(56 days)
None
No
The summary describes a centrifugal blood separation system with embedded software and a modification for single-needle access. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical and software control of the apheresis process and the validation of a new access method.
Yes
The device is described as "intended for use in therapeutic apheresis and may be used to perform Therapeutic Plasma Exchange (TPE) procedures," directly indicating its therapeutic purpose.
No
The device is described as a "blood component separator" used for "therapeutic apheresis" and "Therapeutic Plasma Exchange (TPE) procedures." Its purpose is to separate blood, not to diagnose a condition.
No
The device description explicitly states that the system is comprised of three major sub-systems, including the apheresis machine itself (centrifuge, pumps, valves, etc.) and disposable tubing sets, in addition to embedded software. This indicates significant hardware components are integral to the device's function.
Based on the provided information, the Spectra Optia Apheresis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "therapeutic apheresis" and "Therapeutic Plasma Exchange (TPE) procedures." These are therapeutic procedures performed on a patient's blood within the body (or by processing blood drawn from and returned to the body), not for diagnostic testing of samples outside the body.
- Device Description: The device separates blood components. While this involves handling blood, the purpose is to perform a therapeutic intervention (removing plasma), not to analyze the blood for diagnostic information.
- Lack of Diagnostic Focus: There is no mention of analyzing blood components for diagnostic purposes, identifying diseases, or providing information for diagnosis. The focus is on the physical separation of blood components for therapeutic benefit.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Spectra Optia system's function is therapeutic, not diagnostic.
N/A
Intended Use / 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.
Product codes
LKN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
The safety and efficacy of the Spectra Optia system TPE protocol with single-needle access was validated through a laboratory non-inferiority study to compare the plasma removal efficiency (PRE) of the TPE procedure of single-needle vs. dual-needle access. Study results successfully demonstrated non-inferiority between single-needle and dual-needle options for the Spectra Optia Apheresis System's Therapeutic Plasma Exchange protocol in terms of the efficiency of plasma removal. The study also demonstrated that neither the hematocrit of the processed blood nor the rate at which the blood is processed (Inlet Flow Rate) is impacted by the type of venous access.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
| Owner/Manufacturer: | Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215 |
|------------------------------|-------------------------------------------------------------------------------|
| | AUG 8 2011 |
| Contact Person: | Tina O'Brien
Senior Regulatory Affairs Specialist
Phone: (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 same | |
| intended use as the predicate device |
1
| Attribute | Comparison | |
|---|---|---|
| 2 | Essential | |
| Technology | The essential technology of the Spectra Optia system has not changed |
- it remains an automated blood cell separator and achieves its
essential function (the separation of blood cells and plasma) through
centrifugation. |
| 3 | Materials | The blood-contacting disposable tubing sets are comprised of the
same biocompatible materials as previously cleared Spectra Optia
disposables. |
| 4 | Sterility /
Manufacturing | The single-use, sterile disposables are sterilized using the same
packaging and validated ETO-based sterilization method, as other
cleared Spectra Optia disposables. Likewise, manufacturing methods
for the disposables are similar. |
| | Clinical
Performance | The safety and efficacy of the Spectra Optia system TPE protocol with
single-needle access was validated through a laboratory non-inferiority
study to compare the plasma removal efficiency (PRE) of the TPE
procedure of single-needle vs. dual-needle access. Study results
successfully demonstrated non-inferiority between single-needle and
dual-needle options for the Spectra Optia Apheresis System's
Therapeutic Plasma Exchange protocol in terms of the efficiency of
plasma removal. The study also demonstrated that neither the
hematocrit of the processed blood nor the rate at which the blood is
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.
2
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.
3
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
4
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 _