(195 days)
No reference devices were used in this submission.
No
The document explicitly states that the modifications are to resolve obsolescence issues for electronic components and does not mention AI or ML.
Yes
Explanation: The device is used to perform therapeutic plasma exchange, Red Blood Cell Exchange for Sickle Cell Disease, and reduce White Blood Cells for patients with leukocytosis, all of which are therapeutic interventions.
No
The device description indicates it is a blood component separator used for therapeutic procedures like plasma exchange or red blood cell exchange, not for diagnosing conditions.
No
The device description explicitly states it is comprised of three major subsystems, including the apheresis machine itself (which contains hardware components) and a disposable blood tubing set, in addition to embedded software.
Based on the provided information, the Spectra Optia® Apheresis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses described are therapeutic procedures performed on the patient's blood outside the body (therapeutic plasma exchange, red blood cell exchange, white blood cell reduction). These are treatments, not diagnostic tests performed on samples to provide information about a patient's health status.
- Device Description: The device separates blood components. While this process involves handling blood, it's for the purpose of treatment or collection, not for analyzing the blood to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device performing any tests, analyses, or measurements on the blood to provide diagnostic information.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Spectra Optia® Apheresis System is a therapeutic device used to process blood for treatment purposes.
N/A
Intended Use / Indications for Use
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
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.
The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
Product codes (comma separated list FDA assigned to the subject device)
LKN
Device Description
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:
-
- the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
- a sterile, single-use, disposable blood tubing set 2.
-
- embedded software
The modifications described in this submission are those required to resolve current obsolescence issues for various electronic components found within the Spectra Optia equipment.
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
Prescription Use
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 summary of the verification testing and a summary of the validation testing was presented to show that the modified device met all the performance requirements and that the subject device is as safe and performs as well as the predicate device.
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.
Spectra Optia® Apheresis System, K172590
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.
No reference devices were used in this submission.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 1, 2018
Terumo BCT, Inc. Nicholas Wong Sr. Regulatory Affairs Specialist 10811 West Collins Avenue Lakewood, CO 80215
Re: K181049
Trade/Device Name: Spectra Optia® Apheresis System Regulatory Class: Unclassified Product Code: LKN Dated: October 1, 2018 Received: October 2, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland -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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181049
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.
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.
The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
K181049
510(k) Summary
I. SUBMITTER
| Owner/Manufacturer: | Terumo BCT, Inc. |
|---|---|
| 10811 W. Collins Avenue | |
| Lakewood, Colorado 80215 | |
| Phone: 877-339-4228 | |
| Contact Person: | Nicholas Wong |
| Sr. Regulatory Affairs Specialist | |
| Phone: 303-239-2384 | |
| Fax: 303-231-4756 | |
| Date Prepared: | April 19th, 2018 |
II. DEVICE
| Trade Name of Device: | Spectra Optia® Apheresis System |
|---|---|
| Common or Usual Name: | Apheresis Device or System |
| Regulation Number: | N/A |
| Regulation Name: | N/A |
| Classification Name: | N/A |
| Regulatory Class: | Unclassified |
| Product Code: | LKN |
III. PREDICATE DEVICE
Spectra Optia® Apheresis System, K172590 This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The Spectra Optia® Apheresis System has been cleared for the following therapeutic apheresis, cell collection and cell processing procedures:
- Therapeutic Apheresis Procedures:
- Collection/Processing Procedures (cleared by CBER): ●
- Mononuclear Cell (MNC) Collection BK120012 & BK150251 —
- Granulocyte Collection BK130065 —
- -Bone Marrow Processing - BK140191
Terumo BCT, Inc.
10811 West Collins Ave.
Lakewood, Colorado 80215-4440
USA
USA Phone: 1.877.339.4228
Phone: +1.303.231.4357
Fax: +1.303.542.5215
Europe, Middle East and A
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: +32.2.715.05.90
Fax: +32.2.721.07.70
Room 3903-3903A, 39/F
ACE Tower, Windsor House
311 Gloucester Road
Causeway Bay, Hong Kong
Phone: +852.2283.0700
Fax: +852.2576.1311
Terumo BCT Latin America S.A.
La Pampa 1517 – 12ᵗʰ Floor
C1428DZE
Buenos Aires
Argentina
Phone: +54.11.5530.5200
Fax: +54.11.5530.5201
20-14, 3-chrome
Higashi Gotanda, Shinagawa-ku
Tokyo 141-0022
Japan
Phone: +81.3.6743.7890
Fax: +81.3.6743.9800
UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.CON
4
The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:
-
- the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
- a sterile, single-use, disposable blood tubing set 2.
-
- embedded software
The modifications described in this submission are those required to resolve current obsolescence issues for various electronic components found within the Spectra Optia equipment.
V. INTENDED USE/INDICATIONS FOR USE
The intended use is unchanged as a result of this modification and is identified below:
The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.
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.
The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.
VI. TECHNOLOGICAL COMPARISON
The proposed modification 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.
VII. PERFORMANCE DATA
A summary of the verification testing and a summary of the validation testing was presented to show that the modified device met all the performance requirements and that the subject device is as safe and performs as well as the predicate device.
VIII. CONCLUSIONS
Based on the verification and validation tests performed on the Spectra Optia Apheresis System with the new electrical components, this system is as safe and effective as the legally marketed predicate device. The information provided in the 510(k) demonstrates that the Spectra Optia Apheresis System is substantially equivalent to the identified predicated device.