(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of functionalities focuses on standard PACS features like viewing, storing, filtering, and basic manipulation. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is a PACS system used for viewing, storing, and managing medical images and data for diagnostic purposes, not for direct therapeutic intervention.
No
The device is a Picture Archiving and Communication System (PACS) that displays, processes, stores, and transfers medical data. While it provides image interpretation support, it explicitly states that "it does not directly generate any diagnosis or potential findings," meaning it does not perform a diagnostic function itself but rather aids professionals in making diagnoses.
Yes
The device description explicitly states it is a "stand-alone software as medical device (Stand-alone SaMD)" and the functionalities described are software-based (displaying, processing, storing, transferring, visualization, annotation, quantification). The testing mentioned focuses on software verification and validation (IEC 62304).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's intended use: The EFAI PACS PRO is described as a system for managing, displaying, processing, storing, and transferring medical imaging data (DICOM and non-DICOM). It works with images from OEM equipment.
- No mention of biological samples: The description focuses entirely on image data and its manipulation. There is no mention of analyzing biological samples or performing tests on them.
- Intended users: The intended users are medical professionals who interpret images, not laboratory personnel performing diagnostic tests on biological samples.
The device is clearly focused on the management and visualization of medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
EFAI PACS PRO is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PRO displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The software is a stand-alone software as medical device (Stand-alone SaMD) which provides instant services for clinicians able to use web browsers at client stations to search and view medical data of desired patients which is stored in the software. The software also provides the following visualization, annotation and quantification functionalities which can be applied to the images on the web browser at client stations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals, including but not limited to radiologists, oncologists, and physicians.
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)
To demonstrate safety and effectiveness of EFAI PACS PRO and to show substantial equivalence to the predicate device, Ever Fortune completed the non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The EFAI PACS PRO passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Software verification and validation per IEC 62304/FDA Guidance In Compliance with.
- Application of usability engineering to medical devices Part 1 per IEC 62366-1 In Compliance with.
- Guidance on the application of usability engineering to medical devices per IEC 62366-2. - In Compliance with.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ever Fortune.AI Co., Ltd. Ti-Hao Wang Chief Technology Officer 8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, 403020 Taiwan
August 8, 2023
Re: K232100
Trade/Device Name: EFAI Pacs Picture Archiving and Communication System Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: July 10, 2023 Received: July 14, 2023
Dear Ti-Hao Wang:
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
Jessica Lamb, PhD Assistant Director 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
2
Indications for Use
510(k) Number (if known) K232100
Device Name
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM PRO
Indications for Use (Describe)
EFAI PACS PRO is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PRO displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
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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K232100 510(k) Summary
1. General Information
| 510(k) Sponsor | Ever Fortune.AI Co., Ltd. |
|---|---|
| Address | Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd. |
| West Dist. | |
| Taichung City 403020 | |
| TAIWAN | |
| Applicant | Joseph Chang |
| Contact Information | 886-04-23213838 #216 |
| joseph.chang@everfortune.ai | |
| Correspondence Person | Ti-Hao Wang, CTO |
| Contact Information | 886-04-23213838 #168 |
| tihao.wang@everfortune.ai | |
| Date Prepared | July 10, 2023 |
2. Proposed Device
| Proprietary Name | EFAI PACS PICTURE ARCHIVING AND
COMMUNICATION SYSTEM PRO (EFAI PACS PRO) |
|---------------------|-----------------------------------------------------------------------------|
| Common Name | EFAI PACS PRO |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM (EFAI PACS) |
|---|---|
| Premarket Notification | K211257 |
4
| Classification Name | System, Image Processing, Radiological |
|---|---|
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | LLZ |
| Regulatory Class | II |
4. Device Description
The software is a stand-alone software as medical device (Stand-alone SaMD) which provides instant services for clinicians able to use web browsers at client stations to search and view medical data of desired patients which is stored in the software. The software also provides the following visualization, annotation and quantification functionalities which can be applied to the images on the web browser at client stations.
5. Intended Use
EFAI PACS PRO is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PRO displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
6. Comparison of Technological Characteristics with Predicate Device
Table below provides a comparison of the intended use and key technological features of EFAI PACS PRO with that of the Primary Predicate, EFAI PACS (K211257).
| Company | Ever Fortune.AI Co., Ltd. (EFAI) | Ever Fortune.AI Co., Ltd. (EFAI) |
|---|---|---|
| Device Name | EFAI PACS PRO | EFAI PACS |
| 510k Number | Pending | K211257 |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 |
| Classification | II | II |
EFAI PACS PRO Special 510(k)
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| Product Code | LLZ | LLZ |
|---|---|---|
| Intended | ||
| Use/Indication | ||
| for Use | EFAI PACS PRO is intended to be used as a Digital Imaging and | |
| Communications in Medicine (DICOM) | ||
| and non-DICOM information and data | ||
| management system. The EFAI PACS | ||
| PRO displays, processes, stores, and | ||
| transfers medical data from original | ||
| equipment manufacturers (OEMs) that | ||
| support the DICOM standard, with the | ||
| exception of mammography. It provides | ||
| the capability to store images and patient | ||
| information from OEM equipment, and | ||
| perform filtering, digital manipulation | ||
| and quantitative measurements. The | ||
| client software is designed to run on | ||
| standard personal and business | ||
| computers. The product is intended to be | ||
| used by trained medical professionals, | ||
| including but not limited to radiologists, | ||
| oncologists, and physicians. It is | ||
| intended to provide image and related | ||
| information that is interpreted by a | ||
| trained professional to render findings | ||
| and/or diagnosis, but it does not directly | ||
| generate any diagnosis or potential | ||
| findings. | EFAI PACS is intended to be used as a | |
| Digital Imaging and Communications in | ||
| Medicine (DICOM) and non-DICOM | ||
| information and data management system. | ||
| The EFAI PACS displays, processes, | ||
| stores, and transfers medical data from | ||
| original equipment manufacturers | ||
| (OEMs) that support the DICOM | ||
| standard, with the exception of | ||
| mammography. It provides the capability | ||
| to store images and patient information | ||
| from OEM equipment, and perform | ||
| filtering, digital manipulation and | ||
| quantitative measurements. The client | ||
| software is designed to run on standard | ||
| personal and business computers. The | ||
| product is intended to be used by trained | ||
| medical professionals, including but not | ||
| limited to radiologists, oncologists, and | ||
| physicians. It is intended to provide image | ||
| and related information that is interpreted | ||
| by a trained professional to render | ||
| findings and/or diagnosis, but it does not | ||
| directly generate any diagnosis or | ||
| potential findings. | ||
| Device Property | Stand-alone Software | Stand-alone Software |
| Image Source | Medical data from original | |
| equipment manufacturers | ||
| (OEMs) that support the | ||
| DICOM standard | Medical data from original | |
| equipment manufacturers | ||
| (OEMs) that support the | ||
| DICOM standard | ||
| Transfer/Storage | ||
| /Display | ||
| of Medical | ||
| Images | Yes | Yes |
| DICOM | ||
| Compliant | ||
| (Images file | ||
| format) | Yes | Yes |
| Worklists | Yes | Yes |
6
| Filter and Search
| capabilities | Yes | Yes |
|---|---|---|
| Image analysis | ||
| and | ||
| review capability | Yes | Yes. |
| View DICOM | ||
| data | Yes | Yes |
| Window/level | ||
| determination | Yes | Yes |
| Window/level | ||
| presets | Yes | Yes |
| Adjust | ||
| window/level | Yes | Yes |
| Measuring tools | ||
| (General image | ||
| measurements) | Yes | Yes |
| Text | ||
| and | ||
| graphical | ||
| annotation | ||
| functionalities | Yes | Yes (Only provides Point Annotation: |
| single point measurement) |
7. Performance Data - Non-Clinical
To demonstrate safety and effectiveness of EFAI PACS PRO and to show substantial equivalence to the predicate device, Ever Fortune completed the non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The EFAI PACS PRO passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- · Software verification and validation per IEC 62304/FDA Guidance In Compliance with.
7
- Application of usability engineering to medical devices Part 1 per IEC 62366-1 In ● Compliance with.
- Guidance on the application of usability engineering to medical devices per IEC 62366-2 . - In Compliance with.
8. Conclusion
Based on the information submitted in this premarket notification, and based on the intended use, technological characteristics, and performance testing, the EFAI PACS PRO raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.