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The AMICUS Separator System is an automated blood cell separator intended for use in therapeutic apheresis applications and may be used to perform Therapeutic Plasma Exchange (TPE).

The AMICUS Separator System is an automated blood cell separator intended for use in the collection of blood components and mononuclear cells.

The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE).

The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter.

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:

• Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) .
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double . or triple units)
• Red Blood Cells, Leukocytes Reduced (by apheresis) .
• . Mononuclear Cells
• Plasma .
  • o Fresh Frozen Plasma
    • . Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy.
  • o Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
    • Must be stored at 1-6°C within 8 hours after phlebotomy and placed . in a freezer at -18° C or colder within 24 hours after phlebotomy.
    • Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma.
  • o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)
• . Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product . is not equivalent to Fresh Frozen Plasma.
• o Source Plasma

Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences.

The operator is responsible for preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms.

Once the cell separation is complete, the operator removes the needle(s) from the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

This document describes a 510(k) premarket notification for a software update (version 4.5) to the AMICUS Separator System, an automated blood cell separator. The purpose of this submission is to demonstrate substantial equivalence to the currently marketed AMICUS Separator System.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format with corresponding performance results. Instead, it broadly mentions that "Software verification, systems verification and systems validation were performed in support of this submission. The results of the testing were acceptable."

The core acceptance criterion implicitly stated and tested is substantial equivalence to the predicate device, especially regarding the described enhancements in software version 4.5. These enhancements primarily focus on:

• Automated custom prime in Mononuclear (MNC) and Therapeutic Plasma Exchange (TPE) procedures to maintain isovolemia.
• Functionality to pump saline during TPE procedures.
• Additional input parameters and output values (e.g., Product Volume and ACD in Product for MNC, in line with FACT requirements).
• Additional instruction screens and other minor enhancements.

The "reported device performance" is summarized as:

The conclusion explicitly states: "Based on the validation and verification activities performed, the AMICUS Separator System modified with software 4.5 provides a device system that is substantially equivalent to the currently marketed AMICUS Separator System." This implies all these implicit criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides very limited detail on the specifics of the test set, sample size, or data provenance. It only states: "Software verification, systems verification and systems validation were performed in support of this submission."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a software update for an existing device, it's likely that internal testing, possibly using simulated data or real-world operational data from in-house labs or clinical sites, was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this submission. The device is an automated blood cell separator, and the submission concerns a software update. "Ground truth" in this context would typically refer to the correct functioning of the software according to specifications, and the accuracy of its calculations and controls. This would be established through engineering and software testing protocols, not by expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used in studies where human interpretation (e.g., image reading) requires consensus, which is not the nature of the validation described. Software and system validation typically involve comparing system outputs against predefined specifications and expected results, not human adjudication of subjective interpretations.

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. The AMICUS Separator System is an automated blood processing device, not an AI-assisted diagnostic or interpretive tool for human readers. Therefore, an MRMC study related to human reading performance with or without AI assistance is not relevant to this submission.

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

Yes, implicitly. The "Software verification, systems verification and systems validation" would involve extensive testing of the algorithm (software) in various scenarios, both in isolation ("standalone") and within the full system, to ensure it performs according to its design specifications. While a specific "standalone" study isn't detailed, the nature of software and system validation inherently includes rigorous testing of the automated functions without direct human intervention impacting the internal logic or calculations. The human "operator" monitors the system, but the core function of separation and collection is automated by the device's algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software verification and validation, the "ground truth" would be the pre-defined design specifications and expected outputs of the software and system. For example:

• For the custom prime function: The ground truth would be that the system accurately calculates and delivers the prescribed priming fluid volume while maintaining isovolemia as specified in the design requirements.
• For saline pumping: The ground truth would be precise delivery of saline according to operator input and system control.
• For new output parameters (e.g., MNC Product Volume, ACD in Product): The ground truth would be the accurate calculation and display of these values based on the internal measurements and algorithms, consistent with FACT requirements where applicable.

This "ground truth" is established by the engineering and scientific principles governing the device's operation and the regulatory/clinical standards it must meet (e.g., FACT requirements mentioned for MNC output values).

8. The sample size for the training set

Not applicable. This submission is for a software update to an automated device, not a machine learning or AI-driven system that would typically require a "training set" in the context of learning algorithms. The software's logic is explicitly programmed based on engineering principles and clinical requirements, not "trained" on a dataset.

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

Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" (i.e., correct behavior and outputs) for the software was established through engineering design, scientific principles, and adherence to specific performance requirements and regulatory standards for blood processing devices.

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The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE).

The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange procedure. For use with the AMICUS Separator System.

The AMICUS separator is a continuous-flow, centrifugal device that separates whole blood into its components. Blood components are collected using sterile fluid path, single-use, apheresis kits. The cells are centrifugally separated within the kit by density differences.

The Therapeutic Plasma Exchange (TPE) procedure is an apheresis collection procedure coupled with an infusion procedure. The collected plasma, which contains most of the anticoagulant, is pumped to a waste container(s). The patient's WBCs, the majority of platelets and a small amount of plasma and anticoagulant are mixed with a physician-prescribed replacement fluid, such as FFP, human albumin and/or crystalloid solutions, and returned to the patient. This process continues until the target plasma volume has been removed and replaced per physician order.

The operator is responsible for preparing and monitoring the patient as well as operating and monitoring the AMICUS separator during the TPE procedure. The operator controls the separator through a touch screen. When necessary, the operator is alerted to problems, or given notes via messages displayed on the screen with corresponding audible alarms. Once complete, the operator disconnects the donor/patient, removes the kit, and disposes of the kit per institutional SOPs. The kit is packaged in a recyclable plastic tray.

The Blood Component Filter Set with Vented Spike and Luer Adapter is an optional accessory intended to be used in conjunction with the AMICUS Separator System in Therapeutic Plasma Exchange (TPE) procedures to administer physician prescribed replacement fluids during the TPE procedure, when blood component filtration is needed (e.g. when using fresh frozen plasma). The filter set has a common blood transfusion set design and is comprised of a blood component filter, tubing, vented spike and a luer lock/cap. The filter set is a single use, sterile fluid path intravascular administration set. The filter set is connected to the TPE kit via the male luer connector and the vented spike is used to access the prescribed replacement fluid container. The flow rate through the filter set is controlled by the AMCUS Separator System.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

AMICUS® Separator System - Use in Therapeutic Plasma Exchange

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of patients or procedures. The text refers to "test procedures" and "control procedures" as groups within a clinical evaluation. It doesn't break down the exact number of participants in each.
• Data Provenance: The study was a "clinical evaluation," suggesting a prospective study. The country of origin of the data is not specified in the provided text.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the text. The study evaluates the device's technical performance (plasma removal efficiency, fluid balance, etc.) rather than diagnostic accuracy requiring expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the study focused on objective performance metrics of a medical device, not on diagnostic interpretations requiring adjudication.

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

A MRMC comparative effectiveness study was not conducted. This study evaluates the performance of a medical device (AMICUS Separator System) in performing a therapeutic procedure (Therapeutic Plasma Exchange), not the interpretive skills of human readers.

6. Standalone Performance

Yes, a standalone performance study (clinical evaluation) was done. The study specifically compared the AMICUS Separator System's performance (Test group) against a "Control group" (which, based on context, appears to be the predicate device, COBE Spectra). The reported metrics (plasma removal efficiency, fluid balance, platelet loss, plasma hemoglobin) directly reflect the algorithm's (device's) performance.

7. Type of Ground Truth Used

The "ground truth" for this study was objective clinical performance metrics measured during the Therapeutic Plasma Exchange procedures. These include:

• Efficiency of plasma removal (quantified percentage).
• Fluid balance (accuracy of maintenance).
• Levels of platelet loss in waste plasma.
• Levels of plasma hemoglobin in waste plasma.

8. Sample Size for the Training Set

This information is not applicable/not provided. The AMICUS Separator System is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Its operational parameters and software are developed through engineering and verification/validation processes, not machine learning training.

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

This information is not applicable/not provided for the same reason as point 8. The device's operation is based on established engineering principles and extensive system validation and verification activities, rather than a machine learning training paradigm.

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Administration of blood and blood by-products.

Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.

This document is a 510(k) summary for Fenwal's Blood Component Recipient and Infusion Sets. It does not contain a study evaluating the performance of the device against specific acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K881321 and K811078).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is not part of this 510(k) submission. The submission states: "Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed." This implies that the design and performance characteristics are identical to the predicate devices, and a separate study for this 510(k) was not deemed necessary for safety and effectiveness, as long as it is proven to be substantially equivalent.

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