(69 days)
No
The description focuses on image viewing and access via a PACS network and standard internet protocols, with no mention of AI/ML capabilities or related performance metrics.
No
The device is described as software for remote viewing and display of medical images, not for providing therapy.
No
The device is described as software for remote viewing and display of medical images (PACS system), allowing access to images by medical professionals. It does not perform analysis or interpretation for diagnosis, rather it displays data generated by other medical scanning devices.
Yes
The device description explicitly states it is a "client-server software system" and describes its function as allowing access and review of medical images on a personal computer or workstation using standard Internet access and a web browser. It does not mention any proprietary hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the software is for the remote viewing of files generated by a medical scanning device (like X-rays, CT scans, MRI scans, etc.). It displays images acquired through the DICOM protocol.
- No Specimen Analysis: There is no mention of the device analyzing biological specimens or providing diagnostic information based on such analysis. Its function is purely to display images generated by other medical devices.
The device is a Picture Archiving and Communication System (PACS) component designed for viewing and managing medical images. While it's a medical device used in a diagnostic context, its function does not fall under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0).
The software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation.
Product codes (comma separated list FDA assigned to the subject device)
SYSTEM, DIGITAL IMAGE COMMUNICATIONS
Device Description
AMICAS is an integrated client-server software system designed to allow access to medical inages by radiologists, referring physicians and other licensed professionals. This product is intended to allow the review of images on a digital Picture Archive and Communication System (PACS) network using a personal computer or workstation configured for standard Internet access. The server component of AMICAS is installed on a computer configured with connections to both the PACS and the Internet. Typically, images will be accessed through a World Wide Web (WWW) browser (the client) such as Microsoft Internet Explorer or Netscape Navigator. Radiology workstations can Query and Retrieve images from AMICAS using standard DICOM protocols.
AMICAS can be used for image distribution within a hospital, a managed care organization or an isolated imaging center. It can also serve as a telemedicine link between widely separate organizations.
A radiology imaging device such as a CT, MR or CR scanner on the PACS network of one institution can be linked to the display workstations on the PACS network of another institution via AMICAS servers on each of the PACS. The AMICAS servers communicate with each other via the public Internet or a private intranet.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical scanning devices (e.g., CT, MR, CR scanner)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, referring physicians and other licensed professionals / Within a hospital, a managed care organization or an isolated imaging center, or as a telemedicine link.
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)
Appendix B presents typical performance data and includes original films as examples of device operation.
AMICAS automatically selects a target compression ratio based on the modality information supplied in the DICOM header of each image. This target compression ratio is based on three years of clinical experience with wavelet compression at Massachusetts General Hospital, Boston, MA and is consistent with the typical compression ratios used in the RSTAR Image Management System [510k Number K943994].
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
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
autocytgroup, inc.
MAR 1 7 1997
52 Marshall Street Watertown, MA 02172 800 490 8465 617 926 4170 fax
NO/ヨロのバイクロウ/ダ
SAFFOR
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
510(k) Summary
1. Identification
- January 6, 1997 Date:
- Submitter: Adrian Gropper, M.D.
Autocyt Group, Inc. 52 Marshall Street Watertown, MA 02172
- Adrian Gropper, M.D. Contact: 617-925-5329 617-926-4170 (fax)
2. Device Name
| Trade Name: | AMICAS Web/Intranet Image Server |
|---|---|
| Common Name: | Image Communication Device |
3. Registration Number
None
4. Classification
| Class: | 2 |
|---|---|
| Panel: | RA |
| Product Code: | SYSTEM, DIGITAL IMAGE COMMUNICATIONS |
5. Standards
None established. Performance: Voluntary: ACR/NEMA DICOM 3.0
6. Labeling
See Section 3
1
7. Safety and Effectiveness Information
AMICAS is an imaging software program used to view medical images on a personal computer. The software is designed to function with off the shelf hardware and software products including standard communications products. It does not require specialized, or nonstandard, devices of any type.
Image acquisition is via the industry-standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner. Image acquisition does not depend on the capture of video signals.
The AMICAS software falls in the "Lower Level of Concern" category:
Intended Use: The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry-standard communications format (DICOM 3.0).
System and Software Requirements: The software will run on standard off-the-shelf hardware and system configurations.
Hazard Analysis: Incorrect display of the image data is possible due to incorrect data produced by the scanner or from a software malfunction. The method of control is through the current regulation of these devices by the FDA, and through the testing procedures adhered to during development and testing stages of this software prior to release. The corrective action is the intended use of this software with properly regulated devices, and timely identification and correction of these potential software problems and the subsequent testing procedures.
Factors Considered:
The risk or danger to the patient of using the device: The software can not immediately threaten the patient's life nor directly cause irreversible illness or permanent injury as it deals only with data gathered and processed by regulated devices and viewed by a competent medical professional.
Degree of influence on therapy or diagnosis: The device does not control the delivery of energy, administration of parenteral drugs, or life-sustaining functions. It does not provide a diagnosis. It provides information/data only. It is a stand-alone system and not a part of a regulated classified device nor an accessory to it. Competent health professionals would reasonably be expected to exercise judgment in the use of the information.
The software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation.
Also see Appendix B for discussion of lossy image compression, example films and related data.
8. Photographs
See Section 4 for computer screen captures of principal views.
9. Device Description
AMICAS is an integrated client-server software system designed to allow access to medical inages by radiologists, referring physicians and other licensed professionals. This product is intended to allow the review of images on a digital Picture Archive and Communication System (PACS) network using a personal computer or workstation configured for standard Internet access. The server component of AMICAS is installed on a computer configured with connections to both the PACS and the Internet. Typically, images will be accessed through a World Wide Web (WWW) browser (the client) such as Microsoft Internet Explorer or Netscape Navigator. Radiology workstations can Query and Retrieve images from AMICAS using standard DICOM protocols.
AMICAS can be used for image distribution within a hospital, a managed care organization or an isolated imaging center. It can also serve as a telemedicine link between widely separate organizations.
2
A radiology imaging device such as a CT, MR or CR scanner on the PACS network of one institution can be linked to the display workstations on the PACS network of another institution via AMICAS servers on each of the PACS. The AMICAS servers communicate with each other via the public Internet or a private intranet.
See Section 2 for device description and Appendix C for a Feature Summary (page C-29).
The user's Web browser is a major component of the AMICAS system. Appendix C includes the Initial Configuration document (page C-24) which discusses the characteristics of specific Web browsers in relation to the functioning of the AMICAS system.
10. Comparison with Equivalent Devices
AMICAS has Indications for Use similar to other medical image viewers such as Evergreen Technologies MedVision [ 510(k) Number K924178 ] or the RSTAR Image Management System [ 510(k) Number K943994 ]. AMICAS also shares with these devices a Target Population that is competent health professionals. Also equivalent to these devices, the AMICAS Design will operate with off-the-shelf hardware and systems.
Like the RSTAR Image Management System [ 510(k) Number K943994 ], AMICAS employs image compression to remove redundant or unimportant information in the original image data. The wavelet image compression libraries and default compression settings are believed to be substantially equivalent to the libraries used in the previously cleared product. Images showing the effect of compression are attached to this submission.
| Feature | MedVision [K924178] | RSTAR [K943994] | AMICAS |
|---|---|---|---|
| Indications for Use | Similar | Similar | Similar |
| Target Population | Health Professionals | Health Professionals | Health Professionals |
| Uses Off-the-Shelf | |||
| Monitors | YES | NO | YES |
| Lossy Image | |||
| Compression | NO | YES | YES |
| Lossy Compression | |||
| Technology | NO | Aware, Inc. | Aware, Inc. |
| DICOM Acquisition | YES | NO | YES |
| TCP/IP | |||
| Communications | YES | YES | YES |
Tabular Comparison with Equivalent Devices
11. Image Compression Technology
AMICAS employs wavelet compression software supplied by Aware, Inc., Bedford, MA. This component, together with the input parameters that are determined by the Autocyt Group software (see Appendix B) are the principal determinants of image quality. Aware is also the supplier of compression technology used in the RSTAR [K943994] product to which we claim equivalence.
3
AMICAS has been developed and tested for over one year in collaboration with the Radiology Associates of Massachusetts General Hospital (MGH), Boston, MA. The founders of Autocyt Group have extensive experience with the design and implementation of systems that employ wavelet image compression. Adrian Gropper, M.D. has been a technical consultant to MGH for over 4 years and was the senior system architect of the RSTAR telemedicine system. Sean Doyle, AMICAS lead software developer, was Director of Software at RSTAR for the equivalent product.
The principal academic reference for clinical use of wavelet compression is:
Goldberg MA, Rosenthal DI, Chew FS, Blickman JG, Miller PR. New high-resolution teleradiology system: prospective study of diagnostic accuracy in 685 transmitted clinical cases. Radiology 1993; 186: 429-434
12. Test Data and Conclusions
Appendix B presents typical performance data and includes original films as examples of device operation.
AMICAS automatically selects a target compression ratio based on the modality information supplied in the DICOM header of each image. This target compression ratio is based on three years of clinical experience with wavelet compression at Massachusetts General Hospital, Boston, MA and is consistent with the typical compression ratios used in the RSTAR Image Management System [510k Number K943994].
| Modality | Target Compression Ratio based on
Typical Information Content | Target Compression Ratio as
Displayed to the User |
|----------|------------------------------------------------------------------|------------------------------------------------------|
| CR | 23:1 | 30:1 |
| CT | 11:1 | 15:1 |
| MR | 6:1 | 8:1 |
AMICAS target compression ratios are set to:
13. Software Information
See Sections 4 and 6 and Appendix D.
14. Confidentiality
Portions of the attached enclosure are confidential.
We would appreciate the earliest attention to this 510(k) submission. We are a small business and are depending on AMICAS sales. Please do not hesitate to contact me at 617-924-5329 or via pager at 617-362-8002 if you have questions regarding this submission.
Sincerely,
Adria Groop, MD.
Adrian Gropper, I President enclosure