(47 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image display and visualization, not analysis or interpretation using AI/ML.
No
The device is used to display medical images for diagnosis, not to treat any condition.
Yes
The "Intended Use / Indications for Use" states that the software program is "used to display medical images for diagnosis." Additionally, the "Summary of Performance Studies" mentions "diagnostic reading" and states that its capability as a device for diagnostic reading was confirmed.
Yes
The device is described as an "App for the Apple iPad" and its function is the display and visualization of medical images. While it runs on an iPad (hardware), the device itself, as described in the summary, is the software program ("aycan mobile software program" and "aycan mobile is an App"). The summary focuses on the software's function and performance, not the hardware it runs on.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The aycan mobile software program is used to display medical images (CT and MRI) for diagnosis. It processes and visualizes images that have already been acquired from the patient. It does not perform any tests on biological samples.
The device's function is related to medical imaging interpretation, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.
aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.
aycan mobile is a software for a mobile device (Apple iPad) that receives and visualizes digital medical images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
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)
Designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria.
Extensive performance tests had been conducted regarding the display and other technical aspects. Display tests leveraged capabilities regarding IEC 62563-1 and TG18 guideline. All tests had been passed successfully.
Furthermore a series of studies had been performed by qualified radiologists reading different CT and MRI studies under different environmental lightning conditions. The capability of aycan mobile as a device for diagnostic reading – when used within the indications for use – was confirmed by the results of these studies.
All radiologists came to the conclusion that the devices is safe and effective when used within its defined Intended Use.
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).
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K122260 Page 1 of 4
PACS tor PA
510(k) Summary of Safety and Effectiveness
The following information is in conformance with 21 CFR 807.92.
Submitter's Information: 21 CFR 807.92(a)(1)
| aycan Digitalsysteme GmbH
Innere Aumuehlstr. 5
97076 Wuerzburg
| Germany | |
|---|---|
| Phone: | |
| Fax: | +49 - 931 - 270 40 90 |
| +49 - 931 - 270 40 91 | |
| Contact Person: | Mr. Matthias Broenner |
| Date Prepared: | July 23th, 2012 |
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | aycan mobile |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
FDA has classified the predicate device (K103785) as Class II, CFR 892.2050, LLZ. It is our understanding that aycan mobile device falls under the same classification as the predicate device. Predicate device details are as follows:
| Device Classification Name: | system, image processing, radiological |
|---|---|
| 510(k) Number: | K103785 |
| Regulation Number: | 892.2050 |
| Device Name: | MOBILE MIM |
| Applicant: | MIM SOFTWARE INC. |
| 25200 Chagrin Blvd. | |
| Suite 200 | |
| Cleveland, OH 44122 | |
| Classification Product Code: | LLZ |
| Decision Date: | 02/04/2011 |
| Classification Advisory Committee: | Radiology |
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Device Description: 21 CFR 807 92(a)(4)
aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.
Indications for Use: 21 CFR 807 92(a)(5)
"The avcan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.
aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography."
The Indications for Use of aycan mobile are a subset of the Indications for Use of the predicate device. The predicate device additionally covers registration and fusion of images and it includes the handling of SPECT and PET images. See also the Device Comparison Table below.
The reduction of the Indications for Use (compared to the predicate device) doesn't negatively affect the safety and effectiveness of the devices when used as labeled.
Technological Characteristics: 21 CFR 807 92(a)(6)
aycan mobile is a software for a mobile device (Apple iPad) that receives and visualizes digital medical images.
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed.
2
Device Comparison Table between new device and predicate:
| Topic | aycan mobile | MOBILE MIM |
|---|---|---|
| Intended Use / | ||
| Indications for Use | The aycan mobile software | |
| program is used to display | ||
| medical images for diagnosis | ||
| from CT and MRI modalities | ||
| only. | ||
| aycan mobile provides wireless | ||
| and portable access to medical | ||
| images. This device is not | ||
| intended to replace full | ||
| workstations and should be | ||
| used only when there is no | ||
| access to a workstation. | ||
| This device is not to be used | ||
| for mammography. | The Mobile MIM software | |
| program is used for the | ||
| registration, fusion, and/or | ||
| display for diagnosis of medical | ||
| images from only the following | ||
| modalities: SPECT, PET, CT, | ||
| and MM. | ||
| Mobile MIM provides wireless | ||
| and portable access to medical | ||
| images. This device is not | ||
| intended to replace full | ||
| workstations and should be | ||
| used only when there is no | ||
| access to a workstation. | ||
| This device is not to be used | ||
| for mammography. | ||
| Receive, Store, Retrieve, | ||
| Display, and Process Digital | ||
| Medical Images | Yes | Yes |
| Display of Clinical Patient Data | ||
| When No Access to a | ||
| Workstation | Yes | Yes |
| Image Fusion | No | Yes |
| Standardized Uptake Value | ||
| (SUV) | No | Yes |
| Distance Calculation | Yes | Yes |
| Window / Level | Yes | Yes |
| Zoom, Pan | Yes | Yes |
| User Authentication | Yes | Yes |
| Modalities | CT, MRI | SPECT, PET, CT, MRI |
| Remote Handheld Viewing | ||
| Device | Yes | Yes |
| Operating Platform | Apple (R) iOS | Apple (R) iOS |
| Hardware Requirements | Apple (R) iPad | Apple (R) iOS handheld |
| devices |
The comparison table shows that – besides a reduction of functionality regarding the application on The sompanson images - both Apps are substantially equivalent.
Regarding the hardware aycan mobile is limited to iPad devices compared to MOBILE MIM which can be used on the wider range of all Apple (R) iOS handheld devices.
The differences at the Indications for Use Statement are also based on the fact that MOBILE MIM handles SPECT and PET images additionally.
All these facts provide evidence to facilitate the substantial equivalence determination between aycan mobile and the predicate device, MOBILE MIM (K103785).
3
Performance Data from nonclinical Testing: 21 CFR 807 92(b)(1) ·
Designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria.
Extensive performance tests had been conducted regarding the display and other technical aspects. Display tests leveraged capabilities regarding IEC 62563-1 and TG18 guideline. All tests had been passed successfully.
Performance Data from clinical Testing: 21 CFR 807 92(b)(2)
Furthermore a series of studies had been performed by qualified radiologists reading different CT and MRI studies under different environmental lightning conditions. The capability of aycan mobile as a device for diagnostic reading – when used within the indications for use – was confirmed by the results of these studies.
All radiologists came to the conclusion that the devices is safe and effective when used within its defined Intended Use.
Conclusion: 21 CFR 807 92(b)(3)
According to all evidence collected, we come to the conclusion, that aycan mobile is substantially equivalent to the predicate device and it is safe and effective, when used as labeled.
The 510(k) Pre-Market Notification for aycan mobile contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Matthias Broenner Quality and Regulations Manger Aycan Digitalsysteme GmbH Innere Aumuehlstr. 5 WUERZBURG 97076 GERMANY
SEP 12 2012
Re: K122260
Trade/Device Name: aycan mobile Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2012 Received: July 27, 2012
Dear Mr. Broenner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been mined 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 r ou mays arover 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 11 your device is classified (200 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 I least be advised that I Dris issuantes arour device complies with other requirements of the Act that I DA has made a aved regulations administered by other Federal agencies. You must or any I cueral statutes and regarants, including, but not limited to: registration and listing (21 Compy with an the 71ct 5 requirements, artean and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice modical device-related develop visity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quarny device as described in your Section 510(k) premarket will anow you to begill marketing your intil equivalence of your device to a legally marketed nonicate 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 11 you desire specific da new to: your itro 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou inay 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,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number: K122260
Device Name: aycan mobile
Indications for Use:
The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.
aycan mobile provides wireless and portable access to medical images. This device is 1 not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Prescription Use X (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 Device Evaluation (ODE)
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