(217 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the system as a "software interface and image segmentation system" with a segmentation algorithm validated to have an error rate, but does not mention the use of AI, DNN, or ML for this segmentation or any other function.
No.
LUMYS is intended for medical image visualization and pre-surgical planning, assisting clinicians in analyzing surgical options and displaying images intraoperatively. It is not designed to directly treat or restore the structure/function of the body.
No
LUMYS is explicitly stated as "not intended for primary diagnosis" and "intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions." It's an adjunct tool for visualizing and interacting with images for presurgical planning and intraoperative display.
No
The device description explicitly mentions several hardware components integral to its function: "A Microsoft HoloLens 2 headset," and "A broadcasting computer." While the core of LUMYS is "data visualization standalone software," its operational delivery relies directly on specific hardware, including a head-mounted display and a broadcasting computer, making it more than just a software-only medical device.
No.
An IVD is used for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device processes medical images from a CT scan for visualization and surgical planning, not for in vitro examination of bodily specimens.
N/A
Intended Use / Indications for Use
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out presurgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement.
LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins.
LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.
Product codes
LLZ
Device Description
LUMYS is a data visualization standalone software that is used during medical procedures to visualize medical data and share this visualization with other healthcare professionals attending remotely the procedure. Different components are involved:
- A Microsoft HoloLens 2 headset to access the data in the operating theater,
- A broadcasting computer to broadcast video from a medical imaging device in LUMYS,
- A web browser on a computer to access the data remotely.
LUMYS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. LUMYS is intended to be used by clinician with appropriate clinical judgement.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan source
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians with appropriate clinical judgement / operating theater
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)
Optical testing was carried out according to IEC 63145-20-20. Results confirm that LUMYS is well suited to visualize medical images such as DICOM in Microsoft Hololens™ Head Mounted Display. Other tests, carried out to validate the segmentation algorithm, show that LUMYS' segmentation algorithm allows to segment DICOM from CT scan source with an error lower than 0.9 mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
error lower than 0.9 mm (for segmentation)
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).
FDA 510(k) Clearance Letter - LUMYS (V1)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
INTRADYS
Tiffany VAZ
Head of Quality and Regulatory Affairs
37 rue Jean Marie Le Bris
BREST, 29200
FRANCE
Re: K243069
Trade/Device Name: LUMYS (V1)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: September 27, 2024
Received: March 28, 2025
May 2, 2025
Dear Tiffany VAZ:
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 (the 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 available 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.
Page 2
K243069 - Tiffany VAZ
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
Page 3
K243069 - Tiffany VAZ
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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, PhD
Assistant Director,
Imaging Software Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243069
Device Name: LUMYS (V1)
Indications for Use (Describe)
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out presurgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement.
LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins.
LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Page 5
510(k) SUMMARY
Contact Details
Applicant Name: INTRADYS
Applicant Address: 37 rue Jean Marie Le Bris – 29200 BREST – France
Applicant Contact Telephone: +33 2 98 43 39 03
Applicant Contact: Mrs. VAZ Tiffany
Applicant Contact Email: tiffany@intradys.com
Device Name
Device Trade Name: LUMYS (V1)
Common Name: Medical image management and processing system
Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Product Code(s): LLZ
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221796 | Cysware 4H and Cysart 4H | LLZ |
Device Description Summary
LUMYS is a data visualization standalone software that is used during medical procedures to visualize medical data and share this visualization with other healthcare professionals attending remotely the procedure. Different components are involved:
- A Microsoft HoloLens 2 headset to access the data in the operating theater,
- A broadcasting computer to broadcast video from a medical imaging device in LUMYS,
- A web browser on a computer to access the data remotely.
LUMYS is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. LUMYS is intended to be used by clinician with appropriate clinical judgement.
Page 1 / 3
Page 6
Intended Use / Indications for Use
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out pre-surgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement.
LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins.
LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.
Indications for Use Comparison
LUMYS and the predicate device have the same indications.
Intended use of both medical devices remains the same, i.e. : to import, visualize, annotate, segment medical images, and to display and manipulate 3D images in mixed reality.
Technological Comparison
LUMYS and the predicate device are identical for most of the characteristics that were considered. In particular, both use Microsoft HoloLens 2 as the user interface in the operating room. In this context, optical and display bench testing was carried out on the system Microsoft HoloLens 2 and LUMYS.
When the devices were found to be not identical, the substantial equivalency was demonstrated, and safety and effectiveness were not negatively affected.
Non-Clinical and/or Clinical Tests Summary & Conclusions
LUMYS has been developed, verified and validated in accordance with FDA guidelines, IEC62304/A1:2016, IEC 81001-5-1:2021, IEC 82304-1:2016.
The testing results that all specifications have met the acceptance criteria. LUMYS passed all the tests, and support the claims of substantial equivalence, safety and effectiveness for its intended use.
The usability assessment of LUMYS has been carried out according to FDA guidelines, IEC 62366-1:2015+Amd1:2020 and ISO14971:2019. The Validation demonstrates that LUMYS meets clinician's needs, including in terms of user interface.
Page 2 / 3
Page 7
Equivalency to the predicate device was possible with output data of the software development, in particular with SRS, functional testing, optical testing and validation of the segmentation algorithm.
Optical testing was carried out according to IEC 63145-20-20. Results confirm that LUMYS is well suited to visualize medical images such as DICOM in Microsoft Hololens™ Head Mounted Display. Other tests, carried out to validate the segmentation algorithm, show that LUMYS' segmentation algorithm allows to segment DICOM from CT scan source with an error lower than 0.9 mm.
LUMYS has the same intended use and the same technological characteristics that the predicate device.
It can be demonstrated that both devices are substantially equivalent, and that LUMYS doesn't raise additional questions regarding security and effectiveness compared to a legally market predicate devices.
Page 3 / 3