FDA Grants 510(k) Clearance for Rika Plasma Donation System

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The FDA granted a 510(k) clearance for the Rika Plasma Donation System (Rika) with the individualized nomogram, iNomi Nomogram, which can determine the plasma collection volume needed from the donor on the day of collection. The indication for the 510(k) clearance is for the collection of source plasma with or without saline compensation.^1,2

According to the Plasma Protein Therapeutics Association, it can take 130 plasma donations to effectively meet the annual needs of 1 patient with primary immune deficiency. Rika is the next-generation plasma collection system that is designed and developed to be used in plasma collection centers. Additionally, the device was designed specifically for the comfort and safety of the donor by providing alerts and visual cues to help guide the operator. The system was designed by Terumo BCT, and Rika is just 1 example within a broad suite of medical devices that can collect, separate, and process the blood and cells of donors.¹

"Terumo Blood and Cell Technologies (BCT) continues to innovate for the plasma industry, setting new standards and expanding patient access to care," said Antoinette Gawin, president and CEO at Terumo BCT, in a press release. "As the need for plasma increases, the Rika ecosystem, now including iNomi, is poised to help meet the demand while offering a potentially more comfortable and efficient experience for plasma donors."¹

Rika, according to the experts, is an automated blood component collection system that uses centrifugal force to properly separate the whole blood into plasma and its remaining cells. Collection takes approximately 35 minutes or less while ensuring there is no more than 200 mL of blood outside of the donor’s body at 1 time, using an advanced control system to guide the providers operating the device. Additionally, iNomi uses each individual donor’s characteristics (eg, height, weight, and hematocrit levels) to determine the amount of plasma that needs to be collected.^1,2

The FDA granted Rika the 501(k) clearance following results from various testing methods, including clinical trials, performance testing, and software testing. In both performance and software testing, Rika utilized its individual nomogram to demonstrate its abilities and performed to its requirements by meeting the needs of its user.²

Further, Terumo BCT conducted a prospective, open-label, multicenter study to ensure that the collection volume of plasma collected using Rika met the individualized nomogram for plasma donations. The trial enrolled a total of 124 plasma products across 2 United States sites, and the primary end point was the proportion of plasma products with an acceptable plasma collection volume (determined by the individualized nomogram).²

According to the results, the investigators observed a procedure success in all procedures (CI 95% 0.976). Additionally, there were no new safety signals observed in the study, and all procedure-emergent adverse events (PEAEs) were anticipated and previously reported as potential AEs during apheresis donation (as indicated in consent forms). Additionally, there were no serious AEs or unanticipated adverse device effects reported during the study’s duration.²

Rika was previously cleared for use by the FDA in March 2022, becoming part of an extensive ecosystem in plasma collection. It is believed that Rika will strengthen the productivity and efficiency of support centers by optimizing plasma collections, meeting the needs of patients with life-threatening illnesses that required plasma therapies, and allowing providers to spend more time with donors with its easy operating system.¹

"[We] look forward to the rollout of the individualized nomogram as we continue to introduce the Rika Plasma Donation System to our close to 330 centers in the [United States]. We are eager to implement this latest innovation from Terumo that supports our dedication to our donors, employees, and delivering on our promise to our patients," said Michelle Meyer, VP of Plasma Global Operations at CSL Plasma, in the press release.¹

References

1. PR Newswire. FDA Clears the Individualized Nomogram for Rika Plasma Donation System. News release. May 9, 2024. Accessed May 9, 2024. https://prnmedia.prnewswire.com/news-releases/fda-clears-the-individualized-nomogram-for-rika-plasma-donation-system-302140642.html

2. K231035 510(k) Summary. US Food & Drug Administration. March 7, 2022. Accessed May 9, 2024. https://www.fda.gov/media/177027/download