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).

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the date "JUN 10 2014" at the top left corner. To the right of the date, there is a code "K141019" and "Page 1 of 4". The word "Fenwal" is written in a large font at the bottom left corner of the image.

510(K) SUMMARY

Date Prepared:

April 18, 2014

Owner and Contact Person:

Owner/Operator	Owner/Operator #: 9098803
	Fenwal, Inc.
	Three Corporate Drive
	Lake Zurich, IL 60047
Contact Name:	Kim Forch
Title:	Manager, Regulatory Affairs
Address:	Fenwal, A Fresenius Kabi Company
	Three Corporate Drive, 2nd Floor
	Lake Zurich, IL 60047
Telephone:	847-550-7962
Fax:	847-550-2960
E-mail:	kim.forch@fresenius-kabi.com

Device Trade Name:

AMICUS Separator System

Common Name/Usual Name:

Automated Separator, Blood Cell and Plasma, Therapeutic Automated Blood Cell Separator (Centrifugal Separation Principle)

Classification Name:

Automated separators, used for separation of blood cells and plasma for therapeutic purposes, have not been classified under a regulation by the Center for Devices and Radiological Health due to pre-amendment status.

21 CFR 864.9245 Automated Blood Cell Separator

Automated blood cell separators which are based on centrifugation type technology have been classified by the Center for Biologics Evaluation and Research as Class II devices with Special Controls (Docket 2005N-0017, Final Rule, 30-Nov-07).

Product Code and Classification Panel:

LKN (Gastroenterology/Urology panel) - Unclassified (due to pre-amendment status) GKT (Hematology panel) - Separator, Automated, Apheresis

ee Corporate Drive
xe Zurich, Illinois 60047

f: 812.550.2300
f: 847.550.2946

.farmzline.com

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Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:

Fenwal is claiming substantial equivalence with the currently cleared version of the AMICUS Separator System. The AMICUS Separator System was most recently cleared for Therapeutic Plasma Exchange (TPE) under 510(k) K111702 on March 22, 2012. The AMICUS Separator System was most recently cleared for apheresis under 510(k) BK120082 on January 8, 2013. This includes all operating protocols and changes previously cleared for the AMICUS Separator System.

Device Description:

Modification to the Existing Device:

Software version 4.5 has been developed for use with the AMICUS separator. This new software provides several enhancements including functionality to perform an automated custom prime in Mononuclear (MNC) and Therapeutic Plasma Exchange (TPE) procedures to maintain isovolemia in patients with low blood volume and/or low hematocrit. Specifically, this option allows the operator to fill the kit tubing with a prescribed priming fluid (e.g., blood) after the set is primed with saline and before the patient is connected.

The software also provides functionality to pump saline to a patient when administering saline during a TPE procedure instead of administering it through gravity. It also includes additional input parameters and output values on the MNC and TPE procedure screens. For MNC, this includes Product Volume and ACD in Product output values designed to provide product information in line with FACT (Foundation for the Accreditation of Cellular Therapy) requirements. Also included are additional instruction screens to aid the operator in the steps of kit installation, as well as other minor enhancements and updates.

A new version of the AMICUS Separator Operator's Manual and associated Data Management Supplement has been created to include information relevant to software version 4.5. The operator's manual has been updated to reflect the new functionalities, input parameters and

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output values added as a result of software 4.5 while retaining the current information relevant to software 4.4. The manual and supplement also include updates due to some minor enhancements. Additionally, the manual has been updated to include some instructions and appendices not related to the new software.

Statement of Intended Use:

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.

Indications for Use:

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)

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. 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

Technological Characteristics as Compared to the Predicate Device

The technological characteristics of the AMICUS separator remain the same as the predicate AMICUS device. This includes the centrifuge system, fluid control system, safety management system (including safety sensors and alarms), and anticoagulant management system. The physical design of the AMICUS separator instrument is identical to the marketed AMICUS device. The AMICUS apheresis kits remain the same as the currently cleared kits, including design, materials and manufacturing methods. The data management capabilities remain the same as the cleared AMICUS device.

Performance Data:

Software verification, systems verification and systems validation were performed in support of this submission. The results of the testing were acceptable.

Conclusion:

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.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2014

Fenwal, Inc. Kim Forch Manager, Regulatory Affairs Three Corporate Drive Lake Zurich, IL 60047

Re: K141019

Trade/Device Name: AMICUS Separator System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN, GKT Dated: April 18, 2014 Received: April 21, 2014

Dear Kim Forch,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Kim Forch

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Benjamin Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510{k} Premarket Notification AMICUS Separator System - Software 4.5 Indications for Use Statement Section 4, Page 1 of 2

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K141019

Device Trade Name: AMICUS Separator System

Indication(s) for Use:

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

Prescription Use: X 21 CFR 801 Subpart D AND/OR

Over-The Counter Use: 21 CFR Subpart C

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

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Traditional 510(k) Premarket Notification AMICUS Separator System - Software 4.5 Indications for Use Statement Section 4, Page 2 of 2

. Plasma
- o Fresh Frozen Plasma
  - Must be prepared and placed in a freezer at -18° C or colder . within 8 hours after phlebotomy.
- Plasma Frozen Within 24 Hours After Phlebotomy (PF24) o
  - . 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

Prescription Use: X 21 CFR 801 Subpart D AND/OR

Over-The Counter Use: 21 CFR Subpart C

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

Benjamin R. Fisher -S
2014.06.17 18:27 -04'00'

Regulation Number and Section

N/A