The Sarns™ Centrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control systems. The device may be used for up to 6 hours.

Device Description

The device is a hardshell housing that contains a blood compartment and a non-blood compartment. Within the blood compartment is a rotating mechanism that imparts centrifugal force upon blood as it enters the device. The centrifugal force moves the blood out of the device via the outlet port. The non-blood compartment is designed to magnetically couple with a pump console so that it can be electrically driven by the console. The materials of construction for the Sarns™ Centrifugal Pump with X-Coating are the exact same materials that are used in the predicate uncoated Sarns™ Centrifugal Pump except for the addition of X-coating to the subject device.

AI/ML Overview

The provided text describes the Sarns™ Centrifugal Pump with X-Coating, which is a medical device used in cardiopulmonary bypass procedures. The submission focuses on demonstrating substantial equivalence to an existing predicate device (the uncoated Sarns™ Centrifugal Pump) rather than presenting detailed performance criteria and studies for a novel device. Therefore, the response will focus on the comparison to the predicate device as described in the provided document.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the "acceptance criteria" are essentially the performance characteristics of the predicate device, and the "reported device performance" is how the X-Coating device compared to it. The goal was to show no clinically significant performance differences.

Performance Aspect	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Sarns™ Centrifugal Pump with X-Coating)
Intended Use	Extracorporeal blood pump for cardiopulmonary bypass, exclusively with Sarns centrifugal control system. Duration: up to 6 hours.	Same as predicate device.
Principles of Operation & Technology	Centrifugal force to propel blood.	Same as predicate device (utilizes centrifugal force).
Design and Materials	Hardshell housing with blood/non-blood compartments, rotating mechanism, magnetically couples to pump console.	Same as predicate device, except for the addition of X-Coating. The difference in materials did not raise new safety or effectiveness issues.
Long Duration Circulation Evaluation	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Priming Volume	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
De-priming Volume	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Air Handling Efficiency	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Hemolytic Effects on Cellular Blood Components	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Mechanical Integrity	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Strength of Tubing Connection	Performance characteristics of the uncoated Sarns™ Centrifugal Pump.	Comparisons demonstrated no clinically significant performance differences between the two devices.
Sterilization Assurance Level (SAL)	10⁻⁶ (AAMI guidelines).	Validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶.
Ethylene Oxide Residues	Not to exceed maximum residue limits (Federal Register of June 23, 1978).	Will not exceed proposed maximum residue limits.
Biocompatibility	Meets ISO 10993 standards for blood-contacting devices (Limited Exposure ≤ 24 hours).	Blood-contacting materials found to be biocompatible according to FDA General Program Memorandum #G95-1 (Use of International Standard ISO 10993).

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

The document does not explicitly state the sample sizes for each performance evaluation (e.g., number of pumps tested for circulation, priming volume, etc.). However, it refers to "performance evaluations" and "comparisons," implying a controlled testing environment.

Sample Size: Not explicitly stated in the provided text.
Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation. The nature of these tests (e.g., laboratory bench testing, in-vitro, ex-vivo) is implied for performance evaluations like hemolytic effects and mechanical integrity, but not explicitly stated. It is considered retrospective in the sense that the predicate device's established performance serves as the benchmark for the comparative study.

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

Not applicable. This submission relies on direct performance comparisons against a predicate device and established engineering/biological standards, not expert interpretation of diagnostic images or clinical outcomes that would require a ground truth panel. The "ground truth" for each performance criterion is the measured performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as the performance evaluations are objective measurements and comparisons against established specifications/predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a cardiopulmonary bypass pump, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device, not an algorithm. The performance evaluations are intrinsic to the device's function.

7. The Type of Ground Truth Used

The ground truth is based on:

Predicate Device Performance: The established performance characteristics of the uncoated Sarns™ Centrifugal Pump for most operational aspects (flow, pressure, hemodynamics, etc.).
AAMI Guidelines & ISO Standards: For sterilization and biocompatibility.
Federal Regulations: For Ethylene Oxide residues.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device is evaluated based on its physical and biological performance characteristics.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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APR = 4 2002

Sarns™ Centrifugal Pump with X-Coating

Submitter Information:

Name and Address: Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton MD 21921

Contact Person:

Garry A. Courtney Regulatory Affairs Specialist Telephone: 1-800-283-7866, Ext. 7420

March 8, 2002 Date of Preparation:

Device Names:

Sarns™ Centrifugal Pump with X-Coating Proprietary Name: 164275X Product Code: Cardiopulmonary Bypass Centrifugal Pump Common Name: Classification Name: Non-Roller Type CPB Blood Pump

Predicate Device:

Terumo Cardiovascular Systems Corporation has identified the uncoated Sarns Centrifugal Pump, Product Code 164275, as the predicate device for the determination of The predicate device is cleared with Premarket Notification substantial equivalence. K915363.

Intended Use:

Duration for Use:

The device may be used for up to 6-hours.

Principles of Operation and Technology:

The Sams™ Centrifiugal Pump with X-Coating performs its function using centrifugal force technology. As blood enters the device via the blood inlet port, centrifugal forces created by the pump activity will propel the blood through the pump head and out of the device via a blood outlet port.

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Design and Materials:

The design of the Sarns™ Centrifugal Pump with X-Coating is such that the device meets its stated intended use, and provides an acceptable level of performance and safety to the patient.

The non-blood compartment is designed to magnetically couple with a pump console so that it can be electrically driven by the console.

The materials of construction for the Sarns™ Centrifugal Pump with X-Coating are the exact same materials that are used in the predicate uncoated Sarns™ Centrifugal Pump except for the addition of X-coating to the subject device. The differences in the materials do not raise any new issues of safety or effectiveness of the device.

Performance:

Terumo Cardiovascular Systems Corporation conducted performance evaluations on the Sarns™ Centrifugal Pump with X-Coating to demonstrate its equivalence to the uncoated Sarns™ Centrifugal Pump. The following performance tests were conducted:

Long Duration Circulation Evaluation .
Priming Volume .
De-priming Volume .
Air Handling Efficiency .
Hemolytic Effects of the Device Upon Cellular Blood Components .
Mechanical Integrity .
Strength of Tubing Connection

Substantial Equivalence Comparison:

The Sarns™ Centrifugal Pump with X-Coating is substantially equivalent to the uncoated Sarns™ Centrifugal Pump:

Intended Use: Both the Sarns™ Centrifugal Pump with X-Coating and the predicate . Sarns™ Centrifugal Pump are indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control system.

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Principles of Operation and Technology: The Sarns™ Centrifugal Pump with X-. Coating and the predicate Centrifugal Pump each utilize the same technologies in the operation of the devices. As blood enters the device via the blood inlet port, centrifugal forces created by the pump activity will propel the blood through the pump head and out of the device via a blood outlet port.
Design and Materials: The Sams™ Centrifugal Pump with X-Coating and the ● predicate Centrifugal Pump each have the same identical design. Each device is a hardshell housing that contains a blood compartment and a non-blood compartment. Within the blood compartment is a rotating mechanism that imparts centrifugal force upon blood as it enters the device. The centrifugal force moves the blood out of the device via the outlet port.

The non-blood compartment is designed to magnetically couple with a pump console so that it can be electrically driven by the console.

The materials of construction for the Sarns™ Centrifugal Pump with X-Coating are the exact same materials that are used in the predicate uncoated Centrifugal Pump except for the addition of X-coating to the subject device.

Comparisons between the performance of the Sarns™ Centrifugal Performance: . Pump with X-Coating and the predicate Centrifugal Pump were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the two devices.

Substantial Equivalence Summary:

In summary, the Sarns™ Centrifugal Pump with X-Coating and the uncoated Centrifugal Pump are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the two devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 10-6.
Ethylene Oxide residues will not exceed the maximum residue limits proposed for . Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
Terumo Cardiovascular Systems Corporation conducted the biocompatibility studies ● 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,

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Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.

Conclusion:

In summary, the Sarns™ Centrifugal Pump with X-Coating (164275X) is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the uncoated Sarns™ Centrifugal Pump cleared under K915363.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles, suggesting care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Garry A. Courtney Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921

K020998 Re:

Trade Name: Sarns™ Centrifugal Pump with X-Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump. Regulatory Class: Class III (three) Product Code: KFM Dated: March 25, 2002 Received: March 28, 2002

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 referented 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 provision in the Just for 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.

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 (0S) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Garry A. Courtney

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 premaince nedicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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510(k) Number (if known):

Device Name:

Sarns ™ Centrifugal Pump with X-Coating

Indications For Use:

The Sarns ™ Centrifugal Pump with X-Coating is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures only, and for use exclusively with Sarns centrifugal control systems.

The device may be used for up to 6 hours.

Garry A. Courtney

Regulatory Affairs Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020998

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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.