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510(k) Data Aggregation
(249 days)
The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
The Spectra Optia Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.
The Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (or equipment), embedded software, and a single-use disposable blood tubing set. The modifications described in this submission enhance the disposable set's manufacturability and usability during therapeutic plasma and red blood cell exchange procedures.
Spectra Optia Machine and Embedded Software: The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device that uses pumps, valves and sensors to control and monitor a disposable, plastic extracorporeal circuit, during therapeutic apheresis procedures. The system's embedded software controls pump flow rates and centrifuge speed to establish and maintain the required plasma/cellular interface, and ensure patient safety.
Disposable Blood Tubing Set: The disposable Spectra Optia Exchange Set (Catalog No. 10220) is provide sterile and is intended for single-use only. The set is invasive, in that patients are connected to the disposable using a needle or other blood access device (catheter, port, etc.). The patient's blood comes into direct contact with the biocompatible plastics that comprise the set. Key components of the set include the [1] centrifuge channel (inside which the patient's blood is separated into its components), [2] the plastic cassette that integrates the tubing/defines the fluid path for ease of installation and use and, [3] the pre-attached waste bag into which the diseased blood component is collected.
The provided text is a 510(k) Summary for the Spectra Optia Apheresis System. This document describes modifications made to the disposable blood tubing set of an already cleared apheresis system and aims to demonstrate substantial equivalence to its predicate device. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical trial for an AI/ML diagnostic device with performance metrics like sensitivity/specificity.
The "acceptance criteria" here relate to the functional equivalence and safety of the modifications to the disposable blood tubing set, ensuring they do not negatively impact the established performance of the Spectra Optia Apheresis System itself.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present "acceptance criteria" in a typical quantitative clinical performance metric format (e.g., sensitivity, specificity). Instead, the criteria are implicitly tied to maintaining the functional equivalence, safety, and usability of the device after modifications. The "performance" reported is related to how the modifications themselves behave and if they introduce any new risks or alter the system's core function.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Vent Bag: No functional impact from a slightly larger vent bag. | Result: "None – the original and new vent bags are functionally equivalent." |
| Needleless Injection Port: Maintains fluid sampling/administration function; enhances usability by reducing needle-stick injuries. | Result: "None - like the original return line injection port, the needleless injection port allows the operator to sample or administer fluids during the procedure." "Comprehensive verification testing confirmed that the new needleless access port performed as designed." This involved "mechanical testing, biocompatibility testing, and evaluations of the modified Exchange Set's sterility, packaging and shelf life." |
| Sterile Barrier (IV) Filter: Prevents air from an empty AC container from entering the centrifuge and causing alarms; improves usability. | Result: "Air from an empty AC container does not enter the centrifuge and cause an unwanted system alarm." "Simulated-use testing demonstrated that the IV Filter on the AC Line...are functionally compatible with the system's embedded software and that the linear line length of air in the AC Line during an AC bag empty event is reduced when the IV Filter is installed. Specifically, no air was able to travel past the IV Filter, using the modified Exchange Set, during an 'AC Bag Empty Event'. For the unmodified set, the length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches), compared to 0 inches in the modified set." |
| Overall System: Modifications do not alter the system's fundamental scientific technology, principle of operation, intended use, essential technology, materials, or sterilization/manufacturing processes (when adjusted for modifications). | Result: Confirmed through comparisons of "Intended Use / Labeling," "Essential Technology," "Materials," and "Sterility / Manufacturing" as "Key Similarities – Unmodified vs. Modified Spectra Optia Exchange Set." The core technology of centrifugal blood component separation remains unchanged. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy. However, for the simulated-use testing of the IV Filter, quantitative data is provided: "length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches)" for the unmodified set, and "0 inches in the modified set." The number of trials or "samples" for this specific measurement is not provided. General "comprehensive verification testing" and various "evaluations" are mentioned, but without specific unit counts.
- Data Provenance: The document does not specify the country of origin for the reported testing or if it was retrospective or prospective. It describes testing performed to support regulatory submission for a device manufactured by Terumo BCT in Lakewood, Colorado, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this document. The "ground truth" here is based on engineering verification and simulated-use testing outcomes (e.g., presence/absence of air, functional performance of a port), not expert consensus on medical images or patient diagnoses.
4. Adjudication Method for the Test Set
This is not applicable. The assessments are based on direct measurements, observations, and engineering tests of the modified components and their interaction with the system, not on adjudicated interpretations by multiple reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes modifications to an apheresis system's disposable tubing set, not an AI/ML diagnostic device, and therefore no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is an apheresis system, which is a hardware and embedded software system for blood processing, not a standalone AI algorithm. While it has "embedded software" that controls functions, the evaluation is on the hardware modifications (e.g., a filter, a needleless port, a vent bag) and their functional impact.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations described are based on:
- Physical Measurements and Observation: For example, measuring the length of air in the AC line.
- Engineering and Functional Testing: Verifying that mechanical designs work as intended, and that new components do not impede existing functions or introduce new risks.
- Biocompatibility Testing: Ensuring materials are safe for patient contact.
- Sterility, Packaging, and Shelf Life Testing: Standard regulatory requirements for medical devices.
8. The Sample Size for the Training Set
This is not applicable. As a hardware device with embedded control software, there is no "training set" in the context of an AI/ML algorithm that learns from data. The software controls pre-defined processes.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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(123 days)
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications, and may be used to perform Red Blood Cell Exchange, Depletion, and Depletion/Exchange (RBCX) procedures.
The Spectra Optia Apheresis System, a blood component separator, can be used to perform Red Blood Cell Exchange (RBCx) procedures for the transfusion management of Sickle Cell Disease in adults and children.
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: (1) the apheresis machine itself (centrifuge, pumps, valves. etc.). (2) sterile, single-use, disposable tubing sets and, (3) embedded software.
Modifications to the disposable Exchange Set and embedded software have been made to enable Red Blood Cell Exchange (RBCx) procedures on the Spectra Optia system.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Spectra Optia® Apheresis System for Red Blood Cell Exchange (RBCx)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Endpoints: Consistently achieve target HbS levels as prescribed by the physician in the target population. | "The study resulted in all primary endpoints being met..." |
| Safety: No Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs). | "...with no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported." |
| Performance Equivalence (vs. predicate COBE Spectra): Ability to achieve patient hematocrit targets. | "In both a "simulated-use" laboratory validation study and human clinical trial, Spectra Optia's RBCx protocol was found to perform the same as the COBE Spectra RBCx protocol, with respect to the system's ability to achieve patient hematocrit targets..." |
| Performance Equivalence (vs. predicate COBE Spectra): Ability to maintain patient fluid balance. | "...and to maintain patient fluid balance." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "a prospective, multi-center, single-arm, open-label study," which indicates a clinical study with real patients, but the exact number of patients is not provided.
- Data Provenance: The study was a "prospective, multi-center" clinical study. This implies data was collected from multiple clinical sites (likely within the US, given the FDA submission) actively as the study progressed (prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The concept of "experts establishing ground truth" as seen in diagnostic imaging for example, is not directly applicable here. The device is an apheresis system for treatment, not a diagnostic device.
- The "ground truth" for the primary endpoint (achieving target HbS) would be derived from objective lab measurements of the patients' HbS levels before and after the RBCx procedure, based on the physician's prescription. The "ground truth" for safety would be identified by clinical observation and reporting of adverse events by the clinical staff involved in the study.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are typically used in studies where there's subjectivity in interpreting results (e.g., image reading). This device's primary endpoints (HbS levels, fluid balance, adverse events) are objective measurements or clinical observations. Therefore, a specific "adjudication method" in that sense is not mentioned or likely applicable. The study's design (multi-center, open-label) implies standardized protocols for data collection and reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is an automated apheresis system and does not involve "human readers" or "AI assistance" in the typical sense of a diagnostic or interpretive task. The comparison was between the modified Spectra Optia system and its predicate device (COBE Spectra), both being automated systems.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device itself is an "algorithm only" in the sense that it is an automated system with embedded software. The clinical study evaluated the performance of this automated system in a real-world clinical setting without direct human intervention in the core RBCx procedure execution by the device itself (though human operators initiate and monitor the procedure).
- The comparison against the predicate COBE Spectra system (also an automated system) effectively acts as a standalone performance comparison between two automated systems.
7. The Type of Ground Truth Used
- Clinical Outcomes/Measurements: The ground truth was based on objective clinical measurements and outcomes.
- HbS Levels: Objective laboratory measurements of hemoglobin S in the patients' blood, compared against physician-prescribed targets.
- Safety Data: Clinical observation and reporting of adverse events (SAEs, UADEs).
- Hematocrit Targets & Fluid Balance: Objective physiological measurements taken during the procedures.
8. The Sample Size for the Training Set
- This device is not a machine learning or AI model in the common sense that requires a "training set" for model development. The software algorithms are likely rule-based or control-system based.
- The software was "verified through a variety of verification testing; including Functional, Reliability, Usability, Exploratory, and Robustness." This indicates traditional software engineering testing rather than machine learning training. Therefore, a "training set" in the context of data for model learning is not applicable or stated.
9. How the Ground Truth for the Training Set Was Established
- As concluded in point 8, there isn't a "training set" in the typical machine learning sense for this device. The software was developed using standard engineering practices, and its performance was then validated through non-clinical verification and a prospective clinical study.
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(56 days)
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.
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.
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.
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