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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Terumo ROCSafe™ Hybrid Perfusion System. This system is a pre-connected extra-corporeal circuit designed to offer circulatory support, blood gas maintenance, and blood filtration during cardiopulmonary bypass procedures. The submission argues for substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The submission does not explicitly state acceptance criteria in a quantitative format (e.g., minimum performance thresholds for specific metrics). Instead, the performance evaluations focus on demonstrating substantial equivalence to predicate devices. The "performance evaluations" section lists various aspects that were considered. Since the device is a collection of previously cleared components, the "performance" here refers to confirming that the assembled system retains the performance characteristics of its individual, already-approved parts and that the combination does not introduce new safety or effectiveness concerns.

Therefore, the "acceptance criteria" are implicitly meeting the performance characteristics already established and accepted for the predicate devices across various parameters, and the "reported device performance" is that it achieves this substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Substantial equivalence in:	The ROCSafe™ Hybrid Perfusion Circuit is substantially equivalent to the aforementioned predicate devices.
- Intended use	Substantially equivalent
- Duration of use/6-hour use	Substantially equivalent
- Product labeling	Substantially equivalent
- Operation and technology of the devices	Substantially equivalent (no change in operation or technology)
- Product design	Substantially equivalent
- Materials used in device construction	Substantially equivalent (same materials as individual components)
- Design performance (covering: Gas Transfer, Hemolysis, Pressure Drop, Mechanical Integrity, Static Priming Volume, Heat Exchanger Performance, Filtration Efficiency, Air Handling, Tubing Connection Strength)	Performance previously demonstrated for individual components through in-vitro clinically simulated studies, and determined to be substantially equivalent to predicate devices.
- Sterility Assurance Level (SAL) of 10⁻⁶	Validated in accordance with AAMI guidelines.
- Ethylene oxide residues within limits	Terumo asserts residues will not exceed limits.
- Biocompatibility (conforming to ISO 10993)	Blood contacting materials found to be biocompatible. (in-vivo animal study for X-Coating)

Study Details

The submission explicitly states: "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 "studies" that support the substantial equivalence claim are primarily comparative assessments and analyses of the combined system against its individual predicate components, relying on prior data.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a traditional "test set" for performance evaluation of a novel device. The evaluations rely on prior in-vitro clinically simulated studies of the individual components and comparative assessments of the assembled system. No specific sample sizes for these re-evaluations are provided, as they are not new, standalone performance studies but rather a review of existing data.
- Data Provenance: The data primarily comes from retrospective reviews of prior 510(k) submissions for the individual predicate devices. The submission does not specify a country of origin for these past studies, but given the US FDA submission, it's implied they were conducted in a manner acceptable for US regulatory purposes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was not a study requiring expert readers to establish ground truth for a test set. The validation of the individual predicate device performance came from various engineering and biological tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there was no test set or expert adjudication process for this type of submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-assisted study was conducted. This device is a medical apparatus, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance of the individual components, the "ground truth" would have come from established engineering and biological benchmarks (e.g., specific gas transfer rates, hemolysis limits, pressure drop specifications, material integrity tests, sterility protocols, biocompatibility standards). For the current submission, the "ground truth" is that the assembled system aligns with the established characteristics and safety profiles of its predicate components.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Ⓣ 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:

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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:

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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.

Principles of Operation and Technology:

Design and Materials:

Performance Evaluations:

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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

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.

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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. :

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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.

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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

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SECTION 4 Indications for Use

510(k) Number (if known): K082321

Terumo ROCSafe™ Hybrid Perfusion System Device Name:

Indications for Use:

Prescription Use	XX
(Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. V. Musser
Sign-Off)

Cardiovascular Devices

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.