(173 days)
No
The summary describes a system for visualizing and interacting with medical images in 3D, but there is no mention of AI or ML being used for image analysis, processing, or any other function. The focus is on rendering and interaction.
No.
The device is intended as a medical diagnostic imaging system and preoperative software for simulating surgical treatment options, not for treating any condition.
Yes
The "Intended Use / Indications for Use" explicitly states that it is "Intended as a medical diagnostic imaging system". Although it also functions as preoperative software, its primary classification includes diagnostic imaging.
No
The device description explicitly states that the system is comprised of a commercial off-the-shelf hardware platform (stereoscopic display, motion tracking system, computer system) and a proprietary software application. The performance studies also mention testing to hardware-related standards like IEC EN, ANSI 60601-1 and IEC60601-1-2.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "medical diagnostic imaging system" for processing, reviewing, and analyzing images acquired from CT or MR imaging devices. It's also intended as "preoperative software for simulating surgical treatment options." This focuses on the interpretation and manipulation of medical images, not on testing samples from the human body.
- Device Description: The description details a system that visualizes and interacts with CT and MRI DICOM image data. This is consistent with medical imaging software, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics. The input is image data, not biological specimens.
- Regulatory Classification: The mention of "radiological 21CFR892.2050 (LLZ)" points towards a classification related to radiology devices, not IVDs.
- Performance Studies: The performance studies focus on validating the software's functionality with phantoms and simulated use conditions, which is typical for medical imaging software, not IVDs that would involve clinical studies with patient samples.
In summary, the device's function is centered around the processing and visualization of medical images for diagnostic and surgical planning purposes, which falls under the category of medical imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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.
Product codes
LLZ
Device Description
The True 3D Viewer system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making.
The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.
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
Health Care Professionals / 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
Every specification of the True 3D Viewer device has been validated according to the company's documented development and test procedures. The verification and validation testing conducted by a certified test laboratory included testing to the following applicable standards: IEC EN, ANSI 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (3rd Edition), IEC60601-1-2 Medical Electrical Equipment --- Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests:2007-03, g Risk Management, in accordance with IEC 60601-1 3rd Ed. and ISO 14971 and IEC 60601-1-4 or Clause 14. NEMA PS 3.1 3.18 (2008), Digital Imaging and Communications in Medicine g (DICOM) Set PS 3.1 Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfillsthe requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design. Verification and validation was performed on qualified phantoms as well as in simulated use conditions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
EchoPixel, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K142107
Trade/Device Name: EchoPixel True 3D Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 30, 2014 Received: January 2, 2015
Dear Mr. Job:
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.
Michael D'Hara
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below. 510(k) Number (if known) K142107 N/A Device Name EchoPixel True 3D Viewer Indications for Use (Describe) 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 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. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Attachment 1
510(k) Summary December 15, 2014
| Sponsor: | EchoPixel Inc.
2490 Hospital Dr.
Suite 310
Mountain View CA 94040 |
|-----------------------|----------------------------------------------------------------------------|
| Contact Person: | Sergio Aguirre |
| Telephone: | (650) 404 7097 |
| Fax: | (650) 941 5795 |
| Submission Date: | June 3, 2014 |
| Device Name: | EchoPixel True 3D Viewer (t3 Viewer) |
| Common Name: | Imaging Software System |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | System, image processing, radiological
21CFR892.2050 (LLZ) |
| Classification Panel: | Radiology |
A. Legally Marketed Predicate Devices
The t3D Viewer is substantially equivalent to the "Primary" predicate, the Surgical Theater Surgery Rehearsal Platform (K123023) with regard to both its intended use and its core technological characteristics. The Vitrea 2 v3.8 manufactured by Vital Images (K052632) is a "reference" predicate and has an intended use and core technology that is also substantially equivalent to the t3D Viewer.
B. Device Description:
The True 3D Viewer system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making.
The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to
4
visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.
C. Intended Use
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 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.
| Primary Predicate | Reference Predicate | Subject Device |
|---|---|---|
| Surgical Theater | ||
| Surgery Rehearsal Platform | Vital Images | |
| Vitrea 2 | True 3D Viewer | |
| Echo Pixel | ||
| K123023 | K052632 | |
| intended for use as a | ||
| software inter-face and | ||
| image segmentation system | ||
| for the transfer of imaging | ||
| information from CT or | ||
| MR medical scanner to an | ||
| output file. It is also | ||
| intended as pre-operative | ||
| software for | ||
| simulating/evaluating | ||
| surgical treatment options. | Vitrea 2 is a medical | |
| diagnostic system that | ||
| allows the processing, | ||
| review, analysis, | ||
| communication and media | ||
| interchange | ||
| of multi-dimensional digital | ||
| images acquired from a | ||
| variety of imaging devices. | 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 pre-operative 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 | Intended Users | Intended Users |
| Health Care Professionals | Health Care Professionals | Health Care |
| Professionals | ||
| Intended Environment for | ||
| Use | Healthcare facilities such as | |
| hospitals and clinics | Healthcare facilities such as | |
| hospitals and clinics | ||
| Class II | Class II | Class II |
| 21CFR 892.2050; | ||
| LLZ | 21CFR 892.2050; LLZ | 21CFR 892.2050; |
| LLZ | ||
| Image analysis features: | ||
| interactive manipulation, | ||
| tag, annotate, measure, | ||
| segment | Image analysis features: | |
| interactive manipulation, | ||
| tag, annotate, measure, | ||
| segment | Image analysis features: interactive | |
| manipulation, tag, annotate, | ||
| measure, segment |
D. Substantial Equivalence
E. Performance Data
- Every specification of the True 3D Viewer device has been validated according to the 8 company's documented development and test procedures. The verification and validation testing conducted by a certified test laboratory included testing to the following
5
applicable standards: IEC EN, ANSI 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (3rd Edition),
- IEC60601-1-2 Medical Electrical Equipment --- Part 1-2: General Requirements for Basic @ Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests:2007-03,
- g Risk Management, in accordance with IEC 60601-1 3rd Ed. and ISO 14971 and IEC 60601-1-4 or Clause 14.
- NEMA PS 3.1 3.18 (2008), Digital Imaging and Communications in Medicine g (DICOM) Set PS 3.1
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfillsthe requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design. Verification and validation was performed on qualified phantoms as well as in simulated use conditions.
F. Conclusion
The True 3D Viewer is substantially equivalent to the Primary predicate device with regards to intended use and technological characteristics. It is also substantially equivalent to the reference predicate. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.