(317 days)
No
The document describes standard medical image processing and visualization techniques (2D, 3D, VR) and does not mention AI, ML, or related terms in the intended use, device description, or performance studies. The comparison to a predicate and reference device also suggests a focus on established image processing functionalities.
No
This device is an imaging system and surgical planning software; it does not directly treat or alleviate a disease or condition.
No
The device is intended for processing, reviewing, analyzing, and displaying multi-dimensional digital images acquired from CT or MR imaging devices for preoperative surgical planning and intraoperative display. It assists clinicians in making patient management decisions but does not independently provide a diagnosis.
Yes
The device description explicitly states "The Avatar Medical Software V1 (AMS V1) is a software-only device". While it utilizes off-the-shelf hardware like workstations and VR headsets, the device itself is solely the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AVATAR MEDICAL Software V1 processes, reviews, and displays medical images acquired from CT or MR imaging devices. It is used for surgical planning and intraoperative display of these images.
- Lack of Specimen Handling: The device does not interact with or analyze biological specimens from the human body. Its input is digital image data.
Therefore, while it is a medical device used in healthcare, its function falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
AVATAR MEDICAL Software V1 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, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 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 Avatar Medical Software V1 (AMS V1) is a software-only device that allows trained medical professionals to review CT and MR image data in three-dimensional (3D) format and/or in virtual reality (VR) interface. The 3D and VR images are accessible through the software desktop application and, if desired, through compatible VR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
The AMS V1 product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
AMS V1 includes two main software-based user interface components, the Desktop Interface and the VR Interface. The Desktop Interface runs on a compatible off-the-shelf (OTS) workstation provided by the hospital and only accessed by authorized personnel. The Desktop Interface contains a graphical user interface where a user can retrieve DICOM-compatible medical images locally or on a Picture Archiving Communication System (PACS). Retrieved CT and MR images can be viewed in 2D and 3D formats. Users are able to make measurements, annotations, and apply fixed and manual image filters.
The VR Interface is accessible via a compatible OTS headset to allow users to review the medical images in a VR format. VR formats can be viewed only when the user connects a compatible VR headset directly to the workstation being used to view the Desktop Interface. Additionally. AMS V1 enables the intended users to remotely stream the Desktop Interface to another workstation on the same local area network (LAN).
The 3D images generated using AMS V1 are intended to be used in relation to surgical procedures in which CT or MR images are used for preoperative planning and/or during intervention/surgery.
The intraoperative use of the AMS V1 solely corresponds to the two following cases:
-Display of the AMS V1 Desktop Interface on existing monitors/screens in the operating
-Use in a non-sterile imaqe review room accessible from the operating room during the procedure (AMS V1 operates on VR headsets which are not approved to be used in the sterile environment of the operating room)
Usage During Interventional and Surgical Procedures
The AVATAR MEDICAL Software V1 is not meant to be used in a sterile environment.
The AVATAR MEDICAL Software V1 is not meant to register 3D images to patients.
Two usage scenarios of the AVATAR MEDICAL Software V1 software are possible during an interventional or surqical procedure:
-
Inside the operating room
The Desktop Interface (no VR) can be displayed on a computer monitor (previously installed respecting the management of sterility) inside the operating room. It is not expected that users will analyze the image, optimize filters, and realize measurements in this intraoperative context. This usage is for visualizing results of a previous surgery planning session. The user will follow their scrub-in and scrub-out facility protocols when exiting and entering the sterile field of the operating room. -
Outside the operating room
The full software experience, including VR, can be accessed in an adjacent non-sterile image review room. In this usage, the user will need to scrub-out to access the review room and, after review, scrub-in following their facility protocols as required. The user will not be in contact nor in the presence of the patient while wearing the VR headset
The software is not meant to be used with the user's hands on the patient during an interventional or surqical procedure.
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
Measurement performance testing was conducted by leveraging reference digital phantoms and the comparison with a cleared device (Osirix MD K101342). The quality of the display was successfully evaluated against the AAPM guidance recommendation for visual evaluation of luminance and contrast. Additional optical testing was conducted on compatible VR platforms as per IEC63145-20-20. The homogeneity of luminance, resolution, and contrast was evaluated as acceptable per these standards in the center of the displays for the specified VR platforms. The functioning of the filter technology was assessed by visual inspection. Using a reference DICOM, the opacity and color of specific voxels in the image was demonstrated to be controllable as intended by the filtering principle. The fluidity of the VR experience was assessed by evaluating the average Frame Per Second rate.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of the AMS V1 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 ANSI AAMI IEC 62304:2006/41:2016 - 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." All functional and performance testing occurred on the minimum hardware configuration and the specified operating systems and VR platforms.
Key results:
- Linear Measurements (polylines) and Diameter Measurements: No statistical difference between distributions of measurements obtained for AMS V1 or the reference device Osirix MD, as evaluated per t-test statistics. Tests performed for a series of objects in reference MR and CT phantom images.
- The quality of the display was successfully evaluated against the AAPM guidance recommendation for visual evaluation of luminance and contrast.
- Additional optical testing was conducted on compatible VR platforms as per IEC63145-20-20 and passed as expected.
- The homogeneity of luminance, resolution, and contrast was evaluated as acceptable per these standards in the center of the displays for the specified VR platforms.
- The functioning of the filter technology was assessed by visual inspection. Using a reference DICOM, the opacity and color of specific voxels in the image was demonstrated to be controllable as intended by the filtering principle, which is similar to the cleared device Osirix MD (K101342).
- The fluidity of the VR experience was assessed by evaluating the average Frame Per Second rate. The averaged FPS was superior to the specific threshold for the minimal hardware configuration.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Avatar Medical % Rory Carrillo Quality and Regulatory Consultant Cosm 45 Bartlett St. SAN FRANCISCO CA 94110
May 24, 2023
Re: K222035
Trade/Device Name: Avatar Medical Software V1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 21, 2023 Received: April 24, 2023
Dear Rory Carrillo:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222035
Device Name AVATAR MEDICAL Software V1
Indications for Use (Describe)
AVATAR MEDICAL Software V1 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, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5. 510(k) Summary
1. General Information
K222035
| 510(k) Sponsor | Avatar Medical |
|---|---|
| Address | 11 rue de Lourmel |
| 75015 Paris France | |
| Correspondence Person | Rory A. Carrillo |
| Quality and Regulatory Consultant | |
| Cosm | |
| Contact Information | Email: rory@cosmhq.com |
| Phone: 562-533-7010 | |
| Date Prepared | November 22, 2022 |
2. Subject Device
| Proprietary Name | Avatar Medical Software V1 |
|---|---|
| Common Name | AMS V1 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | LLZ |
| Regulatory Class | II |
Predicate Device 3.
| Proprietary Name | Ceevra Reveal 2.0 |
|---|---|
| Premarket Notification | K173274 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | LLZ |
| Regulatory Class | II |
4. Device Description
The Avatar Medical Software V1 (AMS V1) is a software-only device that allows trained medical professionals to review CT and MR image data in three-dimensional (3D) format and/or in virtual reality (VR) interface. The 3D and VR images are accessible through the software desktop application and, if desired, through compatible VR headsets which are used by users for preoperative surgical planning and for display during intervention/surgery.
4
The AMS V1 product is to be used to assist in medical image review. Intended users are trained medical professionals, including imaging technicians, clinicians and surgeons.
AMS V1 includes two main software-based user interface components, the Desktop Interface and the VR Interface. The Desktop Interface runs on a compatible off-the-shelf (OTS) workstation provided by the hospital and only accessed by authorized personnel. The Desktop Interface contains a graphical user interface where a user can retrieve DICOM-compatible medical images locally or on a Picture Archiving Communication System (PACS). Retrieved CT and MR images can be viewed in 2D and 3D formats. Users are able to make measurements, annotations, and apply fixed and manual image filters.
The VR Interface is accessible via a compatible OTS headset to allow users to review the medical images in a VR format. VR formats can be viewed only when the user connects a compatible VR headset directly to the workstation being used to view the Desktop Interface. Additionally. AMS V1 enables the intended users to remotely stream the Desktop Interface to another workstation on the same local area network (LAN).
The 3D images generated using AMS V1 are intended to be used in relation to surgical procedures in which CT or MR images are used for preoperative planning and/or during intervention/surgery.
The intraoperative use of the AMS V1 solely corresponds to the two following cases:
- Display of the AMS V1 Desktop Interface on existing monitors/screens in the operating ● room
- . Use in a non-sterile imaqe review room accessible from the operating room during the procedure (AMS V1 operates on VR headsets which are not approved to be used in the sterile environment of the operating room)
Usage During Interventional and Surgical Procedures
The AVATAR MEDICAL Software V1 is not meant to be used in a sterile environment.
The AVATAR MEDICAL Software V1 is not meant to register 3D images to patients.
Two usage scenarios of the AVATAR MEDICAL Software V1 software are possible during an interventional or surqical procedure:
1. Inside the operating room
The Desktop Interface (no VR) can be displayed on a computer monitor (previously installed respecting the management of sterility) inside the operating room. It is not expected that users will analyze the image, optimize filters, and realize measurements
5
in this intraoperative context. This usage is for visualizing results of a previous surgery planning session. The user will follow their scrub-in and scrub-out facility protocols when exiting and entering the sterile field of the operating room.
2. Outside the operating room
The full software experience, including VR, can be accessed in an adjacent non-sterile image review room. In this usage, the user will need to scrub-out to access the review room and, after review, scrub-in following their facility protocols as required. The user will not be in contact nor in the presence of the patient while wearing the VR headset
The software is not meant to be used with the user's hands on the patient during an interventional or surqical procedure.
5. Intended Use and Indications for Use
AVATAR MEDICAL Software V1 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, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 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.
6. Comparison of Technological Characteristics
| Feature/
Function | Subject Device:
AMS V1 | Predicate Device:
Ceevra Reveal 2.0
(K173274) |
|-------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Intended Users | Health care Professionals | Health care Professionals |
| Intended
Environment | Healthcare facilities such as
hospitals and clinics | Healthcare facilities such as
hospitals and clinics |
| Device Class | Class II | Class II |
6
| Feature/
Function | Subject Device:
AMS V1 | Predicate Device:
Ceevra Reveal 2.0
(K173274) |
|----------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------|
| Preoperative
Use | Yes | Yes |
| Intraoperative
Display | Yes | Yes |
| Image Analysis
Features | Interactive
manipulation,
filtering, create annotations and
measurements | Interactive
manipulation and
segment |
| Measurements | Yes - linear and diameter
measurements only | No |
| Remote
Streaming | Yes | No |
| Pan image | Pan image in any direction | Pan image in any direction |
| PIN Code | Yes, for remote streaming only | Optional 4-digit security code |
7. Predicate Device Comparison
The subject device and predicate device have similar indications for use in that they are both intended for viewing CT and MR data in multi-dimensional views as well as for preoperative and intraoperative surgical planning using similar technologies. Additionally, both devices have similar technological characteristics with only minor differences that do not raise questions of safety or effectiveness.
8. Performance Data
Safety and performance of the AMS V1 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 ANSI AAMI IEC 62304:2006/41:2016 - 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." All functional and
AMS V1 Traditional 510(k)
7
performance testing occurred on the minimum hardware configuration and the specified operating systems and VR platforms. Measurement performance testing was conducted by leveraging reference digital phantoms and the comparison with a cleared device (Osirix MD K101342). The table below summarizes the acceptance criteria for the measurement tools. The quality of the display was successfully evaluated against the AAPM guidance recommendation for visual evaluation of luminance and contrast . Additional optical testing was conducted on compatible VR platforms as per IEC63145-20-20 and passed as expected. The homogeneity of luminance, resolution, and contrast was evaluated as acceptable per these standards in the center of the displays for the specified VR platforms. The functioning of the filter technology was assessed by visual inspection. Using a reference DICOM, the opacity and color of specific voxels in the image was demonstrated to be controllable as intended by the filtering principle, which is similar to the cleared device Osirix MD (K101342) . The fluidity of the VR experience was assessed by evaluating the average Frame Per Second rate. The averaged FPS was superior to the specific threshold for the minimal hardware configuration.
| Feature/
Function | Tool in Subject
Device:
AMS V1 | Tool in Reference
Device:
Osirix MD
(K101342) | Acceptance criteria |
|---------------------------------------|--------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Linear
Measurements
(polylines) | Curve | Close Polygon | No statistical difference
between distributions of
measurements obtained for
AMS V1 or the reference
device Osirix MD, as evaluated
per t-test statistics.
Tests performed for a series of
objects in reference MR and
CT phantom images. |
| Diameter
Measurements | Ruler | Length | |
9. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the AMS V1 raises no new questions of safety and effectiveness and demonstrates substantial equivalence to the predicate device in terms of safety, effectiveness, and performance.