(311 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on configurable hardware and software for extracorporeal circulation, not AI/ML capabilities.
Yes
The device is used for extracorporeal circulation of blood, including arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, indicating it provides a therapeutic effect for the patient.
No
The device description clearly states its purpose is for "extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures," which are therapeutic interventions, not diagnostic ones.
No
The device description clearly states it is a "configurable heart-lung system with a distributed network architecture" and mentions "system components" and "new or modified components," indicating it includes hardware beyond just software. The performance studies also mention testing for compliance with IEC 60601-1 and IEC 60601-1-2, which are standards for the safety and essential performance of medical electrical equipment, further suggesting the presence of hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in extracorporeal circulation of blood for procedures like arterial perfusion, regional perfusion, and cardiopulmonary bypass. These are procedures performed on the patient's body, not on samples of bodily fluids or tissues outside the body for diagnostic purposes.
- Device Description: The description details a heart-lung system used to manage blood circulation during surgery. This aligns with a therapeutic or life-support device, not a diagnostic one.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to manage blood flow during surgical procedures, which is a different category of medical device.
N/A
Intended Use / Indications 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.
Product codes
DTQ
Device Description
The Advanced Perfusion System 1 is a configurable heart-lung 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 TCVS 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 system components (100/120V or 220/240V)
- Central Control Monitor A touch screen display used for configuration o 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 Module with Centrifugal Drive Motor (up to 2) o
- · Modules
- Air Bubble Detection Module Used to detect air bubbles in the o extracorporeal circuit, in conjunction with the air sensor
- Level Detection Module Used to monitor liquid levels within a hard shell o reservoir.
- Pressure Module ~ Used to monitor the pressure in the extracorporeal O circuit
- Temperature Module Used to monitor the temperature in the o extracorporeal circuit and/or the patient
- Flowmeter Module Used to monitor flow volume and generate an o alarm if backflow is detected
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professional who is experienced in the operation of this or similar equipment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Third party testing was conducted to confirm that, with the engineering modifications in place, the System 1 complies with IEC 60601-1 and IEC 60601-1-2.
Software verficiation and validation testing was conducted for those modules that have undergone software modification since initial clearance.
Moreover functionality testing was conducted on those new or modified components of the Advanced Perfusion System 1 to demonstrate performance compatibility.
All software and performance testing was successful.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Advanced Perfusion System 1: K022947, APS1 6" Roller Pump: K112587
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
| Submitter Information | |
|---|---|
| Name | Terumo Cardiovascular Systems Corporation (TCVS) |
| Address | 6200 Jackson Road |
| Ann Arbor MI, 48103 | |
| Name of Contact Person | Mark Bur |
| Phone number | Tel: (734) 663-4145 |
| Fax number | Fax: (734) 741-6069 |
| Mark.Bur@terumomedical.com | |
| Establishment Registration # | 1828100 |
| Date prepared | April 12, 2013 |
| Name of Device | |
| Trade or proprietary name | Advanced Perfusion System 1 |
| Common or usual name | Heart-Lung Machine |
| Classification name | Console, Heart-Lung Machine, Cardiopulmonary |
| Bypass | |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR §870.4220 |
| Product Code(s) | DTQ |
| Legally marketed device(s) to | |
| which equivalence is claimed | Advanced Perfusion System 1: K022947 |
| APS1 6" Roller Pump: K112587 | |
| Reason for 510(k) | Modifications to previously cleared system and |
| labeling changes |
1
Section 4: 510(k) Summary
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 heart-lung 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 TCVS 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 system components (100/120V or 220/240V)
- Central Control Monitor A touch screen display used for configuration o 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 Module with Centrifugal Drive Motor (up to 2) o
- · Modules
- Air Bubble Detection Module Used to detect air bubbles in the o extracorporeal circuit, in conjunction with the air sensor
- Level Detection Module Used to monitor liquid levels within a hard shell o reservoir.
- Pressure Module ~ Used to monitor the pressure in the extracorporeal O circuit
- Temperature Module Used to monitor the temperature in the o extracorporeal circuit and/or the patient
- Flowmeter Module Used to monitor flow volume and generate an o alarm if backflow is detected
Image /page/1/Picture/22 description: The image shows the logo for Terumo. The logo consists of a circle with a stylized "T" inside of it, followed by the word "TERUMO" in bold, sans-serif font. There is a small degree symbol to the right of the word.
2
Section 4: 510(k) Summary
Image /page/2/Figure/3 description: This image shows a device illustration with several labeled components. The device includes a venous line occluder module, interface modules for data transfer, an electronic gas blender, flexible lamps, and mounting hardware. The illustration labels parts such as the centrifugal control unit, small and large roller pumps, a central control monitor, and an on/off switch.
Section 4 - Page 3 of 6
3
| Section 4: 510(k) Summary | ||
|---|---|---|
| Substantial Equivalence | ||
| The modified Advanced Perfusion System 1 is substantially equivalent to the currently cleared Advanced Perfusion System 1 | ||
| because it has the same intended use, substantially equivalent indications for use, and the same or substantially equivalent | ||
| operating principles and technical specifications. The Advanced Perfusion System 1 has been modified to assure system | ||
| compliance with the IEC 60601-1-2 electromagnetic compatibility standard, and the Operators Manual has been revised to provide | ||
| additional warnings and revised instructions for use. | ||
| Item | Proposed Device | |
| Modified Advanced Perfusion System 1 | Predicate Device | |
| Advanced Perfusion System 1 (K022947) | ||
| 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. | 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. | ||
| System | ||
| Components | • System 1 Base with Central Control Monitor and | |
| various hardware accessories | ||
| • Large (6") and/or Small (4") Roller Pumps | ||
| • Centrifugal Control Unit and centrifugal drive | ||
| motor | ||
| • Modules and accessories, including: | ||
| o Air bubble detector | ||
| o Level sensor | • System 1 Base with Central Control Monitor and | |
| various hardware accessories | ||
| • Large (6") and/or Small (4") Roller Pumps | ||
| • Centrifugal Control Unit and centrifugal drive | ||
| motor | ||
| • Modules and accessories, including: | ||
| o Air bubble detector | ||
| o Level sensor | ||
| tem | Proposed Device | |
| Modified Advanced Perfusion System 1 | Predicate Device | |
| Advanced Perfusion System 1 (K022947) | ||
| Pressure monitor Temperature monitor Flow monitor Occluder Electronic Gas Blender Interface modules for external cardiac and data monitoring systems Lamp | Pressure monitor Temperature monitor Flow monitor Occluder Electronic Gas Blender Interface modules for external cardiac and data monitoring systems Lamp | |
| Principles of Operation | Configurable heart-lung 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. | |
| Each component connects to the system network via points on the Base. There are six pump connections, two connections for the CCM, eighteen connections for modules, and two dedicated connections for a lamp. | Configurable heart-lung 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. | |
| Each component connects to the system network via points on the Base. There are six pump connections, two connections for the CCM, eighteen connections for modules, and two dedicated connections for a lamp. | ||
| Power Supply | The power system within the Base transforms AC power into the DC levels required by the system components. Integrated batteries provide backup power in the event of AC power loss during use and when power needed exceeds power available | The power system within the Base transforms AC power into the DC levels required by the system components. Integrated batteries provide backup power in the event of AC power loss during use and when power needed exceeds power available |
.
dvanced Perfusion System 1 510(k)
Terumo Cardiovascular Systems
4
rumo Cardiovascular System
Section 4: 510(k) Summar
Section 4 - Page 5 of 6
TERUMO
February 18, 2014
5
Section 4: 510(k) Summary
Performance Testing
Third party testing was conducted to confirm that, with the engineering modifications in place, the System 1 complies with IEC 60601-1 and IEC 60601-1-2.
Software verficiation and validation testing was conducted for those modules that have undergone software modification since initial clearance.
Moreover functionality testing was conducted on those new or modified components of the Advanced Perfusion System 1 to demonstrate performance compatibility.
All software and performance testing was successful.
Conclusion
The modified Advanced Perfusion System 1 is substantially equivalent to the currently marketed Advanced Perfusion System 1 because it has the same intended use and substantially equivalent performance specifications.
Image /page/5/Picture/11 description: The image shows the Terumo logo. The logo consists of a circle with a stylized letter 'T' inside, followed by the word 'TERUMO' in bold, sans-serif font. A small circle is present at the upper right of the word.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Terumo Cardiovascular Systems Corporation Mark Bur, Regulatory Affairs Manager 6200 Jackson Road Ann Arbor, MI 48103
Re: K131041
Trade Name: Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4220 Regulation Name: CPB Heart Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: January 27, 2014 Received: January 30, 2014
Dear Mr. Bur:
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
7
Page 2 - Mr. Mark Bur
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Freeman
for
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Terumo Cardiovascular Systems
Section 3: Indication for Use
510(k) Number: _ K131041
Device Name: Advanced Perfusion System 1
Indications 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. A. Hillman
April 12, 2013
TERUMO
Section 3 - Page 1 of 1