(58 days)
The Spectra Optia® Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
The Spectra Optia® Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and replace the removed plasma with healthy donor plasma (i.e. plasma exchange) from patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes, and a machine that controls the separation of blood and the removal and replacement of plasma. The Spectra Optia system's embedded software has been enhanced to reduce the likelihood of excessive platelet loss/removal during Therapeutic Plasma Exchange (TPE) procedures when there are repeated RBC spillover alerts and no remedial action is taken.
This 510(k) summary describes a software enhancement to the Spectra Optia® Apheresis System. The enhancement aims to reduce excessive platelet loss during Therapeutic Plasma Exchange (TPE) procedures when repeated RBC spillover alerts occur and no remedial action is taken.
Acceptance Criteria and Reported Device Performance
The provided documentation does not include a table of explicit acceptance criteria with numerical targets. Instead, it describes various verification activities to ensure the correct functioning of the software modifications. Since no specific performance metrics or acceptance thresholds are detailed, a table cannot be constructed as requested.
However, the "Discussion of Non-clinical Data" section implicitly outlines the areas where the device's enhanced software performance was assessed. The "Discussion of Clinical Data" explicitly states that clinical validation data were not necessary as the modifications did not impact the performance specifications of the system's therapeutic apheresis protocols.
Summary of Reported Device Performance (as inferred from the document):
| Performance Aspect | Reported Device Performance |
|---|---|
| Reliability | Assessed using tests to simulate expected usage profiles. |
| Usability | Verified with simulated use runs on the affected protocol. |
| Robustness | Boundary condition testing conducted to explore the software for expected behavior, addressing critical values, maximum/minimum values, and values just inside/outside established boundaries. |
| Regression | Specific regression testing conducted related to the software updates for platelet loss mitigation. |
| Clinical Performance | The modifications did not impact the performance specifications of the system's therapeutic apheresis protocols, making clinical validation data unnecessary. |
Study Details
Based on the provided 510(k) summary, the study described is a non-clinical verification study for a software modification, rather than a clinical trial or a comparative effectiveness study involving human readers.
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Sample Size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of patient data or clinical samples. The testing described focuses on software verification.
- The sample sizes for the "tests to simulate expected usage profiles," "simulated use runs," and "boundary condition testing" are not explicitly stated.
- Data provenance is not applicable in the sense of country of origin for patient data, as no clinical data was used for this 510(k) submission. All data used was generated through non-clinical simulation and testing of the software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. As the study did not involve clinical data or diagnostic interpretation, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists for images) is not applicable. Software verification likely involved internal engineering and quality assurance teams.
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Adjudication method for the test set:
- Not applicable, as there was no interpretation of clinical data requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not conducted. This submission concerns a software modification to an existing therapeutic apheresis system, not a diagnostic device requiring human interpretation of results. The document explicitly states: "Clinical validation data were not necessary, as the modifications did not impact the performance specifications of the system's therapeutic apheresis protocols."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The verification described (reliability, usability, robustness, regression testing) evaluates the software's behavior and its interaction with the device, which can be considered "algorithm only" testing in the context of its function within the automated system. The software enhancement itself is designed to reduce the likelihood of excessive platelet loss when no remedial action is taken by the user, implying that the algorithm acts to mitigate issues without direct human intervention at that specific point.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software verification, the "ground truth" would be the expected and defined behavior of the software according to its design specifications. This is established through engineering requirements, functional specifications, and predefined output given specific inputs and boundary conditions. It is not based on biological or patient outcomes data for this submission.
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The sample size for the training set:
- Not applicable. This is not a machine learning model that requires a "training set." The software modification described is an update to the system's embedded software based on defined logic and rules, not learned patterns from data.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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JAN 2 0 2012
510(k) Summary
| Owner/Manufacturer: | CaridianBCT, Inc.10811 W. Collins AvenueLakewood, Colorado 80215 |
|---|---|
| Contact Person: | Tina O'BrienSenior Regulatory Affairs SpecialistOffice Phone: (303) 239-2082 |
| Summary Date: | November 18, 2011 |
| Trade Name: | Spectra Optia® Apheresis System |
| Common Name: | Therapeutic Apheresis System |
| Classification Name: | Separator, Automated, Blood Cell and PlasmaTherapeutic |
| Product Code: | LKN |
| Predicate Device: | Spectra Optia Apheresis System |
Device Description:
The Spectra Optia® Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and replace the removed plasma with healthy donor plasma (i.e. plasma exchange) from patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes, and a machine that controls the separation of blood and the removal and replacement of plasma. The Spectra Optia system's embedded software has been enhanced to reduce the likelihood of excessive platelet loss/removal during Therapeutic Plasma Exchange (TPE) procedures when there are repeated RBC spillover alerts and no remedial action is taken.
Intended Use:
The Spectra Optia " Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Technological Comparison:
The base technology of the Spectra Optia system is not affected by this software change to minimize the potential for spillover conditions and to provide earlier detection and notification to the user of a potential platelet loss if appropriate action is not taken. There is no change to the disposable Exchange Set.
Discussion of Non-clinical Data:
The correct functioning of the software modifications was verified through the following activities:
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- Reliability: Reliability was assessed using tests to simulate expected usage . profiles.
- Usability was verified with simulated use runs on the affected . Usability: protocol.
- Boundary condition testing was conducted to explore the Robustness: . software for expected behavior. Boundary conditions address critical values, maximum and minimum values, as well as values just inside/outside established boundaries.
- Regression: Specific regression testing was conducted related to the software . updates for the platelet loss mitigation.
Discussion of Clinical Data:
Clinical validation data were not necessary, as the modifications did not impact the performance specifications of the system's therapeutic apheresis protocols.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tina O'Brien Senior Regulatory Affairs Specialist Caridian BCT, Inc. 10810 West Collins Avenue LAKEWOOD CO 80215
JAN 2 0 2012
Re: K113480
Trade/Device Name: Spectra Optia® Apheresis System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN Dated: December 21, 2011 Received: December 23, 2011
Dear Ms. O'Brien:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass battle in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Evanko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Spectra Optia®Apheresis System Software Version 6.1 Special 510(k) Submission
Intended Use Statement 4
510(k) Number: _
Device Name: Spectra Optia® Apheresis System
Intended Use
The Spectra Optia® Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use: NO (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
n Slanluctive, Gastro-Renal, and
N/A