(91 days)
No
The description of the software updates focuses on data management, networking, protocol enhancements, and general maintenance, with no mention of AI or ML capabilities. The performance studies described are standard software verification and validation, not studies typically associated with AI/ML model training or testing.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "may be used to perform therapeutic plasma exchange," "Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease," and "to reduce White Blood Cells for patients with leukocytosis," all of which are therapeutic interventions.
No
The device is described as a "blood component separator" used for therapeutic procedures like plasma exchange and red blood cell exchange, and for reducing white blood cells in patients with leukocytosis. These are therapeutic, not diagnostic, functions.
No
The device description explicitly states that the system is comprised of three major subsystems, including the apheresis machine itself (which contains hardware components like a centrifuge, pumps, etc.) and a disposable blood tubing set, in addition to the embedded software. The submission describes a software modification to an existing hardware system.
Based on the provided text, the Spectra Optia® Apheresis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses described are therapeutic procedures performed on a patient's blood within the system to separate components for treatment (plasma exchange, red blood cell exchange, white blood cell reduction). This is a direct intervention on the patient's blood for therapeutic purposes, not for diagnostic testing of a sample outside the body.
- Device Description: The description focuses on the system's function in separating blood components through centrifugation and automated processes. It doesn't mention any components or processes related to analyzing blood samples for diagnostic information (e.g., detecting analytes, identifying pathogens, measuring levels of substances).
- Lack of Diagnostic Language: The text does not use language typically associated with IVD devices, such as "diagnosis," "detection," "measurement," "analysis," or "testing of samples."
While the system processes blood, its purpose is therapeutic separation and manipulation of blood components, not diagnostic analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
LKN
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software: The Spectra Optia system software development and verification followed a life-cycle approach. The software testing and verification activities included design reviews, hazard analysis, code reviews and software testing. Software tests included safety tests, functional tests and reliability tests. Testing also included normal, as well as limit and failure conditions. Outcome: All software testing was complete and all testing indicates that the software meets the required functionality.
Specification Testing: System requirements were reviewed for impact by the modification to the new software. Verification testing was conducted on new and existing impacted lower-level requirements. Validation testing including testing impacted user needs. Additionally, Human Factors testing was performed to support the changes introduced in the new software release. Outcome: 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. 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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
2
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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3
510(k) Summary – K183081
I. SUBMITTER
| Owner/Manufacturer: | Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
Phone: 877-339-4228 |
|---------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Nicholas Wong
Sr. Regulatory Affairs Specialist
Phone: 303-239-2384
Fax: 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 | Product
Code | Trade Name of Predicate Device | Manufacturer and
510(k) Holder | 510(k) Clearance
Number |
|-----------|-----------------|--------------------------------|-----------------------------------|----------------------------|
| 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
4
Image /page/4/Picture/0 description: The image shows the TerumoBCT logo in green. Above the logo is the text "K183081" and "Page 2 of 4". The logo is a stylized version of the company name, with the letters in a bold, sans-serif font.
- 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/Feature
| of Subject Device | Comparison to Predicate Device |
|---|---|
| Intended Use | Compared to the Predicate Device: Same. The modifications described in this submission |
| do not alter the intended use of the device. See section V. above for the full intended use | |
| statement. | |
| Essential | |
| Technology | Compared to the Predicate Device: Same. The modifications described in this submission |
| do 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 submission
do not impact the hardware or "equipment" of the Spectra Optia Apheresis System. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Disposable Tubing
Set | Compared to the Predicate Device: Same. The modifications proposed with the subject
device does not impact any of the previously cleared disposable tubing sets. Version 12
Software allows for the option to switch to single-needle mode for a Red Blood Cell
Exchange Procedure as compared to a dual needle procedure originally cleared under
K132429. The Exchange set (K141938) and a Single-Needle Connector (K131744) is all
that is required. |
| Software | Compared to the Predicate Device: The Spectra Optia Apheresis system continues to
have the same underlying architecture and base software, and are implemented using the
same control, safety, and automated process control subsystems.
The predicate device is currently utilizing Version 11.3 software. The modifications
proposed with the subject device introduces a new version of Software (Version 12),
modifications include: 1) data management and network support, 2) enhancements to
existing 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 and | |||
| verification followed a life-cycle approach. The | ||||
| software testing and verification activities included | ||||
| design reviews, hazard analysis, code reviews and | ||||
| software testing. Software tests included safety tests, | ||||
| functional tests and reliability tests. Testing also | ||||
| included normal, as well as limit and failure conditions. | All software testing was | |||
| complete and all testing | ||||
| indicates that the software | ||||
| meets the required | ||||
| functionality. | ||||
| Specification | ||||
| Testing | System requirements were reviewed for impact by the | |||
| modification to the new software. Verification testing | ||||
| was conducted on new and existing impacted lower- | ||||
| level requirements. Validation testing including testing | ||||
| impacted user needs. Additionally, Human Factors | ||||
| testing was performed to support the changes introduced | ||||
| in the new software release. | 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 | ||||
| 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 |
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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.