(70 days)
3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals. imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
3Dicom MD displays and manages diagnostic quality DICOM images.
3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only.
3Dicom MD is not intended for diagnostic use on mobile devices.
Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
3Dicom MD is a software application developed to focus on core image visualization functions such as 2D multi-planar reconstruction, 3D volumetric rendering, measurements, and markups. 3Dicom MD also supports real-time remote collaboration, sharing the 2D & 3D visualization of the processed patient scan and allowing simultaneous interactive communication modes between multiple users online through textual chat, voice, visual aids, and screen-sharing.
Designed to be used by radiologists and clinicians who are familiar with 2D scan images, 3Dicom MD provides both 2D and 3D image visualization tools for CT, MRI, and PET scans from different makes and models of image acquisition hardware.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measurement Accuracy) | Reported Device Performance |
|---|---|
| Length (>10 mm) | 99.3% |
| Length (1-10 mm) | 98.8% |
| Area | 99.52% |
| Angle | 99.46% |
Note: The document states that the tested accuracy for the lowest clinical range (1-10mm) was found to be slightly inferior (98.8%) due to the resolution of the input scan and screen.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 81 Digital Reference Objects (test cases).
- Data Provenance: The Digital Reference Objects were "created...representative of the clinical range typically encountered in radiology practice." The text does not specify a country of origin or whether they were retrospective or prospective data in the clinical sense, as they are synthetically created for testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions that "usability testing involving trained healthcare professionals" was performed, but this is distinct from establishing ground truth for the measurement accuracy tests. For the measurement accuracy tests, the ground truth was "known values" from the "Digital Reference Objects."
4. Adjudication Method for the Test Set
Not applicable. The ground truth for measurement accuracy was established using "known values" from Digital Reference Objects, not through expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or presented in the provided text. The study described focuses on the device's standalone measurement accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done for the measurement accuracy. The reported percentages (e.g., 99.3% accuracy for length > 10mm) represent the device's performance in measuring known values from Digital Reference Objects. There is no indication of human-in-the-loop performance in these specific metrics.
7. Type of Ground Truth Used
The ground truth used for the measurement accuracy tests was known values from Digital Reference Objects. These objects were created to represent the clinical range.
8. Sample Size for the Training Set
The document does not provide information about the sample size for a training set. The descriptions focus on verification and validation activities for the device's performance, not on a machine learning model's training.
9. How the Ground Truth for the Training Set Was Established
As no information about a training set for a machine learning model is provided, there is no description of how its ground truth was established.
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Singular Health Pty. Ltd. % James Hill Chief Operating Officer 3/26 Railway Road Subiaco, Western Australia 6008 AUSTRALIA
Re: K222470
October 25, 2022
Trade/Device Name: 3Dicom MD Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 11, 2022 Received: August 16, 2022
Dear James Hill:
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.
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K222470
Device Name: 3Dicom MD
Indications for Use:
3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals. imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
3Dicom MD displays and manages diagnostic quality DICOM images.
3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only.
3Dicom MD is not intended for diagnostic use on mobile devices.
Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
| 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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510(k) SUMMARY
Image /page/3/Picture/2 description: The image is a logo for Singular Health. The words "singular" and "health" are written in a sans-serif font, with "singular" in gray and "health" in red. To the right of the words is a red circle with a white design inside. The design is two curved lines that meet at a point at the top of the circle.
Submitter information
| Submitter | Singular Health Pty Ltd3/26 Railway RoadSubiaco 6008AUSTRALIA |
|---|---|
| Contact person | James HillChief Operating OfficerSingular Healthjhill@singular.health (alternative: singularhealth@outlook.com)P: +61 8 1300 167 795 |
| Date prepared | 18-Oct-2022 |
Subject device information
| Trade/Proprietary name | 3Dicom MD |
|---|---|
| Model number | V3.1.0 |
| Regulation number | 892.2050 |
| Regulation name | Medical Image Management and Processing System |
| Product class | LLZ |
| Review panel | Radiology |
| Class | II |
Predicate device information
| Trade/Proprietary name | ZeeroMED View (K200546) |
|---|---|
| Regulation number | 892.2050 |
| Regulation name | Picture Archiving and Communications System |
| Product class | LLZ |
| Review panel | Radiology |
| Class | II |
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| Trade/Proprietary name | OsiriX MD TM (K101342) |
|---|---|
| Regulation number | 892.2050 |
| Regulation name | Picture Archiving and Communications System |
| Product class | LLZ |
| Review panel | Radiology |
| Class | II |
Reference device information
Device description
3Dicom MD is a software application developed to focus on core image visualization functions such as 2D multi-planar reconstruction, 3D volumetric rendering, measurements, and markups. 3Dicom MD also supports real-time remote collaboration, sharing the 2D & 3D visualization of the processed patient scan and allowing simultaneous interactive communication modes between multiple users online through textual chat, voice, visual aids, and screen-sharing.
Designed to be used by radiologists and clinicians who are familiar with 2D scan images, 3Dicom MD provides both 2D and 3D image visualization tools for CT, MRI, and PET scans from different makes and models of image acquisition hardware.
Indications for use
3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices, and any user who requires and is granted access to the patient's image, demographic and report information. 3Dicom MD displays and manages diagnostic quality DICOM images.
3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only.
3Dicom MD is not intended for diagnostic use on mobile devices.
Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Comparison table
Comparison of 3Dicom MD with the predicate, ZeeroMED View, is presented in the below table.
| Features | 3Dicom MD | ZeeroMED View(Predicate) |
|---|---|---|
| K number | K222470 | K200546 |
| Class | II | II |
| Regulation number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation name^ | Medical Image Management andProcessing System | Picture archiving andcommunications system |
| Product code | LLZ | LLZ |
| Indications for use | 3Dicom MD software is intendedfor use as a diagnostic andanalysis tool for diagnostic imagesfor hospitals, imaging centers,radiologists, reading practices, andany user who requires and isgranted access to patient image, | ZeeroMED View software isintended for use as a diagnosticand analysis tool for diagnosticimages for hospitals, imagingcenters, radiologists, readingpractices and any user whorequires and is granted access to |
| demographic and reportinformation.3Dicom MD displays and managesdiagnostic quality DICOMimages.3Dicom MD is not intended fordiagnostic use with mammographyimages. Usage for mammographyis for reference and referral only.3Dicom MD is not intended fordiagnostic use on mobile devices.Contraindications: 3Dicom MD isnot intended for the acquisitionof mammographic image dataand is meant to be used byqualified medical personnel. | patient image, demographic andreport information.ZeeroMED View displays andmanages diagnostic qualityDICOM images.ZeeroMED View is not intendedfor diagnostic use withmammography images. Usagefor mammography is forreference and referral only.ZeeroMED View is not intendedfor diagnostic use on mobiledevices.Contraindications: TheZeeroMED View is not intendedfor the acquisition ofmammographic image data andis meant to be used by qualifiedmedical personnel. | |
| Users | Trained healthcare professionals | Trained healthcare professionals |
| Mammographicdiagnostic use | No | No |
| Imaging modalities | CTMRIPET | CTMRIPETXrayUS |
| Communications | DICOM | DICOM |
| Installation | Local computer / Server | Cloud |
| Operating system fordiagnostic viewing | WindowsMac | Web-based(Windows, Mac, Linux) |
| User authentication(unique login) | Yes | Yes |
| Access to DICOMstudies | Connect to existing onsite PACSLocal computer/serverUSB drives / CD / DVD | Connect to existing PACS |
| Patient study searchfunction | Yes | Yes |
| Basic visualisationtools | Grayscale displayRotatePanZoomMagnificationFit to screenScrollFlip horizontal / verticalAxial / coronal / sagittal viewsCross-hairAdjustable windowing (WW/WL)HU (Hounsfield Unit)Slice indicatorReset | Grayscale and colour displayRotatePanZoomMagnificationFit to screenScrollFlip horizontal / verticalAxial / coronal / sagittal viewsCross-hairAdjustable windowing(WW/WL)HU (Hounsfield Unit)Slice indicatorReset |
| Advanced tools | Volume rendering (3D)MPR | Volume rendering (3D)MPRPET fusion |
| Measurements | 2D onlyLineAngle / Cobb angle | 2D onlyLineAngle between lines |
| PolylineArea (elliptical, polygonal) | PolylineArea (elliptical, polygonal) | |
| Edit / Delete | Edit / Delete | |
| Annotations | Yes | Yes |
| Screenshot | Yes | Yes |
| Video & audiorecording | Yes | Unknown |
| Anonymization function | Yes | Yes |
| Studies comparison | No | Yes |
| Share function (email) | Yes | Yes |
| Collaboration function(online meeting) | Yes | Yes |
| Export functions | Yes | Yes |
| JPEG / PNG.nii / .nrrd / .hdr / .img / .mhdMP4 | ||
| Report generation | No | Yes |
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^The Requlation 21 CFR 892.2050 name has been amended in April 2021
Performance data
Software verification and validation activities for 3Dicom MD were performed in accordance with FDA quidance Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005), including measurement accuracy and usability tests.
3Dicom MD is considered a "moderate" level of concern.
Singular Health has implemented security features for the device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance Content of Premarket Submission for Management of Cybersecurity in Medical Devices (Oct 2014).
No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device.
The measurement accuracy for the length, angle, and area features was validated using Digital Reference Objects compared against the known values or the reference device. The Digital Reference Objects (n=81 test cases) created were representative of the clinical range typically encountered in radiology practice (1-180 mm). Inter-operator error (reproducibility), and intra-operator error (repeatability) were assessed.
| Measurement accuracy | |
|---|---|
| Length (>10 mm) | 99.3% |
| Length (1-10 mm)^ | 98.8% |
| Area | 99.52% |
| Angle | 99.46 |
^The tested accuracy for the lowest clinical range (1-10mm) was found to be slightly inferior (98.8%), due to the resolution of the input scan (Row Count and Column Count) and resolution of the screen.
Evaluation of similarities and differences
3Dicom MD and the predicate have the same intended use, main images functionalities, and collaborative/sharing functions. In term of use and functions, both systems access, upload, and display DICOM images and metadata, and provide tools and resources to trained healthcare professionals for study review and analysis.
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The main differences between both systems consist of the system access (local installation for 3Dicom MD versus web-based for the predicate). There are also minor differences in layout and some image functionalities. These differences do not present different questions of safety or effectiveness than the predicate device because safety and cybersecurity requirements have been defined and implemented, then tested and verified by a cybersecurity assessment, and the clinical functionalities have been tested by usability testing involving trained healthcare professionals.
Conclusions
3Dicom MD and the predicate have the same intended use and indications, technological characteristics, and principles of operation. There are no differences between the devices that affect the usage, safety and effectiveness. The non-clinical performance data and software verification and validation demonstrate that 3Dicom MD performs comparably to and is as safe and effective as, the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, 3Dicom MD is substantially equivalent to the predicate.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).