(123 days)
Not Found
No
The document describes a centrifugal blood separation system with embedded software for controlling the process. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is described as "intended for use in therapeutic apheresis applications" and specifically mentions "Red Blood Cell Exchange (RBCx) procedures for the transfusion management of Sickle Cell Disease," which are therapeutic interventions.
No.
The device is described as a "blood component separator" used for "therapeutic apheresis applications" and "Red Blood Cell Exchange (RBCx) procedures." These are treatment procedures, not diagnostic ones.
No
The device description explicitly states it 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 it is a hardware device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a therapeutic apheresis system used for procedures like Red Blood Cell Exchange. This is a treatment performed on a patient's blood outside the body, but the purpose is therapeutic, not diagnostic.
- Device Description: The description details a system for separating blood components using centrifugation, pumps, valves, tubing sets, and software. This aligns with a therapeutic apheresis device, not a device used to diagnose a condition by analyzing samples.
- Lack of Diagnostic Language: The text does not mention analyzing samples to detect, identify, or measure substances or characteristics for the purpose of diagnosis, monitoring, or screening.
IVD devices are typically used to examine samples (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health status, diagnose diseases, or monitor treatment. The Spectra Optia Apheresis System is a therapeutic device used to treat a condition by modifying the patient's blood.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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: (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.
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
adults and children
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
COBE Spectra system (K831004)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K132429 Page 78 of 291 Page 1 of 2
DEC - 6 2013
510(k) Summary
| Owner/Manufacturer: | Terumo BCT. Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215 | |
|------------------------------|-------------------------------------------------------------------------------|--|
| Contact Person: | Tina O'Brien
Senior Regulatory Affairs Specialist
Phone: (303) 239-2082 | |
| 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.
1
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
(Subject Device) | COBE Spectra system
(K831004) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | Therapeutic Plasma Exchange and
Red Blood Cell Exchange | Multiple therapeutic apheresis
procedures, including Red Blood
Cell Exchange |
| Essential
Technology | Both the Spectra Optia and COBE Spectra systems are automated blood
cell separators achieving their essential function (the separation of blood
cells and plasma) through centrifugation. | |
| Software | Software algorithms underlying the red blood cell exchange procedures
on both the Spectra Optia and COBE Spectra systems are controlled by
the same equations. | |
| Performance | In both a "simulated-use" laboratory validation study and human clinical
trial. Spectra Optia's RBCx protocol was found to perform the same as
the COBE Spectra RBCx protocol, with respect to the system's ability to
achieve patient hematocrit targets and to maintain patient fluid balance. | |
Table 1: Spectra Optia system vs. COBE Spectra
2
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
3
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 (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
4
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)
(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
Benjamin R. Fisher -S 2013.12.09 20:01:36 -05'00'