The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.

The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

Device Description

The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack.

The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (COBE Cardiovascular Revolution® Centrifugal Blood Pump with PC Coating) seeking substantial equivalence to a predicate device. It primarily focuses on regulatory approval based on material modification rather than a complex AI-based system. Therefore, many of the requested categories for AI-driven device studies, such as sample sizes for test/training sets, expert qualifications, and MRMC studies, are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate substantial equivalence for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a predicate device, particularly concerning performance characteristics and blood compatibility after the addition of a PC coating. The "performance" is assessed through in-vitro laboratory tests comparing the coated device to the uncoated predicate.

Acceptance Criteria Category	Reported Device Performance
Intended Use	The device has the same intended use as the current Revolution Centrifugal Blood Pump: "for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours."
Technical Characteristics Comparison	Materials, components, design, sterilization, and manufacturing processes for the two devices (coated vs. uncoated) are the same, except for the phosphorylcholine coating on blood-contacting surfaces.
Substantial Equivalence (with PC Coating)	In-vitro laboratory tests were performed to demonstrate that the Revolution Centrifugal Blood Pump with PC Coating is substantially equivalent to the Revolution Centrifugal Blood Pump (K011835). While specific metrics of "blood compatibility" are not detailed, the implication is that the coating did not negatively impact or improved blood compatibility, thus meeting implicit performance standards for safety and effectiveness.

2. Sample size used for the test set and the data provenance

The document states "In-Vitro laboratory tests were performed." It does not specify the sample size of devices or the number of runs/experiments conducted. The data provenance is laboratory testing by COBE Cardiovascular, Inc. (manufacturer), presumably performed in the USA. Given this is a device performance test, it is by nature "prospective" for the devices being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for a physical device's performance in in-vitro tests typically comes from established experimental protocols and measurement standards rather than expert consensus on medical images or diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints where differing opinions need to be resolved.

5. 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

This information is not applicable and not provided. This is a physical medical device, not an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For substantial equivalence of a physical device, the "ground truth" would be the established performance characteristics and safety profile of the predicate device (uncoated Revolution Centrifugal Blood Pump) as demonstrated through its original 510(k) submission (K011835) and relevant industry standards. The in-vitro tests for the new device would be compared against these benchmarks.

8. The sample size for the training set

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable and not provided. This is a physical medical device, not a machine learning model.

Summary

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K030462

SPECIAL 510(K) NOTIFICATION Cobe Cardiovascular Inc. Revolution® Centrifugal Blood Pump with PC Coating

IX.	510(k) SUMMARY	MAR 0 6 2003
-----	----------------	--------------

SUBMITTER:	COBE Cardiovascular, Inc.14401 West 65th WayArvada, CO 80004 USA
CONTACT PERSON:	Charles CopperbergSenior Manager, Regulatory and Clinical AffairsCharlie.Copperberg@cobecv.comPhone: (303) 467-6521Fax: (303) 467-6525
DATE PREPARED:	February 10, 2003
DEVICE TRADENAME:	COBE Cardiovascular Revolution ®Centrifugal Blood Pump with PC Coating
COMMON/USUALNAME:	Centrifugal Blood Pump
CLASSIFICATIONNAME:	Nonroller-type cardiopulmonary bypass blood pump
PREDICATEDEVICE:	COBE Cardiovascular Revolution Centrifugal Blood PumpK011835
	Dideco Monolyth Mimesys Hollow Fiber OxygenatorK004001
	Dideco Avant PH.I.S.I.O. Hollow Fiber OxygenatorK020351

DEVICE DESCRIPTION:

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

SPECIAL 510(K) NOTIFICATION Cobe Cardiovascular Inc. Revolution® Centrifugal Blood Pump with PC Coating

INDICATIONS FOR USE:

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The Revolution Centrifugal Blood Pump with PC coating has the same intended use as the current Revolution Centrifugal Blood Pump. The two devices differ in that the blood contacting surfaces of the Revolution with PC coating have been treated with phosphorylcholine. Otherwise, materials, components, design, sterilization and manufacturing processes for the two devices are the same.

TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:

In-Vitro laboratory tests were performed to demonstrate that the Revolution Centrifugal Blood Pump with PC Coating described in this submission is substantially equivalent to the Revolution Centrifugal Blood Pump (K011835).

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 6 2003

COBE Cardiovascular, Inc. c/o Mr. Charles Copperberg Senior Manager, Regulatory and Clinical Affairs 14401 West 65" Way Arvada, CO 80004

Re: K030462

Trade Name: COBE Cardiovascular Revolution® Centrifugal Blood Pump with PC Coating. Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: February 11, 2003 Received: February 12, 2003

Dear Mr. Copperberg:

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. 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 (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. Charles Copperberg.

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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,

Qelll lll

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

Enclosure

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Indications For Use

510(k) Number (if known): K030462

Device Name: COBE Cardiovascular Revolution™ Centrifugal Blood Pump with PC Coating

Indications For Use:

PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030462

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

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.