(50 days)
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)
- o Fresh Frozen Plasma
- . 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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence of software version 4.5 features: - Automated custom prime for isovolemia management (MNC, TPE) | All new functionalities of software 4.5 perform as intended and designed. |
| - Saline pumping functionality during TPE | |
| - Accuracy/Correctness of new input parameters and output values (e.g., FACT-aligned MNC data) | |
| - Improvements in operator instructions/user interface | |
| Maintenance of existing safety and efficacy of the AMICUS Separator System: (e.g., extracorporeal volume, post platelet count) | Original safety and efficacy profiles of the AMICUS Separator System are maintained with software 4.5. |
| Technological Characteristics: Centrifuge system, fluid control system, safety management, anticoagulant management, physical design, apheresis kits, data management capabilities. | Technological characteristics remain the same as the predicate AMICUS device. |
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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