(63 days)
Not Found
No
The description explicitly states the tool employs a "simple algorithm" based on the Body Surface Area (BSA) model and patient inputs, and there is no mention of AI, ML, or training/test data sets typically associated with such technologies.
No
The device is described as a software modelling program intended to assist with dose activity calculations for selective internal radiation therapy, not to directly treat or diagnose a disease. It functions as a tool for calculations and does not replace the physician's independent determination of therapy.
No
The device is described as a software modeling program that assists with dose activity calculations for therapy, not for diagnosing a condition or disease. It is a tool for prescribing treatment, not for identifying a medical condition.
Yes
The device is described as a "software modelling program" and a "tool" that performs calculations based on user input and established formulas. There is no mention of hardware components being part of the device itself. While it assists with a medical procedure involving a physical product (microspheres), the device being reviewed is solely the software calculator.
Based on the provided information, the SIR-Spheres® Microspheres Activity Calculator (SMAC) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to assist with dose activity calculations for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a software modeling program that computes prescribed activity calculations based on patient characteristics and a published formula (BSA). It's a calculation tool for treatment planning, not for analyzing biological samples to diagnose a condition.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SMAC does not interact with or analyze any biological samples.
- Focus on Treatment Planning: The entire description points towards a tool used by healthcare practitioners to determine the appropriate dose of a therapeutic agent (SIR-Spheres) for a patient.
While the device is used in a healthcare setting and involves calculations related to patient treatment, it does not fit the definition of an In Vitro Diagnostic device, which is focused on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/ or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
Product codes
KPS
Device Description
The SIR-Spheres Microspheres Activity Calculator (SMAC) is a software modelling program that is designed to assist physicians and licensed healthcare practitioners when prescribing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. It allows physicians and licensed healthcare practitioners to determine an individualized dose activity calculation based upon specific patient characteristics. The program computes the prescribed activity calculation using the Body Surface Area (BSA) formula that has been published in peer reviewed journals of medicine and models treatment parameters. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient. The SIR-Spheres Microspheres Activity Calculator (SMAC) tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs. The SMAC tool does not incorporate imaging capabilities.
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
Intended Users: Physicians and licensed healthcare practitioners
Device Environment: Hospital, Clinic Office Based Interventional Suite (OBIS)
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)
The performance evaluation of the proposed SMAC Calculator included testing conducted in accordance to the following FDA Guidance Documents, domestic and international standards: Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
October 23, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Sirtex Medical US Holdings, Inc. Sirtex Medical Pty Ltd. % Mr. Michael P. Hanley Senior Regulatory Affairs Specialist 300 Unicorn Park, 2nd Floor WOBURN MA 01801
Re: K202392
Trade/Device Name: SIR-Spheres Microspheres Activity Calculator (SMAC) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: August 19, 2020 Received: August 21, 2020
Dear Mr. Hanley:
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. 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202392
Device Name
SIR-Spheres Microspheres Activity Calculator (SMAC)
Indications for Use (Describe)
The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/ or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5 K202392 510 (k) Summary
510(k) Summary – SIR-Spheres Microspheres Activity Calculator (SMAC)
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510 (k) summary has been provided in conformance with 21 CFR 807.92(c).
Date Prepared: August 19, 2020
A. Sponsor
Sirtex Medical Pty Ltd Shop 6, 207 Pacific Hwy St Leonards NSW 2065, Australia
B. Contact
Michael Hanley Senior Regulatory Affairs Specialist 781-721-3842 Email: Michael.Hanley@sirtex.com
C. Device Name
Trade Name:
| Trade Name: | SIR-Spheres Microspheres Activity Calculator (SMAC) |
|---|---|
| Common/Usual Name: | System, Imaging Processing, Radiological |
| Classification Panel: | Radiology |
| Pro Code: | KPS/Class II |
| Regulation Number | 21 CFR 892.1200 |
D. Legally Marketed Device (Predicate Device)
The following legally marketed device has been used for comparison.
| Proprietary/Trade Name | |
|---|---|
| Trade Name: | HERMES Hybrid3D v3.0 SIRT (K181468) |
E. Description of the device that is subject of this premarket notification:
The SIR-Spheres Microspheres Activity Calculator (SMAC) is a software modelling program that is designed to assist physicians and licensed healthcare practitioners when prescribing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. It allows physicians
510(k) Premarket Notification Sirtex Medical Pty Ltd.
4
and licensed healthcare practitioners to determine an individualized dose activity calculation based upon specific patient characteristics. The program computes the prescribed activity calculation using the Body Surface Area (BSA) formula that has been published in peer reviewed journals of medicine and models treatment parameters. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient.
The SIR-Spheres Microspheres Activity Calculator (SMAC) tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs. The SMAC tool does not incorporate imaging capabilities.
The HERMES Hybrid3D SIRT (K181468) is an acceptable predicate device because both devices perform dosimetry calculations based on the BSA formula
Calculated Activity (GBq)
BSA (m2) = 0.20247 × height (m)0.725 x weight(kg)0
Figure 1: Prescribed activity calculation of SIR-Spheres resin microspheres
F. Indications for Use/Intended Use
The proposed SMAC Calculator application has the following Indications for Use: The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients underqoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
The proposed SMAC Calculator application has the following Intended Use:
The SIR-Spheres Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres.
5
G. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate. The table below provides the comparison of the devices.
| Characteristic | Proposed Device:
Sirtex
SIR-Spheres Microspheres
Activity Calculator (SMAC) | Predicate: Hermes
Medical Solutions
Hybrid 3D
K181468 | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The SIR-Spheres®
Microspheres Activity
Calculator (SMAC) is
intended as a tool to assist
with developing
personalized dose activity
calculations, based on
relevant patient data, for
patients undergoing
selective internal radiation
therapy (SIRT) with SIR-
Spheres Y-90 resin
microspheres. Using the
BSA formula, the SMAC
automatically performs
calculations that are
typically done manually by
a physician or licensed
healthcare practitioner.
The algorithms used have
been established and
documented in scientific
literature. | Hybrid3D is a software
application that can be
used to process, display,
analyze and manage
nuclear medicine and
other medical imaging
data transferred from
other workstations or
acquisition stations | Similar
Both software
programs
calculate dose
based on the
exact same
SIRTEX BSA
formula as seen
in the
instructions for
use.
Hybrid 3D
includes more
features than
dose calculation,
whereas the
SMAC only
provides the
software
automation of
the formula. |
| Intended
Users | Physicians and licensed
healthcare practitioners | The user may be an
experienced physician,
medical physicist,
technologist nurse or
other operator who has
been trained by an
authorized distributor or | Very Similar |
| Characteristic | Proposed Device:
Sirtex
SIR-Spheres Microspheres
Activity Calculator (SMAC) | Predicate: Hermes
Medical Solutions
Hybrid 3D
K181468 | Comparison |
| | | by Hermes Medical
Solutions. | |
| Device
Environment | Hospital, Clinic
Office Based Interventional
Suite (OBIS) | Hospital
Clinic | Similar:
Both the
proposed and
predicate devices
are intended to
be used in
licensed
healthcare
facilities |
| Operating
Platform | The SMAC system is
designed to be supported
by the last two versions of
the web browsers:
Chrome, Firefox, Safari,
Opera, Mobile Safari, and
Internet Explorer (IE)
mobile as well as Internet
Explorer 9+ and android
browser 2.3. | Microsoft Windows 7 & 10
(64 bit only) / Windows
Server | Similar
Proposed
device's
operating
platform has
been evaluated
for browser
compatibility. |
| Algorithms to
Perform
Calculations | Algorithm performs Y90
dose calculations based
upon the Body Surface
Area (BSA) model using
patient specific
characteristics. | Algorithm performs Y90
dose calculations based
upon the Body Surface
Area (BSA) model using
patient specific
characteristics. | Identical
The proposed
and predicate
devices utilize the
BSA Method to
perform dose
calculations. |
6
H. Performance Data
The performance evaluation of the proposed SMAC Calculator included testing conducted in accordance to the following FDA Guidance Documents, domestic and international standards:
510(k) Premarket Notification Sirtex Medical Pty Ltd.
7
Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence.
I. Substantially Equivalent / Conclusion
The Proposed device is determined to be substantially equivalent to the predicate device based on:
- The Intended Use and Indications for Use
- Operating principles/technology
- . Results of safety and performance testing
- Responses to questions posed in FDA 510 (k) "Substantial Equivalence" Decision Making . Flowchart