(288 days)
Not Found
No
The summary describes standard PACS functionality and image processing techniques, with no mention of AI or ML.
No
The device is a Picture Archiving and Communication System (PACS) software primarily used for managing, storing, processing, and displaying medical images and data, not for direct diagnosis or treatment.
No
Explanation: The device is a Picture Archive and Communications System (PACS) designed to receive, store, communicate, process, print, and display digital images and data. While it handles medical images, its primary function is data management and display for review, not the generation of a medical diagnosis itself. It supports primary review of images but does not inherently perform diagnostic analysis.
Yes
The device is described as a "software device" designed to operate on "specified off-the-shelf hardware and virtual environments," indicating it is the software component of a larger system, but the device itself is the software.
Based on the provided information, the Aspyra AccessNET PACS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Aspyra AccessNET PACS primarily deals with medical images and associated data generated by imaging modalities like CT, MRI, X-ray, etc. These are not specimens in the sense of blood, urine, tissue, etc., which are typically analyzed by IVD devices.
- The intended use focuses on image management, processing, display, and reporting. While it supports the interpretation of medical images, this is distinct from the laboratory analysis of biological samples that characterizes IVD devices.
- The device description aligns with a Picture Archiving and Communication System (PACS). PACS systems are designed for the storage, retrieval, distribution, and presentation of medical images, which is a different category of medical device than IVDs.
Therefore, the Aspyra AccessNET PACS falls under the category of medical imaging software and systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations.
Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotation, zoom, measurement of anatomical structures, image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports.
The Aspyra AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mammographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LMD
Device Description
The Aspyra PACS is a system used for the management of clinical images and reports. It provides Picture Archive and Communications System (PACS) functionality as well as management of clinical workflow.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, DICOM compliant modalities (including mammographic images)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 results of bench testing (software verification and validation) and clinical evaluation have shown the device to be as safe and effective as the predicate devices, and raise of no new issues of safety or effectiveness. Software-related documentation consistent with moderate level of concern software as outlined in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 has been provided in this premarket submission.
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.
K973805, K003438, K013218, K041990, K051553, K082318
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
510(k) Summary
Page 1 of 2
- 1.0 Date Prepared
February 8, 2010
MAR 1 8 2010
-
2.0 Submitter (Contact)
Martin D. Sargent Director, Regulatory Affairs and Quality Assurance Aspyra, Inc. Jacksonville, FL (904) 854-2107 -
3.0 Device Name
Proprietary Name: Common Name(s):
Classification Name(s):
4.0 Device Classification
Classification Name(s): Procode:
System, Image Processing, Radiological LLZ Class II 21 CFR § 892.2050 LMD Class I 21 CFR § 892.2020
System, Image Processing, Radiological
Image Communications Device
AccessNET, AccessMED, AccessRAD, MedVIEW
Picture Archiving and Communications System, Medical
5.0 Device Description
The Aspyra PACS is a system used for the management of clinical images and reports. It provides Picture Archive and Communications System (PACS) functionality as well as management of clinical workflow.
6.0 Indications for Use
The Aspyra AccessNET PACS is a software device designed to operate on specified off-theshelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations.
Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotation, zoom, measurement of anatomical structures,
1
image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports.
The Aspyra AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mammographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
7.0 Performance testing
The results of bench testing (software verification and validation) and clinical evaluation have shown the device to be as safe and effective as the predicate devices, and raise of no new issues of safety or effectiveness. Software-related documentation consistent with moderate level of concern software as outlined in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 has been provided in this premarket submission.
8.0 Substantial Equivalence
The Aspyra PACS is substantially equivalent in operating principle, technology, overall design, function, and intended use to ImageACCESS PACS as described in K973805. Image stitching is substantially equivalent in operating principle, technology, overall design, function, and intended use to CMT SmartRAD|K003438|and Fuji FlashIIp [K013218] [K041990], and Mammography functionality is substantially equivalent in operating principle, technology, overall design, function, and intended use to the Fuji Synapse [K051553] and GE Centricity [K082318].
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
MAR 1 8 2010
Mr. Martin D. Sargent Director, Regulatory Affairs and Quality Assurance Aspyra, Inc. 8649 Baypine Road Ste 101 JACKSONVILLE FL 32256
Re: K091631
Trade/Device Name: AccessNET, AccessMED, AccessRAD, Medview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2010 Received: February 16, 2010
Dear Mr. Sargent:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 109163 1 AccessNET, AccessMED, AccessRAD, MedVIEW Device Name: Indications for Use:
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations.
Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotation, zoom, measurement of anatomical structures, image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports.
The Aspyra AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mammographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use _ X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Braturation (ODE) O LUC
(Division Sign Off)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
911631
AD2-108