 Stoneridge Dr,<br>Pleasanton, CA-94588<br>Project Manager, Regulatory Affairs<br>Ph: 925-315-6483 |
| DEVICE | |
| Trade or Proprietary Name: | CentriMag™ Blood Pump for use with<br>CentriMag™ Acute Circulatory Support<br>System |
| Common or Usual Name: | CentriMag System |
| Classification Name: | Extracorporeal circuit and accessories for<br>long-term respiratory/cardiopulmonary<br>failure |
| 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™ 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.

- 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

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.

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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,<br>monitor, pump,<br>motor) | 30-day reliability |
| | In Vivo Animal Testing |
| | Water Ingress Resistance |
| | Electrical Safety & EMC |
| Motor | Thermal Operating conditions |
| | Fluid Intrusion |
| Console &<br>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.