(32 days)
Not Found
No
The summary describes a standard PACS system for image management and display, with no mention of AI or ML capabilities.
No.
The "Intended Use" section states that the device primarily receives, communicates, processes, manages, manipulates, stores, and displays medical images and data. It does not mention any direct therapeutic action or treatment for patients.
No
The device is described as a PACS system that receives, communicates, processes, manages, manipulates, stores, and displays digital medical images and data. Its purpose is to facilitate the handling of medical images for user types such as radiologists, technicians, and nurses, rather than to provide a diagnosis itself. It does not generate any original medical images or provide analytical outputs for diagnostic purposes.
Yes
The device description explicitly states that Restore PACS utilizes commercially available hardware and operating systems and does not generate original medical images. Its function is to receive, process, manage, store, and display images and data, which are software-based operations.
Based on the provided information, the Restore PACS device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Restore PACS Function: The description of Restore PACS clearly states its function is to receive, process, manage, store, and display digital medical images and data from imaging modalities like MR, CT, and X-ray. It does not involve the analysis of biological specimens.
- Intended Use: The intended use is for trained radiologists, technicians, and nurses to work with medical images for diagnostic purposes, which is distinct from the analysis of in vitro samples.
Therefore, Restore PACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.
Contraindications:
Restore PACS is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations
Product codes
LLZ
Device Description
Restore PACS include features that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations.
Restore PACS is designed to be deployed over TCP/IP networking infrastructure available in customer sites and utilizes commercially available hardware and operating systems. The system of Restore PACS does not generate any original medical images in the Restore PACS are received from DICOM compliant systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologists, technicians and nurses.
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)
The Restore PACS has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Restore PACS and followed the process documented in the Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. % Echo Chou OA Engineer Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist. Xi'an, Shaanxi 710075 CHINA
Re: K162141 Trade/Device Name: Restore PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 3, 2016 Received: August 5, 2016
Dear Echo Chou:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Restore PACS
Indications for Use (Describe)
Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.
Contraindications:
Restore PACS is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."
FORM FDA 3881 (8/14)
3
SECTION 05: 510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date Prepared: July 29, 2016
Submitter's Information:
Company name Xi'an Wingspan Electronic Technology Co., Ltd. Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist., Xi'an, Shaanxi, China Address Contact Name Echo Chou Title QA Engineer Phone number Fax number 86-29-88328071-817 Email e echo@wingspan.cn
Trade Name, Common Name and Classification:
| Name of Device: | Restore PACS |
|---|---|
| Common Name: | Picture Archiving and Communication System |
| Classification: | 21 CFR 892.2050, System, Image Processing, Radiological |
| Regulatory Class: | II |
| Product Code: | LLZ |
Predicate Device:
Restore PACS is substantially equivalent to: K150707 510(k) Number: Trade/Device Name: IntelePACS™ Product Code: LLZ Original Applicant INTELERAD MEDICAL SYSTEMS INCORPORATED Decision Date May 27, 2015
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Device Description:
Restore PACS include features that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations.
Restore PACS is designed to be deployed over TCP/IP networking infrastructure available in customer sites and utilizes commercially available hardware and operating systems. The system of Restore PACS does not generate any original medical images in the Restore PACS are received from DICOM compliant systems.
Indications for Use:
Restore PACS is a device that receives digital medical images and data from various sources (such as, MR scanners, CT Scanners, Digital Xray systems, computers, image gateways or other image sources). Images and other medical data can be communicated, processed, managed, manipulated, stored and displayed within the system and/or across computer networks at distributed locations. Typical users of this system are trained radiologists, technicians and nurses.
Contraindications:
Restore PACS is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Technological Characteristics with Predicate Device:
Restore PACS is a software product that handles and manipulates digital medical images. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The predicate device and the new device are compared below:
| Item | IntelePACS
(K150707) | Restore PACS
(Subject Device) | Substantial
Equivalence
Analyses |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Workstation
Operating System | Windows 7 64-bit
Professional | Windows 7 64-bit or
32 bit Professional | Difference – See
explanation in A. |
| Network | 10/100/100 Ethernet | 10/100/100 Ethernet | Identical |
| User interaction/input | Mouse, keyboard, touch monitor | Mouse, keyboard | Equivalent - Restore PACS does not provide touch monitor |
| Acquisition devices | CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways | CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways | Identical |
| Image search | Yes | Yes | Identical |
| Import/Export Image | Yes | Yes | Identical |
| Image Archive function | Yes | Yes | Identical |
| Image View | Yes | Yes | Identical |
| Image Measurement | Yes | Yes | Identical |
| Image Annotation | Yes | Yes | Identical |
| Image Manipulation | Yes | Yes | Identical |
| Post image data processing | Yes | Yes | Identical |
| Image Pan | Yes | Yes | Identical |
| Image Thumbnail viewing | Yes | Yes | Identical |
| Image Magnify Glass | Yes | Yes | Identical |
| DICOM 3.0 compatibility | Yes | Yes | Identical |
| Multi-user | Yes - at a time, only one user can use it | Yes | Identical |
| Image organization | Patient ID, Name, study instance UID | Yes | Identical |
| Image operations | Yes | Yes | Identical |
| Security | Yes (Priority by user) | Yes | Identical |
| RAW Image data processing | Yes | Yes | Identical |
| Image reset | Yes | Yes | Identical |
| panning | Yes | Yes | Identical |
| Fit image | Yes | Yes | Identical |
| Server Operating
System | Red Hat Enterprise
Linux 6, latest Update,
for 64-bit x86 | Windows Server 2012,
Enterprise Edition | See explanation in B |
| Server Memory | 16 Gigabytes | 8 Gigabytes | See explanation in B |
| Server Database | Sybase and PostgreSQL | Microsoft SQL Server
2012, Enterprise
Edition. | See explanation in B |
| WorkStation
Processor | Intel 6-core Xeon
Processor 3.2GHz | Intel Processor, 2
Cores, 2.0 GHz | See explanation in C |
| Workstation Memory | 6 Gigabytes | 4 Gigabytes | See explanation in C |
Restore PACS - Traditional 510(k)
5
Restore PACS - Traditional 510(k)
6
- A. Workstation Operating System: Restore PACS has been tested and validated with Windows 7 professional 32 bit and 64bit, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- B. Restore PACS 2.0 has been tested and validated on server configuration of Windows Server 2012, Enterprise Edition 64 bit, Microsoft SQL Server 2012, Enterprise Edition and 8 G Memory, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- C. Restore PACS 2.0 has been tested and validated on workstation configuration of Intel Processor, 2 Cores, 2.0 GHz and 4G Memory, the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
Non-Clinical Testing
The Restore PACS has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Restore PACS and followed the process documented in the Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
The subject of this submission did not require animal testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
Conclusion
Comparison of the Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, and intended use.
Restore PACS - Traditional 510(k)
7
Nonclinical testing results demonstrate the difference to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Information provided in this premarket notification submission supports the Restore PACS to be as safe, as effective and substantially equivalent to its predicate device.