Rika Plasma Donation System (42000)

BK241097 · Terumo BCT, Inc. Lakewood, CO · GKT · Nov 5, 2024 · Hematology

Device Facts

• Record ID: BK241097
• Device Name: Rika Plasma Donation System (42000)
• Applicant: Terumo BCT, Inc. Lakewood, CO
• Product Code: GKT · Hematology
• Decision Date: Nov 5, 2024
• Decision: SESE
• Regulation: 21 CFR 864.9245
• Device Class: Class 2

Indications for Use

The Rika Plasma Donation System is an automated blood cell separator device and single-use sterile disposable set intended for use in collecting source plasma with or without saline compensation.

Device Story

Automated blood collection system; uses centrifugal force to separate whole blood into plasma and cellular components. Input: whole blood from donor. Process: channel-based centrifugal separation; plasma collected; remaining cells and saline (if configured) returned to donor. Output: source plasma. Used in blood donation centers; operated by trained personnel. Modified saline hook component facilitates saline administration. System ensures safe and effective plasma collection via automated protocols.

Clinical Evidence

Bench testing only. Performance testing demonstrated that the Rika Plasma Donation System with the modified saline hook meets all established performance requirements and is usable by intended users.

Technological Characteristics

Automated blood cell separator; channel-based centrifugal separation principle. System includes embedded software and protocols. Modified wide saline hook. Operates as a standalone system for blood component collection.

Indications for Use

Indicated for the collection of source plasma from donors, with or without saline compensation, using an automated blood cell separator.

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

• Terumo BCT: Rika Plasma Donation System

Submission Summary (Full Text)

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**Rika Plasma Donation System**

Modified Saline Hook

Traditional 510(k) Submission---

**TERUMO**
BLOOD AND CELL
TECHNOLOGIES

## **510(K) SUMMARY**

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided.

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TERUMO BLOOD AND CELL TECHNOLOGIES

# 510(k) Summary

I. SUBMITTER

Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
Phone: [phone]

Contact Person: Ashley Davis
Title: Principal Specialist, Regulatory Affairs
Phone: [phone]
Fax: [phone]

Date Prepared: DATE

II. DEVICE

Trade Name of Device: Rika Plasma Donation System
Common or Usual Name: Automated Blood Collection System, or Separator, Automated, Blood Cell, Diagnostic/ Automated Blood Cell Separator
Classification Name: Separator, Automated, Blood Cell, Diagnostic
Regulatory Number: 21 CFR 864.9245(b)
Product Code: GKT

III. DEVICE CHARACTERISTICS SUMMARY

The Rika Plasma Donation System is an automated blood component collection system that uses centrifugal force to separate whole blood into plasma and its remaining cells. The plasma is collected, and the remaining cells and saline, if configured, are returned to the donor.

IV. INDICATIONS FOR USE

The Indication for Use statement for the Rika Plasma Donation System is as follows:

The Rika Plasma Donation System is an automated blood cell separator device and single-use sterile disposable set intended for use in collecting source plasma with or without saline compensation.

Terumo BCT, Inc.
10811 West Collins Ave.
Lakewood, Colorado 80215-4440
USA
USA Phone: [phone]
Phone: [phone]
Fax: [phone]

Terumo BCT Europe N.V.
Europe, Middle East and Africa
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: [phone]
Fax: [phone]

Terumo BCT (Asia Pacific) Ltd.
Room 3903-3903A, 39/F
ACE Tower, Windsor House
311 Gloucester Road
Causeway Bay, Hong Kong
Phone: [phone]
Fax: [phone]

Terumo BCT Latin America S.A.
La Pampa 1517 – 12th Floor
C1428DZE
Buenos Aires
Argentina
Phone: [phone]
Fax: [phone]

Terumo BCT Japan, Inc.
20-14, 3-chrome
Higashi Gotanda, Shinagawa-ku
Tokyo 141-0022
Japan
Phone: [phone]
Fax: [phone]

UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM

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**TERUMO**BLOOD AND CELL TECHNOLOGIES

## V. TECHNOLOGICAL COMPARISON

Provided in **Table 1** is a high-level comparison of the Rika Plasma Donation System with modified saline hook to the predicate device.

| Category | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| **Device Name** | **Rika Plasma Donation System** | **Terumo BCT: Rika Plasma Donation System** | N/A |
| **Classification Name** | Automated blood cell separator | Automated blood cell separator | Same |
| **Regulatory Number** | 21 CFR Part 864.9245 | 21 CFR Part 864.9245 | Same |
| **Product Code** | GKT | GKT | Same |
| **Class** | II | II | Same |
| **Indication for Use** | Collection of Source Plasma | Collection of Source Plasma | Similar |
| **Fundamental Scientific Technology** | Channel based centrifugal separation | Channel based centrifugal separation | Similar |
| **Software** | Embedded + Protocol | Embedded + Protocol | Same |
| **Saline Hook** | Modified Wide Hook | Wide Hook | Similar |

## VI. PERFORMANCE DATA

The following types of data were provided in support of the substantial equivalence determination. Each type of data is further expanded upon in the sections below.

- Performance Testing

### A. Performance Testing

The Rika Plasma Donation System with the modified saline hook was tested against its performance requirements through demonstration and direct testing. The testing showed that the Rika Plasma Donation System performed according to its performance requirements and is usable by the intended users.

## VII. CONCLUSIONS

Based on the results of the non-clinical tests performed on the Rika Plasma Donation System with the modified saline hook, it is as safe and effective as the legally marketed predicate device. The information provided in the 510(k) demonstrates that the Rika Plasma Donation System is substantially equivalent to the identified predicate and reference devices.

UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM