(29 days)
K071079, BK140191
No
The document describes a blood component separator with embedded software that controls pumps, valves, and sensors. There is no mention of AI, ML, or related concepts in the provided text. The software's function is described as controlling and monitoring the system based on established parameters, not learning or adapting from data.
Yes
The device is used to perform therapeutic plasma exchange and Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease.
No
The device is a blood component separator used for therapeutic plasma exchange and red blood cell exchange. It performs separation and processing functions, not diagnostic analysis of a disease or condition.
No
The device description explicitly states that the Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (equipment), embedded software, and a single-use disposable blood tubing set. While the submission focuses on software modifications, the device itself is a system that includes hardware components.
Based on the provided information, the Spectra Optia Apheresis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as a "blood component separator" used for therapeutic procedures like plasma exchange and red blood cell exchange. These are procedures performed on the patient's blood within the system, not for analyzing the blood outside the body to diagnose a condition.
- Device Description: The description focuses on the mechanical and software aspects of separating blood components. It doesn't mention any components or functions related to analyzing blood samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood samples for specific analytes (e.g., glucose, cholesterol, markers for disease).
- Providing diagnostic information or aiding in diagnosis.
- Using reagents or assays for testing.
The Spectra Optia Apheresis System is a therapeutic device used to treat patients by manipulating their blood components. It is not designed to provide diagnostic information.
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.
Product codes
LKN
Device Description
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 impact the embedded software.
Spectra Optia Machine and Embedded Software: As described previously (K071079, BK140191, K151368), 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.
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
A summative study was conducted on twenty-three active Spectra Optia users to evaluate Version 11.3 software in the intended use environment. The study was performed using a software simulator which was functionally equivalent to production software. The summative study was conducted to evaluate the ability of the user to use correct units while entering patient height, weight, and TBV (if applicable) to verify that the data entered was correct.
Summary of Performance Studies
Version 11.3 is a minor software update limited in scope to mitigate use-errors where operators are able to enter incorrect patient height and weight combinations that would cause a safety concern for the patient. The Version 11.3 software was verified and validated following our design control process.
Summary of Software Verification Type testing:
- New / Updated Requirements: 110 verifications, 110 Pass, 0 Fail
- Safety Regression Tests: 13 verifications, 13 Pass, 0 Fail
- Compatibility (upgrade): 1 verification, 1 Pass, 0 Fail
- Exploratory: 4 verifications, 4 Pass, 0 Fail
- Internal Usability: 2 verifications, 2 Pass, 0 Fail
- Reliability: 10 verifications, 10 Pass, 0 Fail
The Version 11.3 Software was validated via Human Factors testing. After completing formative evaluations, a summative study was conducted on twenty-three active Spectra Optia users to evaluate Version 11.3 software in the intended use environment. The study was performed using a software simulator which was functionally equivalent to production software. The summative study was conducted to evaluate the ability of the user to use correct units while entering patient height, weight, and TBV (if applicable) to verify that the data entered was correct. These two tasks, which are also the only identified critical tasks, were successfully completed by all subjects and no performance failures were observed during the study.
Key Metrics
Successfully completed by all subjects and no performance failures were observed during the study.
Predicate Device(s)
Reference Device(s)
K071079, BK140191
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Terumo BCT, Inc. Nicholas Wong Regulatory Affairs Specialist 10811 West Collins Ave. Lakewood, CO 80215
Re: K153601
Trade/Device Name: Spectra Optia Apheresis System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN Dated: December 15. 2015 Received: December 16, 2015
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. 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 (reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -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) K153601
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY 6
Terumo BCT requests that the attached "Summary" for the Spectra Optia Apheresis System be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.
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510(k) Summary
I. SUBMITTER
| Owner/Manufacturer: | Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
Phone: 877-339-4228 |
|---------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Nicholas Wong
Regulatory Affairs Specialist
Phone: 303-239-2384
Fax: 303-231-4756 |
| Date Prepared: | 12/11/2015 |
II. DEVICE
| Trade Name of Device: | Spectra Optia® Apheresis System |
|---|---|
| Common or Usual Name: | Apheresis Device or System |
| Classification Name: | Separator, Automated, Blood Cell and Plasma, Therapeutic |
| Regulatory Class: | Unclassified |
| Product Code: | LKN |
III. PREDICATE DEVICE
Spectra Optia - Apheresis System - K151368
This release is a firm initiated recall of the previous software version 11.2 that was submitted in BK140191.
DEVICE DESCRIPTION IV.
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 impact the embedded software.
Spectra Optia Machine and Embedded Software: As described previously (K071079, BK140191, K151368), 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.
V. INTENDED USE/INDICATIONS FOR USE
The intended use is unchanged as a result of this modification and is identified below:
The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
erumo BCT. Inc
Terumo BCT Europe N.V.
Europe, Middle East and Afri
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: +32.2.715.05.90
Fax: +32.2.721.07.70
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.A
La Pampa 1517 – 12th Floor
C1428DZE
Buenos Aires
Argentina
Phone: +54.11.5530.5200
Fax: +54.11.5530.5201
Terumo BCT Japan, Inc.
20-14, 3-chrome
Higashi Gotanda, Shinagawa-ku
Tokyo 141-0022
Japan
Phone: +81.3.6743.7890
Fax: +81.3.6743.9800
UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.CO
5
TERUMOBCT
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.
VI. TECHNOLOGICAL COMPARISON
The proposed modification does not in any way change the system's fundamental scientific technology or principle of operation; that is, the separation of blood into its components using centrifugation. The following technological characteristics are identical to that of the predicate device:
- Materials
- Design ●
- Energy source
VII. PERFORMANCE DATA
Version 11.3 is a minor software update limited in scope to mitigate use-errors where operators are able to enter incorrect patient height and weight combinations that would cause a safety concern for the patient. The Version 11.3 software was verified and validated following our design control process. Table 6-1 below summarizes the Software Verification Type testing that was performed.
| Verification Type | Number of Verifications | Pass | Fail |
|---|---|---|---|
| New / Updated | |||
| Requirements | 110 | 110 | 0 |
| Safety Regression Tests | 13 | 13 | 0 |
| Compatibility (upgrade) | 1 | 1 | 0 |
| Exploratory | 4 | 4 | 0 |
| Internal Usability | 2 | 2 | 0 |
| Reliability | 10 | 10 | 0 |
Table 6-1: Executive Summary
The Version 11.3 Software was validated via Human Factors testing. After completing formative evaluations, a summative study was conducted on twenty-three active Spectra Optia users to evaluate Version 11.3 software in the intended use environment. The study was performed using a software simulator which was functionally equivalent to production software. The summative study was conducted to evaluate the ability of the user to use correct units while entering patient height, weight, and TBV (if applicable) to verify that the data entered was correct. These two tasks, which are also the only identified critical tasks, were successfully completed by all subjects and no performance failures were observed during the study.
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VIII. CONCLUSIONS
Verification and validation test results demonstrate that the modified software (Version 11.3) of the Spectra Optia Apheresis System performed as designed. This modification to the software is minor and does not impact the intended use of the device or the primary technological characteristics. Terumo BCT, Inc. considers the proposed Version 11.3 software to be substantially equivalent to the previously cleared software Version 11.2 (K151368).