(526 days)
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.)
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.
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.
§ 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.