Advanced Perfusion System 1

K153376 · Terumo Cardiovascular Systems Corporation · DTQ · Dec 16, 2015 · Cardiovascular

Device Facts

• Record ID: K153376
• Device Name: Advanced Perfusion System 1
• Applicant: Terumo Cardiovascular Systems Corporation
• Product Code: DTQ · Cardiovascular
• Decision Date: Dec 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

Device Story

Advanced Perfusion System 1 is a configurable heart-lung machine used in clinical settings (e.g., OR) by perfusionists or qualified medical professionals. It circulates blood during cardiopulmonary bypass, arterial, or regional perfusion. System inputs include mechanical rotation from roller pumps or centrifugal pump impellers; various pods monitor air bubbles, liquid levels, pressure, temperature, and flow. The system features a distributed network architecture with a central control monitor (CCM) for configuration and real-time display. Outputs include controlled blood flow and monitoring data. The system provides power and control for components, including gas blenders and venous line occluders. Healthcare providers use the CCM to manage perfusion parameters, enabling precise control of extracorporeal circulation. The device benefits patients by providing life-sustaining circulatory support during cardiac procedures. Hardware modifications include an improved On/Off switch and guard to prevent inadvertent power loss.

Clinical Evidence

Bench testing only. Successful design verification and validation testing were performed to confirm the hardware modification (On/Off switch and guard) satisfies design input requirements and prevents inadvertent loss of system power.

Technological Characteristics

Configurable heart-lung system with distributed network architecture. Components include a base chassis (AC/DC power, battery backup), central control monitor (touchscreen), roller pumps (4" and 6"), centrifugal control unit/motor, and various monitoring pods (air bubble, level, pressure, temperature, flow). Connectivity via dedicated network ports on the base. Software manages component configuration and data display. Hardware modification includes a new On/Off switch and switch guard.

Indications for Use

Indicated for patients requiring extracorporeal circulation of blood for arterial perfusion, regional perfusion, or cardiopulmonary bypass procedures for up to 6 hours. Used by qualified medical professionals experienced in such equipment.

Regulatory Classification

Identification

A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

Predicate Devices

• Advanced Perfusion System 1 (K151349)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2015

Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103

Re: K153376

Trade/Device Name: Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: November 20, 2015 Received: November 23, 2015

Dear Bryan Hann:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K153376

Device Name

Advanced Perfusion System 1

#### Indications for Use (Describe)

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

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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# Section 4: 510(k) Summary

This section includes a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Name | Terumo Cardiovascular Systems Corporation |
|---------------------------------------------------------------|--------------------------------------------------------|
| Address | 6200 Jackson Road<br>Ann Arbor MI, 48103 |
| Name of Contact Person | Bryan Hann |
| Phone number | Tel: [phone] |
| Fax number | Fax: [phone] |
| email | [e-mail] |
| Establishment Registration # | 1828100 |
| Date prepared | November 20, 2015 |
| Trade or proprietary name | Terumo® Advanced Perfusion System 1 |
| Common or usual name | Heart-Lung Machine |
| Classification name | Console, Heart-Lung Machine, Cardiopulmonary<br>Bypass |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR §870.4220 |
| Product Code(s) | DTQ |
| Legally marketed device(s) to<br>which equivalence is claimed | Advanced Perfusion System 1: K151349 |
| Reason for 510(k) | Hardware modification to previously cleared system |

Image /page/3/Picture/5 description: The image contains the logo for Terumo, a medical device company. The logo features a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and appears to be bolded.

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### Device Information

Indication for Use: The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion. regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

Device Description: The Advanced Perfusion System 1) is a configurable heartlung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

- · System 1 Base:
- Chassis platform Provides operating power and back up battery power for all O system components (100/120V or 220/240V)
- Central Control Monitor (CCM) A touch screen display used for O configuration and control of system components
- Two roller pump hand cranks and hand crank bracket O
- · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
- 6" Roller Pump O
- 4" Roller Pump o
- Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
- Pods
- Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
- Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir.
- Pressure Pod Used to monitor the pressure in the extracorporeal circuit O
- Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
- Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected

Image /page/4/Picture/23 description: The image contains the word "TERUMO" in a bold, green font. A red, angled line is above the word. The word is the logo for the Terumo Corporation, a Japanese medical device company.

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- Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line
- Interface Pods to enable data transfer between cardiac monitoring and data o display systems (e.g., Terumo CDI™ 100 Monitor, CDI™ 500 Monitor, and TLink™ Data Management System)
- · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator
- Flexible Lamps (15 inch or 33 inch) for local illumination
- · Mounting hardware (e.g., center poles, crossbars, and brackets)

Image /page/5/Figure/8 description: This image is a device illustration of a centrifugal control unit. The illustration includes labels for various parts of the device, including the centrifugal control unit, local display and control, centrifugal motor, occluder, small roller pump, large roller pump, roller pump local display and control, central control monitor, chassis, electronic gas blender local controls, power status indicator, wheel lock, hand cranks, and on/off switch. There is also a lamp shown in the upper right corner of the image.

Image /page/5/Picture/9 description: The image contains the logo for Terumo. The logo consists of a red curved line above the company name, which is written in green, block letters. The red curved line is positioned above and to the left of the company name.

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Device Function: The System 1 relies on either roller pumps or a centrifugal pump combined with roller pumps to circulate fluids during extracorporeal circulation. Roller pumps rely on a pair of revolving rollers that occlude the tubing of the extracorporeal circuit against a stationary tubing guide in such a way that the fluid in the short segment of tubing between the rollers is propelled within the tubing in the direction of the rollers rotation.

Pumps are typically employed for an arterial (main physiological support) circuit, delivery of cardioplegia solution directly to the heart, suction and venting. According to user preference, a centrifugal pump may be used in place of a roller pump for the arterial circuit. The centrifugal pump is a non-occlusive impeller that propels the fluid within the tubing within the circuit in the direction of the rotation of the impeller blades.

Image /page/6/Picture/5 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The logo is simple and modern, and the colors are bright and eye-catching.

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#### Substantial Equivalence

The System 1 hardware has been modified to prevent inadvertent shut off and / or failure of the On/Off Switch which could result in a loss of system power. The proposed modification does not adversely impact the system functions or operating principles. The Operator's Manual has been revised to include a previous customer communication on what to do in the event of a loss of sytem power. The subject System 1 has the same indications for use, intended use, as well as substantially equivales operating principles and technological charateristics as the predicate device.

| Item | Subject Device | Predicate Device (K151349) |
|----------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Identical to predicate device. | The Terumo® Advanced Perfusion System 1 is<br>indicated for use for up to 6 hours in the<br>extracorporeal circulation of blood for arterial<br>perfusion, regional perfusion, and cardiopulmonary<br>bypass procedures, when used by a qualified medical<br>professional who is experienced in the operation of<br>this or similar equipment. The centrifugal pump is<br>indicated for use in cardiopulmonary bypass<br>procedures only. |
| System<br>Components | Identical to predicate device. | • System 1 Base with CCM and various hardware<br>accessories<br>• Large (6") and/or Small (4") Roller Pumps<br>• Centrifugal Control Unit Local Display and<br>Control and Centrifugal Motor<br>• Optional pods and accessories, including:<br>o Air bubble detector<br>o Level sensor |

Image /page/7/Picture/7 description: The image contains the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The font is sans-serif and bold.

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| Item | Subject Device | Predicate Device (K151349) |
|------|----------------|----------------------------------------------------------------------|
| | | Optional |
| | | • Pressure monitor |
| | | • Temperature monitor |
| | | • Flow monitor |
| | | • Occluder |
| | | • Electronic Gas Blender |
| | | • Interface pods for external cardiac and data<br>monitoring systems |
| | | • Lamps |

Image /page/8/Picture/5 description: The image features the logo for Terumo, a medical device company. The logo consists of the company name in bold, green letters. Above the word "TERUMO" is a red, curved line that resembles a swoosh or an arc, adding a dynamic element to the design.

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| Item | Subject Device | Predicate Device (K151349) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of<br>Operation | Identical to predicate device. | Configurable heart-lung system with a distributed<br>network architecture that allows the user to customize<br>the number and types of system components, which<br>can then be configured, displayed, and controlled<br>from a central monitor. |
| | | Each component connects to the system network via<br>points on the Base. There are six pump connections,<br>two connections for the CCM, eighteen connections<br>for pods and two dedicated connections for a lamp. |
| Chassis | Identical to predicate device with exception of a new<br>On/Off switch, switch guard, and ancillary<br>installation hardware. | The power system within the Chassis transforms AC<br>power into the DC levels required by the system<br>components. Integrated batteries provide backup<br>power in the event of AC power loss during use and<br>when power needed exceeds power available. |
| Operator's<br>Manual | Identical to the predicate device with the exception of<br>an instruction on what to do in the event of loss of<br>system power | The labeling supplied with the device is intended to<br>provided users of the System 1 with proper operating<br>instructions. |

Image /page/9/Picture/4 description: The image shows the logo for Terumo, a medical device company. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters. The font is bold and sans-serif. The logo is simple and modern.

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### Performance Testing

The hardware modification implemented under this Special 510(k) was subjected to successful design verification and validation testing.

### Conclusion

November 20, 2015

The labeling and hardware modification to the System 1 has not changed the device indications for use or fundamental scientific technology. Hardware verification and validation testing has confirmed that the modification sastisfies the design input requirements and prevents inadvertent loss of system power. The modified device is substantially equivalent to the current predicated device cleared under K151349.

Image /page/10/Picture/7 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.