The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

Device Description

The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusate system. The Pump is electrically driven and can only be used with the AB-180 XD Blood Pump Controller. The AB-180 XD Blood Pump Controller provides pump monitoring, manual pump speed variability and a constant flow of infusate to the Pump.

The AB-180 XC Blood Pump consists of an upper and lower housing. The upper housing encloses the blood contact area of the Pump and holds the impeller, which propels the blood through the Pump. This chamber has a low priming volume. Two tubes connect to this chamber allowing easy connection to extracorporeal circulatory support circuits. The lower housing contains the main rotating component (the rotor) and has an inlet port for the infusion fluid. This infusate acts as a fluid bearing and a local anticoagulation delivery system.

AI/ML Overview

This 510(k) summary describes a submission for a Class III centrifugal blood pump. The review process concluded with a substantial equivalence determination to previously approved devices. Therefore, the device did not require a full clinical trial for approval. The acceptance criteria, study design and results from the provided text are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
In-vitro Bench Testing	The AB-180 XC Blood Pump must demonstrate substantial equivalence to commercially distributed centrifugal blood pumps in various performance aspects. Specific acceptance criteria for: - Hydraulic Performance Tests - Safety and Environmental Tests (meeting IEC 60601-1, IEC 60601-1-2 and IEC 68 standards) - Hemolysis Testing	Demonstrated substantial equivalence to commercially distributed centrifugal blood pumps, specifically the Medtronic BP-80 Bio-Pump®, across these tests.
Biocompatibility	Must be biocompatible and non-toxic, safe for intended use. Testing performed in accordance with FDA Blue Book Memorandum - G95-1 and appropriate sections of Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1.	Testing demonstrated the device is biocompatible and non-toxic, thus safe for its intended use. No biocompatibility issues associated with the infusate.
Sterilization	Sterility Assurance Level (SAL) of $10^{-6}$. EtO dissipation curves must assure residual concentrations of ethylene oxide and ethylene chlorohydrin meet limits in ANSI Standard Number ANSV/AAMI/ISO 10993-7:1995.	Sterilization validated to achieve SAL of $10^{-6}$. EtO dissipation curves confirm compliance with residual concentration limits.
Pyrogens	LAL testing performed, and release criteria must be in accordance with the December 1987 Guideline of the FDA, Office of Compliance (Guideline of Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices).	LAL testing performed and meets the specified release criteria.

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

The provided text only discusses in-vitro bench testing and does not mention human subject clinical trials or imaging data. Therefore, the concept of "test set" as typically understood in AI/ML performance evaluation (i.e., human-annotated data) is not applicable here. The "samples" would refer to the physical devices or components tested in the lab.

Sample size for bench testing: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for demonstrating substantial equivalence.
Data Provenance: The data is generated from in-vitro bench testing conducted in a laboratory setting by Cardiac Assist Technologies, Inc. There is no mention of country of origin for human data, as no human data was used. All testing appears to be retrospective in the sense that it evaluates the manufactured device against pre-defined standards and a predicate device.

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

Not applicable. This was a medical device approval based on in-vitro bench testing and comparison to a predicate device, not on AI/ML diagnostic performance evaluation. Therefore, there was no "ground truth" derived from expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable, as there was no expert review or human-in-the-loop assessment requiring adjudication for this type of device approval.

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

Not applicable. This device is a centrifugal blood pump, not an AI diagnostic/assistant tool. No MRMC study was conducted.

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

Not applicable. This device is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval was established by:

Engineering and Performance Standards: Adherence to established international and national standards for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, IEC 68, ISO 10993-1, ANSI/AAMI/ISO 10993-7:1995).
Predicate Device Performance: Direct comparison of the AB-180 XC Blood Pump's in-vitro performance (hydraulic, safety, environmental, hemolysis) against the established performance of the legally marketed predicate device, the Medtronic BP-80 Bio-Pump®.
Biocompatibility Standards: Compliance with FDA Blue Book Memorandum - G95-1 and ISO 10993-1.
Sterilization Standards: Demonstration of a $10^{-6}$ SAL and compliance with EtO residual limits.
Pyrogen Standards: Compliance with FDA's 1987 Guideline for LAL testing.

8. The Sample Size for the Training Set

Not applicable. There was no machine learning model or "training set" involved in the approval of this hardware medical device.

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

Not applicable. No training set was used.

Summary

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NOV = 1 2000

(D) Cardiac Assist Technologies, Inc.

510(k) Summary

February 25, 2000

Company Name and Address

Sponsor/Manufacturer Cardiac Assist Technologies, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Contact Individual: Richard G. Confer Telephone: (412) 963-7770 Fax: (412) 963-0800

Device Name

Proprietary Name: AB-180 XC System Common/Usual Name: Centrifugal Blood Pump Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-roller type

Establishment Registration Number

Manufacturing Site 2531527 Registration Number Owner Operator Number 9028561 Cardiac Assist Technologies, Inc. 240 Alpha Drive Pittsburgh, PA 15238

Device Classification

Non-roller type blood pumps have been classified as Class III devices by the

Cardiovascular Devices Panel Product Code 74KFM

Note: A petition for reclassification of this type of device from Class III to Class II has been approved by the panel, but the final rule has not been promulgated yet.

000041

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Cardiac Assist Technologies, Inc. AB-180 XC System

Predicate Device or Legally Marketed Device

Medtronic BP-80 Bio-Pump®, K973011, K852698 Hemadyne Minnimed™ Model 1861 Extracorporeal Blood Pump, K780953

Device Description

Statement of Intended Use

The AB-180 XC System consists of the AB-180 XC Blood Pump, a single use, disposable device; the AB-180 XD Blood Pump Controller; a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System.

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Cardiac Assist Technologies, Inc. AB-180 XC System

Technological Characteristics

The technological characteristics of the AB-180 XC Blood Pump are identical to the Hemadyne Minnimed™ Model 1861 Extracorporeal Blood Pump with the exception of the following modifications:

The impeller material has been changed from pyrolytic carbon to polysulfone .
The AB-180 XC Blood Pump contains an integral stator winding for the DC brushless motor, whereas the Minnimed 1861 was magnetically coupled to the drive unit.
The Minnimed 1861 was reusable whereas the AB-180 XC Blood Pump is for single . patient use and is disposable.

Summary of Performance Data

In-vitro Bench Testing:

The AB-180 XC Blood Pump was compared to the predicate device, the Medtronic BP-80 Bio-Pump®, via a battery of in-vitro bench tests. These tests demonstrated that the AB-180 XC Blood Pump is substantially equivalent to commercially distributed centrifugal blood pumps. The in-vitro bench testing included analysis of the following:

Hydraulic Performance Tests .
Safety and Environmental Tests to IEC 60601-1, IEC 60601-1-2 and IEC 68 ●
Hemolysis Testing .

Biocompatibility:

Biocompatibility testing of the AB-180 XC Blood Pump was performed in accordance with the FDA Blue Book Memorandum - G95-1 and appropriate sections of Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1.

Biocompatibility testing in accordance with these standards demonstrated that the AB-180 XC Blood Pump is bicompatible and non-toxic and, thus, safe for its intended use. The AB-180 XC Blood Pump is lubricated by the infusion of a sterile biocompatible solution; and, thus, there are no biocompatibility issues associated with the infusate.

Sterilization:

Sterilization of the AB-180 XC Blood Pump has been validated to assure a sterility assurance level (SAL) of 10°.

EtO dissipation curves are used to assure that the EtO sterilized AB-180 XC Blood Pump meets the limits for residual concentrations of ethylene oxide and ethylene chlorohydrin as published in ANSI Standard Number ANSVAAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Part 7: Ehtylene Oxide Sterilization Residuals).

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Cardiac Assist Technologies, Inc. AB-180 XC System

Pyrogens:

The Limlus Amebocyte Lysate (LAL) method is used for pyrogen testing. LAL testing is The Limitus Amooooyie Dycax (ump and release criteria is in accordance to the December performed on the FD 100 the FDA, Office of Compliance (Guideline of Validation of the 1907 Guildomio Institute Test as an End-Product Endotoxin Test for Human and Linnal Parenteral Drugs, Biological Products, and Medical Devices).

Conclusion

The Cardiac Assist Technologies, Inc. AB-180 XC System is substantially equivalent to the Hemadyne Minnimed Model 1861 Blood Pump and control system, K780953, and the Bio-Medicus BP-80 Bio-Pump and Bio-Console, K852698 and K973011. The intended use, indications for use, and technological characteristics, safety information mence abo, mance data support the substantial equivalence of the AB-180 XC System.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or eagle with three wavy lines extending from its head, resembling feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2000

Cardiac Assist Technologies, Inc C/O Joe Schwoebel, RAC Vice President of Regulatory Affairs 240 Alpha Drive 15238 Pittsburgh, PA.

K991783 Re: AB180 XC System, Model AB-180XC Regulatory Class: III (three) Product Code: KFM Dated: June 22, 2000 Received: June 23, 2000

Dear Mr. Schwoebel:

We have reviewed your Section 510(k) notification of intent to market we nave revrenced above and we have determined the device is che device forcemed at (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure, co regarificant to May 28, 1976, the enactment date of the Incercate ocaments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordance with the pamy, therefore, market the device, subject to the general controls provisions of the Act. The general controls ene gollora of the Act include requirements for annual registration, provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is cli (Premarket Approval), it may be subject to such odditional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 our be 19 million in the equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with 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 assumptions. 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. Joe Schwoebel, RAC

This letter will allow you to begin marketing your device as described inis recei will as on formarket notification. The FDA finding of substantial In your Sroth, promainoice to a legally marketed predicate device equivalence or your device and thus, permits your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire Specific and additionally 809.10 for in vitro regulation (Er or: , please contact the Office of Compliance at (301) diagnobers actions on the promotions on the promotion and 594 4040. Thatelonaderice, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). MSDranding by rerorchoo on your responsibilities under the Act may Ocher general information of Small Manufacturers Assistance at its be obtained from the more (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Center for Devices and Radiological Health

Brim E. Atarr

James E. Dillard III
Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation

Enclosure

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Cardiac Assist Technologies, Inc.

Indications For Use Statement

510(k) number: K991783

Device Name: AB-180 XC System

Indications For Use:

The AB-180 XC System consists of the AB-180 XC Blood Pump, a single use, disposable device; the AB-180 XD Blood Pump Controller, a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use: X (Per 21 CFR 801.109) Over the Counter Use

000082

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.