(192 days)
Unknown
The document mentions "image segmentation system" and "segmentation algorithm," which can sometimes utilize AI/ML. However, there is no explicit mention of AI, ML, deep learning, or neural networks in the provided text. The performance metrics focus on accuracy of segmentation and measurements, which could be achieved through traditional image processing techniques as well. Without further information or specific claims about AI/ML in the device description or performance studies, it is not possible to definitively confirm its presence.
No
The device is described as a software interface, image segmentation system, and medical display for surgical planning assistance, visualization, and interaction with medical images. It provides visual information and assists clinicians in surgical options and intraoperative display. It is explicitly stated to be an "adjunct to the interpretation of images" and "not intended for primary diagnosis." It does not directly treat or cure any medical condition.
No
The "Intended Use / Indications for Use" section for Abys® Medical Cysart® 4H explicitly states: "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." While Abys® Medical Cysware® 4H is involved in preparing information for surgical planning, it is described as a "software interface and image segmentation system" and "pre-operative software for surgical planning assistance," not for diagnosing conditions.
No
The device description explicitly mentions the Abys® Medical Cysart® 4H mixed reality application is intended for use with the Microsoft® HoloLens 2 display, which is a hardware component. Performance studies also include testing related to the HoloLens 2 display.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc.
- Device Intended Use: The intended use of both Abys® Medical Cysware® 4H and Abys® Medical Cysart® 4H is focused on:
- Image processing and segmentation: Transferring medical imaging information and segmenting images.
- Pre-operative surgical planning assistance: Providing tools for surgeons to plan procedures.
- 3D image visualization and interaction: Displaying and manipulating 3D images derived from CT scans.
- Adjunct to image interpretation: Assisting clinicians in analyzing surgical options and displaying images intraoperatively.
- Lack of Specimen Examination: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue samples) for diagnostic purposes. The input is medical imaging data (CT scans), not biological specimens.
The device falls under the category of medical imaging software and display systems used for surgical planning and visualization, which are distinct from IVDs.
N/A
Intended Use / Indications 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 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.
Product codes
LLZ
Device Description
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.
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
Clinician with appropriate clinical judgement / office room and in operating room (Cysart® 4H), Hospital (Cysware® 4H)
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)
Non-Clinical Performance Data:
The Cysware® 4H and Cysart® 4H software have been developed, verified, and validated in accordance with FDA guidelines, ISO 62304 "Medical Device Software – Software Life-Cycle Processes", IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" and 14971 "Application of Risk Management to Medical Devices".
The testing results support that all the specifications have met the acceptance criteria. The ABYS® MEDICAL Cysware® 4H device and the ABYS® MEDICAL Cysart® 4H device passed all the tests and support the claims of substantial equivalence and safety for their intended use. The usability assessment of the ABYS® MEDICAL Cysware® 4H and the ABYS® MEDICAL Cysart® 4H under their intended use has been carried out. This validation demonstrated the ease of use of ABYS® MEDICAL Cysware® 4H and ABYS® MEDICAL Cysart® 4H by the clinicians.
Specifics performance test campaigns were carried out for the Cysware® 4H to demonstrate that:
- The global time needed for Cysware® 4H to open a planification assistance file is below 40 seconds, with the mention that it does not include timelapse of credentials entering, Global time with credentials entering is user dependent and may reach 1-2 minutes, as showed by summative tests.
- The features are usable when fifteen users are simultaneously connected to Cysware® 4H.
- The features are usable when three users are simultaneously connected to the same folder.
- Accuracy of measures was described through trueness and showing error lower than 1.6 mm for distances and 2.9° for the angles.
- Accuracy of Cysware 4H segmentation algorithm and Mesh generation for Cysart 4H export allow to segment DICOM from CT scan source with an error lower than 1.25mm.
Specifics performance test campaigns were carried out for the Cysart® 4H to demonstrate that:
- The images displayed have a refresh rate always higher than 30 frames per second, ensuring the smooth movement of the 3D objects
- The autonomy of the HoloLens 2 when the application is open allows for the entirety of a surgery. More specifically 1h30 without sharing the video stream and 45 minutes while sharing the video stream to a workstation connected to the same network
- The Cysart® 4H device reproduces the 3D objects at a scale of 1:1 and thus ensures that the 3D medical images displayed are representative of the medical images acquired from the CT scan
- The global time to connect to a Cysart® 4H session is no longer than 3 minutes
- The quality of display is sufficient for the intended use and no degradation of display occurs when adding objects or documents to an opened session
- The voice commands can be used in operating room as long as the ambient noise does not exceed 60dB
- The performance of the Microsoft® HoloLens 2 display used with Cysart® 4H is adequate and has been demonstrated by verifying: luminance, distortion, contrast, and motion-to photon latency.
Clinical Data:
Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of measures: error lower than 1.6 mm for distances and 2.9° for the angles.
Accuracy of Cysware 4H segmentation algorithm: error lower than 1.25mm.
Refresh rate: always higher than 30 frames per second.
Predicate Device(s)
Simpleware ScanIP Medical (Synopsys (Northern Europe) Ltd, K203195)
Reference Device(s)
Surgimap 2.0 (Nemaris, Inc, K141669), NovaPACS (Novarad Corporation, K171754), HOLOSCOPE-I (Real View Imaging Ltd, K210072), OpenSight (Novarad Corporation, K172418)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/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 ) | |||
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | |||
| Indications | 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. | The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i 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. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions. | The OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis. OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures. OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The |
| 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 assists doctors | |||
| to better understand | |||
| anatomy and pathology | |||
| of patient. | |||
| Intended users | Clinician with | ||
| appropriate clinical | |||
| judgement | Health care | ||
| professional for making | |||
| all final patient | |||
| management decisions | Trained healthcare | ||
| professionals, including | |||
| surgeons, radiologists, | |||
| chiropractors, | |||
| physicians, | |||
| cardiologists, | |||
| technologists, and | |||
| medical educators | |||
| Stereoscopic medical | |||
| image hologram | Yes | Yes | Yes |
| Subspecialties | No restriction | No restriction | No restriction |
| Operating System | Windows Holographic | ||
| Operating System | Not disclosed | Windows Holographic | |
| Operating System | |||
| Holographic device | |||
| connection | Wireless | Embedded to a | |
| workstation | Wireless | ||
| Image source | CT | CT and Ultrasound | CR, DX, CT, MR, and PT |
| Interactive model | |||
| manipulation | Hand Tracking | Remote Control Pad | Hand Tracking |
| Models | |||
| Interactions/Edition | Interactive | ||
| manipulation, zoom, | |||
| rotate, move, scale | Interactive | ||
| manipulation, zoom, | |||
| rotate, move, slice, | |||
| mark, measure | Interactive | ||
| manipulation, zoom, | |||
| rotate, move, slice, mark | |||
| Display settings | Brightness, image | ||
| transparency | Brightness | Quality, color, window | |
| level | |||
| Image type | 3D medical images, 2D | ||
| documents like PDF, | |||
| personal notes | 3D medical images | 3D medical images | |
| Vocal control | Yes | Not disclosed | Yes |
| User interface | Virtual dashboard | Remote Control Pad | Virtual dashboard |
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Table 2 Comparison table with predicates: Cysart® 4H
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The Cysart® 4H software does not raise new questions of safety and effectiveness compared to its predicates, in regards with existing methods to visualize 3D stereoscopic images of the patient, for preoperative planning of surgical options and for intraoperative use.
8. Non-Clinical Performance Data
The Cysware® 4H and Cysart® 4H software have been developed, verified, and validated in accordance with FDA guidelines, ISO 62304 "Medical Device Software – Software Life-Cycle Processes", IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" and 14971 "Application of Risk Management to Medical Devices".
The testing results support that all the specifications have met the acceptance criteria. The ABYS® MEDICAL Cysware® 4H device and the ABYS® MEDICAL Cysart® 4H device passed all the tests and support the claims of substantial equivalence and safety for their intended use. The usability assessment of the ABYS® MEDICAL Cysware® 4H and the ABYS® MEDICAL Cysart® 4H under their intended use has been carried out. This validation demonstrated the ease of use of ABYS® MEDICAL Cysware® 4H and ABYS® MEDICAL Cysart® 4H by the clinicians.
Specifics performance test campaigns were carried out for the Cysware® 4H to demonstrate that:
- . The global time needed for Cysware® 4H to open a planification assistance file is below 40 seconds, with the mention that it does not include timelapse of credentials entering, Global time with credentials entering is user dependent and may reach 1-2 minutes, as showed by summative tests.
- The features are usable when fifteen users are simultaneously connected to Cysware® 4H. ●
- The features are usable when three users are simultaneously connected to the same folder. ●
- Accuracy of measures was described through trueness and showing error lower than 1.6 mm for distances and 2.9° for the angles.
- . Accuracy of Cysware 4H segmentation algorithm and Mesh generation for Cysart 4H export allow to segment DICOM from CT scan source with an error lower than 1.25mm.
Specifics performance test campaigns were carried out for the Cysart® 4H to demonstrate that:
- . The images displayed have a refresh rate always higher than 30 frames per second, ensuring the smooth movement of the 3D objects
- The autonomy of the HoloLens 2 when the application is open allows for the entirety of a surgery. . More specifically 1h30 without sharing the video stream and 45 minutes while sharing the video stream to a workstation connected to the same network
- . The Cysart® 4H device reproduces the 3D objects at a scale of 1:1 and thus ensures that the 3D medical images displayed are representative of the medical images acquired from the CT scan
- . The global time to connect to a Cysart® 4H session is no longer than 3 minutes
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- . The quality of display is sufficient for the intended use and no degradation of display occurs when adding objects or documents to an opened session
- . The voice commands can be used in operating room as long as the ambient noise does not exceed 60dB
- . The performance of the Microsoft® HoloLens 2 display used with Cysart® 4H is adequate and has been demonstrated by verifying: luminance, distortion, contrast, and motion-to photon latency.
9. Clinical Data
Clinical testing was not required to demonstrate substantial equivalence.
10. Conclusion
Cysware® 4H and Cysart® 4H have the same intended use and the same technological characteristics that the predicate devices. It can be demonstrated that the devices are substantially equivalent to the predicate devices, and that these new devices don't raise additional questions regarding its safety and effectiveness as compared to the predicate devices.
The indications for use, features, and technological characteristics of the Cysware® 4H and Cysart® 4H are identical to the predicate devices. The overall indications for use, features, and technological characteristics data lead to the conclusion that Cysware® 4H are substantially equivalent to legally marketed predicate devices.