Spectra Optia Apheresis System

• K Number: K153601
• Device Name: Spectra Optia Apheresis System
• Manufacturer: Terumo BCT, Inc
• Date Cleared: 2016-01-14 ( 29 days)
• Product Code: LKN
• Regulation Number: N/A
• Type: Special
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: K071079 , K151368
• Predicate For: N/A

Intended 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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Spectra Optia Apheresis System, specifically a minor software update (Version 11.3). The document focuses on demonstrating that this software update does not impact the device's fundamental scientific technology or principle of operation and that it has been adequately verified and validated.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly linked to the successful completion of various verification and validation tests, ensuring the software update addresses its intended purpose (mitigating use-errors related to patient height and weight entry) without introducing new safety concerns or altering the device's fundamental function. The reported device performance is that all tests passed.

Acceptance Criteria Category	Reported Device Performance
New / Updated Requirements	110 out of 110 passed
Safety Regression Tests	13 out of 13 passed
Compatibility (upgrade)	1 out of 1 passed
Exploratory Tests	4 out of 4 passed
Internal Usability	2 out of 2 passed
Reliability	10 out of 10 passed
Human Factors (Summative Study)	All subjects (23) successfully completed critical tasks; no performance failures observed.

1. Sample Size for Test Set and Data Provenance

• Software Verification Type testing: The "Number of Verifications" column in Table 6-1 indicates the sample size for these tests (e.g., 110 for "New / Updated Requirements"). Data provenance is not specified but appears to be internal testing by Terumo BCT.
• Human Factors Summative Study:
  • Sample size: 23 active Spectra Optia users.
  • Data Provenance: Not explicitly stated, but the users are described as "active Spectra Optia users," suggesting they are likely from real-world clinical or laboratory settings, implying prospective data collection during the study. The study was conducted on a "software simulator," not directly on patients.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Software Verification Type testing: The document does not specify the number or qualifications of experts for establishing ground truth for the software verification tests. These likely involved internal engineering and quality assurance personnel.
• Human Factors Summative Study: The "ground truth" for this study was the successful completion of tasks related to patient height, weight, and TBV entry with correct units and no performance failures. This "ground truth" was established based on the intended correct usage of the software. The study observed user performance to confirm this. No external experts beyond the study design team are explicitly mentioned for establishing this truth.

3. Adjudication Method for the Test Set

• Software Verification Type testing: The document does not describe an adjudication method beyond the pass/fail results for each test. This suggests that the test outcomes were directly assessed against pre-defined criteria without further expert adjudication post-test.
• Human Factors Summative Study: The study observed subjects' ability to use correct units and verify entered data, with "no performance failures observed." This implies direct observation against predefined success criteria, rather than a multi-expert adjudication of ambiguous cases.

4. 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 document describes a software update for an apheresis system, which is a medical device for blood component separation, not an AI-assisted diagnostic or image interpretation tool. The device facilitates a physical procedure rather than providing diagnostic interpretations involving human "readers" or "AI assistance." Therefore, this type of study and effect size is not applicable.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?

• Partially, yes. The "Software Verification Type testing" (Table 6-1) represents standalone algorithm testing to a significant extent, particularly for "New / Updated Requirements," "Safety Regression Tests," "Compatibility (upgrade)," and "Reliability." These tests assess the software's inherent function without necessarily a human actively operating it in a simulated or real patient scenario for every single verification. For instance, safety regression tests would likely involve automated checks against known hazardous conditions.
• However, "Internal Usability" and the "Human Factors (Summative) Study" did involve humans in the loop to assess the human-device interface and mitigate use-errors by operators.

6. The Type of Ground Truth Used

• Pre-defined Engineering/Software Requirements and Safety Criteria: For the "Software Verification Type testing," the ground truth was derived from the established design specifications, functional requirements, safety criteria, and compatibility requirements for the software. A "pass" indicates the software met these predefined criteria.
• Intended Correct User Performance: For the "Human Factors (Summative) Study," the ground truth was the correct execution of critical tasks (entering patient height, weight, and TBV with correct units and verification). The study assessed whether users could achieve this intended correct performance.

7. The Sample Size for the Training Set

• The document does not mention a training set. This is because the device described is an apheresis system with embedded software, not a machine learning or AI-driven system that typically requires a distinct training dataset. The software update is a traditional, rule-based or algorithmic software modification.

8. How the Ground Truth for the Training Set Was Established

• As a training set is not mentioned, the method for establishing its ground truth is not applicable/not provided.

Summary

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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.

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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 (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 [phone] or [phone] 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 [phone] or [phone] 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 AvenueLakewood, Colorado 80215Phone: [phone]
Contact Person:	Nicholas WongRegulatory Affairs SpecialistPhone: 303-239-2384Fax: [phone]
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: [phone]
Fax: [phone]

Room 3903-3903A, 39/F
ACE Tower, Windsor House
311 Gloucester Road
Causeway Bay, Hong Kong
Phone: [phone]
Fax: [phone]

Terumo BCT Latin America S.A

La Pampa 1517 – 12th Floor

C1428DZE

Buenos Aires

Argentina

Phone: [phone]

Fax: [phone]

Terumo BCT Japan, Inc.

20-14, 3-chrome
Higashi Gotanda, Shinagawa-ku
Tokyo 141-0022
Japan
Phone: [phone]
Fax: [phone]

UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.CO

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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 / UpdatedRequirements	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).

Regulation Number and Section

N/A