(55 days)
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic.
i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
The i-Rapha solution is a professional DICOM web browser application that conforms HTML5 standards to receive, store, and view DICOM images; utilizable under any web browser that supports HTML 5 protocols (e.g. Chrome Browser). This web browser application supports various types of annotation for medical images interpretation.
The i-Rapha solution is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician.
The i-Rapha solution allows displaying of image studies that may not in the location as the modality. With its Web features, it is possible to review and manipulate the images of the studies located in a remote server. The i-Rapha View, a component of i-Rapha Solution, is an HTML5-based DICOM Viewer. The i-Rapha View can be used in any operating system because it can be executed by using a web browsers and especially Google Chrome that supports HTML5 regardless of the type of operating system.
Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
The i-Rapha solution allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.
The users can access their own diagnostic environment anywhere, anytime on PC.
This document is a 510(k) Premarket Notification from IRM, Inc. to the FDA regarding their device, i-Rapha Solution. The primary purpose of this document is to demonstrate "substantial equivalence" of the i-Rapha Solution to a legally marketed predicate device (DG PACS, K152977).
A key takeaway from this document is that no clinical studies (which would typically involve patient data and human readers) were conducted for the i-Rapha Solution. The substantial equivalence claim is based entirely on non-clinical testing and a comparison of technological characteristics with the predicate device.
Therefore, many of the requested details about acceptance criteria, ground truth, sample sizes for test sets, expert qualifications, and MRMC studies, cannot be found in this document because they were not performed as part of this specific 510(k) submission. This device, being a "Picture archiving and communications system" (PACS) device, is primarily about displaying and managing diagnostic images, rather than providing AI-driven diagnostic assistance where such detailed clinical validation would be more commonly required.
Based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative performance acceptance criteria or report specific performance metrics from a clinical study for user performance. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:
- Similar Indications for Use.
- Similar Technological Characteristics.
- Passing Non-Clinical Test Summary (software verification and validation).
The "performance" demonstrated is that the device "was designed and developed according to a software development process and was verified and validated," as stated in the Non-Clinical Test Summary.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device functions as intended for displaying and managing diagnostic images. | "i-Rapha solution contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated." |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns compared to predicate. | "The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject devices are as safe and effective as the predicate." |
| Intended Use Equivalence: Matches predicate's intended use. | "i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic." (This exact text is shared with the predicate, with minor variations not impacting the core use). |
| Technological Equivalence: Similar underlying technology and standards. | The comprehensive table on page 5 compares various technological characteristics, showing many "Same" or "Similar" designations with explanations for differences (e.g., supported browsers, mobile viewer support). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable and not mentioned. No specific test set of medical images for clinical evaluation of diagnostic performance was used. The evaluation was based on software testing and feature comparison.
- Data provenance: Not applicable and not mentioned for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number/Qualifications of Experts: Not applicable. No clinical ground truth was established by experts for a test set, as no clinical study was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. The document explicitly states: "No clinical studies were considered necessary and performed." This device is a PACS system, not an AI diagnostic assistance tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a display and management system for diagnostic images, not an algorithm providing diagnostic outputs. Its function inherently involves a human user for diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No clinical ground truth was established for the purpose of validating diagnostic performance.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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Image /page/0/Picture/0 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
IRM, Inc % Kim Yun Ik Quality Manager 4th-D, Myung-Woo Bldg. 169, Yeoksam-ro Gangnam-gu, Seoul 06247 REPUBLIC OF KOREA
July 9, 2020
Re: K201296
Trade/Device Name: i-Rapha Solution Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 8, 2020 Received: May 15, 2020
Dear Kim Yun Ik:
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.
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
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Indications for Use
510(k) Number (if known) K201296
Device Name i-Rapha Solution
Indications for Use (Describe)
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic.
i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
| 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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Image /page/3/Picture/0 description: The image shows the logo for IRM. The logo consists of the letters "IRM" in bold, black font, followed by three colored circles. The first circle is orange, the second is dark blue, and the third is light blue with a white outline.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
May 8, 2020
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | IRM Inc. |
|---|---|
| - Address: | 4th-D, Myung-Woo Bldg, 169, Yeoksam-ro, Gangnam-gu, Seoul, 06247,Republic of Korea |
| - Contact Name: | Kim Yun Ik / Quality Manager of IRM Inc. |
| - Telephone No.: | +82-70-8230-6690 |
| - Fax No.: | +82-70-8230-6693 |
| - Email Address: | yikim@irm.kr |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name | i-Rapha solution |
|---|---|
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communications system |
| Regulation Class | II |
| Product Code | LLZ |
| Product Code Name | System, Image Processing, Radiological |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
| - 510(k) Number: | K152977 |
|---|---|
| - Applicant: | DICOM Grid, Inc. |
| - Regulation Name: | Picture archiving and communications system |
| - Product Code: | LLZ |
| - Device Class: | II |
| - Device Name: | DG PACS |
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Image /page/4/Picture/0 description: The image shows the logo for IRM. The letters IRM are in bold black font. To the right of the letters are three circles, one dark blue, one orange, and one light blue with a white swirl pattern.
5. Description of the Device [21 CFR 807.92(a)(4)]
The i-Rapha solution is a professional DICOM web browser application that conforms HTML5 standards to receive, store, and view DICOM images; utilizable under any web browser that supports HTML 5 protocols (e.g. Chrome Browser). This web browser application supports various types of annotation for medical images interpretation.
The i-Rapha solution is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician.
The i-Rapha solution allows displaying of image studies that may not in the location as the modality. With its Web features, it is possible to review and manipulate the images of the studies located in a remote server. The i-Rapha View, a component of i-Rapha Solution, is an HTML5-based DICOM Viewer. The i-Rapha View can be used in any operating system because it can be executed by using a web browsers and especially Google Chrome that supports HTML5 regardless of the type of operating system.
Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
The i-Rapha solution allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.
The users can access their own diagnostic environment anywhere, anytime on PC.
6. Indications for Use [21 CFR 807.92(a)(5)]
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic.
i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
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Image /page/5/Picture/0 description: The image shows the logo for IRM. The logo consists of the letters "IRM" in bold, black font. To the right of the letters are three circles. The first circle is orange, the second circle is dark blue, and the third circle is light blue with a white outline.
7. Technological Characteristics
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. The below table is summarized and compared with the technological characteristics between the i-Rapha solution and the predicate device:
| Proposed Device | Predicate Device #1 | SE note | ||
|---|---|---|---|---|
| K Number | K201296 | K152977 | - | |
| Model | i-Rapha Solution | DG PACS | - | |
| Manufacturer | IRM Inc. | DICOM Grid, Inc. | - | |
| Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | Same | |
| Regulatory Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | |
| Product Code | LLZ | LLZ | Same | |
| Classification | ll | ll | Same | |
| Indications for use | i-Rapha Solution is intended for use asa primary diagnostic and analysis toolfor diagnostic images for hospitals,imaging centers, radiologists and anyuser who requires and is grantedaccess to patient image, demographic.i-Rapha View, a component of i-RaphaSolution, displays and managesdiagnostic quality DICOM images.Lossy compressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations.Mammographic images may only beinterpreted using cleared monitorsintended for mammography display. | DG PACS software is intended for useas a primary diagnostic and analysistool for diagnostic images forhospitals, imaging centers,radiologists, reading practices and anyuser who requires and is grantedaccess to patient image, demographicand report information.DG Viewer, a component of DG PACS,displays and manages diagnosticquality DICOM images.Lossy compressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations.Mammographic images may only beinterpreted using cleared monitorsintended for mammography display.Not intended for diagnostic use onmobile devices. | Same | |
| Type of Use | Prescription Use | Prescription Use | Same | |
| Component | Standalone software | Standalone software | Same | |
| Web Standard | HTML5 | HTML5 | Same | |
| Utilization ofStandards | Digital Imaging and Communicationsin Medicine (DICOM)Joint Photographic Experts Group(JPEG)Society of Motion Picture andTelevision Engineers (SMPTE) | Digital Imaging and Communications inMedicine (DICOM)Joint Photographic Experts Group(JPEG)Society of Motion Picture andTelevision Engineers (SMPTE) | Same | |
| Modalitiessupported ondisplay | CR, DR, CT, US, MR, RF and otherDICOM formats | CR, DR, CT, US, MR, RF and otherDICOM formats | Same | |
| Proposed Device | Predicate Device #1 | SE note | ||
| Operating System(Web Browser) | Microsoft Internet Explorer 11 orLater****Apple SafariGoogle ChromeFirefox | Microsoft Internet Explorer 9 or LaterApple SafariGoogle ChromeFirefox | Differences | |
| Image CommunicationStandard | DICOM | DICOM | Same | |
| MobileViewer | MobilePhone | N/A* | Support | Differences |
| Tablet | N/A* | Support | Differences | |
| Feature/ Functionality | ||||
| User Authentication | Log-inLog-out | Log-inLog-out | Same | |
| Worklist (Study List) | Search and display Study ListSearch StudiesView ImageSeries ListSave Search OptionsImport DICOMExport DICOMStudy ManagementImage Preview** | Search and display Study ListSearch StudiesView ImageSeries ListSave Search OptionsImport DICOMExport DICOMStudy ManagementReport***Share Study*** | Similar | |
| DICOMQuery/Retrieve | DICOM Q/R | DICOM Q/R | Same | |
| Patient List | Display Patient List**Search Patient** | Unknown | Differences | |
| Viewer | Image DisplayViewer Layout functionGrid functionImage maximize functionRelated Study ListSeries ThumbnailStudy Information display functionTransformationImage Viewing functionWindow W/LMeasurementAnnotationImage ProcessingImage ResetExport Image | Image DisplayViewer Layout functionGrid functionImage maximize functionRelated Study ListSeries ThumbnailStudy Information display functionTransformationImage Viewing functionWindow W/L | Similar | |
| Proposed Device | Predicate Device #1 | SE note | ||
| Modify Image*** | ||||
| Record*** | ||||
| Report*** | ||||
| DICOM Storage SCP | DICOM Storage SCP (SDHServer) | DICOM Storage SCP (Ambra Gateway) | Same |
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Image /page/6/Picture/0 description: The image shows the logo for IRM. The logo consists of the letters "IRM" in bold, black font, followed by three circles of different colors. The first circle is orange, the second is dark blue, and the third is light blue with a white swirl inside.
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Image /page/7/Picture/0 description: The image shows the logo for IRM. The logo consists of the letters "IRM" in a bold, sans-serif font, followed by three colored circles. The first circle is orange, the second is dark blue, and the third is light blue with a white outline.
- The subject device supports only PC Viewer. This is described in the User's Manual, so the user will be aware of this.
- ** There is additional functionality in the subject device. The added features and functions of the subject device are described in the user's manual, so the user will be aware of the functionality. The additional items do not change the Intended Use of the subject device. The differences do not raise any new potential safety risks and therefore, we believe there is no impact on safety or efficacy for the subject device.
- *** There is no functionality in the subjective device. The functionality in the predicate device is not essential for safety and efficacy and therefore, we believe there is no impact on safety or efficacy for the subject device.
- ****Microsoft Internet Explorer 9, 10 are no longer supported by Microsoft. The differences indicated, do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the subject device.
Non-Clinical Test Summary
i-Rapha solution contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, issued on May 11, 2005.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
8. Determination of Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between i-Rapha solution and the predicate device, K152977 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics
9. Conclusion [21 CFR 807.92(b)(3)]
The i-Rapha solution has similar intended use and technical characteristics to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, performance testing conducted demonstrate that the subject devices are as safe and effective as the predicate. Therefore, the subject devices are 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).