(37 days)
The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are 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 Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.
This document, K162843, is a 510(k) premarket notification for updates to the Terumo Advanced Perfusion System 1 Roller Pumps. The main change described is the inclusion of medical grade silicone tubing as a compatible tubing option for both the Small (4") and Large (6") Roller Pumps. Since the device is substantially equivalent to a previously cleared predicate device (K153376), it primarily relies on demonstrating that the new tubing material does not adversely affect the device's safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for all functionality. Instead, it leverages the substantial equivalence to a predicate device and focuses on confirming that the new medical grade silicone tubing does not compromise the established performance.
However, based on the Functional Summary and Flow Range Accuracy sections, we can infer some performance characteristics and the implicit "acceptance criteria" that the subject device (with silicone tubing) must meet by being "Identical to predicate device."
| Feature/Parameter | Acceptance Criteria (Implicit, based on predicate device K153376) | Reported Device Performance (with medical grade silicone tubing) |
|---|---|---|
| Small Roller Pump | ||
| Max Flow Rate | up to 4 L/min | Met: Small roller pump can accommodate applications requiring flow rates up to 4 L/min |
| Tubing Compatibility | Medical Grade PVC 9/16" OD (max) 1/16" – 3/32" wall thickness | Met: Also compatible with Medical Grade Silicone 9/16" OD (max) 1/16" – 3/32" wall thickness |
| Flow Range Accuracy (0.0-1.0 L/min) | ± 10% of actual | Met: Identical to predicate device |
| Flow Range Accuracy (1.0-4.0 L/min) | ± 8% of actual | Met: Identical to predicate device |
| Large Roller Pump | ||
| Max Flow Rate | up to 10 L/min | Met: Large roller pump can accommodate applications requiring flow rates up to 10 L/min |
| Tubing Compatibility | Medical Grade PVC 11/16" OD (max) 1/16" – 3/32" wall thickness | Met: Also compatible with Medical Grade Silicone 11/16" OD (max) 1/16" – 3/32" wall thickness |
| Flow Range Accuracy (0.0-1.0 L/min) | ± 10% of actual | Met: Identical to predicate device |
| Flow Range Accuracy (1.0-10.0 L/min) | ± 8% of actual | Met: Identical to predicate device |
| Speed Range / Accuracy | 0 - 250 RPM ± 2 RPM or 1% of actual | Met: Identical to predicate device |
| Other Functional Characteristics | Identical to predicate device (e.g., Panel Displays & Controls, Pump Configurations/Modes, Internal Monitoring, Controls & Safety) | Met: Performance testing confirmed design input requirements met. |
The "Reported Device Performance" column essentially states "met" or "identical to predicate device" because the core of this 510(k) is to demonstrate that the addition of silicone tubing compatibility maintains the performance characteristics of the already cleared predicate device. The conclusion explicitly states: "Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully." However, it does not specify the sample size (e.g., number of pumps, number of tests, duration of tests) used for this performance testing.
Regarding data provenance, the document does not explicitly state the country of origin or if the study was retrospective or prospective. It implies the testing was conducted by Terumo Cardiovascular Systems Corporation as part of their 510(k) submission, suggesting it was likely prospective testing specifically for this change.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for performance testing in the context of device function for roller pumps. Performance criteria for such devices (flow rate accuracy, speed accuracy, tubing compatibility, etc.) are typically established through engineering specifications and objective measurements, not subjective expert assessment. Therefore, this question is not directly applicable to the type of device and testing described.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. As noted above, the performance testing for this device is based on objective measurements against engineering specifications, not on subjective assessments that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, and the goal is to evaluate the effectiveness of AI assistance on human reader performance. The Terumo roller pumps are mechanical devices, and their performance is evaluated through objective measurements and engineering tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" typically refers to AI algorithm performance without human intervention, in the context of this mechanical device, the "performance testing" described can be considered analogous to "standalone" in that it evaluates the device's function (with the new tubing) based on its intrinsic capabilities against predefined criteria, without an explicit "human-in-the-loop" interaction as part of the primary performance assessment. The device is designed to operate mechanically, and the performance tests verify its mechanical and fluid dynamics properties.
7. The Type of Ground Truth Used
The ground truth used for this device's performance testing consists of:
- Engineering Specifications: Predefined quantitative thresholds for parameters like flow rate accuracy, speed accuracy, and dimensions.
- Functional Equivalence: The expectation that the subject device, with the new tubing, performs identically or equivalently to the predicate device in terms of all functional aspects (e.g., pump configurations, controls, safety).
- Biocompatibility (implied): The "medical grade silicone tubing" implies that material properties and safety (e.g., non-toxicity, durability) were assessed, although specific details are not provided in this summary.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant to machine learning/AI devices. Since the Terumo roller pump is a mechanical device, there is no training set in the AI/ML sense. Its design and performance are based on engineering principles and physical testing, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this mechanical device, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are connected by flowing lines that resemble ribbons or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
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
November 17, 2016
Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer - Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103
Re: K162843
Trade/Device Name: Small (4") Roller Pump for the Terumo Advanced Perfusion System 1, Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4370 Regulation Name: Roller-Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: DWB Dated: October 7, 2016 Received: October 11, 2016
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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K162843 |
|---|---|
| Device Name | Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1. |
| Indications for Use (Describe) | The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are 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. |
|---|---|
| -------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
{3}------------------------------------------------
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 |
| 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 | October 7, 2016 |
| Name of Device | |
| Trade or proprietary name | Small (4") Roller Pump for the Terumo® AdvancedPerfusion System 1 |
| Trade or proprietary name | Large (6") Roller Pump for the Terumo® AdvancedPerfusion System 1 |
| Common or usual name | Cardiopulmonary bypass roller pump |
| Classification name | Roller-type cardiopulmonary bypass blood pump |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR §870.4370 |
| Product Code(s) | DWB |
| Legally marketed device(s) towhich equivalence is claimed | Terumo® Advanced Perfusion System 1: K153376 |
| Reason for 510(k) | Update to the System 1 Operator's Manual (instructionsfor use) that incorporates the use of medical gradesilicone tubing with the Small (4") and Large (6")System 1 Roller Pumps. |
Image /page/3/Picture/5 description: The image contains the word "TERUMO" in large, bold, green letters. Above the word is a red swoosh that starts thin on the left and gets thicker as it moves to the right. The logo is simple and modern, with a focus on the company name.
{4}------------------------------------------------
Image /page/4/Picture/4 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and bold.
{5}------------------------------------------------
Device Information
Indication for Use: The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 are 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.
Device Description: The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.
Image /page/5/Picture/6 description: The image shows 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 the letters are bold.
{6}------------------------------------------------
Image /page/6/Figure/2 description: This image is a device illustration of a centrifugal control unit. The illustration includes labels for the different parts of the unit, such as the centrifugal control unit, local display and control, centrifugal motor, small roller pump, large roller pump, roller pump local display and control, central control monitor, occluder, chassis, electronic gas blender local controls, wheel lock, power status indicator, hand cranks, and on/off switch. There is also a lamp attached to the unit.
Page 4 of 14
{7}------------------------------------------------
Image /page/7/Picture/3 description: The image shows two different sizes of roller pumps from the Terumo Advanced Perfusion System 1. The left image shows the small (4") roller pump, and the right image shows the large (6") roller pump. The small roller pump has a label that says "NOT FOR CLINICAL USE". The large roller pump has a screen that displays "4.86".
Image /page/7/Picture/4 description: The image features the Terumo logo. The logo consists of the word "TERUMO" in bold, green letters. Above the word is a curved, red swoosh that starts thin on the left and widens as it curves over the letters.
{8}------------------------------------------------
Device Function: The Small (4") or Large (6") System 1 Roller Pumps are designed 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.
Image /page/8/Picture/5 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is curved upwards and to the right. The word "TERUMO" is in a bold, sans-serif font.
{9}------------------------------------------------
Substantial Equivalence
The Small (4") and Large (6") Roller Pumps for the System 1 have been qualified for use with medical grade silicone tubing through performance testing. The use of medical grade silicone tubing does not adversely impact the system functions or operating principles. The Operator's Manual has been revised to include the use of medical grade silicone tubing. The subject Small (4") and Large (6") Roller Pumps for the System 1 have the indications for use, intended use, as well as substantially equivalent operating principles and technological charateristics as the predicate device.
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
|---|---|---|
| Indication for Use | Identical to predicate device. | The Small (4") and Large (6") Roller Pumps of theTerumo® Advanced Perfusion System 1 areindicated for use for up to 6 hours in theextracorporeal circulation of blood for arterialperfusion, regional perfusion, and cardiopulmonarybypass procedures, when used by a qualifiedmedical professional who is experienced in theoperation of this or similar equipment. |
| FunctionalSummary | Identical to predicate device. | Small roller pump can accommodate applicationsrequiring flow rates up to 4 L/min includingpediatric arterial, adult and pediatric cardioplegia,vent and suction pumping. |
| Large roller pump can accommodate applicationsrequiring flow rates up to 10 L/min including adultand pediatric arterial, cardioplegia, vent and suctionpumping. | ||
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| TubingRequirements | Small Roller PumpCommercially available tubing meeting the followingspecifications:Medical Grade PVC 9/16" Outer Diameter (max) 1/16" – 3/32" wall thickness Medical Grade Silicone 9/16" outer diameter (max) 1/16" – 3/32" wall thickness | Small Roller PumpCommercially available tubing meeting thefollowing specifications:Medical Grade PVC 9/16" outer diameter (max) 1/16" – 3/32" wall thickness |
| Large Roller PumpCommercially available tubing meeting the followingspecifications:Medical Grade PVC 11/16" Outer Diameter (max) 1/16" – 3/32" wall thickness Medical Grade Silicone 11/16" outer diameter (max) 1/16 – 3/32" wall thickness | Large Roller PumpCommercially available tubing meeting thefollowing specifications:Medical Grade PVC 11/16" outer diameter (max) 1/16" – 3/32" wall thickness | |
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| Panel Displaysand Controls | Identical to predicate device. | Front panels for user interface controls, functionaldisplays, and alarm conditions. |
| PumpConfigurations /Modes | Identical to predicate device. | Small Roller PumpSmall roller pump can be configured using theSystem 1 Central Control Monitor (CCM) as:• Arterial pump (neonatal / pediatric only)• Cardioplegia pump• Vent pump• Suction pumpArterial pump can be run in Continuous, Pulse,Servo, or Master/Follower mode |
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| Identical to predicate device. | Large Roller PumpLarge roller pump can be configured using theSystem 1 Central Control Monitor (CCM) as:Arterial pump (adult and pediatric) Cardioplegia pump Vent pump Suction pump Arterial pump can be run in Continuous, Pulse,Servo, or Master/Follower mode | |
| InternalMonitoring,Controls andSafety | Identical to predicate device. | The small and large roller pumps both continuouslymonitors its own performance and reports statusinformation and problems to the user via the pumpdisplay panel alarms and to the CCM. Responses todetected problems can include Stop, Pause, ReduceSpeed, or Message Only. |
| Mounting | Identical to predicate device. | The small and large roller pumps can be mounted onthe System 1 base or to the poles via mountingsupport brackets. |
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| Dimensions | Identical to predicate device. | Small Roller Pump• Height: 12.5 in (31.8cm)• Width: 7.1 in (18.0 cm)• Depth: 13.1 (30.0 cm) |
| Large Roller Pump• Height: 12.5 in (31.8cm)• Width: 8.5 in (21.6 cm)• Depth: 13.1 (33.3 cm) | ||
| Weight (nominal) | Identical to predicate device | Small Roller Pump• 23.5 lb (10.7 kg)Large Roller Pump• 28.5 lb (12.9 kg) |
| Housing | Identical to predicate device | External: Molded ABS plastic.Internal: Metal with EMC coating. |
| Cover / Pump Lid | Identical to predicate device | Clear plastic with safety interlock. |
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| Pump ControlAssembly | Identical to predicate device. | A two board assembly, consisting of a computerboard and a motor control board that are mounted tothe frame. |
| Power | Identical to predicate device. | Low voltage, 24 VDC power and battery backupsupplied from APS1 via pump power cables. |
| Flow RangeAccuracy | Identical to predicate device. | Small Roller Pump0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual 0.01 L/min for 1.0 – 4.0 L/min ± 8% of actual Large Roller Pump0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual |
| Speed Range /Accuracy | Identical to predicate device. | 0 - 250 RPM ± 2 RPM or 1% of actual. |
| Item | Subject DevicesSmall (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)Small (4") Roller Pump for the System 1Large (6") Roller Pump for the System 1 |
| EnvironmentalConditions(Operations) | Identical to predicate device. | 10°C to 40°C ≤ 75% Relative Humidity Non-condensing |
| EnvironmentalConditions(Storage) | Identical to predicate device. | Stored in ventilated area -30°C to 54°C ≤ 95% Relative Humidity Non-condensing |
| Electrical Rating | Identical to predicate device. | 24 VDC (nominal) +5 VDC 7.4 A maximum @ 24 VDC |
Image /page/9/Picture/7 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and to the left of the word, creating a dynamic and modern look.
{10}------------------------------------------------
Image /page/10/Picture/4 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is sans-serif and bold. The logo is simple and modern.
{11}------------------------------------------------
Image /page/11/Picture/4 description: The image contains the logo for Terumo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is curved and positioned above the left side of the word "TERUMO".
{12}------------------------------------------------
Image /page/12/Picture/5 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters. The font is bold and sans-serif.
{13}------------------------------------------------
Image /page/13/Picture/5 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, block letters. Above the word is a red, curved line that resembles a swoosh. The logo is simple and modern.
{14}------------------------------------------------
Image /page/14/Picture/4 description: The image contains the logo for Terumo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and bolded.
{15}------------------------------------------------
Image /page/15/Picture/4 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh starts thin on the left and gets thicker as it curves over the word.
{16}------------------------------------------------
Performance Testing
Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully.
Conclusion
The use of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has not changed the device indications for use or fundamental scientific technology. Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps. The device is substantially equivalent to the current predicated device cleared under K153376.
Image /page/16/Picture/7 description: The image shows the Terumo company logo. The logo features a red checkmark-like symbol on the upper left. To the right of the symbol is the company name "TERUMO" in green, block letters.
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).