(137 days)
Not Found
No
The description focuses on standard PACS functionalities like viewing, storing, and basic image manipulation and measurement. There is no mention of AI, ML, or any advanced analytical capabilities that would typically indicate the use of such technologies.
No
The device is a PACS system for managing, displaying, and processing medical images and data, intended to assist professionals in diagnosis by providing information; it does not directly treat or alleviate a disease or condition.
No
The device is explicitly stated to not diagnose or provide potential findings. It provides image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not perform the diagnosis itself.
Yes
The device is explicitly described as "stand-alone software as medical device (Stand-alone SaMD)" and its functionalities are purely software-based (display, processing, storage, transfer, visualization, annotation, quantification). It relies on external OEM equipment for the initial data but the device itself is the software system.
Based on the provided information, the EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids to provide information about a person's health.
- The EFAI PACS system deals with medical imaging data. Its primary function is to manage, display, process, and store medical images (DICOM and non-DICOM) from various imaging modalities. It does not perform any tests on biological specimens.
- The intended use clearly states it's for managing and displaying medical data from imaging equipment. It's used by medical professionals to interpret images and related information, but it does not perform diagnosis itself.
Therefore, while it's a medical device used in a clinical setting, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM 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 PICTURE ARCHIVING AND COMMUNICATION SYSTEM 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 diagnosis or potential findings.
Product codes
LLZ
Device Description
The software is a stand-alone software as medical device (Stand-alone SaMD) which provide to instant services for clinician can able to use web browser at client stations to search and view medical data of desired patient which is stored in 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:
Visualization Functionalities:
- a). 2D image view
- b). Zoom ratio adjust
- c). Pan
- d). Window Level and Window Width adjust
- e). Positive & Negative film effect
- f). Mirror Flip
- g). Multi-screen display
- h). Cine Loop Play
Annotation Functionality:
- Point Annotation
Quantification Functionalities:
- a). Distance measurement
- b). Area measurements
- c). Angle measurement
- d). Single Point measurement
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 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 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. o
- 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.
EFAI PACS did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute:
- Design features;
- Indications for Use;
- 0 Fundamental scientific technology:
- Non-clinical performance testing;
- 0 Safety and effectiveness.
The clinical evaluation is conducted on the device following FDA Guidance "Software as a Medical Device (SAMD): Clinical Evaluation".
Based on the requirements recommended by FDA regarding the Clinical Evaluation, Ever Fortune has conducted the Clinical Evaluation for the EFAI PACS, the Clinical Evaluation Plan, Report and the adverse event data base search results are provided as Attachment 31 (EFAI PACS P-CKEVIEWER001), Attachment 32 (EFAI PACS R-CKE-VIEWER001), Attachment 15 – 18 CER Annex I-FDA Recall LLZ 2011-2021). The three clinical articles mentioned in the CEP and CER are uploaded to the Reference section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
September 10 , 2021
Ever Fortune.AI Co., Ltd. % Chen Ming-Fong Chairman Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, 403020 TAIWAN
Re: K211257
Trade/Device Name: EFAI PACS Picture Archiving and Communication System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 29, 2021 Received: August 2, 2021
Dear Chen Ming-Fong:
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.
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
Indications for Use
510(k) Number (if known)
K211257
Device Name
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM
Indications for Use (Describe)
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM 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 PICTURE ARCHIVING AND COMMUNICATION SYSTEM displays, processes, stores, and ransfers 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 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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Image /page/3/Picture/0 description: The image shows the logo for Ever Fortune.AI at the top. Below the logo is the text "5. 510(k) Summary". The text is in a large, bold font and is likely a section heading within a document. The number 5 suggests that this is the fifth section of the document.
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| 5.1 Submitter Information | |
|---|---|
| Company: | CHEN MING-FONG |
| Chairman | |
| EVER FORTUNE.AI Co., Ltd. | |
| Rm. D, 8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist., | |
| Taichung City 403020, Taiwan | |
| Telephone: (886)-4-2321-3838 | |
| Fax: (886)-4-2322-9797 | |
| ra05@everfortuneai.com.tw | |
| Contact: | CHEN MING-FONG |
| Chairman | |
| EVER FORTUNE.AI Co., Ltd. | |
| Rm. D, 8 F., No. 573, Sec. 2, Taiwan Blvd. West Dist., | |
| Taichung City 403020, Taiwan | |
| Telephone: (886)-4-2321-3838 | |
| Fax:(886)-4-2322-9797 | |
| ra05@everfortuneai.com.tw | |
| Date Summary Prepared: | April 20, 2021 |
5.2 Name of the Device
The product name "EFAI PACS Picture Archiving and Communication System" will be replaced by "EFAI PACS" abbreviation in the whole document.
| Trade Name: | EFAI PACS Picture Archiving and Communication System (or
EFAI PACS) |
|--------------|------------------------------------------------------------------------|
| Common Name: | EFAI PACS Picture Archiving and Communication System (or
EFAI PACS) |
4
Image /page/4/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure with a circular head made of interconnected nodes, suggesting a network or global connection. The text "EVER FORTUNE.AI" is written in a sans-serif font, with "EVER" positioned above "FORTUNE.AI", indicating the company's name and its focus on artificial intelligence.
| Classification Name: | Radiology |
|---|---|
| Review Panel: | Radiology |
| Regulation: | 892.2050 - Medical image management and processing system |
| Class: | Class II |
| Product Code: | LLZ |
5.3 Equivalence Claimed to Predicate Device
The EFAI PACS is equivalent to the Arterys Viewer (K171544), manufactured by Arterys Inc. is provided as primary predicate device.
5.4 Indication for Use
EFAI PACS Picture Archiving and Communication System 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 Picture Archiving and Communication System 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.
5.5 Device Description
The software is a stand-alone software as medical device (Stand-alone SaMD) which provide to instant services for clinician can able to use web browser at client stations to search and view medical data of desired patient which is stored in 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:
Visualization Functionalities:
- a). 2D image view
- b). Zoom ratio adjust
- c). Pan
- d). Window Level and Window Width adjust
- e). Positive & Negative film effect
- f). Mirror Flip
5
Image /page/5/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure in teal, with a green globe-like structure above its head. The text "EVER" is positioned above "FORTUNE.AI" in a sans-serif font, also in teal. The overall design is clean and modern.
- g). Multi-screen display
- h). Cine Loop Play
Annotation Functionality:
-
Point Annotation
Quantification Functionalities: -
a). Distance measurement
-
b). Area measurements
-
c). Angle measurement
-
d). Single Point measurement
5.6 Substantial Equivalence
The following table compares the EFAI PACS to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Table 5.1: Comparison Table | |||
|---|---|---|---|
| Attribute | EFAI PACS | Arterys Viewer (K171544) | Comparison |
| Device Name/510(k) # | EFAI PACS Picture | ||
| Archiving and | |||
| Communication System | |||
| (Ever Fortune.AI Co., Ltd.) / | |||
| K#TBD | Arterys Viewer (Arterys | ||
| Inc.) / K171544 | -- | ||
| Support Mammography | No | No | Same |
| Device Property | Stand-alone Software | Stand-alone Software | Same |
| Classification | - Class II |
- Picture archiving and
communications system - LLZ (21 CFR 892.2050) | - Class II
- Picture archiving and
communications system - LLZ (21 CFR 892.2050) | Same |
| Operating System
(Web accessible) | Client server architecture
using Linux server and web | Client server architecture
using Linux server and web | Same |
| | browser client (Web-based
only) | browser client (Web-based
only) | |
| 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 | Same |
| Transfer/Storage/Display
of Medical Images | Yes | Yes | Same |
| Network Access | Web browser connects to
existing PACS | Web browser connects to
existing PACS | Same |
| Image
storage/Compression
(Image Data
Compression) | Support JPEG2000 and
compression | Support JPEG2000 and
compression | Same |
| Mammography Use | No support for the
examination modality files of
mammography | No support for the
examination modality files
of mammography | Same |
| DICOM Compliant
(Images file format) | Yes | Yes | Same |
| Worklists | Yes | Yes | Same |
| Filter and Search
capabilities | Yes | Yes | Same |
| Ability to search studies | Yes | Yes | Same |
| Image analysis and
review capability | Yes | Yes | Same |
| Zoom in/Out | Yes | Yes. Default settings can
zoom interactively | Same |
| View DICOM data | Yes | Yes. You can view the
DICOM information about
the patient and study, and
the pixel information | Same |
| Window/level
determination | Yes. Window width/length in
menu | Yes. Let the user adjust W/L | Same |
| Window/level presets | Yes | Yes | Same |
| Adjust window/level | Yes | Yes | Same |
| Measuring tools
(General image
measurements) | Yes | Yes. Linear, area, and pixel
intensity and location of a
point | Same |
| Custom filters | Yes | Yes. Can set filters to affect
the studies listed | Same |
| Set reading state | Yes. Study description in
menu icon | Yes | Same |
6
Image /page/6/Picture/0 description: The image contains a logo for a company called EVER. The logo consists of a stylized teal-colored symbol resembling a person with a network of connected dots above their head, followed by the word "EVER" in a sans-serif font. Below "EVER" is the text "FORTUNE.AI" in a smaller font size.
7
Image /page/7/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure with a circular head made of interconnected dots, suggesting a network or connection. The figure and the text are in a teal color, creating a clean and modern look. The text "EVER" is in a larger, bolder font, while "FORTUNE.AI" is in a smaller font below it.
5.7 Performance Data - Non-Clinical
To demonstrate safety and effectiveness of EFAI PACS 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 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. o
- 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.
5.8 Performance Date - Clinical
EFAI PACS did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute:
- Design features;
- Indications for Use;
- 0 Fundamental scientific technology:
- Non-clinical performance testing;
- 0 Safety and effectiveness.
The clinical evaluation is conducted on the device following FDA Guidance "Software as a Medical Device (SAMD): Clinical Evaluation".
8
Image /page/8/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a green icon that looks like a person with a network of dots above their head. To the right of the icon is the text "EVER" in a larger font and "FORTUNE.AI" in a smaller font. The text is also green.
Based on the requirements recommended by FDA regarding the Clinical Evaluation, Ever Fortune has conducted the Clinical Evaluation for the EFAI PACS, the Clinical Evaluation Plan, Report and the adverse event data base search results are provided as Attachment 31 (EFAI PACS P-CKEVIEWER001), Attachment 32 (EFAI PACS R-CKE-VIEWER001), Attachment 15 – 18 CER Annex I-FDA Recall LLZ 2011-2021). The three clinical articles mentioned in the CEP and CER are uploaded to the Reference section.
5.9 Statement of Substantial Equivalence
The EFAI PACS has the same intended use as the Arterys Viewer, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the EFAI PACS is as safe and effective as the predicate device. Therefore, the EFAI PACS is substantially equivalent to the predicate device.