Who is the manufacturer of Cyware 4H and Cysart 4H?

Abys Medical filed the 510(k) submission for Cyware 4H and Cysart 4H (K221796).

What is the FDA product code for Cyware 4H and Cysart 4H?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Cyware 4H and Cysart 4H?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cyware 4H and Cysart 4H?

Simpleware ScanIP Medical (K203195); Surgimap 2.0 (K141669); NovaPACS (K171754); HOLOSCOPE-I (K210072); OpenSight (K172418).

Who can help prepare an FDA 510(k) submission like Cyware 4H and Cysart 4H?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cyware 4H and Cysart 4H

K221796 · Abys Medical · LLZ · Dec 30, 2022 · Radiology

Device Facts

Record ID	K221796
Device Name	Cyware 4H and Cysart 4H
Applicant	Abys Medical
Product Code	LLZ · Radiology
Decision Date	Dec 30, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

Abys® Medical Cysware® 4H is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Abys® Medical Cysware® 4H is also intended as pre-operative software for surgical planning assistance. Abys® Medical Cysware® 4H is intended to be used by clinician with appropriate clinical judgement. Abys® Medical Cysart@ 4H is a medical display intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from CT scan source. The device is intended to provide visual information to be used by clinical with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. Abys® Medical Cysart@ 4H 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. Abys® Medical Cysart® 4H is intended to be used as a reference display for consultation to assist the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.

Device Story

Cysware 4H is a web-based platform for importing, annotating, and segmenting CT medical images to create surgical planning files; these files are exported to Cysart 4H. Cysart 4H is a mixed-reality application running on Microsoft HoloLens 2, used in office and operating rooms to display and manipulate 3D stereoscopic holograms of patient anatomy. Clinicians use hand tracking and voice commands to zoom, rotate, and scale 3D models for surgical planning and intraoperative reference. The system provides visual information to assist clinical decision-making; it is not for primary diagnosis. The device benefits patients by providing surgeons with interactive, 1:1 scale 3D anatomical visualizations during procedures.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including software verification and validation per ISO 62304, IEC 62366-1, and ISO 14971. Performance testing confirmed segmentation accuracy (error <1.25mm), measurement accuracy (distance <1.6mm, angle <2.9°), and system performance (refresh rate >30fps, latency, and connectivity).

Technological Characteristics

Web-based platform (Cysware 4H) and mixed-reality application (Cysart 4H) running on Microsoft HoloLens 2. Inputs: CT DICOM data. Outputs: 3D stereoscopic holograms, planning files. Connectivity: Wireless. Software: Windows Holographic OS. Features: Image segmentation, 3D visualization, hand tracking, voice control. Sterilization: Not applicable (software).

Indications for Use

Indicated for clinicians requiring pre-operative surgical planning assistance and 3D image visualization/interaction. Cysware 4H is for image segmentation and transfer; Cysart 4H is for intraoperative 3D display of CT-derived stereoscopic images. Not for primary diagnosis. Contraindications: None stated.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Simpleware ScanIP Medical (K203195)
Surgimap 2.0 (K141669)
NovaPACS (K171754)
HOLOSCOPE-I (K210072)
OpenSight (K172418)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Abys Medical Arnaud Destainville CEO 40 Rue Chef De Baie La Rochelle. 17000 France December 30, 2022 Re: K221796 Trade/Device Name: Cyware 4H and Cysart 4H Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 2, 2022 Received: December 2, 2022 Dear Arnaud Destainville: 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 mediation-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) K221796 Device Name Cysware 4H Cysart 4H #### Indications for Use (Describe) Abys® Medical Cysware® 4H is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Abys® Medical Cysware® 4H is also intended as pre-operative software for surgical planning assistance. Abys® Medical Cysware® 4H is intended to be used by clinician with appropriate clinical judgement. Abys® Medical Cysart@ 4H is a medical display intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from CT scan source. The device is intended to provide visual information to be used by clinical with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. Abys® Medical Cysart@ 4H 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. Abys® Medical Cysart® 4H is intended to be used as a reference display for consultation to assist 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 ) | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <table><tr><td><div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | 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." {3}------------------------------------------------ K221796 ### 510(k) SUMMARY # ABYS MEDICAL's CYSWARE® 4H and CYSART® 4H Date Prepared: December 29, 2022 ## 1. Submitter Abys Medical 40 rue Chef de Baie 17000 LA ROCHELLE France ### 2. Contact person Arnaud Destainville 40 rue Chef de Baie 17000 LA ROCHELLE France adestainville@abys-medical.com +33 6 63 51 47 75 #### 3. Device identification Trade/Proprietary Names: Cysware® 4H / Cysart® 4H Common/Usual Name: Medical Image Management and Processing System Classification Name: System, image processing, radiological Regulation Number: 21 CFR §892.2050 Product Code: LLZ Class: Il {4}------------------------------------------------ ### 4. Legally Marketed Predicate Devices #### Primary predicate device: - Simpleware ScanIP Medical (Synopsys (Northern Europe) Ltd, K203195) . #### Additional predicate devices: - . Surgimap 2.0 (Nemaris, Inc, K141669) - NovaPACS (Novarad Corporation, K171754) . - HOLOSCOPE-I (Real View Imaging Ltd, K210072) . - . OpenSight (Novarad Corporation, K172418) One Urgent Medical Device Correction Notice has been published on 09/24/2019 for the NovaPACS (Novarad Corporation, K171754) for the issue: "The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open." The action required a software update. None of those devices have not been subject to a design-related recall. ### 5. Description of the devices Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software. The Abys® Medical Cysart® 4H mixed reality application is a medical device designed and intended for use in office room and in operating room to display and manipulate all documents in the planning assistance file generated from the Abys® Medical Cysware® 4H web platform. {5}------------------------------------------------ ### 6. Indication for Use Abys® Medical Cysware® 4H is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Abys® Medical Cysware® 4H is also intended as pre-operative software for surgical planning assistance. Abys® Medical Cysware® 4H is intended to be used by clinician with appropriate clinical judgement. Abys® Medical Cysart® 4H is a medical display intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from CT scan source. The device is intended to provide visual information to be used by clinician with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. Abys® Medical Cysart® 4H 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. Abys® Medical Cysart® 4H is intended to be used as a reference display for consultation to assist the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions. {6}------------------------------------------------ ## 7. Substantial Equivalence The following table compares the Cysware ® 4H to the Simpleware ScanlP Medical, the Surgimap 2.0 and the NovaPACS predicate devices with respect to indications for use, features, and technological characteristics. | Devices information's | Cysware® 4H ABYS® MEDICAL (Submitted device) 21 CFR 892.2050 | Simpleware ScanIP Medical Synopsys (Northern Europe) Ltd (Primary predicate) 21 CFR 892.2050 | Surgimap 2.0 Nemaris, Inc (Additional predicate) 21 CFR 892.2050 | NovaPACS Novarad Corporation (Additional predicate) 21 CFR 892.2050 | |--------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Sponsor | ABYS® MEDICAL | Synopsys (Northern Europe) Ltd | Nemaris, Inc | Novarad Corporation | | 510(k) Number | Present submission | K203195 | K141669 | K171754 | | Product code | LLZ | LLZ | LLZ | LLZ | | Device class | II | II | II | II | | Device classification | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | | Intended environment | Hospital | Hospital | Hospital | Hospital | | Intended use | Intended for use to import, visualize, annotate, segment medical images | Intended for use to import, visualize, annotate, segment medical images | Intended for use to import, visualize, annotate, segment medical images | Intended for use to import, visualize, annotate, segment medical images | | | Abys® Medical | Simpleware | Surgimap | NovaPACS | | | Cysware® 4H is | ScanIP Medical is | The software assists | is intended for the | | | intended for use as | intended for use | healthcare | viewing, archiving, | | | a software | as a software | professionals in | analysis, | | | interface and | interface and | viewing, storing, | annotation, | | | image | image | and measuring | registration, | | | segmentation | segmentation | images as well as | distribution, | | | system for the | system for the | planning of | editing, fusion, and | | | transfer of medical | transfer of | orthopedic | processing of | | | imaging | medical imaging | surgeries. The | digital medical | | | information to an | information to an | device allows | images and data | | | output file. Abys® | output file. It is | service providers | acquired from | | | Medical Cysware® | also intended as | to perform generic | diagnostic imaging | | | 4H is also intended | pre-operative | as well as specialty | devices and all | | | as pre-operative | software for | measurements of | DICOM devices, | | | software for | diagnostic and | the images, and to | including | | | surgical planning | surgical planning. | plan surgical | mammography. | | | assistance. Abys® | For these | procedures. The | NovaPACS is | | | Medical Cysware® | purposes, output | device also | intended for use by | | | 4H is intended to | files can also be | includes tools for | trained healthcare | | | be used by | used for the | measuring | professionals, | | Indications | clinician with | fabrication of | anatomical | including | | | appropriate clinical | physical replicas | components for | radiologists, | | | judgement. | using traditional | placement of | physicians, | | | | or additive | surgical implants, | technologists, | | | | manufacturing | and offer online | clinicians, and | | | | methods. The | synchronization of | nurses. NovaPACS | | | | physical replicas | the database with | allows the end user | | | | can be used for | the possibility to | to display, | | | | diagnostic | share data among | manipulate, | | | | purposes in the | Surgimap users. | archive, and | | | | field of | Clinical judgment | evaluate images. | | | | orthopedic, | and experience are | Mobile devices are | | | | maxillofacial and | required to | not intended to | | | | cardiovascular | properly use the | replace a full | | | | applications. The | software. | workstation and | | | | software is | | should be used | | | | intended to be | | only when there is | | | | used in | | no access to a | | | | conjunction with | | workstation. They | | | | other diagnostic | | are not to be used | | | | tools and expert | | for mammography | | | | clinical judgment. | | or fMRI. Mobile | | | | | | devices are used | | | | | | for diagnosis of | | | | | | medical images | {7}------------------------------------------------ {8}------------------------------------------------ | | | from different modalities. including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual. While NovaPACS full workstation provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application. NovaPACS is intended for | |--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in | | | | a clinically useful context. | {9}------------------------------------------------ | Intended users | Clinician with appropriate clinical judgement | Healthcare professionals | Healthcare professionals | Healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | User interface | PC | PC | PC or mobile device | PC or dedicate workstation | | Web-based | Yes | None | Yes | Yes | | Operating system | PC: Windows | PC: Windows, + Windows server 2016 | PC: Windows + MAC Mobile: Android + iOS | Not disclosed | | Medical Image type | CT DICOM | CT and MRI DICOM | All DICOM | All DICOM including CT, MR, US, CR/DX, NM, PT, and XA | | Other type of content | JPEG, PNG, PDF, URL | Not disclosed | Not disclosed | JPEG | | Subspecialties | No restriction | No restriction | Orthopedic | No restriction | | Output file | Yes | Yes | Yes | Unknown | | MPR view | Yes | Yes | Yes | Yes | | Provides Values for Measurement | Yes Distance and angle measurement | Yes Including distance and angle measurement | Yes Generic and specific measurement | Yes Distance measurement | | Preoperative annotation and analysis | Yes | Yes | Not disclosed | Yes | | Image filtering and segmentation tools | Yes | Yes | Not disclosed | Not disclosed | | Obtaining images | Local transfer from the computer | Local transfer from the computer | Transferred from other devices or mobile device camera | Not disclosed | | | Yes | | Yes | Yes | | Case sharing with collaborator | By granting limited access right to other health professional users of Cysware® 4H | None | By granting limited access right to other health professional users of Surgimap 2.0 | By granting limited access right to other health professional users of NovaPACS | | Restricted permission in case of case sharing | Yes View or edition permission Case sharing duration limited by an end date specified by the user | Not applicable | Yes View or edition permission | Yes Several states of case review | | Access to case through 3D mixed reality application | Yes Sharing to ABYS® MEDICAL Cysart® 4H | None | None | Yes Sharing to Novarad Corporation Opensight (K172418) | {10}------------------------------------------------ Table 1 Comparison table with predicates: Cysware® 4H The Cysware® 4H does not raise new questions of safety and effectiveness than its predicates regarding with existing methods to visualize 2D and 3D imaging of the patient, for preoperative planning of surgical options. The following table compares the Cysart® 4H to the HOLOSCOPE-I and the OpenSight predicate devices with respect to indications for use, features, and technological characteristics. | Devices information's | Cysart® 4H | HOLOSCOPE-i | OpenSight | |-----------------------|---------------------------------|------------------------|------------------------| | Devices information's | ABYS® MEDICAL | Real View Imaging Ltd | Novarad Corporation | | Devices information's | (Submitted device) | (Additional predicate) | (Additional predicate) | | Devices information's | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Sponsor | ABYS® MEDICAL | Real View Imaging Ltd | Novarad Corporation | | 510(k) Number | Present submission (K221796) | K210072 | K172418 | | Product code | LLZ | LLZ | LLZ | {11}------------------------------------------------ | Devices information's | Cysart® 4H | HOLOSCOPE-i | OpenSight | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ABYS® MEDICAL | Real View Imaging Ltd | Novarad Corporation | | | (Submitted device) | (Additional predicate) | (Additional predicate) | | | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | | Device class | II | II | II | | Device classification | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | | Intended environment | Operating room | Operating room | Healthcare settings, such as hospitals and clinics | | Intended holographic display | Microsoft® HoloLens®2 | HOLOSCOPE-I workstation | Microsoft® HoloLens® | | Intended use | Intended for use to display and manipulate 3D images in mixed reality | Intended for use to display and manipulate 3D images in mixed reality | Intended for use to display and manipulate 3D images in mixed reality | | |…