SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET

K132429 · Terumobct, Inc. · LKN · Dec 6, 2013 · GU

Device Facts

• Record ID: K132429
• Device Name: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
• Applicant: Terumobct, Inc.
• Product Code: LKN · GU
• Decision Date: Dec 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Centrifugal blood component separator; separates whole blood into cellular and plasma components. Comprised of apheresis machine (centrifuge, pumps, valves), sterile single-use disposable tubing sets, and embedded software. Used in clinical settings for therapeutic apheresis. Operator (clinician) manages procedure via system interface. Device performs RBCx by controlling blood flow and separation based on programmed protocols. Output includes separated blood components; enables physician-prescribed target hematocrit and fluid balance management. Benefits patients with Sickle Cell Disease by automating exchange procedures to manage hemoglobin S (HbS) levels.

Clinical Evidence

Prospective, multi-center, single-arm, open-label study. Evaluated ability of Spectra Optia RBCx protocol to achieve target HbS levels in adults and children with Sickle Cell Disease. Primary endpoints met; no serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported.

Technological Characteristics

Centrifugal blood cell separator. System components: apheresis machine, sterile single-use disposable tubing sets, embedded software. Technology relies on centrifugation for blood component separation. Software-controlled via algorithms using established equations for RBCx. Connectivity/materials not specified beyond system architecture.

Indications for Use

Indicated for Red Blood Cell Exchange (RBCx) procedures for transfusion management of Sickle Cell Disease in adults and children.

Predicate Devices

• Spectra Optia Apheresis System (K132429)
• COBE Spectra system (K831004)

Submission Summary (Full Text)

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K132429 Page 78 of 291 Page 1 of 2

DEC - 6 2013

510(k) Summary

| Owner/Manufacturer: | Terumo BCT. Inc.<br>10811 W. Collins Avenue<br>Lakewood, Colorado 80215 | |
|------------------------------|-------------------------------------------------------------------------------|--|
| Contact Person: | Tina O'Brien<br>Senior Regulatory Affairs Specialist<br>Phone: [phone] | |
| 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:

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.

#### Indications for Use:

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.

#### 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<br>(Subject Device) | COBE Spectra system<br>(K831004) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | Therapeutic Plasma Exchange and<br>Red Blood Cell Exchange | Multiple therapeutic apheresis<br>procedures, including Red Blood<br>Cell Exchange |
| Essential<br>Technology | Both the Spectra Optia and COBE Spectra systems are automated blood<br>cell separators achieving their essential function (the separation of blood<br>cells and plasma) through centrifugation. | |
| Software | Software algorithms underlying the red blood cell exchange procedures<br>on both the Spectra Optia and COBE Spectra systems are controlled by<br>the same equations. | |
| Performance | In both a "simulated-use" laboratory validation study and human clinical<br>trial. Spectra Optia's RBCx protocol was found to perform the same as<br>the COBE Spectra RBCx protocol, with respect to the system's ability to<br>achieve 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 [phone] or [phone] 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:

.. ... ..

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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