SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE

K131744 · Terumobct, Inc. · LKN · Aug 8, 2013 · GU

Device Facts

• Record ID: K131744
• Device Name: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
• Applicant: Terumobct, Inc.
• Product Code: LKN · GU
• Decision Date: Aug 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Spectra Optia Apheresis System is a centrifugal blood component separator. System comprises apheresis machine (centrifuge, pumps, valves), sterile single-use disposable tubing sets, and embedded software. Modification introduces single-needle access for TPE procedures via new connector and software update. Device separates whole blood into cellular and plasma components. Used in clinical settings for therapeutic apheresis. Healthcare providers operate system to perform TPE. Output consists of separated blood components; system monitors and controls flow rates and separation efficiency. Single-needle access provides alternative to dual-needle access without impacting plasma removal efficiency or processed blood hematocrit. Benefits include expanded venous access options for patients undergoing TPE.

Clinical Evidence

Laboratory non-inferiority study compared plasma removal efficiency (PRE) of single-needle vs. dual-needle access for TPE. Results demonstrated non-inferiority between access methods. Study confirmed neither processed blood hematocrit nor inlet flow rate were impacted by access type. No clinical patient data required.

Technological Characteristics

Centrifugal blood cell separator. Blood-contacting components use biocompatible materials identical to predicate. Sterilization via validated ETO method. System includes centrifuge, pumps, valves, and embedded software. Single-needle connector features tortuous pathway design.

Indications for Use

Indicated for patients requiring therapeutic apheresis, specifically Therapeutic Plasma Exchange (TPE) procedures.

Predicate Devices

• Spectra Optia Apheresis System (K071070)

Submission Summary (Full Text)

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510(k) Summary

| Owner/Manufacturer: | Terumo BCT, Inc.<br>10811 W. Collins Avenue<br>Lakewood, Colorado 80215 |
|------------------------------|-------------------------------------------------------------------------------|
| | AUG 8 2011 |
| Contact Person: | Tina O'Brien<br>Senior Regulatory Affairs Specialist<br>Phone: [phone] |
| 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 /<br>Labeling | The Spectra Optia system with single-needle access has the same<br>intended use as the predicate device |

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| | Attribute | Comparison |
|---|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Essential<br>Technology | The essential technology of the Spectra Optia system has not changed<br>- it remains an automated blood cell separator and achieves its<br>essential function (the separation of blood cells and plasma) through<br>centrifugation. |
| 3 | Materials | The blood-contacting disposable tubing sets are comprised of the<br>same biocompatible materials as previously cleared Spectra Optia<br>disposables. |
| 4 | Sterility /<br>Manufacturing | The single-use, sterile disposables are sterilized using the same<br>packaging and validated ETO-based sterilization method, as other<br>cleared Spectra Optia disposables. Likewise, manufacturing methods<br>for the disposables are similar. |
| | Clinical<br>Performance | The safety and efficacy of the Spectra Optia system TPE protocol with<br>single-needle access was validated through a laboratory non-inferiority<br>study to compare the plasma removal efficiency (PRE) of the TPE<br>procedure of single-needle vs. dual-needle access. Study results<br>successfully demonstrated non-inferiority between single-needle and<br>dual-needle options for the Spectra Optia Apheresis System's<br>Therapeutic Plasma Exchange protocol in terms of the efficiency of<br>plasma removal. The study also demonstrated that neither the<br>hematocrit of the processed blood nor the rate at which the blood is<br>processed (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 [phone] or [phone] 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)

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## Herbert P. Lerner -S

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