(52 days)
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No
The document describes standard medical image viewing and management software without mentioning AI or ML capabilities. The performance studies focus on rendering and managing images compared to a predicate device, not on AI/ML performance metrics.
No
The device is a software application for viewing, storing, and managing medical images; it does not provide any treatment or therapy.
No
The software is for "viewing" and "visualization" of existing medical images, not for making a diagnosis itself. It is a tool for managing and displaying diagnostic images, but it does not perform diagnostic functions. The predicate device, OsiriX MD, is also an image viewing and processing software, supporting this interpretation.
Yes
The device description explicitly states "Collage is an interactive imaging software" and "The Collage software is intended as a platform". It also mentions utilizing "standard PC hardware" and running in "Windows operating systems", indicating it is a software application designed to run on general-purpose computing hardware, not a dedicated hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Collage is for viewing, storing, and managing medical images from scanning devices (CT, MRI, Ultrasound) and 2D patient images (photographs, x-rays). These are images of the body or parts of the body, not specimens derived from the body (like blood, urine, tissue samples, etc.).
- The purpose of an IVD is to provide information for diagnosis, monitoring, or treatment. While Collage is used by medical professionals for reviewing images that contribute to these processes, it is a tool for visualizing existing image data, not a test that analyzes a biological sample to provide diagnostic information itself.
Collage falls under the category of medical image management and visualization software, which is typically regulated as a medical device but not specifically as an IVD.
N/A
Intended Use / Indications for Use
Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Collage is an interactive imaging software used for the visualization, storage, and management of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Doctors, dental clinicians, and other qualified individuals can retrieve, process, render, review, store and print images, utilizing standard PC hardware. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The Collage software is intended as a platform bridging different sets of patient data for comprehensive studies. With Collage software, doctors can manage all of their patient images, including both 2D and 3D image data, in a single software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, 3D Ultrasound, 2D patient images (patient photographs, intraoral photographs, dental x-rays)
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
doctors, clinicians, and other qualified individuals utilizing standard PC hardware.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Bench testing of the software with predicate software was performed by evaluation of images rendered by Collage and predicate software. This testing and evaluation included testing of rendering both 2D and 3D images in both predicate and subject software and was evaluated by an expert in the field of radiology.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing to compare with predicate software. Testing confirmed that the software is stable and operating as designed. Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels. This testing confirms that Collage is as effective as its predicate in its ability to perform its essential functions of rendering and managing medical images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Anatomage Inc. % Mr. Sean Xu Program Director 111 N. Market Street. #500 SAN JOSE CA 95113
Re: K150976 Trade/Device Name: Collage Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2015 Received: April 15, 2015
Dear Mr. Xu:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150976
Device Name Collage
Indications for Use (Describe)
Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.
| 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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5. 510K Summary
| Submitter | Anatomage Inc.
111 N. Market Street #500
San Jose, CA 95113
Phone: (408) 885-1474
Fax: (408) 295-9786 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact Person | Sean Xu, Program Director
Phone Number: (408) 885-1474 ext 108 |
| Device Name | Collage |
| 510(k) Preparation Date | 04/08/2015 |
| Common Name | System, Image Processing, Radiological |
| Classification | Class II |
| Classification Name | Imaging Processing System, LLZ, 21 CFR 892.2050 |
| Product Code | LLZ, 21 CFR 892.2050 |
| Device Description | Collage is an interactive imaging software used for the
visualization, storage, and management of 3D medical image files
from scanning devices, such as CT, MRI, or 3D Ultrasound as
well as 2D patient images, such as patient photographs, intraoral
photographs, and dental x-rays. Doctors, dental clinicians, and
other qualified individuals can retrieve, process, render, review,
store and print images, utilizing standard PC hardware. The
software runs in Windows operating systems and visualizes
medical imaging data on the computer screen. The Collage
software is intended as a platform bridging different sets of patient
data for comprehensive studies. With Collage software, doctors
can manage all of their patient images, including both 2D and 3D
image data, in a single software. |
| Intended Use | Collage is a software application intended for viewing of 3D
medical image files from scanning devices, such as CT, MRI, or
3D Ultrasound as well as 2D patient images, such as patient
photographs, intraoral photographs, and dental x-rays. Images and
data can be stored, communicated, processed and displayed within
the system and or across computer networks at distributed
locations. It is intended for use by doctors, clinicians, and other |
| Equivalent Devices | K101342, OsiriX MD |
| Technological Characteristic | Collage is a software that handles digital medical images. This
device does not contact the patient, nor does it control any life
sustaining devices. Diagnosis is not performed by this software
but by doctors, clinicians and other qualified individuals. A
physician, providing ample opportunity for competent human
intervention, interprets images and information being displayed
and printed.
Collage is installed on standard off-the-shelf x86 processor based
computers running the Windows operating system. |
| Non-Clinical Test Results | The following quality assurance measures were applied to the
development of the system:
· Risk Analysis
· Requirements Reviews
· Design Reviews
· Performance testing
· Usability testing
· Final acceptance testing
· Bench testing to compare with predicate software
Testing confirmed that the software is stable and operating as
designed. Testing also confirmed that the software has been
evaluated for hazards and that risk has been reduced to acceptable
levels.
Bench testing of the software with predicate software was
performed by evaluation of images rendered by Collage and
predicate software. This testing and evaluation included testing of
rendering both 2D and 3D images in both predicate and subject
software and was evaluated by an expert in the field of radiology.
This testing confirms that Collage is as effective as its predicate in
its ability to perform its essential functions of rendering and
managing medical images. |
| Summary | Based on the intended use, product, performance, and testing
information provided in this notification, the subject device has
been shown to be substantially equivalent in the area of technical
characteristics, general functionality, and indicated use to the
currently marketed predicate device and does not introduce any
new potential risks. |
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