(18 days)
No
The document describes a PACS software with image display and manipulation features, but there is no mention of AI or ML capabilities.
No.
The device is described as PACS software for viewing and managing diagnostic images, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that "Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images".
Yes
The device description explicitly states it is "Ambra PACS software" and "Ambra Pro Viewer, a component of Ambra PACS". The description focuses on the software architecture and its functionality for displaying and managing images. While it interacts with diagnostic images, there is no mention of accompanying hardware being part of the submitted device. The validation testing described is software verification and validation.
Based on the provided information, the Ambra PACS software, including the Ambra Pro Viewer component, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Ambra PACS Functionality: The description clearly states that Ambra PACS and Pro Viewer are intended for the display, modification, and management of diagnostic images. These images are generated by imaging modalities (like X-ray, CT, MRI, etc.) which are separate medical devices. The software itself does not interact with or analyze biological specimens.
- Intended Use: The intended use is for the primary diagnosis and analysis of diagnostic images, not for testing biological samples.
- Device Description: The description focuses on software features for image handling, visualization, and management, not on laboratory testing or analysis of biological materials.
In summary, Ambra PACS is a medical device, specifically a Picture Archiving and Communication System (PACS) with a viewer component, used for handling and displaying medical images. It falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Ambra PACS software is intended for use as a primary 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.
Ambra Pro Viewer, a component of Ambra PACS, displays, modifics and manages diagnostic quality DICOM images including 3D visualization and reordering functionality.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for manmography Display.
Not intended for diagnostic use on mobile devices.
Product codes
LLZ
Device Description
Ambra ProViewer, a component of Ambra PACS, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering functionality. It is designed to target standards-compliant, cross-platform web browsers with an underlying architecture built on top of ReactJS and Material-UI, as well as WebGL2 for advanced visualization tools. The Ambra ProViewer is designed to utilize modern web application APIs.
Ambra PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
Mentions image processing
Yes
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
hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to Patient image, demographic and report information.
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)
Ambra Health has provided validation testing of DICOM images to demonstrate substantially equivalent performance of the measurement and visualization tools in the Ambra ProViewer.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury or or delayed information or through the action of a care provider.
Risk Analysis demonstrating acceptable risk including cybersecurity risks has been provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
September 4, 2020
Image /page/0/Picture/1 description: The image shows 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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
Dicom Grid, Inc., dba Ambra Health % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Suite 403 LUDLUM FL 33155
Re: K202335
Trade/Device Name: Ambra PACS including Ambra ProViewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 14, 2020 Received: August 17, 2020
Dear Rafael Aguila:
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 (OS) 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 medical devices and radiation-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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202335
Device Name Ambra PACS including Ambra Pro Viewer
Indications for Use (Describe)
Ambra PACS software is intended for use as a primary 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.
Ambra Pro Viewer, a component of Ambra PACS, displays, modifics and manages diagnostic quality DICOM images including 3D visualization and reordering functionality.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for manmography Display.
Not intended for diagnostic use on mobile devices.
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."
FORM FDA 3881 (6/20)
Page 1 of 1
EF Publishing Narcicos (104) 441 6740
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the logo for Ambra Health. The logo consists of the word "AMBRA" in large, orange, sans-serif font. Below the word "AMBRA" is the tagline "Your Medical Imaging Cloud" in a smaller, orange, sans-serif font. The logo is simple and modern, and it conveys the company's focus on medical imaging and cloud technology.
510(k) Summary
This 510(k) summary of safety and effectiveness information for the Ambra ProViewer is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
May 13, 2020
Submitter Information:
DICOM Grid Inc., dba Ambra Health 199 Water Street, 34th Floor New York, NY 10038 888-587-2280
Company Contact:
Patrice Nedelec Director of Compliance and Regulatory Affairs pnedelec@ambrahealth.com
Device:
Trade Name: Ambra PACS including Ambra ProViewer Common Name: Picture Archive and Communication System Classification: II Product Code: LLZ Classification Name – Picture Archive and Communication System (21 CFR 892.2050)
Primary Predicate Device:
Trade Name: Ambra PACS Manufacturer: DICOM GRID Inc., dba Ambra Health Common Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K152977 Predicate Device Regulation number: 21 CFR 892.2050 Predicate Classification and Product Code: Class II, LLZ
Reference Predicate Device:
Trade Name: Osirix MD Manufacturer: PIXMEO SARL Common Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K101342 Predicate Device Regulation number: 21 CFR 892.2050
4
Image /page/4/Picture/0 description: The image shows the logo for Ambra Health. The logo consists of the word "AMBRA" in large, orange letters, with the tagline "Your Medical Imaging Cloud" in smaller letters below. The logo is simple and modern, and the orange color is eye-catching.
Predicate Classification and Product Code: Class II, LLZ
Device Description:
Ambra ProViewer, a component of Ambra PACS, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering functionality. It is designed to target standards-compliant, cross-platform web browsers with an underlying architecture built on top of ReactJS and Material-UI, as well as WebGL2 for advanced visualization tools. The Ambra ProViewer is designed to utilize modern web application APIs.
Ambra PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
Indications for Use:
Ambra PACS software is intended for use as a primary 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.
Ambra ProViewer, a component of Ambra PACS, displays, modifies, and manages diagnostic quality DICOM images, including 3D visualization and reordering functionality.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display.
Not intended for diagnostic use on mobile devices.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Ambra ProViewer is a substantially equivalent viewer in the intended use and technology to the predicate Ambra Viewer (K152977). Display and management of diagnostic quality DICOM images is the technological principal for both the subject and predicate devices.
The primary difference when compared to the predicate is the advanced visualization and reordering functionality. These advanced features are substantially equivalent to the PIXMEO
5
Image /page/5/Picture/0 description: The image contains the word "AMBRA" in large, bold, orange letters. Below the word "AMBRA" is the phrase "Your Medical Imaging Cloud" in smaller, lighter-colored letters. The logo is simple and modern, with a focus on the company name and its connection to medical imaging.
SARL Osirix MD system marketed under (K101342). These features have been demonstrated to be substantially equivalent through direct comparison testing utilizing the same reference DICOM images.
Summary of Supporting Data:
Ambra Health has provided validation testing of DICOM images to demonstrate substantially equivalent performance of the measurement and visualization tools in the Ambra ProViewer.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury or or delayed information or through the action of a care provider.
Risk Analysis demonstrating acceptable risk including cybersecurity risks has been provided.
Conclusion
Based upon design, functional testing, and non-clinical results. The Ambra ProViewer performs similarly to the Ambra PACS Viewer, and the Pixmeo SARL Osirix MD viewer that is currently marketed for the same intended use.