(195 days)
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.
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
- 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.
The provided text describes a 510(k) premarket notification for the Terumo BCT, Inc. Spectra Optia® Apheresis System. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding hardware modifications due to obsolescence. Crucially, the document does not contain information about the device's performance through a clinical study with acceptance criteria in the way one might expect for an AI/ML medical device.
Instead, the "performance data" section states: "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." This refers to engineering verification and validation (V&V) activities for hardware changes, not a clinical study involving human subjects or AI performance metrics.
Therefore, many of the requested details, such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with ground truth, and training set information for AI, are not applicable or available in this document.
However, I can extract the acceptance criteria (in terms of performance requirements) as implied by the statement regarding meeting "all the performance requirements" and being "as safe and performs as well as the predicate device." The study proving this is the "verification and validation tests" mentioned.
Here's the breakdown of the available and applicable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| The modified device meets all performance requirements of the predicate device. | The modified device met all performance requirements. (Based on V&V tests) |
| The modified device performs as well as the predicate device. | The modified device performs as well as the predicate device. (Based on V&V tests and demonstration of substantial equivalence) |
| The modified device is as safe as the predicate device. | The modified device is as safe as the predicate device. (Based on V&V tests and demonstration of substantial equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document describes engineering verification and validation for hardware component changes, not a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No "ground truth" in the context of clinical expert review is mentioned, as this is not a clinical study using patient data for diagnostic classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method for a test set is relevant to the type of V&V described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This document does not describe an AI/ML device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is a hardware system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for the engineering verification and validation would be the design specifications and performance characteristics of the original (predicate) device, against which the modified device was tested to ensure it met those pre-defined engineering and functional requirements.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI/ML device, this question is not relevant.
In summary: The provided document is a 510(k) submission for a hardware modification to an existing apheresis system. The "study" proving acceptance criteria is the verification and validation (V&V) tests conducted on the modified system to ensure it performs equivalently to the predicate device, specifically addressing functional and safety requirements rather than clinical performance metrics in a patient population or AI/ML diagnostic accuracy.
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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.
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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
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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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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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
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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.
N/A