The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications, and may be used to perform Red Blood Cell Exchange, Depletion, and Depletion/Exchange (RBCX) procedures.

The Spectra Optia Apheresis System, a blood component separator, can 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 a centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems: (1) the apheresis machine itself (centrifuge, pumps, valves. etc.). (2) sterile, single-use, disposable tubing sets and, (3) embedded software.

Modifications to the disposable Exchange Set and embedded software have been made to enable Red Blood Cell Exchange (RBCx) procedures on the Spectra Optia system.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Spectra Optia® Apheresis System for Red Blood Cell Exchange (RBCx)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Primary Endpoints: Consistently achieve target HbS levels as prescribed by the physician in the target population.	"The study resulted in all primary endpoints being met..."
Safety: No Serious Adverse Events (SAEs) or Unanticipated Adverse Device Effects (UADEs).	"...with no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported."
Performance Equivalence (vs. predicate COBE Spectra): Ability to achieve patient hematocrit targets.	"In both a "simulated-use" laboratory validation study and human clinical trial, Spectra Optia's RBCx protocol was found to perform the same as the COBE Spectra RBCx protocol, with respect to the system's ability to achieve patient hematocrit targets..."
Performance Equivalence (vs. predicate COBE Spectra): Ability to maintain patient fluid balance.	"...and to maintain patient fluid balance."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "a prospective, multi-center, single-arm, open-label study," which indicates a clinical study with real patients, but the exact number of patients is not provided.
Data Provenance: The study was a "prospective, multi-center" clinical study. This implies data was collected from multiple clinical sites (likely within the US, given the FDA submission) actively as the study progressed (prospective).

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

The concept of "experts establishing ground truth" as seen in diagnostic imaging for example, is not directly applicable here. The device is an apheresis system for treatment, not a diagnostic device.
The "ground truth" for the primary endpoint (achieving target HbS) would be derived from objective lab measurements of the patients' HbS levels before and after the RBCx procedure, based on the physician's prescription. The "ground truth" for safety would be identified by clinical observation and reporting of adverse events by the clinical staff involved in the study.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where there's subjectivity in interpreting results (e.g., image reading). This device's primary endpoints (HbS levels, fluid balance, adverse events) are objective measurements or clinical observations. Therefore, a specific "adjudication method" in that sense is not mentioned or likely applicable. The study's design (multi-center, open-label) implies standardized protocols for data collection and reporting.

5. 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 device is an automated apheresis system and does not involve "human readers" or "AI assistance" in the typical sense of a diagnostic or interpretive task. The comparison was between the modified Spectra Optia system and its predicate device (COBE Spectra), both being automated systems.

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

The device itself is an "algorithm only" in the sense that it is an automated system with embedded software. The clinical study evaluated the performance of this automated system in a real-world clinical setting without direct human intervention in the core RBCx procedure execution by the device itself (though human operators initiate and monitor the procedure).
The comparison against the predicate COBE Spectra system (also an automated system) effectively acts as a standalone performance comparison between two automated systems.

7. The Type of Ground Truth Used

Clinical Outcomes/Measurements: The ground truth was based on objective clinical measurements and outcomes.
- HbS Levels: Objective laboratory measurements of hemoglobin S in the patients' blood, compared against physician-prescribed targets.
- Safety Data: Clinical observation and reporting of adverse events (SAEs, UADEs).
- Hematocrit Targets & Fluid Balance: Objective physiological measurements taken during the procedures.

8. The Sample Size for the Training Set

This device is not a machine learning or AI model in the common sense that requires a "training set" for model development. The software algorithms are likely rule-based or control-system based.
The software was "verified through a variety of verification testing; including Functional, Reliability, Usability, Exploratory, and Robustness." This indicates traditional software engineering testing rather than machine learning training. Therefore, a "training set" in the context of data for model learning is not applicable or stated.

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

As concluded in point 8, there isn't a "training set" in the typical machine learning sense for this device. The software was developed using standard engineering practices, and its performance was then validated through non-clinical verification and a prospective clinical study.

Summary

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K132429 Page 78 of 291 Page 1 of 2

DEC - 6 2013

510(k) Summary

Owner/Manufacturer:	Terumo BCT. Inc.10811 W. Collins AvenueLakewood, Colorado 80215
Contact Person:	Tina O'BrienSenior Regulatory Affairs SpecialistPhone: (303) 239-2082
Date of Summary Preparation:	August 2, 2013
Trade Name:	Spectra Optia" Apheresis Svstem
Common Name:	Apheresis System
Classification Name:	Automated Blood Cell Separator
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 device is comprised of three major sub-systems: (1) the apheresis machine itself (centrifuge, pumps, valves. etc.). (2) sterile, single-use, disposable tubing sets and, (3) embedded software.

Modifications to the disposable Exchange Set and embedded software have been made to enable Red Blood Cell Exchange (RBCx) procedures on the Spectra Optia system.

Intended Use:

Indications for Use:

Technological Comparison:

The system's base technology is not changed by the introduction of the RBCx protocol.

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Discussion of Non-clinical Data:

The modified Spectra Optia system software was verified through a variety of verification testing; including Functional, Reliability, Usability, Exploratory, and Robustness.

Discussion of Clinical Data:

A prospective, multi-center, single-arm, open-label study was conducted to demonstrate that the Spectra Optia's RBCx protocol could consistently achieve the target HbS in the target population as prescribed by the physician. The study resulted in all primary endpoints being met with no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported.

Substantial Equivalence:

Provided below is a summary of substantial equivalence.

	Spectra Optia system(Subject Device)	COBE Spectra system(K831004)
Intended Use	Therapeutic Plasma Exchange andRed Blood Cell Exchange	Multiple therapeutic apheresisprocedures, including Red BloodCell Exchange
EssentialTechnology	Both the Spectra Optia and COBE Spectra systems are automated bloodcell separators achieving their essential function (the separation of bloodcells and plasma) through centrifugation.
Software	Software algorithms underlying the red blood cell exchange procedureson both the Spectra Optia and COBE Spectra systems are controlled bythe same equations.
Performance	In both a "simulated-use" laboratory validation study and human clinicaltrial. Spectra Optia's RBCx protocol was found to perform the same asthe COBE Spectra RBCx protocol, with respect to the system's ability toachieve patient hematocrit targets and to maintain patient fluid balance.

Table 1: Spectra Optia system vs. COBE Spectra

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 6, 2013

Terumo BCT, Inc. Tina O' Brien Sr. Regulatory Affairs Specialist 10811 West Collins Avenue Lakewood, CO 80215

Re: K132429

Trade/Device Name: Spectra Optia® Apheresis System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN Dated: November 1, 2013 Received: November 4, 2013

Dear Tina 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 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.

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

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Page 2 - Tina O' Brien

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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Section 4 - 2

TERUMOBCT

Spectra Optia® Apheresis System Red Blood Cell Exchange (RBCx) Traditional 510(k) Submission

Indications for Use

510(k) Number (if known): K132429

Device Name: Spectra Optia® Apheresis System

Indications for Use:

.. ... ..

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Benjamin R. Fisher -S 2013.12.09 20:01:36 -05'00'

Regulation Number and Section

N/A