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 enhance the disposable set's manufacturability and usability during therapeutic plasma and red blood cell exchange procedures.

Spectra Optia Machine and Embedded Software: 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.

Disposable Blood Tubing Set: The disposable Spectra Optia Exchange Set (Catalog No. 10220) is provide sterile and is intended for single-use only. The set is invasive, in that patients are connected to the disposable using a needle or other blood access device (catheter, port, etc.). The patient's blood comes into direct contact with the biocompatible plastics that comprise the set. Key components of the set include the [1] centrifuge channel (inside which the patient's blood is separated into its components), [2] the plastic cassette that integrates the tubing/defines the fluid path for ease of installation and use and, [3] the pre-attached waste bag into which the diseased blood component is collected.

AI/ML Overview

The provided text is a 510(k) Summary for the Spectra Optia Apheresis System. This document describes modifications made to the disposable blood tubing set of an already cleared apheresis system and aims to demonstrate substantial equivalence to its predicate device. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical trial for an AI/ML diagnostic device with performance metrics like sensitivity/specificity.

The "acceptance criteria" here relate to the functional equivalence and safety of the modifications to the disposable blood tubing set, ensuring they do not negatively impact the established performance of the Spectra Optia Apheresis System itself.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present "acceptance criteria" in a typical quantitative clinical performance metric format (e.g., sensitivity, specificity). Instead, the criteria are implicitly tied to maintaining the functional equivalence, safety, and usability of the device after modifications. The "performance" reported is related to how the modifications themselves behave and if they introduce any new risks or alter the system's core function.

Acceptance Criteria (Implicit)	Reported Device Performance
Vent Bag: No functional impact from a slightly larger vent bag.	Result: "None – the original and new vent bags are functionally equivalent."
Needleless Injection Port: Maintains fluid sampling/administration function; enhances usability by reducing needle-stick injuries.	Result: "None - like the original return line injection port, the needleless injection port allows the operator to sample or administer fluids during the procedure." "Comprehensive verification testing confirmed that the new needleless access port performed as designed." This involved "mechanical testing, biocompatibility testing, and evaluations of the modified Exchange Set's sterility, packaging and shelf life."
Sterile Barrier (IV) Filter: Prevents air from an empty AC container from entering the centrifuge and causing alarms; improves usability.	Result: "Air from an empty AC container does not enter the centrifuge and cause an unwanted system alarm." "Simulated-use testing demonstrated that the IV Filter on the AC Line...are functionally compatible with the system's embedded software and that the linear line length of air in the AC Line during an AC bag empty event is reduced when the IV Filter is installed. Specifically, no air was able to travel past the IV Filter, using the modified Exchange Set, during an 'AC Bag Empty Event'. For the unmodified set, the length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches), compared to 0 inches in the modified set."
Overall System: Modifications do not alter the system's fundamental scientific technology, principle of operation, intended use, essential technology, materials, or sterilization/manufacturing processes (when adjusted for modifications).	Result: Confirmed through comparisons of "Intended Use / Labeling," "Essential Technology," "Materials," and "Sterility / Manufacturing" as "Key Similarities – Unmodified vs. Modified Spectra Optia Exchange Set." The core technology of centrifugal blood component separation remains unchanged.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy. However, for the simulated-use testing of the IV Filter, quantitative data is provided: "length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches)" for the unmodified set, and "0 inches in the modified set." The number of trials or "samples" for this specific measurement is not provided. General "comprehensive verification testing" and various "evaluations" are mentioned, but without specific unit counts.
Data Provenance: The document does not specify the country of origin for the reported testing or if it was retrospective or prospective. It describes testing performed to support regulatory submission for a device manufactured by Terumo BCT in Lakewood, Colorado, USA.

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

This type of information is not applicable to this document. The "ground truth" here is based on engineering verification and simulated-use testing outcomes (e.g., presence/absence of air, functional performance of a port), not expert consensus on medical images or patient diagnoses.

4. Adjudication Method for the Test Set

This is not applicable. The assessments are based on direct measurements, observations, and engineering tests of the modified components and their interaction with the system, not on adjudicated interpretations by multiple reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This document describes modifications to an apheresis system's disposable tubing set, not an AI/ML diagnostic device, and therefore no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is an apheresis system, which is a hardware and embedded software system for blood processing, not a standalone AI algorithm. While it has "embedded software" that controls functions, the evaluation is on the hardware modifications (e.g., a filter, a needleless port, a vent bag) and their functional impact.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations described are based on:

Physical Measurements and Observation: For example, measuring the length of air in the AC line.
Engineering and Functional Testing: Verifying that mechanical designs work as intended, and that new components do not impede existing functions or introduce new risks.
Biocompatibility Testing: Ensuring materials are safe for patient contact.
Sterility, Packaging, and Shelf Life Testing: Standard regulatory requirements for medical devices.

8. The Sample Size for the Training Set

This is not applicable. As a hardware device with embedded control software, there is no "training set" in the context of an AI/ML algorithm that learns from data. The software controls pre-defined processes.

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

This is not applicable for the reasons stated in point 8.

Summary

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

March 23, 2015

Terumo BCT, Inc. Nicholas Wong Regulatory Affairs Specialist 10811 West Collins Avenue Lakewood, CO 80215-4440

Re: K141938

Trade/Device Name: Spectra Optia Apheresis System Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKN Dated: February 5, 2015 Received: February 6, 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. 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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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 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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Indications for Use

510(k) Number (if known) K141938

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.

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 7

Owner/Manufacturer:	Terumo BCT10811 W. Collins AvenueLakewood, Colorado 80215877-339-4228
Contact Person:	Nicholas WongRegulatory Affairs Specialist
Date of Preparation:	March 20, 2015
Trade Name of Device:	Spectra Optia® Apheresis System
Common Name:	Apheresis Device or System
Classification Name:	Automated Blood Cell Separator, Therapeutic
Classification Regulation:	Unclassified
Product Code:	LKN
Predicate Device:	Spectra Optia Exchange Set (K071079, K132429)

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 enhance the disposable set's manufacturability and usability during therapeutic plasma and red blood cell exchange procedures.

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blood component is collected. Modifications to the FDA-cleared Exchange Set are described in the following table.

	Modification	Reason for Change	Functional Impact of Change
1	The set's current Vent Bagwill be replaced with a slightlylarger bag.	Ease of Manufacturing –almost all other TerumoBCT-manufactureddisposable sets are madewith the larger Vent Bag.	None – the original and newvent bags are functionallyequivalent.
2	A Needleless Injection Portwill be provided on the set'sReturn Line.	Enhance system/setusability, by reducing theopportunity for needle-stickinjuries.	None - like the originalreturn line injection port, theneedleless injection portallows the operator to sampleor administer fluids duringthe procedure.
3	A Sterile Barrier (IV) Filterwill be added to the set'sAnticoagulant (AC) Line.	The filter allows air from anempty AC container to bevented, improving thesystem's usability.	Air from an empty ACcontainer does not enter thecentrifuge and cause anunwanted system alarm.

Table 1: Modifications to the Disposable Spectra Optia Exchange Set

Intended Use/Indications for Use:

Intended Use:

The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma and red blood cell exchange procedures.

Indication for Use:

The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

Technological Comparison: The modified Spectra Optia Exchange Set 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.

Substantial Equivalence: The modified disposable set's substantial equivalence to its predicate is summarized below.

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Table 2: Key Similarities – Unmodified vs. Modified Spectra Optia Exchange Set

Attribute	Comparison
1	Intended Use /Labeling	The modifications to the Spectra Optia Exchange Set do not change theSpectra Optia Apheresis System's intended use. The disposable set'sInstructions for Use have been modified to describe the proper use of the newneedleless injection port.
2	EssentialTechnology	The modifications to the disposable blood tubing set do not alter the SpectraOptia System's essential technology.
3	Materials	The Spectra Optia Exchange Set, in both its original and modifiedconfigurations, is comprised of well-characterized, biocompatible materials.
4	Sterility /Manufacturing	The original and modified Exchange Sets are sterilized in the same way andare manufactured using almost identical processes. Manufacturing procedureshave been modified to reflect the use of the larger vent bag, the addition of theneedleless access port/manifold to the set's Return Line, and the new IV filteron the AC line.
5	ClinicalPerformance	Comprehensive verification testing confirmed that the new needleless accessport performed as designed. A broad range of activities were conducted,including mechanical testing, biocompatibility testing, and evaluations of themodified Exchange Set's sterility, packaging and shelf life.Simulated-use testing demonstrated that the IV Filter on the AC Line and theLarger Vent Bag are functionally compatible with the system's embeddedsoftware and that the linear line length of air in the AC Line during an AC bagempty event is reduced when the IV Filter is installed. Specifically, no air wasable to travel past the IV Filter, using the modified Exchange Set, during an"AC Bag Empty Event". For the unmodified set, the length of air measured inthe AC line averaged 13.3 inches (S.D.: 1.3 inches), compared to 0 inches inthe modified set.

Regulation Number and Section

N/A