Reveos® Automated Whole Blood Processing System

{0} **Reveos® Automated Whole Blood Processing System** 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. {1} **Reveos® Automated Whole Blood Processing System** 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: 720-480-6702 Contact Person: Jennifer Burton Title: Sr. Regulatory Affairs Specialist Phone: (b) (6) Fax: 303-231-4756 Date Prepared: June 23, 2023 ### II. DEVICE Trade Name of Device: Reveos® Automated Whole Blood Processing System Common or Usual Name: Automated Whole Blood Processing System Classification Name: Separator, Semi-Automated, Blood Component Regulatory Class: In accordance with 21 CFR 864.9245(b), the classification for this device is Class I Product Code: MYY ### 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 | MYY | Atreus Whole Blood Processing System | Terumo BCT | BK080010 | ### IV. DEVICE DESCRIPTION #### A. Device Identification The Reveos® Automated Blood Processing System, hereafter referred to as Reveos, consists of the primary device with embedded software that can separate whole blood into its components and the Reveos SELECT Disposable Set intended to collect and store separated components. #### B. Device Characteristics The device includes valves, sensors and centrifuge which draw in the whole blood, create the appropriate separation, and express the blood components to their respective product bags depending on the protocol. **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 {2} **Reveos® Automated Whole Blood Processing System** Traditional 510(k) Submission **TERUMO** BLOOD AND CELL TECHNOLOGIES The Reveos device consists of a centrifuge rotor with four fixed buckets and product bag holders; hydraulic bladders for expression of blood components in their respective product bags and valves for opening/closing the tubing to each product bag when appropriate as signaled by sensors and finally sealing the tubing to the product bags. # **C. Device Description** Reveos is an integrated and automated manufacturing system that processes blood components from four units of whole blood. The Reveos System uses centrifugal force to separate one to four units of whole blood into constituent components (plasma, platelets, red blood cells (RBCs), and residual leukocytes). After separation, each product bag is automatically sealed by valves. # **D. Environment of Use** The operation of Reveos is intended to be used in blood centers or a hospital-based blood bank. # **E. Key Performance Specifications/Characteristics of the Device** The Reveos device is a centrifuge that uses optical sensing to detect the interfaces between different blood components while being centrifuged. A variable speed motor controls the centrifuge speed to ensure optimum separation. # **V. INTENDED USE** The Reveos device is intended to automatically separate units of whole blood into blood components. # **VI. TECHNOLOGICAL COMPARISON** Provided in **Table 5.2** is a high-level comparison of Reveos to the predicate device. **Table 5.2: Device Comparison Table** | Category | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Indication for use | The Reveos device is intended to automatically separate units of whole blood into blood components. | The Atreus® Whole Blood Processing System is indicated for the automatic separation and leukoreduction of one unit of whole blood into its blood components: • Red Blood Cells; • Plasma and; • Residual leukocytes The RBCs and Plasma may be transfused. | Similar. Subject has a higher throughput and can process up to four units of whole blood. The difference does not impact the safety or effectiveness of the Subject. | | Fundamental Scientific Technology | Centrifugal separation | Centrifugal separation | Same | | Variable Speed Centrifugal Separation of Blood Components | Variable speed motor uses optical sensing to detect different blood components | Variable speed motor uses optical sensing to detect different blood components | Same | UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {3} **Reveos® Automated Whole Blood Processing System** Traditional 510(k) Submission TERUMO BLOOD AND CELL TECHNOLOGIES | Category | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Auto-balancing of centrifuge rotor | Processes up to **four** units of whole blood with an auto-balancing centrifuge. Up to three counter-balance bags can be used. | Processes one unit of whole blood with an auto-balancing centrifuge. | Similar. The same technology is used; however, Subject has a higher throughput and can process up to four units of whole blood. | | Blood Component Interface | Electronic closed loop feedback control | Electronic closed loop feedback control | Same | | Controlled Expression of Blood Components | Use of a hydraulic pump and valves | Use of a hydraulic pump and valves | Same | | Use of valves to direct fluid pathways | Valves facilitate correct routing of the tubing | Valves facilitate correct routing of the tubing | Same | | Radio Frequency (RF) Tube Sealing | RF energy automatically seals the individual product bags | RF energy automatically seals the individual product bags | Same | | Software | Software manages the operation of automated whole blood processing | Software manages the operation of automated whole blood processing | Same | | Hardware | Electro-mechanical device | Electro-mechanical device | Same | ## VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. Each type of data is further expanded upon in the sections below: - Software Testing - Electrical Safety and Electromagnetic Compatibility Testing - Functional Performance Testing (Bench) - Bench Testing – In vitro performance - Clinical Testing ### A. Software Testing Software verification testing was conducted on the Reveos device. The system complies with ANSI AAMI IEC 62304. ### B. Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on the Reveos device. The system complies with the IEC 61010-1, IEC 61010-2-020, and IEC 61010-2-081 standards for electrical safety. For EMC, the Reveos device is compliant with the prescribed performance criteria for IEC 61326-1 test levels and the pass/fail criteria designated in the test plan for IEC 60601-1-2 test levels. ### C. Function Performance Testing (Bench) Verification bench testing has demonstrated that Reveos works as intended and is substantially equivalent to the predicate device. Bench verification testing for Reveos consisted of specification verification, functional and blood performance testing, human factors and design validation. The testing showed that Reveos performed according to its performance requirements, met its user needs and is usable by the intended users. UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {4} Reveos® Automated Whole Blood Processing System Traditional 510(k) Submission TERUMO BLOOD AND CELL TECHNOLOGIES ### D. Bench Testing – In Vitro Performance Terumo BCT conducted an in vitro study to demonstrate whole blood (WB) collected into the Reveos SELECT disposable set and processed on the Reveos device produced components that met all in vitro acceptance criteria. The following is a summary of the key findings. #### Primary Endpoint All primary endpoints were met, and the results are summarized in Table 5.3. Table 5.3: Primary Endpoint Summary of Results | Blood Component | Standard | Confidence/ Conformity | Evaluable N | Number of Units Meeting Standard | Mean ± SD (Range) | Lower One-sided 95% CI^{a} (threshold) | Result | | --- | --- | --- | --- | --- | --- | --- | --- | | Plasma Products, LR | Residual WBC content <5 × 10^{9} per unit† | 95%/95% | 65 | 65 | (× 10^{9} per unit) 0.21 ± 0.23 (0.00 – 1.34) | 0.955 (> 0.95) | Pass | | Red Blood Cells, LR | Residual WBC content <5 × 10^{9} per unit† | 95%/95% | 65 | 65 | (× 10^{9} per unit) 0.22 ± 0.21 (0.03 – 1.13) | 0.955 (> 0.95) | Pass | | | Post-Filtration ≥85% recovery of original RBC content† | 95%/95% | 63 | 63 | (%) 94.0 ± 1.8 (90.5 – 99.8) | 0.954 (> 0.95) | Pass | | | Hemolysis ≤1% at expiration (42 days)†† | 95%/95% | 65 | 65 | (%) 0.20 ± 0.11 (0.07 – 0.89) | 0.955 (> 0.95) | Pass | | Platelets (IPU) | Yield ≥5.5 × 10^{10} platelets* | 95%/75% | 65 | 58 | (× 10^{10} platelets) 9.60 ± 3.59 (0.39 – | 0.807 (> 0.75) | Pass | | | pH_{25°C} ≥6.2 (at the time of pooling) | 95%/95% | 65 | 65 | 7.225 ± 0.222 (6.520 – 7.735) | 0.955 (> 0.95) | Pass | $^{a}$ From an exact binomial Clopper and Pearson confidence interval computed for a proportion † Acceptance Criteria suggested in Pre-Storage Leukocyte Reduction of Whole Blood Components Intended for Transfusion FDA Guidance for Industry †† Acceptance Criteria suggested in Vostal, Jaro Presentation: FDA Evaluation of Red Cell Products, Laboratory of Cellular Hematology OBRR, CBER, FDA on October 6, 2016 *Acceptance Criteria suggested in 21 eCFR 640.24 (c): (Platelet) Processing All Reveos pooled IPU platelet products, prepared and stored using the IMUGARD WB PLT Platelet Pooling Set, met expectations for leukoreduction, platelet recovery, and pH at the end of storage, whether pooling occurred on Day 1 or Day 2 after collection. 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. ### Safety UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {5} **Reveos® Automated Whole Blood Processing System** Traditional 510(k) Submission **TERUMO** BLOOD AND CELL TECHNOLOGIES Two device deficiencies (DDs) were reported. One resulted in removing and discarding the disposable set from evaluation. No DDs resulted in AEs. ### **E. Clinical Studies** A clinical study was conducted to evaluate whether the leukoreduced red blood cells (LR-RBCs) derived from whole blood (WB) and processed with the Reveos System met acceptance criteria for 24-hour recovery after 42-day storage. ### **Device Performance Study** The clinical study was a prospective, open-label, multicenter study to evaluate WB derived red blood cells (RBCs) processed using the Reveos System. ### ***Location of Study*** The study was conducted under IDE 27752 at locations within the United States only. ### ***Primary Endpoint*** The primary efficacy endpoint of this study was RBC 24-hour recovery using single label (Cr-51) and dual label with Cr-51/Tc-99m. For the single label method, there were 23 successes and 3 failures with a mean 24-hour recovery value of 83% (SD = 9%) and a one-sided 95% lower confidence limit for the proportion of successes of 73%. For the dual label method, there were 24 successes and 2 failures with a mean 24-hour recovery value of 90% (SD = 9%) and a one-sided 95% lower confidence limit of 78%. Both single label (Cr-51) and dual label Cr-51/Tc-99m met the three FDA criteria of 1) LR-RBC mean 24-hour recovery $\geq 75\%$ with 2) SD $\leq 9\%$ and 3) a one-sided lower confidence limit for the population proportion of RBCs in vivo recovery of 70% with a “success” being LR-RBC recovery $>75\%$. ### ***Safety*** Three confirmed DDs were reported. Out of the three DDs, one resulted in the participant discontinuing from the study. Two out of the three confirmed DDs did not result in discontinuation of the participants and were addressed by replacements of affected parts. No DDs resulted in AEs. Overall, no safety signals were observed in this study. All reported Procedure-Emergent Adverse Events (PEAEs) were anticipated, related to medical history or had been previously reported as potential AEs during a blood donation. There were no device related PEAEs or Unanticipated Adverse Device Effects (UADEs) reported during this study. All PEAEs reported during the study were related to the study procedures; no PEAEs were related to the investigational device. There were no device related PEAEs or UADEs observed during this study. ### ***Summary*** Based on the clinical performance, Reveos worked as expected, performed in safe manner, and met FDA’s criteria for in vivo 24-hour recovery after 42-day storage. UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM {6} **Reveos® Automated Whole Blood Processing System** Traditional 510(k) Submission--- **TERUMO** BLOOD AND CELL TECHNOLOGIES ### VIII. CONCLUSIONS Based on the non-clinical and clinical tests performed on Reveos, it is as safe and effective as the predicate device. The information provided in the 510(k) demonstrates that Reveos is substantially equivalent to its identified predicate device. UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM