K Number

Device Name

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.

Date Cleared

2009-02-13

(184 days)

Product Code

KFM

Regulation Number

870.4360

Intended Use

The ROCSafe™ Hybrid Perfusion System is a pre-connected extra-corporeal circuit that is designed to offer circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures lasting not more than 6-hours in duration. The ROCSafe may only be used with Terumo's System 1 Heart/Lung Pump Platform. The System includes the following: The Capiox RX Hollow Fiber Oxygenators are intended to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The Capiox RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Oxygenators are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The Centrifugal Pump is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifingal pump is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The Capiox AF125X Arterial Line Blood Filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit for up to 6 hours. The Arterial Filter is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The Capiox Venous Bubble Trap is intended to facilitate the removal of air and bubbles from incoming venous blood as it flows into the extra-corporeal bypass circuit. The Bubble Trap is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration. The CDI Cuvette is intended for use with the CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin and oxygen saturation is desired. The Cuvettes are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

Device Description

The components included in the Terumo ROCSafe™ Hybrid Perfusion System are medical devices that have been previously cleared by the United States Food and Drug Administration in prior 510(k) applications. This particular system is a collection of those "cleared" devices that are herein being presented in a pre-assembled configuration to satisfy the needs of clinical perfusionists. As such, there has been no change in the operation or technology employed by the individual devices. The blood contacting surfaces of the ROCSafe™ circuit are coated with Terumo's exclusive X-Coating surfactant that is designed to reduce the adhesion of platelets to the foreign surfaccs of the circuit. The materials that are used in the construction of the Terumo ROCSafe™ Hybrid Perfusion System includes, but not limited to, polycarbonate, steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. These materials are the same materials that are used in the construction of the individual components that were previously cleared by FDA.

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

K062381, K051997, K040210, K020998, K052205, K915265, K031700

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that there has been "no change in the operation or technology employed by the individual devices" which are previously cleared components. There is no mention of AI, ML, or any related technologies.

Therapeutic

Yes
The device is designed to provide circulatory support, blood gas maintenance, and blood filtration, all of which directly address and mitigate physiological issues during cardiopulmonary bypass procedures.

Diagnostic

The ROCSafe™ Hybrid Perfusion System is designed for circulatory support, blood gas maintenance, and blood filtration during cardiopulmonary bypass, which are therapeutic functions, not diagnostic ones. One component, the CDI Cuvette, is explicitly stated to be for "continuous monitoring of blood hematocrit, hemoglobin and oxygen saturation," which is diagnostic, but the question asks about the device as a whole. The primary intended use of the complete system is support and filtration, making it a therapeutic device with a monitoring component, rather than solely a diagnostic device.

SaMD (Software as a Medical Device)

The device is described as a pre-connected extra-corporeal circuit composed of various hardware components like oxygenators, pumps, filters, and cuvettes. The description focuses on the physical components and materials, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, the ROCSafe™ Hybrid Perfusion System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly describes the system as providing "circulatory support, blood gas maintenance and blood filtration during cardiopulmonary bypass procedures." This involves directly interacting with and supporting the patient's physiological functions, not analyzing samples taken from the body.
Device Description: The description focuses on the physical components of the extracorporeal circuit and their function in circulating and treating blood outside the body.
Performance Studies: The performance studies described focus on the physical and functional performance of the system components (gas transfer, pressure drop, filtration efficiency, etc.) and their effects on blood components (hemolysis) within the extracorporeal circuit. These are not studies related to the analytical performance of a diagnostic test.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

The CDI Cuvette, while used for monitoring blood parameters (hematocrit, hemoglobin, oxygen saturation), is a component of the system used during the bypass procedure to provide real-time information about the blood being circulated, not for a separate in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Capiox RX Hollow Fiber Oxygenators are intended to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The Capiox RX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Oxygenators are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Centrifugal Pump is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifygal purnp is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Capiox AF125X Arterial Line Blood Filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit for up to 6 hours. The Arterial Filter is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The Capiox Venous Bubble Trap is intended to facilitate the removal of air and bubbles from incoming venous blood as it flows into the extra-corporeal bypass circuit. The Bubble Trap is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

The CDI Cuvette is intended for use with the CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin and oxygen saturation is desired. The Cuvettes are intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

Product codes

DTZ, KFM, DTR, DTP, DTM, DRY

Device Description

The Terumo ROCSafe™ Hybrid Perfusion System is a pre-connected extra-corporeal circuit consisting of components previously cleared by the FDA. The system is a collection of these "cleared" devices presented in a pre-assembled configuration. The materials used in its construction, including polycarbonate, steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene, and X-Coating™, are the same as those used in the individual components previously cleared by the FDA. The blood contacting surfaces of the ROCSafe™ circuit are coated with Terumo's X-Coating surfactant to reduce platelet adhesion.

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

Not Found

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)

Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject Terumo ROCSafe™ Hybrid Perfusion System to the individual predicate devices. The safety and performance of each of the system devices has been previously demonstrated through in-vitro clinically simulated studies in prior submissions, and have been found to be substantially equivalent to predicate devices by FDA. Those prior studies have included: Gas Transfer, Effects on Blood Components (Hemolysis), Pressure Drop, Mechanical Integrity, Static Priming Volume, Heat Exchanger Performance, Filtration Efficiency, Air Handling, Tubing Connection Strength.

In demonstrating substantial equivalence of the ROCSafe™ Hybrid Perfusion System to predicate devices, a comparative study and/or assessment was performed in each of the following areas: Intended use, Duration of use/6-hour use, Product labeling, Operation and technology of the devices, Product design, Materials used in device construction, Design performance.

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

Not Found

Predicate Device(s)

K062381, K051997, K040210, K020998, K052205, K915265, K031700

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Summary

Ⓣ TERUMO
K082321

FEB 1 3 2009

SECTION 5 510(k) Summary

	Page
Submitter Information	18
Device Names	18
Identification of Predicate Device	18
Intended Use	19
Principles of Operation and Technology	19
Design and Materials	19
Performance Evaluations	20
Substantial Equivalence Comparison	20
Substantial Equivalence Statement	20
Additional Safety Information	20
Conclusion for 510(k) Summary	21

: 1

Submitter Information:

This submission was prepared in July 2008 by: Garry A. Courtney, MBA, RAC Regulatory Affairs / Quality Systems Mgr. Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephonc: 1-800-283-7866, Ext. 7420 Fax: 410-398-6079

This submission was prepared for:

Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

Device Names/Classifications: Proprietary Name

Terumo ROCSafe™ Hybrid Perfusion System

Classification Name

TERUMO

Common Name

Oxygenator

Centrifugal

Heat Exchanger

Air Removal -

Arterial Filter

Defoamer

Pump

Cardiopulmonary Bypass Oxygenator (Codc: DTZ)

Centrifugal Pump (Non-Roller) (Code: Pump KFM)

Cardiopulmonary Bypass Heat Exchanger (Code: DTR)

Cardiopulmonary Bypass Defoamer (Code: DTP)

Cardiopulmonary Bypass Arterial Line Blood Filter (Code: DTM)

Monitor, Blood-Gas, On-Line Cardiopulmonary Bypass (Code: DRY)

Cuvette -Adaptor

Predicate Device(s):

The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices:

Terumo's Capiox® RX15 Oxygenator K062381 and K051997 .
Terumo's Capiox® RX25 Oxygenator - K062381 and K040210
Terumo's Capiox® Hardshell Reservoir Filter K062381
Sarns Centrifugal Pump K020998
Terumo's Capiox® AF125X Arterial Filter K052205
Terumo's CDI Cuvette K915265
Medtronic Resting Heart System K031700

Intended Use:

The blood contacting surfaces of the ROCSafe™ circuit are coated with Terumo's exclusive X-Coating surfactant that is designed to reduce the adhesion of platelets to the foreign surfaccs of the circuit.

Principles of Operation and Technology:

Design and Materials:

The materials that are used in the construction of the Terumo ROCSafe™ Hybrid Perfusion System includes, but not limited to, polycarbonate, steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. These materials are the same materials that are used in the construction of the individual components that were previously cleared by FDA.

Performance Evaluations:

Gas Transfer
Effects on Blood Components (Hemolysis) .
Pressure Drop .
Mechanical Integrity .
Static Priming Volume .
Heat Exchanger Performance .
Filtration Efficiency .
Air Handling .
Tubing Connection Strength

Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the ROCSafe™ Hybrid Perfusion System to predicate devices, a comparative study and/or assessment was performed in each of the following areas:

Intended use .
Duration of use/6-hour use
Product labeling .
. Operation and technology of the devices
Product design .
Materials used in device construction .
Design performance

Substantial Equivalence Statement:

The Terumo ROCSafe™ Hybrid Perfusion Circuit is substantially equivalent in intended use, duration of use, labeling, operation and technology, design, materials, and performance to the aforementioned predicate devices.

Additional Safety Information:

Sterilization conditions for the ROCSafe™ Hybrid Perfusion Circuit are validated in . accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10°. Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.
Terumo maintains biocompatibility studies as recommended in the FDA General Program . Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration). The blood contacting materials were found to be biocompatible.
The X-Coating material that is applied to the blood-contacting surfaces of the devices was evaluated in an in-vivo animal study conducted by Terumo Cardiovascular and Sierra Biomedical Laboratories in 1999. No adverse conditions were noted.

Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Capiox ROCSafe™ Hybrid Perfusion Circuit is substantially equivalent to the collective use of each of the corresponding predicate devices. It is further concluded that any recognized differences noted during the assessments do not raise any new issues of patient/user safety or product effectiveness. :

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2009

Terumo Cardiovascular Systems Corp. c/o Mr. Gary A. Courtney Regulatory Affairs/Quality Systems Mgr. 125 Blue Ball Road Elkton, MD 21921

Re: K082321

Terumo ROCSafe™ Hybrid Perfusion System Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III Product Code: KFM Dated: December 26, 2008 Received: December 29, 2008

Dear Mr. Courtney:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

Page 2 - Mr. Gary A. Courtney

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

R. vachner

Bram D. Zuckerman, M.D. Director 1 8 . 1 . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

SECTION 4 Indications for Use

510(k) Number (if known): K082321

Terumo ROCSafe™ Hybrid Perfusion System Device Name:

Indications for Use:

The Centrifugal Pump is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures and is a component of the ROCSafe Hybrid Perfusion System. It is intended to propel blood through the cardiopulmonary bypass circuit. The centrifingal pump is intended to be used in cardiopulmonary bypass procedures that do not exceed 6 hours in duration.

Prescription Use	XX
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. V. Musser
Sign-Off)

Cardiovascular Devices