FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

Device Description

The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems: ( ) ) the apheresis machine itself (centrifuge, pumps, valves, etc.), (2) sterile, single-use, disposable tubing sets and, (3) embedded software. A software modification and new disposable connector have been made to accommodate single-needle access for Therapeutic Plasma Exchange (TPE) procedures on the Spectra Optia system. This additional access option does not alter the operating parameters or performance of the Spectra Optia system.

AI/ML Overview

This document describes the acceptance criteria and the study conducted to demonstrate that the Spectra Optia® Apheresis System, with a software modification and new disposable connector for single-needle access during Therapeutic Plasma Exchange (TPE) procedures, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Plasma Removal Efficiency (PRE): Non-inferiority between single-needle and dual-needle access for TPE procedures.	Demonstrated non-inferiority between single-needle and dual-needle options for the Spectra Optia Apheresis System's TPE protocol in terms of the efficiency of plasma removal.
Impact on Hematocrit of Processed Blood: No significant impact by the type of venous access (single-needle vs. dual-needle).	The study demonstrated that the hematocrit of the processed blood is not impacted by the type of venous access.
Impact on Inlet Flow Rate: No significant impact by the type of venous access (single-needle vs. dual-needle).	The study demonstrated that the rate at which the blood is processed (Inlet Flow Rate) is not impacted by the type of venous access.
Physical integrity and function of the Single-Needle Connector: The connector's tortuous pathway functions as intended.	Physical testing for the Single-Needle Connector focused on testing of the connector's tortuous pathway. (Implied successful verification, though specific numerical results are not provided in this summary)
Software Functionality and Performance: The modified Spectra Optia system software performs as intended according to specified requirements (control, safety, functional, reliability, usability, exploratory, robustness).	The modified Spectra Optia system software was verified via Control, Safety, Functional, Reliability, Usability, Exploratory, and Robustness testing. (Implied successful verification of all stated aspects, though specific numerical results are not provided in this summary)

2. Sample Size and Data Provenance for the Test Set

Sample Size Used for the Test Set: Not explicitly stated in the provided text. The study is described as a "laboratory non-inferiority study."
Data Provenance: The study was conducted in a "laboratory" setting. No specific country of origin is mentioned, but the manufacturer is based in the USA (Colorado). The study was prospective as it was conducted specifically to validate the new single-needle access option.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth for this device's performance (plasma removal efficiency, hematocrit, inlet flow rate) was established through objective laboratory measurements rather than expert interpretation of medical images or conditions.
Qualifications of Experts: Not applicable for this type of objective performance study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The study measured objective physiological parameters (plasma removal efficiency, hematocrit, inlet flow rate) rather than subjective assessments requiring adjudication. The comparison was statistical (non-inferiority).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is not relevant for a device that performs automated blood component separation. MRMC studies are typically used to assess the diagnostic accuracy of imaging systems or AI algorithms that require human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance Done: Yes, in essence. The study's focus was on the performance of the device's TPE protocol with single-needle access compared to dual-needle access. This measures the algorithmically controlled separation process and fluid dynamics generated by the device itself, independent of immediate human intervention on the separation process itself (though a human operates the machine).

7. Type of Ground Truth Used

Type of Ground Truth: Objective physiological measurements and device performance metrics. Specifically:
- Plasma Removal Efficiency (PRE)
- Hematocrit of processed blood
- Inlet Flow Rate

8. Sample Size for the Training Set

Sample Size for the Training Set: Not applicable. This submission concerns a physical device modification (new connector) and a software modification for an existing device's protocol. The software modification likely involves engineering and verification testing rather than machine learning training on a "training set" in the conventional AI sense.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for the Training Set Was Established: Not applicable. There is no mention of a machine learning component requiring a distinct "training set" with established ground truth in the provided information. The device's operation is based on established principles of centrifugation and fluid dynamics.

Summary

Regulation Number and Section

N/A