(64 days)
Not Found
No
The document describes a PACS system for image management and display, with no mention of AI or ML capabilities. The focus is on standard image processing, storage, and display functionalities.
No
The device is a Picture Archiving and Communication System (PACS) software designed for displaying, storing, and communicating medical images; it does not directly treat or diagnose a disease or condition.
Yes
The text explicitly mentions that the device supports "diagnostic interpretation of Mammography studies" and is used within the "AMICAS LightBeam Diagnostic Workstation" which itself is a diagnostic workstation. It manages images from "FDA-cleared Computer-Aided Detection systems" which are used for diagnosis.
No
The device description explicitly states that the software "must be installed on suitable, commercial-standard hardware," indicating it is not solely software and requires specific hardware for operation.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is for processing, displaying, and storing medical images acquired from imaging modalities like digital mammography. It does not involve the analysis of biological samples.
- The focus is on image processing and display for diagnostic interpretation. The text emphasizes soft copy reading, communication, printing, and storage of images, particularly for mammography. This aligns with the function of a Picture Archiving and Communication System (PACS), not an IVD.
Therefore, the Vision Series PACS 4.3 is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography.
Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.
Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
AMICAS Vision Series PACS 4.3 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digitally acquired images, DICOM-compliant medical imaging systems
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, technologists and clinicians.
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
Amicas Vision Series 4.3 is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing.
Functional testing is an integral part of Amicas, Inc. Product Development process known as "VDEV" (Vision Development Elaboration Validation), also included in this filing (see section G).
The Amicas Compliance Department, per process, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectivenessbefore issuing release authorizations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
K.062477
510(k) Summary of Safety and Effectiveness - as required by 21 CFR part 807.92
| Date prepared: | August, 22 2006 |
|---|---|
| Submitted by: | Amicas, Inc. OCT 27 2006 |
| 20, Guest St. | |
| Boston, MA 02135 | |
| Contact: | |
| Contact email: | |
| Contact Telephone: | |
| Contact Fax: | Patrice Nedelec |
| pnedelec@amicas.com | |
| 617-779-7858 or 617-372-1331 | |
| 617-783-7209 or 806-313-1214 | |
| Device Trade Name: | |
| Device Common Name: | |
| Regulation number: | |
| Device Classification: | |
| Name: | |
| Predicate Device: | |
| Predicate Device Manufacturer: | Amicas Vision Series PACS 4.3 |
| Picture Archiving Communication System (PACS) | |
| 892.2050 | |
| Class II | |
| Amicas Vision Series PACS | |
| Amicas Light Beam Diagnostic Workstation | |
| AMICAS Inc. | |
| 20 Guest Street | |
| Boston, MA 021235 | |
| Predicate Device 510(k) number: | |
| Date received: | |
| Decision date: | |
| Decision: | |
| Panel Code Device reviewed by: | |
| Panel Code Device classified by: | |
| Product Code: | |
| Regulation number: | |
| Device Classification: | K022970 |
| 09/06/2002 | |
| 11/22/2002 | |
| Substantially equivalent | |
| Radiology | |
| Radiology | |
| LLZ | |
| 892.2050 | |
| Class II |
Device Description and intended use:
AMICAS Vision Series PACS 4.3 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Typical users of Vision PACS Series 4.3 are radiologists, technologists and clinicians.
Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 1 of 3
1
| Feature | Amicas LightBeam
Workstation
(predicate) | Amicas Vision Series
PACS 4.3 |
|------------------------------|------------------------------------------------|----------------------------------|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000 | Yes | Yes |
| Compression | | |
| Lossy JPEG2000 Compression | Yes | Yes |
| DICOM Overlay supporting | No | Yes |
| MQSA-requirements | | |
| DICOM Printing | No | Yes |
Technological characteristics:
General Safety Considerations
Amicas Vision Series 4.3 software and the computer platform that it is installed on together constitute a system for the interpretation of medical image data by trained and qualified professionals. It is the user's responsibility to ensure that image quality, display quality, environmental lighting and other possible distractions are consistent with the clinical application. Refer to the instruction manuals for your specific computer and display hardware for information regarding installation, calibration and additional safety issues.
Amicas Vision Series 4.3, as its predicate, includes tools for enlarging, highlighting and obscuring portions of an image relative to other portions. Inappropriate application of these tools can result in the obscuration of important anatomy and contribute to an erroneous interpretation. It is the user's responsibility to understand the effect of image manipulation tools and to apply in a manner consistent with the clinical application. The user must review the cautionary statements in the User's guide.
Be sure to limit access to patient data to authorized individuals who are fully trained and qualified to use this equipment.
Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 2 of 3
2
Testing:
Amicas Vision Series 4.3 is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing.
Functional testing is an integral part of Amicas, Inc. Product Development process known as "VDEV" (Vision Development Elaboration Validation), also included in this filing (see section G).
The Amicas Compliance Department, per process, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectivenessbefore issuing release authorizations.
Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or forms, possibly representing health, people, and services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 2 7 2006
Ms. Patrice J.C. Nedelec Director, Compliance AMICAS, Inc. 20 Guest Street, Suite 200 BOSTON MA 02135
Re: K062477
Trade/Device Name: AMICAS Vision Series PACS 4.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 23, 2006 Received: August 24, 2006
Dear Mr. Nedelec:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a black and white logo. The logo is circular and contains the text "1906-2006" at the top. Below the text is the letters "FDA" in a bold font. Below the letters is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health.
4
Page 2 -
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: AMICAS Vision Series PACS 4.3
Indications For Use:
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography.
Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.
Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Prescription Use (Part 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 In Vitro Diagnostic Devices (OIVD)
David h. Lyynn
Division of Reproductiv and Radiological Device 510(k) Number