The Large (6") Roller Pump for 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.

Device Description

The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (Results Summary)
Strength	Design Verification Protocol: Knob/Cam Follower Impact Strength Verification	Pass – All pre-defined acceptance criteria met
Reliability/Durability	Design Validation Protocol: Simulated use testing on new and aged parts; multiple cycles under worst-case conditions	Pass – All pre-defined acceptance criteria met

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for the test set in the performance studies. It mentions "new and aged parts" but no specific quantity.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a design change, the testing would generally be prospective, conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The performance tests appear to be engineering-based (strength, reliability/durability) rather than requiring expert clinical interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (Pass/Fail based on engineering criteria), formal adjudication by clinical experts is unlikely.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the performance tests described (Strength, Reliability/Durability) are standalone tests of the device's mechanical integrity and function. The device itself (a roller pump) is a standalone piece of equipment. The assessment of its performance did not involve a "human-in-the-loop" component for interpretation of results, but rather its mechanical operation and ability to withstand stress.

7. Type of Ground Truth Used

The ground truth used for these performance tests appears to be engineering specifications and pre-defined acceptance criteria. For "Strength," the ground truth is defined by the "Knob/Cam Follower Impact Strength Verification" protocol. For "Reliability/Durability," the ground truth is established by "Simulated use testing... under worst-case conditions." The "Pass" result indicates that the device met these engineering and design validation targets.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI/ML-based system that requires a "training set" in the context of machine learning. The design and manufacturing process would involve internal testing and validation, but not a "training set" in the computational sense.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of medical device.

Summary

{0}------------------------------------------------

K112587

Section 6 – 510(k) Summary

510(K) Premarket Notification

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information
Name	Terumo Cardiovascular SystemsCorporation
Address	6200 Jackson RoadAnn Arbor MI, 48103
Phone number	Tel: (734) 741-6113
Fax number	Fax: (734) 741-6069
E-mail	Rebecca.andersen@terumomedical.com
Establishment Registration Number	1828100
Name of contact person	Rebecca Andersen
Submission Co-Authors	December 2, 2011
Date prepared	Terumo Cardiovascular SystemsCorporation
Name of Device
Trade or proprietary name	Large (6") Roller Pump for theTerumo® Advanced PerfusionSystem 1
Common or usual name	Cardiopulmonary Bypass Roller Pump
Classification name	Pump, blood, cardiopulmonary bypass,roller type
Classification panel	74 Cardiovascular
Regulation	21 CFR § 870.4370
Product Code(s)	DWB
Legally marketed device(s) to whichequivalence is claimed	Sarns™ 8000 Roller Pump (K953901)Sarns™ 9000 Universal Roller Pump(K953904)
Reason for 510(k) submission	6" Large Roller pump for the APS1- Redesign in support of Corrective

{1}------------------------------------------------

510(K) Premarket Notification

Image /page/1/Figure/4 description: The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min. The Large (6") Roller Pump for 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.

Section 6- Page 2 of 7

TERUMO

{2}------------------------------------------------

Section 6- Page 3 of 7

(DTERUMO

{3}------------------------------------------------

510(K) Premarket Notification

Section 6- Page 4 of 7

(1) TERUMO

{4}------------------------------------------------

Section 6 - 510(k) Summary

510(K) Premarket Notification

{5}------------------------------------------------

510(K) Premarket Notification

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*

The APS1 Large Roller Pump was previously found substantially equivalent to the named predicate devices under K022947. The purpose of this 510(k), K 112587, is to document a design change to the tube clamp assembly. The change addresses a failure mode, discovered during postmarket surveillance, which results in failure.

Design and system verification and validation testing demonstrated that the modified design of the Tube Clamp assembly assures system reliability by enabling the internal assembly components to withstand impact forces that may be encountered during use.

Performance Test Summary-Proposed Device
Characteristic	Standard/Test/FDAGuidance	Results Summary
Strength	Design VerificationProtocol:Knob/Cam FollowerImpact StrengthVerification	Pass –All pre-defined acceptancecriteria met
Reliability/Durability	Design ValidationProtocol:Simulated use testing onnew and aged parts;multiple cycles underworst case conditions	Pass –All pre-defined acceptancecriteria met

Section 6- Page 6 of 7

{6}------------------------------------------------

510(K) Premarket Notification

Summary of then clinied tests conducted for light of substautial equivalence .

TCVS concludes that the Large 6" Roller Pump that is the subject of this 510k is substantially equivalent to the Sarns 8000, and 9000 Roller pump assemblies as cleared under K953901 and K953904. The devices have the same intended use and substantially equivalent performance.

{7}------------------------------------------------

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

DEC 1 9 2011

Terumo Cardiovascular Systems c/o Rebecca Andersen, Ph.D. 6200 Jackson Road Ann Arbor, MI 48103

Re: K112587

Trade/Device Name: Large (6") Roller Pump for Terumo Advanced Perfusion System 1 (APS1) Regulation Number: 21 CFR 870.4370 Regulation Name: Roller-type cardiopulmonary bypass blood pump. Regulatory Class: Class II Product Code: DWB Dated: December 2, 2011 Received: December 6, 2011

:・

Dear Dr. Andersen:

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

{8}------------------------------------------------

Page 2 - Rebecca Andersen, Ph.D.

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.

ﻨﻴﺬ ﺎﻧﻪ

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Filipe

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

Enclosure

{9}------------------------------------------------

Terumo Cardiovascular Systems Corporation

Indications for Use

ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

510(k) Number: K112587

Large (6") Roller Pump for the Terumo® Advanced Device Name: Perfusion System 1

Prescription Use X (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use (Part 21 CFR 807

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fili Gara for BDZ

vision Sign Off) Division of Cardiovascular Devices

510(k) Number K112587

Regulation Number and Section

§ 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).

Summary of the technological characteristics of the device compared to the
predicate device
Characteristic	Proposed Device:Large (6") RollerPump for the APS 1 -(K112587)	Predicate# 1:SarnsTM 8000 RollerPump (K953901)	Predicate# 2:SarnsTM 9000Universal Roller Pump(K953904)
Indication forUse	The Large (6") RollerPump for the Terumo®Advanced PerfusionSystem 1 is indicatedfor use for up to 6hours in theextracorporealcirculation of blood forarterial perfusion,regional perfusion, andcardiopulmonarybypass procedures,when used by aqualified medicalprofessional who isexperienced in theoperation of this orsimilar equipment.	For use inextracorporealcirculation of blood forarterial perfusion,regional perfusion, andcardiopulmonarybypass proceduresonly, when used by aqualified medicalperfusionist who isexperienced in the useof SarnsTM or similarequipment	For use inextracorporealcirculation of blood forarterial perfusion,regional perfusion, andcardiopulmonarybypass proceduresonly, when used by aqualified medicalperfusionist who isexperienced in the useof SarnsTM or similarequipment
For Use With	Terumo AdvancedPerfusion System 1	Stand alone or withSarnsTM 8000 ModularPerfusion System	SarnsTM 9000 PerfusionSystem
FunctionalSummary	Large roller pump is aperistaltic roller pumpwith 6" race and canaccommodateapplications requiringflow rates up to 10L/min including• adult and• pediatric	Peristaltic roller pumpwith 6" race canaccommodateapplications requiringflow rates up to 10L/min including• adult and• pediatric• arterial	Peristaltic roller pumpwith 6" race canaccommodateapplications requiringflow rates up to 10L/min including• adult and• pediatric• arterial
	• arterial• cardioplegia• vent• suctionpumping	• cardioplegia• vent• suction pumping	• cardioplegia• vent• suction pumping
Tube ClampAssembly	Variable tube clamp toaccommodate a varietyof tubing sizes,including dual tubesets. Does not requiredifferent size tubinginserts.	Tube clamp mechanismto accommodate avariety of tubing sizesincluding dual tube sets,through the use ofvarious fixed inserts	Tube clamp mechanismto accommodate avariety of tubing sizesincluding dual tube sets,through the use ofvarious fixed inserts
TubingRequirements	• Medical GradePVC tubing• 11/16" OD (max)• 1/16" – 3/32" wallthickness	• Medical Grade PVCtubing• 3/4" OD (max) equals12/16"• 1/16" – 3/32" wallthickness	• Medical Grade PVCtubing• 3/4" OD (max)• 1/16" – 3/32" wallthickness
Panel Displaysand Controls	Front panel for userinterface controls,functional displays, andalarm conditions.	Front panel for userinterface controls,functional displays, andalarm conditions.	Front panel for userinterface controls,functional displays, andalarm conditions.
PumpConfigurations /Modes	Pump can beconfigured using theAPS1 Central ControlMonitor (CCM) as:• Arterial pump• Cardioplegiapump	Pump can beconfigured viacorresponding cablefrom Sarns base as• Arterial pump• Cardioplegiapump	Pump can beconfigured viacorresponding cablefrom Sarns base as• Arterial pump• Cardioplegiapump
	Arterial pump can berun in Continuous,Pulse, Servo, orMaster/Follower mode.	Arterial pump can berun in Continuous orPulse mode. Pulsemode is enabled byconnecting an optionalPulse Module.	Arterial pump can berun in Continuous orPulse mode. Pulsemode is enabled byconnecting an optionalpulse module.
InternalMonitoring,Controls andSafety Features	Pump continuouslymonitors itsown performance andreports	Pump continuouslymonitors its ownperformance andreports status	Pump continuouslymonitors its ownperformance andreports status
	status information andproblems to the uservia the pump displaypanel alarms and to theCCM, including:Pump jam Belt-slip Over speed Under speed Internal temperature	information andproblems to the user viathe pump display panelalarms, including:Pump jam Belt-slip Over speed Under speed	information andproblems to the user viathe pump display panelalarms, including:Pump jam Belt-slip Over speed Under speed
Mounting	Pump can be mountedon APS 1 base or pole.	Pump is mounted onSarns base.	Pump is mounted onSarns base.
Dimensions(nominal)	Height: 12.5 in (31.8cm)Width: 8.5 in (21.6 cm)Depth: 13.1 in (33.3cm)	Height: 14 in (35.6 cm)Width: 8.2 in (20.8 cm)Depth: 19.7 in (50.0 cm)	Height: 8.0 in (20.3 cm)Width: 8.75 in (22.2 cm)Depth: 14.0 in (35.6 cm)
Weight(nominal)	26 lb (11.7 kg)	50 lb (22.6 kg)	31 lb (14 kg)
Power	Low voltage, 24v DCpower and batterybackup	Pump AC/DC powersupply and batterybackup	Low voltage, 24v DCpower and batterybackup
Flow Range	0 - 10 L/min	0 - 10 L/min	0 - 10 L/min
Speed Range /Accuracy	0 - 250 RPM ± 2 RPMor 1% of actual,whichever is greater	0 - 200 RPM ± 2 RPM 200 - 258 RPM ± 1% of actual	0 - 245 or 255 RPM ± 2RPM or 1% of actual,whichever is greater
EnvironmentalConditions(Operation)	10°C to 40°C ≤ 75%RH Non-condensing	10°C to 40°C ≤ 95%RH Non-condensing	10°C to 40°C ≤ 75%RH Non-condensing
EnvironmentalConditions(Storage)	Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing	Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing	Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing