Efai Pacs Picture Archiving and Communication System Pro

K232100 · Ever Fortune.Ai, Co., Ltd. · LLZ · Aug 8, 2023 · Radiology

Device Facts

• Record ID: K232100
• Device Name: Efai Pacs Picture Archiving and Communication System Pro
• Applicant: Ever Fortune.Ai, Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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, 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 Story

EFAI PACS PRO is a stand-alone software-as-a-medical-device (SaMD) for medical image management. It ingests DICOM and non-DICOM data from OEM imaging equipment; stores, transfers, and displays images via web browsers on standard computers. Clinicians use the system to perform image filtering, digital manipulation, and quantitative measurements. The device does not generate automated diagnoses or findings; it provides processed images for interpretation by trained professionals (radiologists, oncologists, physicians) to support clinical decision-making. Benefits include centralized access to patient imaging data and tools for review and measurement, facilitating efficient clinical workflows in hospital or clinic settings.

Clinical Evidence

Bench testing only. Software verification and validation performed per IEC 62304 and FDA guidance. Usability engineering conducted per IEC 62366-1 and IEC 62366-2. No clinical data provided.

Technological Characteristics

Stand-alone SaMD; web-browser based client-server architecture. Supports DICOM and non-DICOM data. Features include image storage, filtering, digital manipulation, window/level adjustment, and quantitative measurement tools. Software verification/validation per IEC 62304; usability engineering per IEC 62366-1/2.

Indications for Use

Indicated for use by trained medical professionals (radiologists, oncologists, physicians) to manage, store, display, and process DICOM and non-DICOM medical images (excluding mammography) for clinical interpretation and diagnosis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• EFAI PACS (K211257)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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#### 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.<br>West Dist.<br>Taichung City 403020<br>TAIWAN |
| Applicant | Joseph Chang |
| Contact Information | 886-04-23213838 #216<br>[e-mail] |
| Correspondence Person | Ti-Hao Wang, CTO |
| Contact Information | 886-04-23213838 #168<br>[e-mail] |
| Date Prepared | July 10, 2023 |

# 2. Proposed Device

| Proprietary Name | EFAI PACS PICTURE ARCHIVING AND<br>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 |

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| 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<br>Use/Indication<br>for Use | EFAI PACS PRO is intended to be used as a Digital Imaging and<br>Communications in Medicine (DICOM)<br>and non-DICOM information and data<br>management system. The EFAI PACS<br>PRO displays, processes, stores, and<br>transfers medical data from original<br>equipment manufacturers (OEMs) that<br>support the DICOM standard, with the<br>exception of mammography. It provides<br>the capability to store images and patient<br>information from OEM equipment, and<br>perform filtering, digital manipulation<br>and quantitative measurements. The<br>client software is designed to run on<br>standard personal and business<br>computers. The product is intended to be<br>used by trained medical professionals,<br>including but not limited to radiologists,<br>oncologists, and physicians. It is<br>intended to provide image and related<br>information that is interpreted by a<br>trained professional to render findings<br>and/or diagnosis, but it does not directly<br>generate any diagnosis or potential<br>findings. | EFAI PACS is intended to be used as a<br>Digital Imaging and Communications in<br>Medicine (DICOM) and non-DICOM<br>information and data management system.<br>The EFAI PACS displays, processes,<br>stores, and transfers medical data from<br>original equipment manufacturers<br>(OEMs) that support the DICOM<br>standard, with the exception of<br>mammography. It provides the capability<br>to store images and patient information<br>from OEM equipment, and perform<br>filtering, digital manipulation and<br>quantitative measurements. The client<br>software is designed to run on standard<br>personal and business computers. The<br>product is intended to be used by trained<br>medical professionals, including but not<br>limited to radiologists, oncologists, and<br>physicians. It is intended to provide image<br>and related information that is interpreted<br>by a trained professional to render<br>findings and/or diagnosis, but it does not<br>directly generate any diagnosis or<br>potential findings. |
| Device Property | Stand-alone Software | Stand-alone Software |
| Image Source | Medical data from original<br>equipment manufacturers<br>(OEMs) that support the<br>DICOM standard | Medical data from original<br>equipment manufacturers<br>(OEMs) that support the<br>DICOM standard |
| Transfer/Storage<br>/Display<br>of Medical<br>Images | Yes | Yes |
| DICOM<br>Compliant<br>(Images file<br>format) | Yes | Yes |
| Worklists | Yes | Yes |

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| Filter and Search<br>capabilities | Yes | Yes |
|-----------------------------------------------------------|-----|-------------------------------------------------------------------|
| Image analysis<br>and<br>review capability | Yes | Yes. |
| View DICOM<br>data | Yes | Yes |
| Window/level<br>determination | Yes | Yes |
| Window/level<br>presets | Yes | Yes |
| Adjust<br>window/level | Yes | Yes |
| Measuring tools<br>(General image<br>measurements) | Yes | Yes |
| Text<br>and<br>graphical<br>annotation<br>functionalities | Yes | Yes (Only provides Point Annotation:<br>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.

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- 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.