(91 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, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:
- the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
- a sterile, single-use, disposable blood tubing set
- embedded software
The modification described in this submission introduces a new software version to the Spectra Optia Apheresis System. The current release is Version 11.3 which was cleared in K153601. The new software version is Version 12 and introduces the following new features:
- Data Management Support,
- Network Support,
- Enhancements to existing protocols including the ability to run the Red Blood Cell Exchange procedure in single-needle mode,
- General Software Maintenance Updates
The provided text describes a 510(k) premarket notification for the "Spectra Optia® Apheresis System" with an updated software version (Version 12). The submission aims to establish substantial equivalence to a predicate device (Spectra Optia® Apheresis System with Version 11.3 software).
The information provided is not sufficient to fully answer all aspects of your request, especially regarding specific acceptance criteria values and a detailed study report that would typically accompany a clinical trial or performance study. The document primarily focuses on demonstrating substantial equivalence through software and specification testing, rather than a detailed device performance study against specific, quantified acceptance criteria for clinical outcomes.
However, I can extract the available information as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria established prior to testing, nor does it present detailed numerical performance results for the device. Instead, it states high-level outcomes indicating that the device met its functional requirements and specifications.
| Aspect Tested | Acceptance Criteria (Implied / General) | Reported Device Performance |
|---|---|---|
| Software | Software development and verification followed a life-cycle approach. Hazard analysis, code reviews, safety tests, functional tests, and reliability tests, including normal, limit, and failure conditions, must be met. | "All software testing was complete and all testing indicates that the software meets the required functionality." |
| Specifications | System requirements (new and existing impacted) were met. Validation testing addressed impacted user needs. Human Factors testing supported the changes. | "The system performed according to its design specifications and Spectra Optia Version 12 has been found to be safe and effective for the intended users, user, and use environments." |
| Single-needle functionality (RBCX) | The single-needle mode for Red Blood Cell Exchange (RBCX) performance measures (not specified in detail) needed to be evaluated across multiple RBCX Procedure Types. Clinical evidence for safety and effectiveness of single-needle RBCX on the Spectra Optia® Apheresis System needed to be summarized. | "The single-needle functionality was supported with a simulated-patient laboratory study evaluating varying performance measures across the multiple RBCX Procedure Types. A clinical overview report was also performed summarizing clinical evidence supporting safety and effectiveness of Red Blood Cell Exchange Performed on the Spectra Optia® Apheresis System Using Single-Needle Access." |
2. Sample Size Used for the Test Set and Data Provenance
- Software Testing: No specific sample size (e.g., number of test cases run) is provided, but it states "All software testing was complete."
- Specification Testing: No specific sample size (e.g., number of tests or subjects) is provided.
- Single-Needle Functionality (Simulated Patient Study): The clinical overview report mentions a "simulated-patient laboratory study evaluating varying performance measures across the multiple RBCX Procedure Types." No specific sample size (number of simulated patients or runs) is given.
- Data Provenance: Not specified. The document does not indicate country of origin or if the "simulated-patient laboratory study" was retrospective or prospective. The "clinical overview report" likely summarizes existing clinical evidence, which would be retrospective if it refers to previously published data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies mentioned (software testing, specification testing, simulated-patient study) do not explicitly refer to "ground truth" established by external experts in the way that, for example, an AI diagnostic device would. For the simulated-patient study, the "ground truth" would likely be the known parameters of the simulated blood and the expected output of the device.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the testing described (software, specification, simulated patient), an external adjudication method (like 2+1 or 3+1 for expert review) is not typically applicable or detailed in this type of submission.
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
There is no indication of an MRMC study being performed. The device is an apheresis system, not an AI diagnostic imaging system that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The provided text describes software testing, which inherently assesses the algorithm's functionality. The "simulated-patient laboratory study" for single-needle functionality assesses the device's performance in a controlled environment, which could be considered a standalone performance assessment of the system for that specific function. However, the term "standalone" in the context of AI is usually understood as the algorithm making a decision without human intervention in a diagnostic setting. This is not the context of this device.
7. The Type of Ground Truth Used
- Software and Specification Testing: The ground truth for this testing would be the predefined system requirements and software specifications. The software is expected to operate according to its design and functional specifications.
- Simulated-patient laboratory study: The ground truth would be the known properties of the simulated blood and the expected physiological outcomes or separation efficiencies established as part of the study design.
8. The Sample Size for the Training Set
This information is not applicable / not provided. The Spectra Optia® Apheresis System is a medical device with an updated software version; it is not described as an AI/ML system that utilizes a "training set" in the conventional sense for developing a predictive model. The software is developed through traditional software engineering processes.
9. How the Ground Truth for the Training Set was Established
This information is not applicable / not provided, as there is no mention of a "training set" for an AI/ML model.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2019
Terumo BCT, Inc. Nicholas Wong Sr. Regulatory Affairs Specialist 10811 W. Collins Avenue Lakewood. CO 80215
Re: K183081
Trade/Device Name: Spectra Optia® Apheresis System Regulatory Class: Unclassified Product Code: LKN Dated: November 29, 2018 Received: November 30, 2018
Dear Nicholas Wong:
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 commerce prior to 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland -S
for
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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Indications for Use
510(k) Number (if known) K183081
Device Name Spectra Optia® Apheresis System
Indications for Use (Describe)
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, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K183081
I. SUBMITTER
| Owner/Manufacturer: | Terumo BCT, Inc.10811 W. Collins AvenueLakewood, Colorado 80215Phone: 877-339-4228 |
|---|---|
| Contact Person: | Nicholas WongSr. Regulatory Affairs SpecialistPhone: 303-239-2384Fax: 303-231-4756 |
| Date Prepared: | January 22nd, 2019 |
II. DEVICE
| Trade Name of Device: | Spectra Optia® Apheresis System |
|---|---|
| Common or Usual Name: | Apheresis Device or System |
| Regulation Number: | N/A (Pre-amendment) |
| Regulation Name: | N/A |
| Classification Name: | N/A |
| Regulatory Class: | Unclassified |
| Product Code: | LKN |
III. PREDICATE & REFERENCE DEVICE
| Device | ProductCode | Trade Name of Predicate Device | Manufacturer and510(k) Holder | 510(k) ClearanceNumber |
|---|---|---|---|---|
| Predicate | LKN | Spectra Optia Apheresis System | Terumo BCT | K172590 |
| Reference | LKN | Spectra Optia Apheresis System | Terumo BCT | K132429 |
| Reference | LKN | Spectra Optia Apheresis System | Terumo BCT | K131744 |
Table 1: Predicate & Reference Device Information
DEVICE DESCRIPTION IV.
The Spectra Optia® Apheresis System has been cleared for the following therapeutic apheresis, cell collection and cell processing procedures:
- Therapeutic Apheresis Procedures: ●
10811 West Collins Ave.
Lakewood, Colorado 80215-4440
+1.303.542.5215
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..
La Pampa 1517 – 12th Floor
C1428DZE
Buenos Aires
Argentina
Phone: +54.11.5530.5200
Fax: +54.11.5530.5201
K183081 Page 1 of 4
Tokyo Opera City Tower 49F
3-20-2, Nishi-Shinjuki, USA
Shinjuku-ku, Tokyo 163-1450,
Japan
Phone: +81.3.6743.7890
Fox: 91267430800
UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM
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- Collection/Processing Procedures (cleared by CBER): ●
- Mononuclear Cell (MNC) Collection BK120012 & BK150251 —
- -Granulocyte Collection - BK130065
- Bone Marrow Processing BK140191 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:
-
- the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
- a sterile, single-use, disposable blood tubing set 2.
-
- embedded software
The modification described in this submission introduces a new software version to the Spectra Optia Apheresis System. The current release is Version 11.3 which was cleared in K153601. The new software version is Version 12 and introduces the following new features:
- Data Management Support,
- Network Support, ●
- Enhancements to existing protocols including the ability to run the Red Blood Cell Exchange procedure in single-needle mode,
- . General Software Maintenance Updates
V. INTENDED USE/INDICATIONS FOR USE
The intended use is unchanged as a result of the new modification and is identified below:
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, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
TECHNOLOGICAL COMPARISON VI.
A comparison between the predicate device and the subject device is provided in the following table.
| Attribute/Featureof Subject Device | Comparison to Predicate Device |
|---|---|
| Intended Use | Compared to the Predicate Device: Same. The modifications described in this submissiondo not alter the intended use of the device. See section V. above for the full intended usestatement. |
| EssentialTechnology | Compared to the Predicate Device: Same. The modifications described in this submissiondo not alter the essential technology of the Spectra Optia Apheresis System. It continues to |
Table 2: Device Comparison Table - Subject Device Compared to Predicate Device
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| Hardware or"Equipment" | Compared to the Predicate Device: Same. The modifications described in this submissiondo not impact the hardware or "equipment" of the Spectra Optia Apheresis System. |
|---|---|
| Disposable TubingSet | Compared to the Predicate Device: Same. The modifications proposed with the subjectdevice does not impact any of the previously cleared disposable tubing sets. Version 12Software allows for the option to switch to single-needle mode for a Red Blood CellExchange Procedure as compared to a dual needle procedure originally cleared underK132429. The Exchange set (K141938) and a Single-Needle Connector (K131744) is allthat is required. |
| Software | Compared to the Predicate Device: The Spectra Optia Apheresis system continues tohave the same underlying architecture and base software, and are implemented using thesame control, safety, and automated process control subsystems.The predicate device is currently utilizing Version 11.3 software. The modificationsproposed with the subject device introduces a new version of Software (Version 12),modifications include: 1) data management and network support, 2) enhancements toexisting protocol (allowing for the Red Blood Cell Exchange Procedure to be run in single-needle mode), and 3) general software maintenance updates. |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Table 3: Performance Testing | |
|---|---|
| Type | Method | Outcome | ||
|---|---|---|---|---|
| Software | The Spectra Optia system software development andverification followed a life-cycle approach. Thesoftware testing and verification activities includeddesign reviews, hazard analysis, code reviews andsoftware testing. Software tests included safety tests,functional tests and reliability tests. Testing alsoincluded normal, as well as limit and failure conditions. | All software testing wascomplete and all testingindicates that the softwaremeets the requiredfunctionality. | ||
| SpecificationTesting | System requirements were reviewed for impact by themodification to the new software. Verification testingwas conducted on new and existing impacted lower-level requirements. Validation testing including testingimpacted user needs. Additionally, Human Factorstesting was performed to support the changes introducedin the new software release. | The system performedaccording to its designspecifications and SpectraOptia Version 12 has beenfound to be safe and effectivefor the intended users, user, anduse environments | ||
| The single-needle functionality was supported with asimulated-patient laboratory study evaluating varyingperformance measures across the multiple RBCXProcedure Types. A clinical overview report was alsoperformed summarizing clinical evidence supportingsafety and effectiveness of Red Blood Cell ExchangePerformed on the Spectra Optia® Apheresis SystemUsing Single-Needle Access |
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VIII. CONCLUSIONS
Based on the performance data provided on the subject device, the Spectra Optia® Apheresis System with Version 12 software is substantially equivalent to the legally marketed predicate device, the Spectra Optia® Apheresis System with Version 11.3 software.
N/A