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Section 5 510(k) Summary
I. Manufacturer Information
Name: Terumo BCT, Inc.
Address: 10811 W. Collins Avenue
Lakewood, CO 80215
Telephone No.: (303) 231-4832
Contact Person: Patti L. Arndt
Summary Preparation Date: October 15, 2013
II. Name of Device
|Trade Name||Spectra Optia Apheresis System|
|Common Name||Apheresis Device or System|
|FDA Device Classification Name||Automated Blood Cell Separator|
III. Legally Marketed Predicate Device
|Trade Name||COBE® Spectra Apheresis System – PMN Collection Procedure|
|Relevant 510(k) Clearance Numbers||K831004, BK020041|
|Manufacturer and 510(k) Holder||Terumo BCT|
IV. Device Description
The Spectra Optia Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, (1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems), (2) a sterile, single-use, disposable blood tubing set and, (3) embedded software.
Terumo BCT has implemented the new cell collection procedure by modifying the FDA-cleared MNC Cell Collection Protocol (BK120012). Specifically, the system’s embedded software, disposable tubing set and, (3) centrifuge filler have been modified to facilitate the collection of granulocytes. When the PMN Collection Procedure is released for sale in the U.S., the Spectra Optia system will be configured as follows:
|Subsystem||PMN Collection Procedure||Described in 510(k) Submission|
|1||Apheresis Machine||Catalog No. 61000||No|
(component of apheresis machine)
|2||Disposable Tubing Set||Spectra Optia IDL Set, Catalog No. 10300||Yes|
|3||Embedded Software||Version 9.0||Yes|
V. Indications for Use / Intended Use
The system’s intended use has been modified to include PMN Collection procedures.
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform procedures for the collection of granulocytes (PMN) and mononuclear cells (MNC) from the peripheral blood.
VI. Technological Comparisons
Key similarities between the Spectra Optia PMN Collection Procedure, the COBE Spectra PMN Collection Procedure (predicate device) and the Spectra Optia MNC Collection Procedure (reference device) are summarized in the following table.
|Key Attribute/Feature||Compared to the Predicate and/or Reference Device...|
|1||Intended Use||Compared to the Predicate Device: Both the Spectra Optia and predicate COBE Spectra systems may be used to collect granulocytes (PMN Cells) form the peripheral blood. The cells are collected from healthy blood donors and are used in allogeneic transfusions.|
|2||Essential Technology||Compared to the Predicate and Reference Devices: Both Apheresis systems achieve their essential function (the separation of blood into its components) through centrifugation - when used either for MNC or PMN collections.
Compared to the Predicate Device: Compared to the COBE Spectra System, the Spectra Optia System includes a variety of features that automate procedures and enhance the system's overall usability, including an optical interface management system (see K071079).
|3||Hardware or “Equipment”||Compared to the Reference Device: The Spectra Optia System's MNC and PMN Collection procedures are implemented using the same hardware or "equipment" – with the exception of the centrifuge filler. As described in Section 11, MNC collections are conducted using the Spectra Optia System’s Standard Filler, while PMN collections require the new IDL Filler.|
|4||Software||Compared to the Predicate Device: Many of the software algorithms that underlie the COBE Spectra's PMN procedure are controlled by the same equations in the Spectra Optia System.
Compared to the Reference Device: The Spectra Optia System's MNC and PMN procedures share the same underlying architecture and base software, and are implemented using the same control, safety, and automated process control subsystems.
|5||Disposable Tubing Set||Compared to the Reference Device: The new Spectra Optia IDL Set is similar to the FDA-cleared Collection Set, which is used to collect mononuclear cells. Both sets are designed to minimize operator errors during procedure set-up (e.g., are cassette-based and color-coded), and are comprised of the same well-characterized biocompatible materials. The IDL and Collection Sets are EtO-sterilized in Terumo BCT's Lakewood facility, have a 2-year shelf life, and are sterilized and shipped using the same validated packaging system.|
VII. Performance Data
A prospective, multisite clinical trial was conducted under IDE 14591 and confirmed that the Spectra Optia system’s PMN Collection Protocol (1) performs as designed, (2) is safe and effective with respect to its intended use and, (3) is substantially equivalent to the same procedure conducted using the predicate COBE Spectra Apheresis System.
The randomized, open-label, paired crossover study was designed to demonstrate that the Spectra Optia Apheresis System’s PMN Cell Collection Procedure performed at least as well as the predicate device in a representative sample of 32 mobilized blood donors. The multisite study included several different measures of device performance (measured as collection efficiency) and also characterized the collected cellular product with respect to volume, purity, target cell count, and PMN cell viability and functionality. Adverse events and device malfunctions were tracked throughout the investigation to evaluate the procedure’s safety using both devices. Lastly, a usability assessment demonstrated the highly automated Spectra Optia system’s “ease of use”, compared to the predicate device.
The pivotal study achieved its primary endpoint, demonstrating that the Spectra Optia system’s PMN collection efficiency was non-inferior to the same protocol implemented on the predicate COBE Spectra system. PMN collection efficiency was 10.4% higher for the more automated Spectra Optia system compared to the COBE Spectra system: 53.7% ± 6.91% versus 43.2% ± 6.23%, respectively.
The clinical study also met its secondary endpoints. The absence of device-related adverse events confirmed that the new procedure is safe for routine clinical use. Product measurements indicated that the collected product is appropriate for transfusion, and process measurements validated the system’s usability. As described in K071099, the Spectra Optia device includes an optically based, automated interface management system (AIM)). The AIM system was incorporated into the design to improve the Spectra Optia system’s usability, compared to the 30 year-old, predicate device. Data from the clinical trial directly validated this important design feature. On average, system operators adjusted the predicate device 10 times during each collection, compared to just 5 times for the more-automated Spectra Optia system.
|Outcome||Predicate COBE Spectra Apheresis System
(Mean and SD)
|Modified Spectra Optia Apheresis System
(Mean and SD)
|Adverse Events||No serious or unanticipated adverse events occurred during the investigation|
|Device Performance – Measured as PMN Collection Efficiency (CE1 %)||43.2 +/- 6.23||53.7% +/- 6.91||<0.001|
|PMN Cells Collected (x 1010)||6.9 +/-1.59||8.6 +/-1.88||<0.001|
|Viability (%)||99.4 +/- 1.26||99.6 +/- 0.25||NS|
|Product Volume (mL)||315.1 +/- 55.89||472.3 +/- 1.65||<0.001|
|Platelet Collection Efficiency (CE1 %)||10.8 +/- 2.82||10.9 +/- 1.45||NS|
|Hematocrit (%)||7.5 +/- 3.71||7.4 +/- 2.62||NS|
|Process Parameters / Usability|
|Number of Operator Adjustments During the Procedure||10.0 +/- 4.17||5.2 +/- 2.34||<0.001|
|Whole Blood Processed (mL)||6003.3 +/- 5.73||6000.9 +/- 0.35||0.025|
|Procedure Time Including Rinseback (mins)||116.2 +/- 19.26||121.0 +/- 20.56||0.003|