(23 days)
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.
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
- 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)
This document pertains to the resubmission of the Terumo Advanced Perfusion System 1 (K153376) due to a hardware modification. As such, the information provided focuses on the substantial equivalence to a previously cleared device (K151349) rather than a full de novo acceptance criteria study for a new device. Therefore, many of the typical study details for an AI/algorithm-based device are not applicable or not provided in this regulatory document.
However, based on the provided text, I can infer and extract the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from modification goal) | Reported Device Performance (From Conclusion) |
|---|---|
| Prevent inadvertent shut off and/or failure of the On/Off Switch leading to loss of system power. | "Hardware verification and validation testing has confirmed that the modification satisfies the design input requirements and prevents inadvertent loss of system power." |
Explanation: The primary goal of the hardware modification was to address a potential issue with the On/Off switch that could lead to power loss. The "acceptance criteria" here is implicitly that the modification successfully resolves this issue. The "reported device performance" directly states that the modification achieves this.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The document states "successful design verification and validation testing," but does not provide details on the number of units or test scenarios used.
- Data Provenance: Not specified. Given this is a hardware modification for an existing device, it's likely testing was conducted internally by the manufacturer, Terumo Cardiovascular Systems Corporation, based in Ann Arbor, Michigan, USA. The nature of testing points to prospective testing of the modified hardware.
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):
- Number of Experts: Not applicable. This is a hardware modification of a medical device, not an AI/algorithm-based diagnostic or prognostic tool that relies on expert interpretation for ground truth. The "ground truth" here is the functional performance of the hardware.
- Qualifications of Experts: Not applicable in the context of expert review for ground truth as described for AI/algorithm studies. The testing would have been performed by engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a study requiring adjudication of interpretations from multiple experts. The "ground truth" is determined by successful functional testing of the hardware.
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:
- MRMC Study: No. This document describes a hardware modification to an existing heart-lung machine console, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This device is a console that requires human operation ("when used by a qualified medical professional who is experienced in the operation of this or similar equipment"). It is not an algorithm that performs a function independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this hardware modification is the demonstrable stable and reliable operation of the On/Off switch and the prevention of inadvertent power loss, as confirmed by design verification and validation testing. This would involve functional tests, electrical safety tests, and potentially stress tests to ensure the new component meets its intended performance specifications.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a hardware system, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this hardware device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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 RoadAnn Arbor MI, 48103 |
| Name of Contact Person | Bryan Hann |
| Phone number | Tel: (734) 741-5816 |
| Fax number | Fax: (734) 741-6069 |
| bryan.hann@terumomedical.com | |
| 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, CardiopulmonaryBypass |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR §870.4220 |
| Product Code(s) | DTQ |
| Legally marketed device(s) towhich 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 isindicated for use for up to 6 hours in theextracorporeal circulation of blood for arterialperfusion, regional perfusion, and cardiopulmonarybypass procedures, when used by a qualified medicalprofessional who is experienced in the operation ofthis or similar equipment. The centrifugal pump isindicated for use in cardiopulmonary bypassprocedures only. |
| SystemComponents | Identical to predicate device. | • System 1 Base with CCM and various hardwareaccessories• Large (6") and/or Small (4") Roller Pumps• Centrifugal Control Unit Local Display andControl and Centrifugal Motor• Optional pods and accessories, including:o Air bubble detectoro 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 datamonitoring 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 ofOperation | Identical to predicate device. | Configurable heart-lung system with a distributednetwork architecture that allows the user to customizethe number and types of system components, whichcan then be configured, displayed, and controlledfrom a central monitor. |
| Each component connects to the system network viapoints on the Base. There are six pump connections,two connections for the CCM, eighteen connectionsfor pods and two dedicated connections for a lamp. | ||
| Chassis | Identical to predicate device with exception of a newOn/Off switch, switch guard, and ancillaryinstallation hardware. | The power system within the Chassis transforms ACpower into the DC levels required by the systemcomponents. Integrated batteries provide backuppower in the event of AC power loss during use andwhen power needed exceeds power available. |
| Operator'sManual | Identical to the predicate device with the exception ofan instruction on what to do in the event of loss ofsystem power | The labeling supplied with the device is intended toprovided users of the System 1 with proper operatinginstructions. |
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.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
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.(b)
Classification. Class II (performance standards).