IMUGARD WB PLT Platelet Pooling Set

BK230838 · Terumo BCT Lakewood, CO · KSR · Jul 27, 2023 · Hematology

Device Facts

• Record ID: BK230838
• Device Name: IMUGARD WB PLT Platelet Pooling Set
• Applicant: Terumo BCT Lakewood, CO
• Product Code: KSR · Hematology
• Decision Date: Jul 27, 2023
• Decision: SESE
• Regulation: 21 CFR 864.9100
• Device Class: Class 2

Indications for Use

IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool and store whole-blood-derived platelets. For platelets prepared through manual methods, leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. For platelets prepared by the Reveos® Automated Blood Processing System, leukoreduction and pooling occur on Day 1 or Day 2, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a 'safety measure.'

Device Story

Disposable set for leukoreduction, pooling, and storage of up to six whole-blood-derived platelet units; utilizes gravity drainage through integrated leukoreduction filter into ELP storage bag; includes sampling assembly for bacterial testing. Used in blood centers and hospitals; operated by trained personnel. Enables creation of pooled platelet product comparable to single apheresis therapeutic dose; extends storage capability up to 7 days when combined with FDA-cleared bacterial detection. No changes to device design; submission extends intended use to include platelets processed via Reveos system.

Clinical Evidence

Bench testing only. Evaluated platelet quality (leukoreduction, recovery, pH) for units processed via Reveos system and pooled/stored on Day 1 or Day 2. Results confirmed acceptable platelet quality maintained through 7-day storage duration.

Technological Characteristics

Single-use, ethylene oxide (ETO) sterilized disposable set. Components primarily Polyvinyl chloride (PVC) with variable plasticizers; ELP storage bag constructed of citrated PVC. Gravity-driven filtration system. No electronic components, software, or energy sources.

Indications for Use

Indicated for the leukoreduction, pooling, and storage of whole-blood-derived platelets for transfusion. Applicable to platelets prepared via manual methods or the Reveos Automated Whole Blood Processing System.

Regulatory Classification

Identification

An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Predicate Devices

• IMUGARD WB PLT Platelet Pooling Set (BK210658)

Submission Summary (Full Text)

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**IMUGARD WB PLT Platelet Pooling Set**
Traditional 510(k) Submission---

**TERUMO**
BLOOD AND CELL
TECHNOLOGIES

## 5 510(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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**IMUGARD WB PLT Platelet Pooling Set**
Traditional 510(k) Submission

TERUMO
BLOOD AND CELL
TECHNOLOGIES

## 510(k) Summary

### I. SUBMITTER

Terumo BCT, Inc.
10810 W. Collins Avenue
Lakewood, Colorado 80215
Phone: [phone]

Contact Person: Jennifer Burton
Title: Sr. Regulatory Affairs Specialist
Phone: (b) (6)
Fax: [phone]

Date Prepared: June 23, 2023

### II. DEVICE

Trade Name of Device: IMUGARD WB PLT Platelet Pooling Set
Common or Usual Name: Platelet Pool and Store Set with Filter
Classification Name: Container, empty, for collection & processing of blood
& blood components
Regulatory Class: In accordance with 21 CFR 864.9245(b), the
classification for this device is Class II.
Product Code: KSR

### III. PREDICATE DEVICE

Table 5.1: Predicate and Reference Device Information

| Device | Product Classification | Trade Name Of Predicate Device | Manufacturer and 510(k) Holder | 510(k) Clearance Number |
| --- | --- | --- | --- | --- |
| Predicate | KSR | IMUGARD WB PLT Platelet Pooling Set | Terumo BCT | BK210658 |

### IV. DEVICE DESCRIPTION

This 510(k) is to extend the intended use of the IMUGARD WB PLT Platelet Pooling Set to include platelets derived using the Reveos® Automated Whole Blood Processing System. There are no changes to the design or use of the device.

#### A. Device Identification

The IMUGARD WB PLT Platelet Pooling Set, hereafter referred to as IMUGARD, can be used to leukoreduce (LR), pool and store up to six single units of whole blood derived platelets. For platelets prepared through manual methods, LR and pooling occur on Day 1. For platelets prepared by Reveos Automated Whole Blood Processing System, LR and pooling occur on Day 1 or Day 2. The resulting platelet product is comparable to a single apheresis therapeutic dose and can be stored up to seven days.

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]

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**IMUGARD WB PLT Platelet Pooling Set**
Traditional 510(k) Submission

**TERUMO**
BLOOD AND CELL
TECHNOLOGIES

## **B. Device Characteristics**

IMUGARD is an ethylene oxide (ETO) sterilized, single use disposable set.

## **C. Device Description**

IMUGARD is designed to allow the attachment of up to six (6) Whole Blood Derived Platelet (WBDP) concentrates for filtration, pooling and storage. WBDPs can be prepared using commercially available manual/semi-automated blood collection systems or automated blood processing systems. Up to 6 single units of WBDPs are sterile docked to the pooling arms and are then gravity drained through a leukoreduction filter. The leukoreduced and pooled platelet product then enters the ELP platelet storage bag (ELP bag). A sampling assembly is attached to the ELP bag. The sampling assembly allows aseptic removal of a sample from the ELP bag for subsequent bacterial or other applicable testing conducted by the blood center. The platelet pooling set allows for the combination of WBDPs to create a leukoreduced product that is comparable to a single apheresis therapeutic dose.

## **D. Environment of Use**

IMUGARD is intended to be used in blood centers, hospitals and healthcare facilities.

## **E. Materials of Use**

IMUGARD is generally comprised of Polyvinyl chloride (PVC) components with variable plasticizers depending on the component. The ELP bag is constructed of Polyvinyl chloride (PVC) citrated.

## **F. Key Performance Specifications/Characteristics of the Device**

IMUGARD is designed to allow the attachment of up to six (6) Whole Blood Derived Platelet (WBDP) concentrates for filtration, pooling and storage in the ELP bag. Single units of WBDPs are sterile docked to the pooling arms and are then gravity drained through a leukoreduction filter. A sampling assembly allows aseptic removal of a sample from the ELP bag for subsequent bacterial or other applicable testing conducted by the blood center. The platelet pooling set allows for the combination of WBDPs to create a leukoreduced product that is comparable to a single apheresis therapeutic dose.

## **V. INTENDED USE**

IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool and store whole-blood-derived platelets. For platelets prepared through manual methods, leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. For platelets prepared by the Reveos® Automated Blood Processing System, leukoreduction and pooling occur on Day 1 or Day 2, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a 'safety measure.'

## **VI. LABELING COMPARISON**

A comparison of IMUGARD labeling with the predicate device to establish substantial equivalence is provided in **Table 5.2**.

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**IMUGARD WB PLT Platelet Pooling Set**
Traditional 510(k) Submission

**TERUMO**
BLOOD AND CELL
TECHNOLOGIES

**Table 5.2: Labeling Comparison**

| Category | Predicate Device (BK210658) | Subject Device | Comparison |
| --- | --- | --- | --- |
| Intended Use | IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool and store whole-blood-derived platelets. Leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a 'safety measure.' | IMUGARD WB PLT Platelet Pooling Set is intended to be used to leukocyte-reduce, pool and store whole-blood-derived platelets. For platelets prepared through manual methods, leukoreduction and pooling occur on Day 1, the day after whole blood collection and processing, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. For platelets prepared by the Reveos® Automated Blood Processing System, leukoreduction and pooling occur on Day 1 or Day 2, with subsequent platelet storage up to Day 7 in the Terumo BCT ELP storage bag when used with FDA-cleared or approved bacterial detection tests. Additionally, for platelet units stored past 5 days and through 7 days, every pooled platelet product must be tested with a bacterial detection device cleared by FDA and labeled as a 'safety measure.' | The intended use is identical for whole blood platelets prepared through manual methods. The subject device includes additional text for whole blood platelets prepared by Reveos. There have been no modifications or changes in the safety or effectiveness of the device since clearance; therefore, the difference in platelet preparation does not impact the safety or effectiveness of IMUGARD. |

As shown in **Table 5.2**, the intended use is identical for whole blood platelets prepared through manual methods. There have been no modifications of the device since clearance; therefore, the additional text included for whole blood platelets prepared by Reveos does not impact the safety or effectiveness of IMUGARD.

## VII. PERFORMANCE DATA

*In vitro* bench testing performance data was provided in support of the substantial equivalence determination.

Platelets prepared using the Reveos Automated Whole Blood Processing System were pooled and stored using the IMUGARD WB PLT Platelet Pooling Set. Platelets met expectations for leukoreduction, platelet recovery, and pH at the end of storage, whether pooling occurred on Day 1 or Day 2 after collection.

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**IMUGARD WB PLT Platelet Pooling Set**
Traditional 510(k) Submission---

**TERUMO**
BLOOD AND CELL
TECHNOLOGIES

Reveos platelet pools are capable of being stored for up to 7 days in the Terumo BCT ELP storage bag, whether pooling occurs on Day 1 or Day 2 after collection, when used with FDA-cleared or approved bacterial detection tests. Acceptable platelet quality was well-maintained for the 7-day storage duration.

### VIII. CONCLUSIONS

Based upon the results of the non-clinical tests performed, IMUGARD is shown to be as safe and effective as the identified predicate device. The information provided in the 510(k) demonstrates that IMUGARD is substantially equivalent to its identified predicate device.

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