The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

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: ( ) ) the apheresis machine itself (centrifuge, pumps, valves, etc.), (2) sterile, single-use, disposable tubing sets and, (3) embedded software. A software modification and new disposable connector have been made to accommodate single-needle access for Therapeutic Plasma Exchange (TPE) procedures on the Spectra Optia system. This additional access option does not alter the operating parameters or performance of the Spectra Optia system.

AI/ML Overview

This document describes the acceptance criteria and the study conducted to demonstrate that the Spectra Optia® Apheresis System, with a software modification and new disposable connector for single-needle access during Therapeutic Plasma Exchange (TPE) procedures, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Plasma Removal Efficiency (PRE): Non-inferiority between single-needle and dual-needle access for TPE procedures.	Demonstrated non-inferiority between single-needle and dual-needle options for the Spectra Optia Apheresis System's TPE protocol in terms of the efficiency of plasma removal.
Impact on Hematocrit of Processed Blood: No significant impact by the type of venous access (single-needle vs. dual-needle).	The study demonstrated that the hematocrit of the processed blood is not impacted by the type of venous access.
Impact on Inlet Flow Rate: No significant impact by the type of venous access (single-needle vs. dual-needle).	The study demonstrated that the rate at which the blood is processed (Inlet Flow Rate) is not impacted by the type of venous access.
Physical integrity and function of the Single-Needle Connector: The connector's tortuous pathway functions as intended.	Physical testing for the Single-Needle Connector focused on testing of the connector's tortuous pathway. (Implied successful verification, though specific numerical results are not provided in this summary)
Software Functionality and Performance: The modified Spectra Optia system software performs as intended according to specified requirements (control, safety, functional, reliability, usability, exploratory, robustness).	The modified Spectra Optia system software was verified via Control, Safety, Functional, Reliability, Usability, Exploratory, and Robustness testing. (Implied successful verification of all stated aspects, though specific numerical results are not provided in this summary)

2. Sample Size and Data Provenance for the Test Set

Sample Size Used for the Test Set: Not explicitly stated in the provided text. The study is described as a "laboratory non-inferiority study."
Data Provenance: The study was conducted in a "laboratory" setting. No specific country of origin is mentioned, but the manufacturer is based in the USA (Colorado). The study was prospective as it was conducted specifically to validate the new single-needle access option.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth for this device's performance (plasma removal efficiency, hematocrit, inlet flow rate) was established through objective laboratory measurements rather than expert interpretation of medical images or conditions.
Qualifications of Experts: Not applicable for this type of objective performance study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The study measured objective physiological parameters (plasma removal efficiency, hematocrit, inlet flow rate) rather than subjective assessments requiring adjudication. The comparison was statistical (non-inferiority).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is not relevant for a device that performs automated blood component separation. MRMC studies are typically used to assess the diagnostic accuracy of imaging systems or AI algorithms that require human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance Done: Yes, in essence. The study's focus was on the performance of the device's TPE protocol with single-needle access compared to dual-needle access. This measures the algorithmically controlled separation process and fluid dynamics generated by the device itself, independent of immediate human intervention on the separation process itself (though a human operates the machine).

7. Type of Ground Truth Used

Type of Ground Truth: Objective physiological measurements and device performance metrics. Specifically:
- Plasma Removal Efficiency (PRE)
- Hematocrit of processed blood
- Inlet Flow Rate

8. Sample Size for the Training Set

Sample Size for the Training Set: Not applicable. This submission concerns a physical device modification (new connector) and a software modification for an existing device's protocol. The software modification likely involves engineering and verification testing rather than machine learning training on a "training set" in the conventional AI sense.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for the Training Set Was Established: Not applicable. There is no mention of a machine learning component requiring a distinct "training set" with established ground truth in the provided information. The device's operation is based on established principles of centrifugation and fluid dynamics.

Summary

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510(k) Summary

Owner/Manufacturer:	Terumo BCT, Inc.10811 W. Collins AvenueLakewood, Colorado 80215
	AUG 8 2011
Contact Person:	Tina O'BrienSenior Regulatory Affairs SpecialistPhone: (303) 239-2082
Date of Summary Preparation:	June 11, 2013
Trade Name:	Spectra Optia® Apheresis System
Common Name:	Apheresis System
Classification Name:	Automated Blood Cell Separator
Product Code:	LKN
Predicate Device:	Spectra Optia Apheresis System (K071070)

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: ( ) ) the apheresis machine itself (centrifuge, pumps, valves, etc.), (2) sterile, single-use, disposable tubing sets and, (3) embedded software.

A software modification and new disposable connector have been made to accommodate single-needle access for Therapeutic Plasma Exchange (TPE) procedures on the Spectra Optia system. This additional access option does not alter the operating parameters or performance of the Spectra Optia system.

Intended Use:

The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

Technological Comparison:

The system's base technology is not changed by this modification to the Spectra Optia filler. Refer to Table 1 for a comparison of technological characteristics.

Table 1: Key Similarities - Spectra Optia system - TPE with Single Needle Access (subject) vs. TPE with Dual Needle Access (predicate)

Attribute	Comparison
1	Intended Use /Labeling	The Spectra Optia system with single-needle access has the sameintended use as the predicate device

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	Attribute	Comparison
2	EssentialTechnology	The essential technology of the Spectra Optia system has not changed- it remains an automated blood cell separator and achieves itsessential function (the separation of blood cells and plasma) throughcentrifugation.
3	Materials	The blood-contacting disposable tubing sets are comprised of thesame biocompatible materials as previously cleared Spectra Optiadisposables.
4	Sterility /Manufacturing	The single-use, sterile disposables are sterilized using the samepackaging and validated ETO-based sterilization method, as othercleared Spectra Optia disposables. Likewise, manufacturing methodsfor the disposables are similar.
	ClinicalPerformance	The safety and efficacy of the Spectra Optia system TPE protocol withsingle-needle access was validated through a laboratory non-inferioritystudy to compare the plasma removal efficiency (PRE) of the TPEprocedure of single-needle vs. dual-needle access. Study resultssuccessfully demonstrated non-inferiority between single-needle anddual-needle options for the Spectra Optia Apheresis System'sTherapeutic Plasma Exchange protocol in terms of the efficiency ofplasma removal. The study also demonstrated that neither thehematocrit of the processed blood nor the rate at which the blood isprocessed (Inlet Flow Rate) is impacted by the type of venous access

Discussion of Non-clinical Data:

The new Single-Needle Connector and modification to the Spectra Optia's software to support single-needle access were verified through the following activities:

. Physical testing for the Single-Needle Connector focused on testing of the connector's tortuous pathway.
The modified Spectra Optia system software was verified via Control, Safety, . Functional, Reliability, Usability, Exploratory, and Robustness testing.

Discussion of Clinical Data:

Laboratory testing was conducted to verify and validate the functionality and effectiveness of the single-needle access option for TPE procedures on the Spectra Optia system. Clinical validation data were not necessary, based on an analysis of clinical evidence on the use of single-needle access in apheresis procedures and the fact that the modification did not impact the implementation, control, or effectiveness of the system for the system's intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 8, 2013

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

Re: K131744

Trade/Device Name: Spectra Optia® Apheresis System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN Dated: July 11, 2013 Received: July 12, 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.

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Page 2 - Tina O' Brien

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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.

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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TERUMOBCT

Spectra Optia® Apheresis System Therapeutic Plasma Exchange with Single-Needle Access Traditional 510(k) Submission

Indications for Use Statement 4

Indications for Use

510(k) Number (if known): K131744

Device Name: Spectra Optia® Apheresis System

Indications for Use:

The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures.

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

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131744 510(k) Number _

Regulation Number and Section

N/A