NexSys PCS® Plasma Collection System with Express®Plus Technology

BK220798 · Haemonetics Corporation Boston, MA · GKT · Jun 20, 2023 · Hematology

Device Facts

• Record ID: BK220798
• Device Name: NexSys PCS® Plasma Collection System with Express®Plus Technology
• Applicant: Haemonetics Corporation Boston, MA
• Product Code: GKT · Hematology
• Decision Date: Jun 20, 2023
• Decision: SESE
• Regulation: 21 CFR 864.9245
• Device Class: Class 2

Indications for Use

The NexSys PCS® plasma collection system with Express®Plus Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion. Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only.

Device Story

Automated blood cell separator using centrifugation to separate whole blood into plasma and remaining components for return to donor. Express®Plus technology introduces updated flow control algorithms and compatibility with 0625Q-00 plasma bowl. Operated by trained personnel in plasma collection centers. System monitors and manages fluid flow and separation parameters to ensure safe collection. Output is collected plasma for transfusion or source plasma for fractionation. Benefits include optimized collection efficiency and maintained safety profile consistent with predicate devices.

Clinical Evidence

Bench testing only. No clinical trials performed. Evidence includes non-clinical bench testing, comparison to predicate/reference devices, and analysis of TPLC/MAUDE adverse event databases for product code GKT, supported by expert analysis and literature review.

Technological Characteristics

Automated centrifugal blood cell separator. Uses single-use sterile disposable sets. Includes updated flow control algorithm and 0625Q-00 plasma bowl. Operates via centrifugation. No change in materials or energy source from predicate.

Indications for Use

Indicated for use as an automated cell separator and blood component collector for the collection of source plasma and plasma for transfusion in donors, using single-use sterile disposable sets.

Regulatory Classification

Identification

An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”

Predicate Devices

• NexSys PCS Plasma Collection System with Persona Technology (BK200498)
• Amicus Separator System (BK170099)

Submission Summary (Full Text)

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# HAEMONETICS®

## 510(k) Summary

**Date:** June 20, 2023

# **Submitter:**

Haemonetics Corporation
125 Summer Street
Boston, MA 02110

# **Contact:**

Amy Tannenbaum
Senior Regulatory Affairs Specialist
Phone: [phone]
Email: [e-mail]

# **Device Information:**

*Trade Name:* NexSys PCS® Plasma Collection System with Express®Plus Technology
*Common Name:* Automated Blood Cell Separator
*Classification Name:* Separator, Automated, Blood Cell, Diagnostic
*Regulation Number:* 21 CFR 864.9245
*Review Panel:* Hematology
*Product Code:* GKT
*Device Class:* 2

# **Legally Marketed Predicate Device:**

| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| BK200498 | NexSys PCS Plasma Collection System with Persona Technology | GKT |
| BK170099 | Amicus Separator System | GKT |

# **Device Description Summary:**

The Haemonetics NexSys PCS® Plasma Collection System is designed for separation of whole blood by centrifugation, collection of plasma, and return of the remaining components to the donor. The plasma may be designated for use in therapeutic transfusion or be conserved, used as source plasma, and subsequently fractioned into plasma-derived products.

---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110

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# HAEMONETICS®

The Express®Plus technology updates the NexSys PCS® software algorithm and device firmware, and enables the use of the new 0625Q-00 Plasma bowl.

## Intended Use/Indications for Use:

The NexSys PCS® plasma collection system with Express®Plus Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation.

Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion.

Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only.

## Indications for Use Comparison:

There is no change to the indications for use of the NexSys PCS® Plasma Collection System with Express®Plus Technology. The currently cleared indications of the predicate (BK200498) continue to be supported with the software upgrade. The 0625Q-00 plasma bowl has a subset of these indications for the collection of source plasma only.

The NexSys PCS® plasma collection system with Express®Plus Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation.

Products that can be collected using the NexSys PCS® system include source plasma and plasma for transfusion.

Using the 0625Q-00 bowl, the NexSys PCS® system with Express®Plus Technology is intended to collect source plasma only.

## Technological Comparison:

There is no change to the material, composition, principle of operation, or energy source from the predicate NexSys PCS® (BK200498). The device functions with the same intended use for the collection of plasma via apheresis.

The change in design for the subject NexSys PCS® Plasma Collection System with Express®Plus Technology introduces enhancements to the flow control algorithm and enables the use of the 0625Q-00 plasma bowl. These changes are within the parameters of the AMICUS

---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110

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# HAEMONETICS®

reference device (BK170099). Through the discussion on substantial equivalence and the bench testing provided, it is concluded that the changes associated with the Express®Plus Technology upgrade do not change the benefit-risk profile of the NexSys PCS® system.

## Non-Clinical and/or Clinical Tests Summary & Conclusions

The non-clinical bench testing and comparison to the predicate and reference devices show the subject NexSys PCS® Plasma Collection System with Express®Plus Technology to be substantially equivalent to the devices on the market and that there is no impact to the safety and effectiveness of the device. Additional analysis of TPLC/MAUDE database for related adverse events for product code GKT and relevant clinical literature and expert analysis, supports the safety and effectiveness of the proposed changes to the NexSys PCS® device and that there is no change to the benefit-risk profile of the device.

Results from the non-clinical bench testing demonstrate that the NexSys PCS Plasma Collection System with ExpressPlus Technology and is as safe and effective, and performs as well as its proposed predicate device.

---Haemonetics Corporation | 125 Summer Street | Boston, MA 02110