(86 days)
Not Found
No
The summary describes image processing and 3D/VR visualization but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on rendering and viewing existing image data.
No.
The device is described as a medical imaging system and software for preoperative surgical planning, intended to assist clinicians in decision-making, rather than directly treating or mitigating a disease or condition.
No
Explanation: The device is described as a medical imaging system for processing, review, analysis, communication, and media interchange of digital images and for preoperative surgical planning. While it assists clinicians in decision-making, it does not explicitly state it provides a diagnosis or diagnostic information. Its primary function is image visualization and planning.
Yes
The device description explicitly states "Clarity Reveal is a software-only device". While it utilizes off-the-shelf hardware (mobile device, VR headset), the medical device itself is the software application.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Clarity Reveal's Function: Clarity Reveal processes and visualizes medical images acquired from CT or MR imaging devices. It is used for review, analysis, communication, and preoperative surgical planning. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's a medical imaging system for processing and reviewing images from CT/MR devices and for preoperative surgical planning. This aligns with imaging software, not IVD.
- Device Description: The description details software for reviewing and processing image data, not for analyzing biological samples.
Therefore, Clarity Reveal falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Product codes
LLZ
Device Description
Clarity Reveal is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Clarity Reveal mobile application which is used by clinicians for preoperative planning.
Clarity Reveal includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format.
The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR imaging devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: Healthcare Professionals
Intended Environment: Healthcare facilities such as hospitals and clinics
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)
Safety and performance of Clarity Reveal has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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" arranged around the perimeter. Inside the circle is a stylized design 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
August 3, 2017
Ceevra, Inc. % Mr. Russ Yoshinaka Chief Executive Officer 3960 Franke Lane LAFAYETTE CA 94549
Re: K171356 Trade/Device Name: Clarity Reveal Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 10, 2017 Received: July 12, 2017
Dear Mr. Yoshinaka:
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.
1
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.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171356
Device Name Clarity Reveal
Indications for Use (Describe)
Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
| 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 a logo for CEEVRA. The logo consists of a blue, curved design that resembles a wave or a crescent shape, with a series of smaller, progressively shorter lines emanating from the top left of the curve. Below the curved design, the word "CEEVRA" is written in a simple, sans-serif font, also in blue. The overall design is clean and modern.
Section 5. 510(k) Summary
General Information 1.
| 510(k) Sponsor | Ceevra, Inc. |
|---|---|
| Address | 180 Sansome St., Floor 4 |
| San Francisco, CA 94104 | |
| Correspondence Person | Rory A. Carrillo |
| Quality and Regulatory | |
| Ceevra, Inc. | |
| Contact Information | Email: rcarrillo@gmail.com |
| Phone: 562-533-7010 | |
| Date Prepared | July 14, 2017 |
2. Proposed Device
| Proprietary Name | Clarity Reveal |
|---|---|
| Common Name | Reveal |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communication system |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | EchoPixel True3D Viewer (t3 Viewer) |
|---|---|
| Premarket Notification | K142107 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communications system |
| Product Code | LLZ |
| Regulatory Class | II |
4. Device Description
Clarity Reveal is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Clarity Reveal mobile application which is used by clinicians for preoperative planning.
Clarity Reveal includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D
4
Image /page/4/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a blue, semi-circular design made up of small squares that appear to be moving in a circular motion. Below the design, the word "CEEVRA" is written in a blue, sans-serif font.
format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format.
The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.
5. Intended Use
Clarity Reveal is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning. Clarity Reveal is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Substantial Equivalence 6.
| Feature/
Function | Proposed Device:
Clarity Reveal | Predicate Device:
EchoPixel True3D Viewer
(K142107) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended as a medical imaging
system that allows the
processing, review, analysis,
communication and media
interchange of multi-dimensional
digital images acquired from CT
or MR imaging devices. It is also
intended as software for
preoperative surgical planning.
Clarity Reveal is designed for use
by health care professionals and
is intended to assist the clinician
who is responsible for making all
final patient management
decisions. | Intended as a medical diagnostic
imaging system that allows the
processing, review, analysis,
communication and media
interchange of multi-dimensional
digital images acquired from CT
or MR imaging devices. It is also
intended as preoperative software
for simulating / evaluating
surgical treatment options. The
True 3D Viewer is designed for
use by health care professionals
and is intended to assist the
clinician who is responsible for
making all final patient
management decisions. |
| Intended Users | Healthcare Professionals | Healthcare Professionals |
| Intended
Environment | Healthcare facilities such as
hospitals and clinics | Healthcare facilities such as hospitals
and clinics |
Ceevra, Inc., Traditional 510(k)
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Image /page/5/Picture/0 description: The image shows the logo for CEEVRA. The logo features a stylized, curved design in blue, resembling a series of interconnected arcs or pathways. Above the arcs are smaller, fragmented shapes that suggest movement or progression. Below the design, the word "CEEVRA" is written in a simple, sans-serif font, also in blue.
| Feature/
Function | Proposed Device:
Clarity Reveal | Predicate Device:
EchoPixel True3D Viewer
(K142107) |
|-------------------------------|--------------------------------------------|-----------------------------------------------------------------|
| Device Class | Class II | Class II |
| Image
Analysis
Features | Interactive
manipulation and
segment | Interactive
manipulation, tag, annotate,
measure, segment |
Performance Data 7.
Safety and performance of Clarity Reveal has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Clarity Reveal raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.