The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours. The pump is a non-roller type pump and is a sterile device for single use only. The pump will be used with, and is electrically driven by BioMedicus BioConsole Models 540 and 550 via the SP Pump Head adaptor. A biocompatible coating, polymethoxyethylacrylate (PMEA), is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.

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 CAPIOX® SP Pump with X-Coating are the exact same materials that are used in the predicate uncoated CAPIOX® SP Pump – except for the addition of X-coating to the subject device.

AI/ML Overview

Here's an analysis of the provided text regarding the CAPIOX® SP Pump with X-Coating, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating equivalence to a predicate device rather than setting specific, quantifiable acceptance criteria. The "performance evaluations" are comparative, aiming to show "no clinically significant performance differences." Therefore, the "acceptance criteria" are implicitly that the X-Coated pump performs no worse than the uncoated predicate device.

Performance Test / Acceptance Criteria (Implicit)	Reported Device Performance
Long Duration (9-hour) Circulation Evaluation	No clinically significant performance differences compared to predicate device.
Priming Volume	No clinically significant performance differences compared to predicate device.
Air Handling Efficiency	No clinically significant performance differences compared to predicate device.
Hemolytic Effects on Cellular Blood Components	No clinically significant performance differences compared to predicate device.
Evaluation for Heat Generation	No clinically significant performance differences compared to predicate device.
Mechanical Integrity	No clinically significant performance differences compared to predicate device.
Strength of Tubing Connection	No clinically significant performance differences compared to predicate device.
Sterility Assurance Level (SAL)	Validated in accordance with AAMI guidelines to provide an 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.
Biocompatibility	Blood contacting materials found to be biocompatible (per ISO 10993).

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

The document does not explicitly state the sample sizes for the performance tests. It only mentions that Terumo Cardiovascular Systems Corporation "conducted performance evaluations." This is a premarket notification (510(k)) seeking substantial equivalence, and often such submissions rely on internal testing results without publishing detailed sample sizes in the public summary.

The data provenance is internal testing performed by Terumo Cardiovascular Systems Corporation. The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, but given it's a new device being compared to a predicate, the performance tests would typically be prospective laboratory or bench tests.

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

This information is not provided in the document. The studies described are primarily technical and engineering performance tests on the device itself (e.g., hemolytic effects, mechanical integrity), which would likely be evaluated by engineers, biologists, or lab technicians rather than clinical experts like radiologists. There is no mention of "ground truth" in the diagnostic sense, as this is a blood pump, not an imaging or diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving expert review of diagnostic cases (e.g., in radiology studies) to resolve disagreements among reviewers. The performance tests described here are technical measurements, not subjective expert interpretations requiring adjudication.

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

This information is not applicable and therefore not provided. The device is a cardiopulmonary bypass pump, not an AI-powered diagnostic or assistive tool for human readers. Thus, no MRMC study, human reader improvement, or AI assistance is relevant here.

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

This information is not applicable and therefore not provided. The device is a mechanical blood pump, not an algorithm.

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" would be the established scientific and engineering measurement standards and methodologies for evaluating device performance parameters like priming volume, air handling, hemolysis, heat generation, mechanical integrity, and tubing connection strength. For sterility and biocompatibility, the ground truth refers to validated methods and adherence to international standards (AAMI guidelines for SAL, ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these specific performance evaluations as described.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI model that requires a "training set."

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

This information is not applicable and therefore not provided, as there is no training set for this device.

Summary

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

K012209
p1 of 3

AUG 1 5 2001 CAPIOX® SP 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

June 29, 2001 Date of Preparation:

Device Names:

Proprietary Name: CAPIOX® SP Pump with X-Coating Product Code: CX*SP45X Common Name: Cardiopumonary Bypass Centrifugal Pump Classification Name: Non-Roller Type CPB Blood Pump

Predicate Device:

I Ferumo Cardiovascular Systems Corporation has identified the uncoated CAPIOX® SP I crumo Cartio vasual by start as the predicate device for the determination of I ump, I rouate Cour . The predicate device is cleared with Premarket Notification K962981.

Intended Use:

The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the The CATION - B1 - 2 and reculatory support during extracorporeal circulation for up to 6 hours.

Principles of Operation and Technology:

The CAPIOX® SP Pump with X-Coating performs its function using centrifugal force The CATOA - ST - St - amp - w the blood inlet port, centrifugal forces created toonlorogy. Tis crounding propel the blood through the pump head and out of the device via a blood outlet port.

Design and Materials:

The design of the CAPIOX® SP Pump with X-Coating is such that the device meets its The design of the errand provides an acceptable level of performance and safety to the patient.

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

The device is a hardshell housing that contains a blood compartment and a non-blood The device is a natures no and compartment is a rotating mechanism that imparts contrifugal 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 CAPIOX® SP Pump with X-Coating are the exact The materials of constants of consisted uncoated CAPIOX® SP Pump – except for same materials that are asso 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 of the Foranto Ourch P Pump with X-Coating to demonstrate its equivalence to the uncoated CAPIOX® SP Pump. The following performance tests were conducted:

Long Duration (9-hour) Circulation Evaluation .
Priming Volume ●
Air Handling Efficiency �
Hemolytic Effects of the Device Upon Cellular Blood Components ●
Evaluation for Heat Generation .
Mechanical Integrity .
Strength of Tubing Connection .

Substantial Equivalence Comparison:

The CAPIOX® SP Pump with X-Coating is substantially equivalent to the uncoated CAPIOX® SP Pump:

Intended Use: Both the CAPIOX® SP Pump with X-Coating and the predicate ● CAPIOX® SP Pump are intended to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
Principles of Operation and Technology: The CAPIOX® SP Pump with X-Coating . and the predicate SP 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 CAPIOX® SP Pump with X-Coating and the predicate SP . 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

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

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 CAPIOX® SP Pump with X-Coating are the exact same materials that are used in the predicate uncoated CAPIOX® SP Pump except for the addition of X-coating to the subject device.

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

Substantial Equivalence Summary:

In summary, the CAPIOX® SP Pump with X-Coating and the uncoated CAPIOX® SP 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, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.

Conclusion:

In summary, the CAPIOX® SP Pump with X-Coating is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the uncoated CAPIOX® SP Pump (K962981).

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

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2001

Mr. Gary A. Courtney, RAC Regulatory Affairs Specialist Terumo Cardiovascular System Corporation 126 Blue Ball Road Elkton, MD 21921

Re: K012209

CAPIOX® SP Pump with X-Coating Regulation Number: 870.4360 Regulatory Class: III (three) Product Code: KFM Dated: July 13, 2001 Received: July 16, 2001

Dear Mr. Courtney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. Iisting 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 (Premarket Approval). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Gary A. Courtney, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nodication: "The FDA miams of basian 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, (Joase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respect 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,

Walter Tell

Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):

CAPIOX® SP Pump with X-Coating (CX*SP45X) Device Name:

Indications For Use:

The CAPIOX® SP Pump with X-Coating is used to facilitate blood flow in the The CFF 1011 - Suit for circulatory support during extracorporeal circulation for up to 6 hours.

The pump is a non-roller type pump and is a sterile device for single use only. The pump The painp is a will be to, and is electrically driven by BioMedicus BioConsole Models 540 and 550 via the SP Pump Head adaptor.

A biocompatible coating, polymethoxyethylacrylate (PMEA), is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.

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)

J. Oake Hill
Division of Cardiovascular & Respiratory Devices
510(k) Number K012209

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.