Ambra PACS

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DICOM Grid dba Ambra Health % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 Re: K231360 June 7, 2023 Trade/Device Name: Ambra PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 10, 2023 Received: May 10, 2023 Dear Prithul Bom: 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 {1}------------------------------------------------ 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 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 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 Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231360 Device Name Ambra PACS #### 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, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality. Lossy compressed mammographic images and digitized film screen mages 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for AMBRA, which is written in large, orange, sans-serif font. Below the logo, in a smaller font, is the text "An Intelerad Company". The logo is simple and modern, and the text below it provides context about the company. # Ambra Health 510(k) – Ambra PACS 510(k) Summary K231360 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for AMBRA, which is written in a stylized orange font. Below the logo, the text "An Intelerad Company" is written in a smaller, sans-serif font. The logo is simple and modern, and the text below it provides context for the company's affiliation. # 510(k) Summary K231360 This 510(k) summary of safety and effectiveness information for the Ambra PACS is provided as required by section 807.92(c). ## Date Prepared: March 8, 2023 # Submitter Information: DICOM Grid Inc., dba Ambra Health 450 Park Avenue South New York, NY 10016 USA intelerad.com 514-931-6222 #### Company Contact: Ashley Brown Regulatory Compliance Manager regulatory@intelerad.com #### Device: Trade Name: Ambra PACS Regulation Name: Medical image management and processing system Classification: II Product Code: LLZ Device Classification Name: System, image processing, radiological (21 CFR 892.2050) #### Predicate Device: Trade Name: Ambra PACS with ProViewer Manufacturer: DICOM GRID Inc., dba Ambra Health Regulation Name: Picture Archive and Communication System Predicate Device Premarket Notification #: K202335 Predicate Device Regulation number: 21 CFR 892.2050 Predicate Classification and Product Code: Class II, LLZ {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ambra Health, which is an Intelerad company. The word "AMBRA" is written in large, bold, orange letters. Below the word "AMBRA" is the text "An Intelerad Company" in a smaller font size. ## Device Description: Ambra PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images and reporting for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and supplementary information. Ambra PACS is considered a 'Continuous Use' device is compliant with HIPAA 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. Ambra PACS provides common diagnostic and analytic radiology functionality. Specifically, Ambra PACS enables: - Real-time viewing and management of DICOM images for diagnostic, clinical, ● research and education purposes; - . Ingestion and normalization of DICOM content for review and archiving; - Electronic distribution and secure storage of images; ● - Off-site viewing and reporting (distance education, tele-diagnosis). 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. # 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 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ambra Health, an Intelerad Company. The logo consists of the word "AMBRA" in large, bold, orange letters. Below the word "AMBRA" is the text "An Intelerad Company" in a smaller font size. ### Comparison to Predicate Device: The Ambra PACS with ProViewer is substantially equivalent in the intended use and technology to the predicate Ambra PACS with ProViewer (K202335). 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 change of programming language from Java to C++ for the Transcoding component of Ambra PACS. The primary function of Transcoding is to convert the supported DICOM compression formats into a web-viewer readable format. The subject Ambra PACS device has been demonstrated to be substantially equivalent through verification and validation testing using the same protocol and acceptance criteria as the predicate Ambra PACS with ProViewer (K202335). Table 1 below shows a feature comparison to the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for AMBRA, which is written in a bold, sans-serif font in orange. Below the logo, it says "An Intelerad Company" in a smaller, thinner font, also in orange. The logo is simple and modern, and the colors are bright and eye-catching. # Table 1 - Additional elements to consider demonstrating Substantial Equivalence | Category | Ambra PACS (Proposed) | Ambra PACS (Predicate)<br>K202335 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | LLZ | | Indications for Use | Ambra PACS software is intended<br>for use as a primary diagnostic<br>and analysis tool for diagnostic<br>images for hospitals, imaging<br>centers, radiologists, reading<br>practices and any user who<br>requires and is granted access to<br>patient image, demographic and<br>report information.<br><br>Ambra ProViewer, a component of<br>Ambra PACS, displays, modifies,<br>and manages diagnostic quality<br>DICOM images, including 3D<br>visualization and reordering<br>functionality.<br><br>Lossy compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary diagnosis or image<br>interpretations. Mammographic<br>images may only be viewed using<br>cleared monitors intended for<br>mammography display.<br><br>The Ambra PACS and Ambra<br>ProViewer are not intended for<br>diagnostic use on mobile devices. | Ambra PACS software is intended<br>for use as a primary diagnostic<br>and analysis tool for diagnostic<br>images for hospitals, imaging<br>centers, radiologists, reading<br>practices and any user who<br>requires and is granted access to<br>patient image, demographic and<br>report information.<br><br>Ambra ProViewer, a component of<br>Ambra PACS, displays, modifies,<br>and manages diagnostic quality<br>DICOM images, including 3D<br>visualization and reordering<br>functionality.<br><br>Lossy compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary diagnosis or image<br>interpretations. Mammographic<br>images may only be viewed using<br>cleared monitors intended for<br>mammography display.<br><br>The Ambra PACS and Ambra<br>ProViewer are not intended for<br>diagnostic use on mobile devices. | | Software-only system | Yes | Yes | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for AMBRA, an Intelerad Company. The word "AMBRA" is written in large, bold, orange letters. Below the word "AMBRA" is the text "An Intelerad Company" in a smaller font size. The logo is simple and modern, and the orange color is eye-catching. | User Patient database | Postgres - cloud | Postgres - cloud | |--------------------------------------------------------------------------------|--------------------------------|---------------------| | Coding Language for Transcoding<br>Component | C++, with built in http server | Java, Scala, Spring | | Imaging review capability | Yes | Yes | | Image annotation and<br>measurement capability | Yes | Yes | | Browser-based application | Yes | Yes | | User Interface Design | Browser based | Browser based | | Secure Login | Yes | Yes | | Interface with Electronic Medical<br>Records (EMR) | Yes | Yes | | Connection of the imaging<br>instruments via DICOM and/or<br>non-DICOM methods | Yes | Yes | # Summary of Supporting Data: Ambra Health has provided a summary validation testing of DICOM images to demonstrate substantially equivalent performance of the measurement and visualization tools in the Ambra ProViewer. #### Non-Clinical Performance Data 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." {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for AMBRA, an Intelerad Company. The word "AMBRA" is written in large, bold, orange letters. Below the word "AMBRA" is the text "An Intelerad Company" in a smaller font size. The logo is simple and modern, and the orange color is eye-catching. Verification and validation testing was performed against functional, design, measurement, and deployment requirements, to confirm the product continues to meet the software requirements defined by the manufacturer. Simulated use testing was conducted to confirm that the device can achieve its intended use. All verification and validation acceptance criteria were met. ## Conclusion Based upon design, functional testing, and non-clinical results, the Ambra PACS performs similarly to the predicate device, Ambra PACS (which includes Ambra ProViewer) (K202335), that is currently marketed for the same intended use. The conclusions drawn from the nonclinical tests discussed above demonstrate that the device is as safe, as effective, and performs as well or better than the predicate device, as required by 807.92(b)(3).