(28 days)
No
The device description explicitly states that Ashvins does not utilize artificial intelligence or computer-aided diagnosis.
No.
Ashvins is a software solution for viewing, processing, storing, and managing medical images and data, intended to assist professionals in diagnosis and treatment planning, but it does not generate a diagnosis or treatment plan itself, nor does it deliver any therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used for "viewing, reporting, storing, printing, and archiving... digital, multimodal medical images... as well as findings and demographic information," and explicitly mentions its use "For primary image diagnosis in Mammography". The "Device Description" also clarifies that it "is used at a physician's workplace to assist the physician with diagnosis and treatment planning." While it clarifies it does not generate automated diagnoses, its purpose is to provide tools for medical image viewing and processing that assist professionals in making a diagnosis.
Yes
The device is explicitly described as a "modular software solution" and its functions are entirely software-based (viewing, reporting, storing, processing images, managing data). While it integrates with hardware like diagnostic monitors and other medical devices, the Ashvins product itself is presented as software.
Based on the provided information, Ashvins is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological or pathological state, or to monitor therapeutic measures.
- Ashvins' Function: Ashvins is a software solution primarily focused on managing, viewing, processing, and distributing medical images and related information. It works with digital images and bio-signals, which are not typically considered specimens for in vitro examination in the traditional sense of IVD.
- Lack of Specimen Analysis: The description of Ashvins does not mention any analysis of biological specimens. Its functions revolve around image manipulation, storage, and display.
- Intended Use: The intended use is for trained professionals to assist with diagnosis and treatment planning based on medical images and information, not through the analysis of in vitro samples.
While Ashvins is a medical device and plays a role in the diagnostic process, its function falls outside the scope of an In Vitro Diagnostic device. It's more accurately described as a medical image management and processing system.
N/A
Intended Use / Indications for Use
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, NFJ
Device Description
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammoqraphic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis.
For primary image diagnosis in Mammography only uncompressed images and only preprocessed DICOM *For Presentation" images must be used. Existing regulatory or legal require-ments regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiolo-gists, ophthalmologists, nurses, medical technicians, and assistants.
Ashvins integrates systems including, but not limited to, devices and information systems for medical practices and hospitals (such as radiology and/or ophthalmology information systems, etc.) in accord-ance with international standards. Ashvins also provides manufacturer-specific interfaces for other sys-tems/devices.
Ashvins offers the possibility of capturing and digitizing documents such as PDFs, single images, image sequences and film sequences, as well as converting and archiving them in DICOM format. As such, Ash-vins serves as a manufacturer-independent image management system and archive, a so-called "Vendor Neutral Archive."
Ashvins also provides functions for the collection, processing, and transfer of medical and administrative data in hospitals or medical practices, including billing functions.
Ashvins allows the visualization and statistical evaluation of meta data provided by the devices.
Ashvins is used at a physician's workplace to assist the physician with diagnosis and treatment planning, but the product itself does not generate an automated diagnosis, findings, or a treatment plan. The final decision regarding the diagnosis always remains with the physician or the medical staff within their own decision-making area.
Ashvins is offered in different variants with different ranges of functions for different application areas depending on the configuration (for further information see document "General Description of Product Vari-ants").
Mentions image processing
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
Mentions AI, DNN, or ML
Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis.
Input Imaging Modality
digital, multimodal medical images, including mammographic images and bio-signals
Anatomical Site
Not Found
Indicated Patient Age Range
There are no specific requirements related to gender, age, or other biological and anatomical characteris-tics of patients for the use of Ashvins.
Ashvins is applicable for all patients. The imaging data is delivered by the imaging devices on which the patients are examined.
Intended User / Care Setting
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
Ashvins is used at a medical site such as a medical practice or a hospital, and it has components hosted in the Cloud.
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)
Performance tests were conducted to test the functionality of Ashvins (and variants). These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
Testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate level of concern", since a failure or latent design flaw could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
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
FDA U.S. FOOD & DRUG
ADMINISTRATION
MedicalCommunications GmbH % Mrs. Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Drive MEDINA OH 44256
February 18, 2020
Re: K200132
Trade/Device Name: Ashvins Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, NFJ Dated: January 17, 2020 Received: January 21, 2020
Dear Mrs. Lena Sattler:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200132
Device Name Ashvins
Indications for Use (Describe)
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The word "ASHVINS" is written in large, bold, dark blue letters. Below it, in smaller letters, it says "Solutions by Medical Communications". There is a light green curved line above the word "ASHVINS".
1.510(k) Summary as required by section 807.92(c)
510(k)-number
Date Prepared February 7, 2020
1.1 510(k) Owner/ Manufacturer
MedicalCommunicatoins GmbH
Max-Jarecki-Strasse 8
69115 Heidelberg, Germany
| Telephone: | +49 6221 7531 0 |
|---|---|
| Facsimile: | +49 6221 7531 119 |
| Email: | FDA@MedicalCommunications.com |
| Establishment Registration No.: | 3003995303 |
1.2 Official Contact Person
Lena Sattler
| President, Orasi Consulting, LLC. | |
|---|---|
| 1655 Forest Dr. | |
| Medina, OH 44256 | |
| Telephone: | (440) 554-3706 |
| Facsimile: | (866) 904-4315 |
| E-Mail: | lena@orasiconsulting.com |
1.3 Common/Usual Name
Picture Archive And Communication System (PACS)
Image /page/3/Picture/15 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" made up of two curved lines in different shades of green, with a black circle in the center. To the right of the symbol is the text "MedicalCommunications" in a sans-serif font.
MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg
info@medicalcommunications.com www.medicalcommunications.de
MCDOC-1419004256-2672 Version: 0.1 Template Version: 1.0
510(k) Summary_K200132_cleanversion
4
Image /page/4/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The word "ASHVINS" is in large, bold, blue letters. Below that, in smaller blue letters, it says "Solutions by Medical Communications". There is a green swoosh above the word "ASHVINS".
Proprietary or Trade Names 1.4
Proprietary Name:
-
. Ashvins
Trade Names: -
Ashvins Diagnostic Workstation ●
-
Ashvins Web Extreme .
-
Ashvins Image & Web Management (Data Management) .
-
HEYEX 2 / HEYEX PACS (Product Family: HEIDELBERG EYE EXPLORER) .
Classification Information 1.5
| Classification Name: | System, Image Processing, Radiological [LLZ],
System, Image Management, Ophthalmic [NFJ] |
|----------------------|---------------------------------------------------------------------------------------------|
| Medical Specialty: | Radiology |
| Device Class: | II |
| Product Code: | LLZ, NFJ |
Product Code: Classification / CFR Title 1.6
| LLZ, NFJ: | Class II § 21 CFR 892.2050 |
|---|---|
| Regulation Name: | Picture Archiving and Communications System |
1.7 Predicate Devices
Table 2: Primary Predicate Device, Secondary Predicate Device
| Primary Predicate Device: JiveX 5.0 | Secondary Predicate Device: FORUM |
|---|---|
| Radiology | Ophthalmology |
| VISUS Health IT | Carl Zeiss Meditec AG |
| Device Class: II | Device Class: II |
| Product Code: LLZ | Product Code: NFJ |
| 21 CFR 892.2050 | 21 CFR 892.2050 |
| K142750 | K122938 |
MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg
info@medicalcommunications.com www.medicalcommunications.de
Image /page/4/Picture/19 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter C made up of two curved lines, one in dark blue and the other in light green. Inside the C is a black circle. To the right of the logo is the text "MEDICALCOMMUNICATIONS" in a sans-serif font.
5
Image /page/5/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "Solutions by MedicalCommunications."
General Device Description 1.8
Device Description
Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammoqraphic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis.
For primary image diagnosis in Mammography only uncompressed images and only preprocessed DICOM *For Presentation" images must be used. Existing regulatory or legal require-ments regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiolo-gists, ophthalmologists, nurses, medical technicians, and assistants.
Ashvins integrates systems including, but not limited to, devices and information systems for medical practices and hospitals (such as radiology and/or ophthalmology information systems, etc.) in accord-ance with international standards. Ashvins also provides manufacturer-specific interfaces for other sys-tems/devices.
Ashvins offers the possibility of capturing and digitizing documents such as PDFs, single images, image sequences and film sequences, as well as converting and archiving them in DICOM format. As such, Ash-vins serves as a manufacturer-independent image management system and archive, a so-called "Vendor Neutral Archive."
Ashvins also provides functions for the collection, processing, and transfer of medical and administrative data in hospitals or medical practices, including billing functions.
Ashvins allows the visualization and statistical evaluation of meta data provided by the devices.
Ashvins is used at a physician's workplace to assist the physician with diagnosis and treatment planning, but the product itself does not generate an automated diagnosis, findings, or a treatment plan. The final decision regarding the diagnosis always remains with the physician or the medical staff within their own decision-making area.
Ashvins is offered in different variants with different ranges of functions for different application areas depending on the configuration (for further information see document "General Description of Product Vari-ants").
Image /page/5/Picture/14 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" formed by two curved lines in different shades of blue and green, with a black dot in the center. To the right of the symbol, the words "MedicalCommunications" are written in a simple, sans-serif font.
MedicalCommunications GmbH Max-Jarecki-Str. 8. D-69115 Heidelberg CDOC-1419004256-2672
6
Image /page/6/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The logo features the company name in a bold, sans-serif font, with the word "ASHVINS" in a larger font size than "Solutions by MedicalCommunications". A teal swoosh appears above the company name. The overall design is clean and professional.
- Ashvins variant Ashvins Diagnostic Workstation ●
- . Ashvins variant Ashvins Web Extreme
- Ashvins variant Ashvins Image & Web Management (Data Management)
- . Ashvins variant HEYEX 2 / HEYEX PACS
Intended patient groups
There are no specific requirements related to gender, age, or other biological and anatomical characteris-tics of patients for the use of Ashvins.
Ashvins is applicable for all patients. The imaging data is delivered by the imaging devices on which the patients are examined.
Intended usage environment/use environment
Ashvins is used at a medical site such as a medical practice or a hospital, and it has components hosted in the Cloud.
Generally, the diagnostic workstations are used in darkened rooms. These relevant directives and stand-ards must be observed. For other client stations of Ashvins there are no restrictions regarding the place of use.
Service and maintenance
Maintenance and configuration of Ashvins may only be carried out by professionals after appropriate train-ing. It is recommended that a maintenance contract be attained from the manufacturer.
1.9 Indications for Use
Intended Use
Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information.
Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions.
Image /page/6/Picture/17 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" formed by two curved lines in different shades of green and blue, with a black circle inside the "C". To the right of the symbol is the text "MedicalCommunications" in a simple, sans-serif font. The text is in a dark color, likely black or a dark shade of gray, providing a clear contrast against the white background.
MedicalCommunications GmbH Max-Jarecki-Str. 8. D-69115 Heidelberg
info@medicalcommunications.com
CDOC-1419004256-2672
7
Image /page/7/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The logo features the company name in a bold, sans-serif font, with the word "ASHVINS" in a larger font size than "Solutions by Medical Communications". A teal swoosh appears above the company name. The overall design is clean and professional.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed.
Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.
1.10 Substantial Equivalence
The Substantial Equivalence table below illustrate the comparison of Ashvins to the predicate devices.
Table 3: Subjected device Ashvins compared to the Predicate devices K142750 and K12293
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate
Device
(K122938) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ashvins | JiveX 5.0 | FORUM |
| Submitter/Manufac-
turer | MedicalCommunications
GmbH | VISUS Health IT | Carl Zeiss Meditec AG |
| Indications for Use | Ashvins is a modular soft-
ware solution and is used
for viewing, reporting, pro-
cessing, storing, printing,
and archiving, as well as for
the exchange and distribu-
tion or web-based distribu-
tion of digital, multimodal
medical images, including
mammographic images and
bio-signals, as well as find-
ings and demographic infor-
mation. Ashvins also col-
lects, manages, and distrib-
utes patient-related and de-
vice-related information. | JiveX is a software only
Picture Archiving and
Communication System
intended to display, pro-
cess, read, report, com-
municate, distribute,
store, and archive medi-
cal data which is available
as DICOM or HL7 data, in-
cluding mammographic
images, and bio signals.
JiveX also converts case
related non-image docu-
ments, archives them as
DICOM data and serves | FORUM is a software
system intended for use
in storage, manage-
ment, processing, and
display of patient, diag-
nostic, video and image
data and measurement
from computerized di-
agnos-tic instruments
or documentation sys-
tems through networks.
It is intended to work
with other FO-RUM ap-
plications. |
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate
Device
(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| | Ashvins offers advanced im-
age processing functions
such as multiplanar recon-
struction, 3D reconstruc-
tion and measurement
functions.
For primary image diagnosis
in Mammography only un-
compressed or non-lossy
compressed images and
only preprocessed DICOM
"For Presentation" images
must be used. Existing reg-
ulatory or legal require-
ments regarding hardware,
such as diagnostic moni-
tors, that are applicable for
diagnosing in respective im-
aging specialties must be
observed.
Ashvins is designed to be
used by trained profession-
als, including but not limited
to physicians, radiolo-gists,
ophthalmologists, nurses,
medical technicians, and as-
sistants. | as a vendor neutral ar-
chive.
It supports the physician
in diagnosis.
For primary image diag-
nosis in Mammography
only uncompressed or
non-lossy compressed
images must be used.
Also monitors (displays)
and printers which re-
ceived FDA clearance for
Mammography must be
used.
Typical users of this sys-
tem are trained profes-
sionals, including but not
limited to physicians, ra-
diolo-gists, nurses, medi-
cal technicians, and assis-
tants.
Note: Web-based image
distribution and mobile
device display are not in-
tended for diagnostic pur-
pos-es. | FORUM is intended for
use in review of patient,
diagnostic and image
data and measurement
by trained healthcare
professionals. |
| Regulation description | Picture archiving and communication system | Picture archiving and communication system | Picture archiving and communication system |
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate
Device
(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| Prescription/over-
the-counter use | Prescription | Prescription | Prescription |
| Classification | Device Class: II | Device Class: II | Device Class: II |
| | Product
Code:
LLZ, NFJ | Product
Code:
LLZ | Product
Code:
NFJ |
| | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Target Population | Images/System is not pa-
tient population specific | Images/System is not pa-
tient population specific | Images/System is not
patient population spe-
cific |
| Design/ Architecture | Client/server | Client/server | Client/server |
| Operating systems | Server: Win 2016/19
Client: Win 7/10 | Server: Win
7/8.1/10/
Srv. 2008/2012
Client: Win. 7/8.1/10 | Windows XP, Windows
Server 2003 (Server
only) Windows 7, Win-
dow Server 2008 R2,
Mac Lion (Client only) |
| Hardware
require-
ments | Windows based, manufac-
turer | Windows based, manu-
facturer | Windows based, manu-
facturer |
| | independent server, work-
stations and | independent
server,
workstations and | independent
server,
workstations and |
| | client hardware, iPAD | client hardware, iPAD | client hardware |
| Image communica-
tion | TCP/IP, DICOM, proprietary
internal image transfer pro-
tocol | TCP/IP, DICOM, proprie-
tary internal image trans-
fer protocol | TCP/IP, DICOM, propri-
etary internal image
transfer protocol |
| Accepted
Image
Formats | DICOM
data + data ac-
cepted as non DICOM and
converted to DICOM
for | DICOM data + data ac-
cepted as non DICOM and
converted to DICOM for | DICOM |
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate Device
(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| | storage: PDF, standard and other proprietary formats | storage: PDF, standard and proprietary ECG formats | |
| Supported storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions | Local storage on HDD/RAID/DVD, Network: NAS, SAN, long term storage solutions |
| Image data compression | JPEG 2000 lossless& lossy, ZIP, JPEG lossless & lossy, MPEG-1, MPEG-2, MPEG-4 | JPEG 2000 lossless & lossy, ZIP, JPEG lossy for web clients Display as received: JPEG lossless & lossy, RLE lossless, MPEG-2 | JPEG 2000 lossless, JPEG lossless, RLE lossless, MPEG-2, MPEG-4 |
| Web based acces | Yes, Desktop & mobile devices (not intended for reading) | Yes, Desktop & mobile devices (not intended for reading) | No |
| Virtualization | Yes, VMware. Desktop and web clients can be distributed via Citrix | Yes | Yes |
| Cebtralized user administration | Yes | Yes | Yes |
| RIS/HIS/EMR integration | Yes, Via standards HL7 and DICOM, aligned to IHE Framework | Yes, Image Call Up from RIS, Patient Information Reconciliation, Instance Availability. Receive documents via HL7 MDM. Supported Standards: HL7, IHE | Yes, Via standards HL7 and DICOM |
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate
Device
(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| IHE XDS | no | XDS-Consumer | no |
| Image Processing
Algorithms | - Zoom, Pan, Rotate, Flip, Magnify | - Zoom, Pan, Rotate, Flip, Magnify | - Pan/Zoom
- Image Measurements
- Brightness/Contrast |
| | - Geometrical Measurements | - Geometrical Measurements | |
| | - ROI statistics | - ROI statistics | |
| | - Mammography auto shutter | - Mammography auto shutter | |
| | - 3D Cross Reference | - 3D Cross Reference | |
| | - ECG measurements | - ECG measurements | |
| | - Interpolation: nearest neighbor, bilinear | - Interpolation: nearest neighbor, bilinear | |
| | - Filters: sharpen | - Filters: sharpen, CLAHE | |
| | - Windowing and LUT mapping | - Windowing and LUT mapping | |
| Image Processing
Algorithms 3D | - MPR | - MPR | |
| | - Max. Int. Projection | - Max. Int. Projection | |
| | - Min. Int. Projection | - Min. Int. Projection | |
| | | - Volume Rendering | |
| | | - MIP for tomosynthesis data (not for diagnostic use) | |
| Feature | Subject | Primary Predicate Device
(K142750) | Secondary Predicate
Device
(K122938) |
| | Ashvins | JiveX 5.0 | FORUM |
| | | - 3D image registration | |
| Hanging proto-
cols/Clinical Displays | Yes | Yes | Yes |
| Centrally Schedule Patient Examinations | Yes | No | Yes |
| Server/Client Technology | Yes | Yes | Yes |
| Integrate 3rd Party Systems | Yes | Yes | Yes |
| Multi Site Query | Yes | Yes | Yes |
| Patient Administration | Yes | Yes | Yes |
| Patient Directory/Patient Navigator/Study Manager | Yes | Yes | Yes |
| Patient Search | | | |
| Order Management | Yes | Yes | Yes |
| Automatic Forwarding (based on DICOM) | Yes | Yes | Yes |
| Marking of Favorites | Yes | Yes | Yes |
| User Profiles | Yes | Yes | Yes |
MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg
Image /page/7/Picture/9 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter 'C' made up of two curved lines in different shades of green and blue. Inside the 'C' is a black circle. To the right of the 'C' is the text 'MEDICALCOMMUNICATIONS' in a sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, dark blue letters. Above the word is a light green curved line. Below the word is the phrase "Solutions by MedicalCommunications" in smaller, dark blue letters.
MCDOC-1419004256-2672
Version: 0.1
Template Version: 1.0
Image /page/8/Picture/5 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.
MedicalCommunications
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Image /page/9/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Below that, the words "Solutions by MedicalCommunications" are in smaller, blue letters. A green curved line is above the word "ASHVINS".
info@medicalcommunications.com
www.medicalcommunications.de
MCDOC-1419004256-2672
Version: 0.1
Template Version: 1.0
Image /page/9/Picture/5 description: The image is completely white and contains no discernible objects, shapes, or patterns. The image appears to be a blank canvas with a uniform white color throughout. There are no variations in shading or texture. It is a simple, unadorned image with no content.
MedicalCommunications
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Image /page/10/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Below that, in smaller letters, are the words "Solutions by MedicalCommunications."
info@medicalcommunications.com
www.medicalcommunications.de
Image /page/10/Picture/5 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" in blue and green, with a black dot in the center. To the right of the symbol is the text "MedicalCommunications" in a sans-serif font.
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Image /page/11/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Below that, the words "Solutions by MedicalCommunications" are in smaller, blue letters. A green curved line is above the word "ASHVINS".
info@medicalcommunications.com
www.medicalcommunications.de
Image /page/11/Picture/5 description: The image contains the text "MedicalCommunications". The text is in a sans-serif font and is right-aligned to a logo. The logo is a green semi-circle with a black circle above it.
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Image /page/12/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue font. Below that, the words "Solutions by MedicalCommunications" are in a smaller, blue font. There is a green swoosh above the word "ASHVINS".
Image /page/12/Picture/2 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter C formed by two curved lines in different shades of green and blue, with a black dot in the center. To the right of the symbol, the words "MedicalCommunications" are written in a simple, sans-serif font.
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Image /page/13/Picture/0 description: The image shows the logo for ASHVINS Solutions by MedicalCommunications. The word "ASHVINS" is in large, bold, blue letters. Above the word is a green curved line. Below the word is the phrase "Solutions by MedicalCommunications" in smaller, blue letters.
Ashvins described in this 510(k) has an equivalent intended use, shares the technological characteristics and provides a similar feature set as the predicate devices.
Ashvins does not raise any new issues of safety and efficacy.
1.11 Design Control
The Design Control procedure of MedicalCommunications complies with the FDA Quality System Regulations CFR Part 820 and ISO 13485:2016. The Design Control procedure also incorporates Risk Management procedures, which comply with ISO 14971:2007.
MedicalCommunications performed software verification and validation, to confirm that Ashvins functions as intended.
1.12 Non-Clinical Performance Summary
Ashvins has been validated for its intended use to determine substantial equivalence to the predicate device.
Our Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Ashvins (and variants) during product development.
The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Medical Communications GmbH conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.
Summary:
The device is intended for prescription use, identical to the predicate device. The device is not an in vitro diagnostic device, identical to the predicate device.Performance tests were conducted to test the functionality of Ashvins (and variants). These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
Testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate level of concern", since a failure or latent design flaw could lead
Image /page/13/Picture/15 description: The image shows the logo for Medical Communications. The logo consists of a stylized "C" shape in two shades of green, with a black circle in the center. To the right of the symbol, the words "MedicalCommunications" are written in a sans-serif font. The word "Medical" is capitalized, and the rest of the text is in lowercase.
MedicalCommunications GmbH Max-Jarecki-Str. 8. D-69115 Heidelberg
info@medicalcommunications.com
CDOC-1419004256-2672
510(k) Summary_K200132_cleanversion
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Image /page/14/Picture/0 description: The image shows the logo for ASHVINS Solutions by Medical Communications. The word "ASHVINS" is in large, bold, dark blue letters. Above the word is a light green curved line. Below the word is the phrase "Solutions by Medical Communications" in a smaller, dark blue font.
to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
1.13 Conclusion
Ashvins is substantially equivalent to the primary predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrate that the design requirements and as well the user needs.
Image /page/14/Picture/4 description: The image shows the logo for Medical Communications. The logo consists of a stylized letter "C" made up of three curved lines in different colors: dark blue, black, and light green. To the right of the "C" is the text "MedicalCommunications" in a simple, sans-serif font. The text is all one word, with the first letter of each word capitalized.
MedicalCommunications GmbH Max-Jarecki-Str. 8, D-69115 Heidelberg