The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Device Description

The AVECOR Cardiovascular Affinity Pump System consists of the Model 2000 Affinity Pump Console, Affinity Pump Rotor, Affinity Pump Holder, Affinity Pump Chamber, 5/8" Connecting Tube and an AVECOR venous reservoir with 5/8" outlet. The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking. The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status. The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.

AI/ML Overview

This document describes the premarket notification (510(k)) for the AVECOR Affinity Blood Pump System, establishing its substantial equivalence to the Stockert Instrumente (Sorin) Pump System.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the Affinity Blood Pump System was substantial equivalence in performance to the Stockert Instrumente (Sorin) Pump System. This was assessed across various aspects, particularly focusing on blood trauma.

Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device)	Reported Device Performance (Affinity Blood Pump System)
In Vitro Operating Characteristics	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section III of the full application).
In Vitro Cellular Damage	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section III of the full application).
Material Biocompatibility	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section IV of the full application).
Sterility	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application).
Pyrogenicity	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application).
Sterilant Residuals	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application).
Software Validation & Verification	Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Appendix E of the full application).
Blood Trauma (Hemolysis, Platelet and White Cell Response)	"Blood trauma testing shows that in all aspects evaluated (hemolysis, platelet and white cell response) the Affinity Blood Pump System and the Stockert Instrumente (Sorin) Pump System are equivalent."

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

The document does not specify the sample sizes for the various tests (In Vitro Operating Characteristics, In Vitro Cellular Damage, etc.) used to establish equivalence. It refers to these details being in other sections/appendices of the 510(k) application.

The data provenance is retrospective, as the tests were conducted by AVECOR to compare their new device against an existing, already marketed predicate device. The country of origin of the data is implicitly the USA, as AVECOR Cardiovascular Inc. is based in Minnesota, and the application is to the US FDA.

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

This type of information is not applicable in this context. The "ground truth" for a medical device's performance in a 510(k) submission for substantial equivalence is typically established by comparing its performance to a predicate device, as opposed to expert consensus on clinical outcomes or diagnoses. The "truth" is whether the new device performs acceptably and similarly to the predicate. The FDA acts as the ultimate arbiter by reviewing the provided data.

4. Adjudication Method for the Test Set

This type of information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials involving expert interpretation of medical images or diagnoses. In this 510(k) submission, the "adjudication" is essentially the review process by the FDA based on the technical and performance data submitted by AVECOR, comparing it against the predicate device.

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

No, an MRMC comparative effectiveness study was not done. This device is a blood pump system, not an AI-assisted diagnostic tool.

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

This concept is not applicable to a mechanical blood pump system. The device itself operates, and its performance is measured directly, not as an algorithm's output for human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantial equivalence determination is the established performance characteristics of the predicate device (Stockert Instrumente (Sorin) Pump System). The new device's performance (e.g., blood trauma, operating characteristics) was tested and compared against the known performance of the predicate. This is a direct comparative performance evaluation against an already approved device.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-based device that would require training data. The "training" for such a mechanical device involves engineering design, material selection, and iterative physical testing and refinement, not data-driven model training.

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

This information is not applicable for the same reasons as #8.

Summary

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K 964017

SECTION II

AVECOR CARDIOVASCULAR INC.

AFFINITY BLOOD PUMP SYSTEM

AUG - 5 1997

SUPPORTING SUMMARY FOR 510 (k) NOTIFICATION

September 30, 1996 1 . Date Prepared:
1. AVECOR Cardiovascular Inc. Submitter: 13010 County Road 6 Plymouth, MN 55441
1. Contact: Dennis E. Steger Director Regulatory Affairs/ Quality Assurance (800) 328-3320
1. Device Name: Cardiopulmonary Bypass Roller-Type Pumps, Consoles and Bypass Pump Tubing have been classified by the Cardiovascular Device Classification Panel as Class II devices, as proposed in Section 870.4220/4370/4380/4390, Title 21 of the Code of Federal Regulations
న్. Device Description & Comparison to Predicate Device:

To establish the substantial equivalency of the AVECOR Affinity Pump System to the Stockert Instrumente (Sorin) Pump design, specifications, materials, indications for use, and performance characteristics were compared.

DESIGN

The AVECOR Affinity Blood Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking.

The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status.

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The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.

The Stockert Instrumente (Sorin) Pump Console Model No. 10-10-00, provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure and timed events.

The Stockert Instrumente (Sorin) Pump is designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyvinyl chloride tubing segment with polycarbonate connectors at each end. Flow rate is affected by the RPM's, of the pump rotor, total circuit resistance and the size of the tubing segment used.

SPECIFICATIONS & MATERIALS

A detailed comparison of specifications and materials can be found in Table 1. Specifications for the Stockert (Sorin) console are taken from Stockert's labeling.

Table 1 Pump Console Comparison of Specifications

	Affinity Console	Stockert Console
Input Power	• 100 or 110-120 Vac, 50-60 Hz,• 220-240 Vac, 50-60 Hz	• 100 or 110-120 Vac, 50-60 Hz• 220-240 Vac, 50-60 Hz
Internal Batteries	Yes	No (External Battery Pack Optional)
Case Dimensions	13" H x 7" W x 17" D	12" H x 7" W x 19" D
Weight	50 lb.	48 lb.

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Pump Chamber Comparison of Materials

	Affinity	Stockert (Sorin)
Chamber	Polyurethane	Polyvinyl Chloride
Connectors	Polycarbonate	Polycarbonate
Protective Caps	PVC	PVC

INDICATIONS FOR USE

The Affinity Blood Pump System and the Stockert Instrumente (Sorin) Pump System are indicated for use in an extracorporeal perfusion circuit to pump blood during cardiopulmonary bypass procedures.

PERFORMANCE CHARACTERISTICS

The following tests were conducted by AVECOR to establish the safety and effectiveness of the Affinity Blood Pump System.

Test Description	Location
In Vitro Operating Characteristics	Section III
In Vitro Cellular Damage	Section III
Material Biocompatibility	Section IV
Sterility	Section V
Pyrogenicity	Section V
Sterilant Residuals	Section V
Software Validation & Verification	Appendix E

Protocols describing the test methods utilized in this application may be found in the appropriate Appendix.

The results indicate that the Affinity Blood Pump System is substantially equivalent in performance to the Stockert Instrumente (Sorin) Pump System.

BLOOD TRAUMA SUMMARY STATEMENT

Blood trauma testing shows that in all aspects evaluated (hemolysis, platelet and white cell response) the Affinity Blood Pump System and the Stockert Instrumente (Sorin) Pump System are equivalent.

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CONCLUSION

WE HAVE CONSIDERED DESIGN, MATERIALS, INDICATIONS FOR USE, PERFORMANCE CHARACTERISTICS, ALONG WITH A DIRECT COMPARISON OF TEST RESULTS BETWEEN THE AFFINITY AND STOCKERT PUMP SYSTEMS IN OUR APPLICATION. IT IS BASED UPON THE REVIEW OF ALL OF THESE PARAMETERS THAT AVECOR CARDIOVASCULAR INC. DETERMINES THAT THE AFFINITY BLOOD PUMP SYSTEM IS SUBSTANTIALLY EQUIVALENT TO THE CURRENTLY MARKETED STOCKERT INSTRUMENTE (SORIN) BLOOD PUMP SYSTEM.

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Dennis E. Steger Director Requlatory Affairs/ Quality Assurance Avecor Cardiovascular, Inc. 7611 Northland Drive Minneapolis, Minnesota 55428 -

AUG - 5 1997 -

K964017 Re: AFFINITY™ Blood Pump System Regulatory Class: II (Two) Product Code: 74 DTQ Dated: May 9, 1997 Received: May 12, 1997

Dear Mr. Steger:

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 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, Druq, 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 reqistration, listing of devices, qood 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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Page 2 - Mr. Dennis E. Steger

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 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callehan

Thomas J. Callawan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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870.4370- DWB II - Roller-type CPB Blood Pump

Labels	Values
510(k) Number (if known):	K.964017
Device Name:	AFFINITY Blood Pump System

Indications For Usc:

The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Dennis E. Hughes

Dennis E. Steger Director Regulatory Affairs/ Quality Assurance AVECOR Cardiovascular Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette Lempuele

Division Sign-Off) Division of Cardiovascular, Respiratory, nd Neurological Devices

510(k) Number: K964017

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).