(63 days)
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.
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.
The provided document describes the SIR-Spheres Microspheres Activity Calculator (SMAC) and its performance evaluation.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the SMAC uses the same Body Surface Area (BSA) formula for calculating Y90 dose activity as the predicate device, HERMES Hybrid3D v3.0 SIRT (K181468). The primary performance claim is the accurate calculation of this dose.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of Y90 Dose Activity Calculation (BSA Formula) | "The SMAC tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs.""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.""The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Functional Equivalence to Predicate Device | "Both software programs calculate dose based on the exact same SIRTEX BSA formula as seen in the instructions for use.""The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Software Design, Function, and Operation | "The proposed SMAC software is equivalent when compared to the marketed predicate in comparison to software design, function, and operation as the identified predicate." |
| Safety and Effectiveness | "Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence." (Though specific metrics beyond the calculation accuracy are not detailed in the provided text.) |
| Conformity to FDA Guidance and Standards | "The performance evaluation of the proposed SMAC Calculator included testing conducted in accordance to the following FDA Guidance Documents, domestic and international standards." (Specific guidance documents and standards are not listed in the provided text, but the general conformity is stated.) |
| Browser Compatibility | "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." (This is a compatibility criterion rather than a performance criterion for calculation accuracy.) |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or the provenance of the data used for performance evaluation. It only states that "testing" was conducted.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not mention the number of experts used or their qualifications for establishing ground truth for any test set.
4. Adjudication Method for the Test Set
The provided document does not mention any adjudication method (e.g., 2+1, 3+1) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size regarding human reader improvement with AI assistance. The SMAC is presented as a tool to automate calculations typically done manually, implying a replacement or augmentation of manual calculation, rather than assisting in image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the information suggests that a standalone performance was done for the algorithm's accuracy. The SMAC is described as a "software modelling program" that "automatically performs calculations" using a "simple algorithm." The comparison with the predicate device focuses on the identical algorithms for Y90 dose calculations. The device "does not incorporate imaging capabilities." This implies that the core function of the SMAC is purely algorithmic computation without human intervention in the calculation process itself.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be primarily based on the established and documented BSA formula used in scientific literature and the equivalence to the predicate device's calculations. The document states:
- "The algorithms used have been established and documented in scientific literature."
- "Both software programs calculate dose based on the exact same SIRTEX BSA formula as seen in the instructions for use."
- "The proposed and predicate devices utilize the BSA Method to perform dose calculations."
This suggests that the "ground truth" for the calculations is the accepted mathematical formula itself, and the device is evaluated on its ability to accurately implement that formula.
8. Sample Size for the Training Set
The provided document does not specify a sample size for a training set. As the device performs calculations based on a known formula rather than a machine learning model trained on data to predict outcomes, a traditional "training set" in the machine learning sense is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since a traditional training set with associated ground truth (e.g., expert labels, pathology) is not applicable for this type of calculation software, this question is not directly addressed. The "ground truth" for the algorithm itself is the inherent mathematical correctness of the BSA formula, which is "established and documented in scientific literature." The validation would then be to confirm the software implements this formula correctly.
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October 23, 2020
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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
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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
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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) |
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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.
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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.
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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:SirtexSIR-Spheres MicrospheresActivity Calculator (SMAC) | Predicate: HermesMedical SolutionsHybrid 3DK181468 | Comparison |
|---|---|---|---|
| Indicationsfor Use | The SIR-Spheres®Microspheres ActivityCalculator (SMAC) isintended as a tool to assistwith developingpersonalized dose activitycalculations, based onrelevant patient data, forpatients undergoingselective internal radiationtherapy (SIRT) with SIR-Spheres Y-90 resinmicrospheres. Using theBSA formula, the SMACautomatically performscalculations that aretypically done manually bya physician or licensedhealthcare practitioner.The algorithms used havebeen established anddocumented in scientificliterature. | Hybrid3D is a softwareapplication that can beused to process, display,analyze and managenuclear medicine andother medical imagingdata transferred fromother workstations oracquisition stations | SimilarBoth softwareprogramscalculate dosebased on theexact sameSIRTEX BSAformula as seenin theinstructions foruse.Hybrid 3Dincludes morefeatures thandose calculation,whereas theSMAC onlyprovides thesoftwareautomation ofthe formula. |
| IntendedUsers | Physicians and licensedhealthcare practitioners | The user may be anexperienced physician,medical physicist,technologist nurse orother operator who hasbeen trained by anauthorized distributor or | Very Similar |
| Characteristic | Proposed Device:SirtexSIR-Spheres MicrospheresActivity Calculator (SMAC) | Predicate: HermesMedical SolutionsHybrid 3DK181468 | Comparison |
| by Hermes MedicalSolutions. | |||
| DeviceEnvironment | Hospital, ClinicOffice Based InterventionalSuite (OBIS) | HospitalClinic | Similar:Both theproposed andpredicate devicesare intended tobe used inlicensedhealthcarefacilities |
| OperatingPlatform | The SMAC system isdesigned to be supportedby the last two versions ofthe web browsers:Chrome, Firefox, Safari,Opera, Mobile Safari, andInternet Explorer (IE)mobile as well as InternetExplorer 9+ and androidbrowser 2.3. | Microsoft Windows 7 & 10(64 bit only) / WindowsServer | SimilarProposeddevice'soperatingplatform hasbeen evaluatedfor browsercompatibility. |
| Algorithms toPerformCalculations | Algorithm performs Y90dose calculations basedupon the Body SurfaceArea (BSA) model usingpatient specificcharacteristics. | Algorithm performs Y90dose calculations basedupon the Body SurfaceArea (BSA) model usingpatient specificcharacteristics. | IdenticalThe proposedand predicatedevices utilize theBSA Method toperform dosecalculations. |
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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.
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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
§ 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.