The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

Device Description

The A-Med Large Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.

AI/ML Overview

Acceptance Criteria and Device Performance Study for A-Med Large Centrifugal Blood Pump

This document outlines the acceptance criteria for the A-Med Large Centrifugal Blood Pump and describes the study that supports its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K020529) does not explicitly list specific acceptance criteria with numerical targets for the A-Med Large Centrifugal Blood Pump. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, performance, and physical characteristics.

The core of the "acceptance" in this context is the FDA's determination of substantial equivalence, meaning the device is "as safe and effective as a legally marketed device."

Acceptance Criteria Category	Description (as inferred from submission)	Reported Device Performance (as described in submission)
Intended Use	The device must be indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours), and for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc.). It must also be indicated for use only with the A-Med Blood Pump Controller. This must be substantially equivalent to the predicate devices.	The A-Med Large Centrifugal Blood Pump's intended use statement precisely matches the acceptance criteria. It is stated to be "identical in design, material, intended use and technological characteristics to the predicate devices" with the only difference being "size and pressure only." This implies that its functional performance for the stated duration is comparable since the intended use is the same.
Technological Characteristics	The device must be substantially equivalent in design, material, and technological characteristics to the predicate devices. This implies similar principles of operation (non-pulsatile, non-roller, centrifugal impeller), and blood compatibility.	The device "is identical in design, material, intended use and technological characteristics to the predicate devices. The difference is size and pressure only." This indicates that the fundamental technology and how it interacts with blood are considered equivalent, despite the physical dimension and the resulting capacity to generate more pressure. The mechanism of being "demand responsive" is also noted as a function.
Safety and Effectiveness	The device must be demonstrated to be as safe and effective as the predicate devices, despite the larger size and ability to produce more pressure. This would implicitly involve considerations of hemolysis, thrombosis, and adequate flow/pressure delivery for the indicated procedures.	The submission explicitly states that "The line extension A-Med Large Centrifugal Blood Pump is substantially equivalent to the predicates in intended use, material, design, performance and physical characteristics." While no specific test data on hemolysis or pressure/flow curves are provided in this summary, the claim of substantial equivalence, particularly regarding "performance," suggests that any necessary testing to demonstrate comparable safety and effectiveness (e.g., concerning blood damage) for the increased size and pressure capability was conducted and found acceptable. The reliance on literature discussing aspects like pulsatile vs. non-pulsatile perfusion, hemorrhagic complications, and hemolytic characteristics of similar pumps (though not directly on this specific device) further suggests a consideration of these safety aspects.
Compatibility	The device must be compatible with the A-Med Blood Pump Controller.	The indications for use explicitly state that the device "is indicated for use only with the A-Med Blood Pump Controller." This directly confirms the compatibility requirement.

Description of the Study Proving Acceptance Criteria

The provided 510(k) summary for the A-Med Large Centrifugal Blood Pump (K020529) does not describe an explicit, dedicated clinical or performance study to prove the device meets specific acceptance criteria in the manner one might expect for a novel device. Instead, the entire submission is a comparative effectiveness argument based on substantial equivalence to predicate devices.

The study "proving" the device meets the acceptance criteria is effectively the demonstration of substantial equivalence to the A-Med Miniature Centrifugal Blood Pump System (K992592) and the Medtronic Bio-Medicus Centrifugal Blood Pump (K973011).

The rationale for substantial equivalence is based on the following:

Identical Intended Use: The indications for use are described as being the same as the predicate devices.
Identical Design, Material, and Technological Characteristics: The device is stated to be "identical in design, material, intended use and technological characteristics to the predicate devices." The only stated difference is "size and pressure only," implying a scaled-up version of an already approved technology.
Performance: While not detailed with specific metrics, the claim of substantial equivalence in "performance" implies that the larger pump, despite its increased pressure capability, operates within acceptable parameters for its intended use, similar to its smaller counterpart or the Medtronic predicate. This would implicitly cover aspects like blood flow, pressure generation, and potential for blood damage (hemolysis), though specific test data is not provided in this summary.

The literature cited (Driessen et al., Glauber et al., Noon et al., Dantas & Costa, Takami et al.) are general medical literature related to cardiopulmonary bypass, centrifugal pumps, and their physiological effects. These references appear to provide background and context for the technology and its implications rather than being specific performance studies conducted on the A-Med Large Centrifugal Blood Pump itself. For instance, Takami et al. discusses hemolytic characteristics of a different gyro centrifugal pump, suggesting these are relevant considerations for this type of device, but not data generated for this device.

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

Given that this is a substantial equivalence (510(k)) submission relying on comparison to predicate devices and not a de novo clinical trial, there is no "test set" in the traditional sense with a specific sample size of patients or physical devices subjected to a statistical performance study for this specific device.

The "data provenance" would refer to the existing regulatory approvals and performance data for the two predicate devices (A-Med Miniature Centrifugal Blood Pump System (K992592) and Medtronic Bio-Medicus Centrifugal Blood Pump (K973011)), which would have previously undergone their own approval processes. The current submission leverages the safety and effectiveness established by those prior approvals.

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

Since there was no dedicated "test set" or de novo clinical study described in this summary requiring expert adjudication for ground truth, this information is not applicable. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices as determined by prior FDA clearances.

4. Adjudication Method for the Test Set

As there was no dedicated "test set" or de novo clinical study, adjudication methods are not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is mentioned in the provided 510(k) summary. This type of study is typically associated with AI/imaging devices where human interpretation is a key component, and the impact of AI assistance on human performance needs to be quantified. The A-Med Large Centrifugal Blood Pump is a medical device (a mechanical pump), not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a mechanical blood pump, not an algorithm. Therefore, there is no "standalone (algorithm only)" performance to evaluate. The device inherently involves a human operator (surgeon/perfusionist) during its use, but its core function is mechanical.

7. Type of Ground Truth Used

The "ground truth" for this substantial equivalence determination is the regulatory precedent and established safety and effectiveness of the legally marketed predicate devices. The device's "acceptance" is based on its demonstrated similarity (in function, material, design) to devices already deemed safe and effective by the FDA. This is a common approach for Class II and Class III (pre-amendments, 510k pathway) devices where a new device doesn't raise new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. As this is a mechanical medical device submission and not a machine learning model, there is no "training set."

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

Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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K020529 p.113. "

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

AUG 2 6 2002

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR $807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

21 CFR §807.92 a (1)

A-Med Systems, Inc 2491 Boatman Avenue West Sacramento, CA 95691-3817 (916) 375-7400 ext. 5316 Contact person: Cynthia G. Royster Date prepared: 13 February 2002

21 CFR §807.92 a (2)

Trade name:	A-Med Large Centrifugal Blood Pump
-------------	------------------------------------

Common name:	Centrifugal Pump
Classification name:	"Non-roller type Cardiopulmonary Bypass BloodPumps"870.4360

21 CFR §807.92 a (3)

Identification of predicate(s): Substantial equivalence for the A-Med Large Centrifugal Blood Pump is based on its similarities to the predicate devices, A-Med Miniature Centrifugal Blood Pump System (K992592) and Medtronic Bio-Medicus Centrifugal Blood Pump (K973011). The line extension A-Med Large Centrifugal Blood Pump is substantially equivalent to the predicates in intended use, material, design, performance and physical characteristics. The line extension included a larger motor to the existing larger housing to enable it to produce more pressure.

21 CFR §807.92 a (4)

Device Description-parts and function/concept: The A-Med Large Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by

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K020529 p.2-13

automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump.

A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.

21 CFR 8807.92 a (5)

Intended use and relationship to predicate(s): The A-Med Large Centrifugal Blood Pump is indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.

CFR 8807.92 a (6)

Technological characteristics and relationship to predicate(s): The A-Med Large Centrifugal Blood Pump is identical in design, material, intended use and technological characteristics to the predicate devices. The difference is size and pressure only.

21 CFR §807.92 b

This substantial equivalence is based on similarities to the predicate devices in terms of intended uses and technological characteristics.

21 CFR §807.92 c

In accordance with the specifications of this subsection, this summary (two pages) is its own section, and has been clearly identified as such.

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K020529 p 3 /3

Literature (cited)

1. Driessen JJ. Dhaese H. Fransen G. Verrelst P. Rondelez L. Gevaert L. van Becelaere M, Schelstraete E. "Pulsatile Compared with Nonpulsatile Perfusion Using a Centrifugal pump for Cardiopulmonary Bypass during Coronary Artery Bypass Grafting. Effect on Systemic Haemodynamics. Oxygenation, and Inflammatory Response Parameters", Perfusion 10 No. 1: 3-12 1995.
1. Glauber M, Szefner J, Senni M, Gamba A, Mamprin F, Fiocchi R, Somachini M, Ferrazzi P. "Reduction of Haemorrhagic Complications during Mechanically Assisted Circulation with the Use of a Multi-System Anticoagulation Protocol", Artificial Organs Vol. 18 No. 10: 649-55 Oct. 1995.
1. Noon GP, Lafuente JA, Irwin S. " Acute and Temporary Ventricular Support with Bio-Medicus Centrifugal Pump", Ann Thorac Surg. Vol 68 2: 650-4.68 Aug 1999.
1. Ricardo Grossi Dantas, Eduardo Tavares Costa. "Ultrasonic Pulsed Doppler Blood Flowmeter for Use in Extracorporeal Circulation," Artificial Organs Vol. 24 No.3: 198-201 March 2000.
1. Takami Y, Makinoushi K, Nakazawa T, Benkowski R, Glueck J, Ohara Y, Nose Y . "Hemolytic characteristics of a Pivot Bearing Supported Gyro Centrifugal Pump (C1E3) Simulating Various Clinical Applications", Artif Organs Vol. 20 No.9: 1042-9 Sept. 1996.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

AUG 26 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A-Med Systems, Inc. Ms. Cynthia G. Royster Director, Regulatory Affairs 2491 Boatman Avenue West Sacramento, CA 95691-3817

Re: K020529

Trade/Device Name: A-Med Large Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump. Regulatory Class: Class III Product Code: KFM Dated: June 3, 2002 Received: June 21, 2002

Dear Ms. Royster:

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.

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

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Page 2 - Ms. Cynthia G. Royster

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 and additionally 21 CFR Part 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, 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 vours.

Elia Mallis

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

Enclosure

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Indication Statement

Page

510(k) Number (if known): N/A K 020529

Device Name: A-Med Large Centrifugal Blood Pump

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109)

Over-The-Counter

Optional Format 1-

Elias Mollis
Sign-Off

Fratory Device

imber.

10(; .

CONFIDENTIAL

7of 101

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.