Rika Plasma Donation System (V2.1)

{0} TERUMO BLOOD AND CELL TECHNOLOGIES # 510(k) Summary I. SUBMITTER Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 Phone: 720-480-6702 Contact Person: Ashley Davis Title: Principal Specialist, Regulatory Affairs Phone: 303-542-5494 Fax: 303-231-4756 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. When the Rika Plasma Donation System utilizes the individualized nomogram, it uses a donor's characteristics to determine the amount of plasma to collect. 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: 1.877.339.4228 Phone: +1.303.231.4357 Fax: +1.303.542.5215 Terumo BCT Europe N.V. Europe, Middle East and Africa Ikaroslaan 41 1930 Zaventem Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 Terumo BCT (Asia Pacific) Ltd. Room 3903-3903A, 39/F ACE Tower, Windsor House 311 Gloucester Road Causeway Bay, Hong Kong Phone: +852.2283.0700 Fax: +852.2576.1311 Terumo BCT Latin America S.A. La Pampa 1517 – 12th Floor C1428DZE Buenos Aires Argentina Phone: +54.11.5530.5200 Fax: +54.11.5530.5201 Terumo BCT Japan, Inc. 20-14, 3-chrome Higashi Gotanda, Shinagawa-ku Tokyo 141-0022 Japan Phone: +81.3.6743.7890 Fax: +81.3.6743.9800 UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {1} **TERUMO**BLOOD AND CELL TECHNOLOGIES ## V. TECHNOLOGICAL COMPARISON Provided in **Table 1** is a high-level comparison of the Rika Plasma Donation System utilizing the individualized nomogram to the predicate and reference devices. **Table 1: Device Comparison Table** | Category | Subject Device | Predicate Device | Reference Device | Comparison | | --- | --- | --- | --- | --- | | **Device Name** | **Rika Plasma Donation System** | **Terumo BCT: Rika Plasma Donation System** | **Haemonetics: NexSys PCS® Plasma Collection System with Persona®** | N/A | | **Classification Name** | Automated blood cell separator | Automated blood cell separator | Automated blood cell separator | Same | | **Regulatory Number** | 21 CFR Part 864.9245 | 21 CFR Part 864.9245 | 21 CFR Part 864.9245 | Same | | **Product Code** | GKT | GKT | GKT | Same | | **Class** | II | II | II | Same | | **Indication for Use** | Collection of Source Plasma | Collection of Source Plasma | Collection of Source Plasma and Plasma for Transfusion | Similar | | **Fundamental Scientific Technology** | Channel based centrifugal separation | Channel based centrifugal separation | Blow-molded bowl centrifugal separation | Similar | | **Collection Nomograms** | Plasma Volume Collection Volume Individualized | Plasma Volume Collection Volume | Plasma Volume Collection Volume Persona | Similar | | **Software** | Embedded + Protocol | Embedded + Protocol | Embedded | Similar | | **Max Plasma Volume Limits** | 1000 mL | 1992 Nomogram Limits | 1000 mL | Similar | | **AC Ratio** | 1:16 | 1:16 | 1:16 | Same | ## 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 utilizing the Individualized Nomogram was tested against its performance requirements and user needs through demonstration and direct testing. The testing showed that the Rika Plasma Donation System performed according to its performance requirements, met its user needs and is usable by the intended users. ### B. Software Testing Software testing was successfully conducted, and documentation was provided in alignment with Enhanced Documentation requirements of FDA’s Guidance for Industry and FDA Staff, “Contents of Premarket Submissions for Device Software Functions.” UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {2} **TERUMO**BLOOD AND CELL TECHNOLOGIES ### C. Clinical Studies Terumo BCT conducted a prospective, open-label, multi-center study to ensure the collection volume of plasma collected with the Rika Plasma Donation system met the individualized nomogram for plasma donations. The study collected 124 evaluable plasma products at 2 investigative sites in the US. #### *Primary endpoint* The primary endpoint of the investigation was the proportion of plasma products with an acceptable plasma collection volume as determined by the individualized nomogram. The overall procedure success was achieved in 100% of the procedures in the Evaluable Analysis Set. The lower bound of a one-sided 95% confidence interval was 0.9761 which is above 0.95, demonstrating that the test product met the individualized nomogram. #### *Safety* No safety signals were observed in this study. All reported procedure-emergent adverse events (PEAEs) were anticipated and have been previously reported as potential AEs during apheresis donation as indicated in the Clinical Investigation Plan and Informed Consent Form. There were no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported during this study. ### VII. CONCLUSIONS Based on the results of the non-clinical and clinical tests performed on the Rika Plasma Donation System utilizing the individualized nomogram, it is as safe and effective as the legally marketed predicate and reference devices. 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