(70 days)
OsiriX MD TM (K101342)
No
The document describes standard image visualization and measurement tools, and explicitly states that AI, DNN, or ML were "Not Found" in the analysis. The performance studies focus on measurement accuracy and usability, not AI/ML model performance.
No
The device is described as a diagnostic and analysis tool for images, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that "3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images".
Yes
The device description explicitly states that 3Dicom MD is a "software application" and the performance studies focus on software verification and validation, including measurement accuracy using digital objects, without mentioning any associated hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "diagnostic and analysis tool for diagnostic images." It focuses on displaying and managing diagnostic quality DICOM images and providing visualization tools (2D and 3D).
- Device Description: The description reinforces this by highlighting image visualization functions, measurements, and markups.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This software does not perform any such analysis on biological specimens. It processes and displays medical images acquired from the patient's body.
The software is a medical device used for the interpretation and analysis of medical images, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, PET
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologists, reading practices, and any user who requires and is granted access to the patient's image, demographic and report information.
Trained healthcare professionals
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Length (>10 mm): 99.3%
Length (1-10 mm): 98.8%
Area: 99.52%
Angle: 99.46%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Length (>10 mm): 99.3%
Length (1-10 mm): 98.8%
Area: 99.52%
Angle: 99.46%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ZeeroMED View (K200546)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
OsiriX MD TM (K101342)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 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.
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
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.
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 Ltd
3/26 Railway Road
Subiaco 6008
AUSTRALIA |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | James Hill
Chief Operating Officer
Singular Health
jhill@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 and
Processing System | Picture archiving and
communications system |
| Product code | LLZ | LLZ |
| 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, | ZeeroMED View 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 |
| | 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. | patient image, demographic and
report information.
ZeeroMED View displays and
manages diagnostic quality
DICOM images.
ZeeroMED View is not intended
for diagnostic use with
mammography images. Usage
for mammography is for
reference and referral only.
ZeeroMED View is not intended
for diagnostic use on mobile
devices.
Contraindications: The
ZeeroMED View is not intended
for the acquisition of
mammographic image data and
is meant to be used by qualified
medical personnel. |
| Users | Trained healthcare professionals | Trained healthcare professionals |
| Mammographic
diagnostic use | No | No |
| Imaging modalities | CT
MRI
PET | CT
MRI
PET
Xray
US |
| Communications | DICOM | DICOM |
| Installation | Local computer / Server | Cloud |
| Operating system for
diagnostic viewing | Windows
Mac | Web-based
(Windows, Mac, Linux) |
| User authentication
(unique login) | Yes | Yes |
| Access to DICOM
studies | Connect to existing onsite PACS
Local computer/server
USB drives / CD / DVD | Connect to existing PACS |
| Patient study search
function | Yes | Yes |
| Basic visualisation
tools | Grayscale display
Rotate
Pan
Zoom
Magnification
Fit to screen
Scroll
Flip horizontal / vertical
Axial / coronal / sagittal views
Cross-hair
Adjustable windowing (WW/WL)
HU (Hounsfield Unit)
Slice indicator
Reset | Grayscale and colour display
Rotate
Pan
Zoom
Magnification
Fit to screen
Scroll
Flip horizontal / vertical
Axial / coronal / sagittal views
Cross-hair
Adjustable windowing
(WW/WL)
HU (Hounsfield Unit)
Slice indicator
Reset |
| Advanced tools | Volume rendering (3D)
MPR | Volume rendering (3D)
MPR
PET fusion |
| Measurements | 2D only
Line
Angle / Cobb angle | 2D only
Line
Angle between lines |
| | Polyline
Area (elliptical, polygonal) | Polyline
Area (elliptical, polygonal) |
| | Edit / Delete | Edit / Delete |
| Annotations | Yes | Yes |
| Screenshot | Yes | Yes |
| Video & audio
recording | 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 / .mhd
MP4 | |
| 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.