K Number

Device Name

ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.

Date Cleared

2011-12-19

(104 days)

Product Code

DWB

Regulation Number

870.4370

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K953901,K953904

Reference Devices

K022947, K112587

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of a peristaltic pump and does not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is used in extracorporeal circulation for procedures like arterial perfusion and cardiopulmonary bypass, which are therapeutic interventions.

Diagnostic

No
The device is a roller pump used for extracorporeal circulation of blood, which is a therapeutic function, not a diagnostic one. It pumps blood during medical procedures like cardiopulmonary bypass.

SaMD (Software as a Medical Device)

The device description clearly describes a physical peristaltic pump with a 6-inch diameter race, designed to be mounted on a console or pole. This indicates a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures." This involves circulating blood outside the body during medical procedures.
Device Description: The description details a "peristaltic pump" used to move blood.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis or examination of specimens. It is a mechanical device for moving blood during a procedure.

Therefore, the Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is a medical device used in surgical procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DWB

Device Description

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.

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

The Large roller pump is a peristaltic roller pump with 6" race and can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric.

Intended User / Care Setting

...when used by a 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)

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.

Strength: Design Verification Protocol: Knob/Cam Follower Impact Strength Verification; Results Summary: 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; Results Summary: Pass – All pre-defined acceptance criteria met.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

SarnsTM 8000 Roller Pump (K953901), SarnsTM 9000 Universal Roller Pump (K953904)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

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 Systems
Corporation
Address	6200 Jackson Road
Ann 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 Systems
Corporation
Name of Device
Trade or proprietary name	Large (6") Roller Pump for the
Terumo® Advanced Perfusion
System 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 which
equivalence 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 |

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

Summary of the technological characteristics of the device compared to the
predicate device
Characteristic	Proposed Device:
Large (6") Roller
Pump for the APS 1 -
(K112587)	Predicate# 1:
SarnsTM 8000 Roller
Pump (K953901)	Predicate# 2:
SarnsTM 9000
Universal Roller Pump
(K953904)
Indication for
Use	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.	For use in
extracorporeal
circulation of blood for
arterial perfusion,
regional perfusion, and
cardiopulmonary
bypass procedures
only, when used by a
qualified medical
perfusionist who is
experienced in the use
of SarnsTM or similar
equipment	For use in
extracorporeal
circulation of blood for
arterial perfusion,
regional perfusion, and
cardiopulmonary
bypass procedures
only, when used by a
qualified medical
perfusionist who is
experienced in the use
of SarnsTM or similar
equipment
For Use With	Terumo Advanced
Perfusion System 1	Stand alone or with
SarnsTM 8000 Modular
Perfusion System	SarnsTM 9000 Perfusion
System
Functional
Summary	Large roller pump is a
peristaltic roller pump
with 6" race and can
accommodate
applications requiring
flow rates up to 10
L/min including
• adult and
• pediatric	Peristaltic roller pump
with 6" race can
accommodate
applications requiring
flow rates up to 10
L/min including
• adult and
• pediatric
• arterial	Peristaltic roller pump
with 6" race can
accommodate
applications requiring
flow rates up to 10
L/min including
• adult and
• pediatric
• arterial
	• arterial
• cardioplegia
• vent
• suction
pumping	• cardioplegia
• vent
• suction pumping	• cardioplegia
• vent
• suction pumping
Tube Clamp
Assembly	Variable tube clamp to
accommodate a variety
of tubing sizes,
including dual tube
sets. Does not require
different size tubing
inserts.	Tube clamp mechanism
to accommodate a
variety of tubing sizes
including dual tube sets,
through the use of
various fixed inserts	Tube clamp mechanism
to accommodate a
variety of tubing sizes
including dual tube sets,
through the use of
various fixed inserts
Tubing
Requirements	• Medical Grade
PVC tubing
• 11/16" OD (max)
• 1/16" – 3/32" wall
thickness	• Medical Grade PVC
tubing
• 3/4" OD (max) equals
12/16"
• 1/16" – 3/32" wall
thickness	• Medical Grade PVC
tubing
• 3/4" OD (max)
• 1/16" – 3/32" wall
thickness
Panel Displays
and Controls	Front panel for user
interface controls,
functional displays, and
alarm conditions.	Front panel for user
interface controls,
functional displays, and
alarm conditions.	Front panel for user
interface controls,
functional displays, and
alarm conditions.
Pump
Configurations /
Modes	Pump can be
configured using the
APS1 Central Control
Monitor (CCM) as:
• Arterial pump
• Cardioplegia
pump	Pump can be
configured via
corresponding cable
from Sarns base as
• Arterial pump
• Cardioplegia
pump	Pump can be
configured via
corresponding cable
from Sarns base as
• Arterial pump
• Cardioplegia
pump
	Arterial pump can be
run in Continuous,
Pulse, Servo, or
Master/Follower mode.	Arterial pump can be
run in Continuous or
Pulse mode. Pulse
mode is enabled by
connecting an optional
Pulse Module.	Arterial pump can be
run in Continuous or
Pulse mode. Pulse
mode is enabled by
connecting an optional
pulse module.
Internal
Monitoring,
Controls and
Safety Features	Pump continuously
monitors its
own performance and
reports	Pump continuously
monitors its own
performance and
reports status	Pump continuously
monitors its own
performance and
reports status
	status information and
problems to the user
via the pump display
panel alarms and to the
CCM, including:
Pump jam Belt-slip Over speed Under speed Internal temperature	information and
problems to the user via
the pump display panel
alarms, including:
Pump jam Belt-slip Over speed Under speed	information and
problems to the user via
the pump display panel
alarms, including:
Pump jam Belt-slip Over speed Under speed
Mounting	Pump can be mounted
on APS 1 base or pole.	Pump is mounted on
Sarns base.	Pump is mounted on
Sarns base.
Dimensions
(nominal)	Height: 12.5 in (31.8
cm)
Width: 8.5 in (21.6 cm)
Depth: 13.1 in (33.3
cm)	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 DC
power and battery
backup	Pump AC/DC power
supply and battery
backup	Low voltage, 24v DC
power and battery
backup
Flow Range	0 - 10 L/min	0 - 10 L/min	0 - 10 L/min
Speed Range /
Accuracy	0 - 250 RPM ± 2 RPM
or 1% of actual,
whichever is greater	0 - 200 RPM ± 2 RPM 200 - 258 RPM ± 1% of actual	0 - 245 or 255 RPM ± 2
RPM or 1% of actual,
whichever is greater
Environmental
Conditions
(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
Environmental
Conditions
(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

Section 6- Page 3 of 7

(DTERUMO

510(K) Premarket Notification

Section 6- Page 4 of 7

(1) TERUMO

Section 6 - 510(k) Summary

510(K) Premarket Notification

PERFORMANCE DATA

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

Performance Test Summary-Proposed Device
Characteristic	Standard/Test/FDA
Guidance	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

Section 6- Page 6 of 7

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.

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

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

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