MIM – Y90 Dosimetry

K172218 · Mim Software, Inc. · LLZ · Nov 21, 2017 · Radiology

Device Facts

• Record ID: K172218
• Device Name: MIM – Y90 Dosimetry
• Applicant: Mim Software, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment planning, · Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. · Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans. · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). · Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

Device Story

MIM-Y90 Dosimetry is a software feature within the MIM SurePlan system used by clinicians (radiologists, oncologists, physicists) in clinical settings. It processes PET or SPECT images post-administration of Yttrium-90 (Y90) microsphere implants. The device performs retrospective dose calculations using three methods: Local Deposition Model, Local Deposition Model with scaling for known injected activity, and Voxel S Value approach (MIRD Pamphlet 17). It allows for decay correction, branching fraction adjustment, and isotope substitution parameters. The software outputs dose distribution maps and calculations, which clinicians review to evaluate the post-treatment dose. This aids in patient follow-up and management. It operates on Windows and Mac platforms.

Clinical Evidence

Bench testing only. Validation performed by board-certified clinicians comparing software output against independently implemented, industry-standard solutions. Software passed all performance requirements and specifications.

Technological Characteristics

Software-based medical image management and dosimetry system. Operates on Windows and Mac platforms. Implements dose calculation algorithms (Local Deposition Model, Voxel S Value). Supports DICOM 3.0 standards. Connectivity via standard network protocols for image retrieval/transmission. No hardware components; standalone software application.

Indications for Use

Indicated for trained medical professionals (radiologists, oncologists, physicians, technologists, dosimetrists, physicists) to manage/evaluate digital medical images (CT, MRI, CR, DX, MG, US, SPECT, PET, XA). Used for image processing, registration, fusion, cardiac function evaluation, contouring, brain scan analysis, and brachytherapy planning. Specifically indicated for post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants. Contraindicated for prospective Y90 dose calculation, retreatment planning with Y90, and mammography CAD.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• MIM - Thin Client (Mobile) (K151913)
• MIM 5.2 (BRACHY) (K103576)
• OLINDA EXM (K033960)

Submission Summary (Full Text)

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November 21, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MIM Software Inc. % Ms. Lynn Hanigan Quality Assurance Director 25800 Science Park Drive - Suite 180 CLEVELAND OH 44122

Re: K172218

Trade/Device Name: MIM - Y90 Dosimetry Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 19, 2017 Received: October 20, 2017

Dear Ms. Hanigan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Ms. Lynn Hanigan

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K172218

Device Name

MIM - Y90 Dosimetry

Indications for Use (Describe)

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

· Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.

· Create, display and print reports from medical images.

· Registration, fusion display, and review of medical images for diagnosis, treatment planning,

· Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.

· Localization and definition of objects such as tumors and normal tissues in medical images.

· Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.

· Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.

· Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).

· Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

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)

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Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in bold black letters, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, and the colors are eye-catching.

## 510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92)

#### Submitter:

MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122

| Phone:<br>Fax: | 216-455-0600<br>216-455-0601 |
|------------------------|------------------------------|
| Contact Person: | Lynn Hanigan |
| Date Summary Prepared: | 11/07/2017 |
| <b>Device Name</b> | |
| Trade Name: | MIM - Y90 Dosime |

| Trade Name: | MIM – Y90 Dosimetry |
|-----------------------------------|------------------------------------------|
| Common Name: | Medical Imaging Software |
| Regulation Number / Product Code: | 21 CFR 892.2050 Product Code LLZ |
| Classification Name: | System, Imaging Processing, Radiological |

#### Predicate Devices

| K151913 | MIM - Thin Client (Mobile) | MIM Software Inc. |
|---------|----------------------------|-----------------------|
| K103576 | MIM 5.2 (BRACHY) | MIM Software Inc. |
| K033960 | OLINDA EXM | Vanderbilt University |

#### Intended Use

MIM software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists.

MIM is a medical image and information management system that is intended to receive, transmit. store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0.

MIM provides the user with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.

The Region of Interest (ROI) feature reduces the time necessary for the user to define objects in medical image volumes by providing an initial definition of object contours. The objects include, but are not limited to, tumors and normal tissues.

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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.

MIM provides tools to quickly create, transform, and modify contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems and archiving contours for patient follow-up and management.

MIM aids in the assessment of PET/SPECT brain scans. It provides automated quantitative and statistical analysis by automatically registering PET/SPECT brain scans to a standard template and comparing intensity values to a reference database or to other PET/SPECT scans on a voxel by voxel basis, within stereotactic surface projections or standardized regions of interest.

MIM allows the dose distribution of an implant to be individually shaped for each patient and is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using permanent implants of various radioisotopes (not including radioactive microspheres).

For Yttrium-90 (Y90) microspheres, MIM should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y90 microspheres.

#### Indications for Use

MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:

- . Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
- . Create, display and print reports from medical images.
- . Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
- Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
- Localization and definition of objects such as tumors and normal tissues in medical images.
- Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
- . Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
- Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
- Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants.

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Image /page/6/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.

## Device Description

MIM - Y90 Dosimetry is a feature of MIM SurePlan. It is designed for use in diagnostic imaging and oncology and operates on both Windows and Mac computer systems. MIM - Y90 Dosimetry extends the functionality of MIM 5.2 (BRACHY) (K103576) and MIM – Thin client (mobile) (K151913) software. The following functions have been added to allow dose calculations for patients undergoing a course of brachytherapy using permanent Yttrium-90 (Y90) microsphere implants:

- · Allows dose calculation on PET or SPECT images after administration of permanent Y90 microsphere implants with three available methods for dose calculation: Local Deposition Model. Local Deposition Model with scaling for known injected activity, and the Voxel S Value approach based on the schema in MIRD Pamphlet 17(1). All three methods are available for PET while only the Local Deposition Model with scaling for known injected activity is available for SPECT images that are not in Becquerel per milliliter (Bq/ml).
- · Allows user to decay correct imaqe back to the time of injection if needed,
- Allows correction of branching fraction and decay parameters to reflect the values for Y90 for cases where a PET scanner does not provide Y90 as a possible radioisotope and a substitute radioisotope was used for acquisition.
- · Should not be used to change a treatment plan after treatment has been delivered with Yttrium-90 (Y90) microsphere implants.
- (1) Bolch WE, Bouchet LG, Robertson JS, Wessels BW, Siegel JA, Howell RW, Erdi AK, Aydogan B, Costes S, Watson EE. MIRD Pamphlet No. 17: The Dosimetry of Nonuniform Activity Distributions – Radionuclide S Values at the Voxel Level. J Nucl Med 1999; 40 pages 11S-36S

#### Substantial Equivalence

MIM - Y90 Dosimetry is substantially equivalent to a combination of the predicate devices MM - Thin Client (mobile) (K151913), which was substantially equivalent to MIM 5.2 (BRACHY) (K103576), and OLINDA EXM (K033960).

MIM - Y90 Dosimetry extends the indications for use of MIM -Thin Client (mobile) (K151913) to include the post-treatment dose calculation and evaluation of permanent Yttrium-90 (Y90) microsphere implants. This functionality is also provided in the OLINDA software (see reference K033960).

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Image /page/7/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the word "mim" in large, bold, black letters, with the word "SOFTWARE" in smaller black letters below it.

### Performance Data

Validation testing with MIM - Y90 Dosimetry was performed by board certified clinicians. In all cases, the software passed its performance requirements and met specifications. Additionally, clinicians using MIM - Y90 Dosimetry performed validation in comparison to independently implemented, industry-standard solutions. It was demonstrated that MIM software, when used according to operating instructions, can be used safely and effectively.

Furthermore, MIM Software Inc. has conducted performance and functional testing on the MIM - Y90 Dosimetry software. In all cases, the software passed its performance requirements and met specifications.