(307 days)
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No
The document describes a software device for image visualization and manipulation, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on 3D rendering and display capabilities.
No
The device is described as software for displaying and manipulating medical images for review, planning, and diagnostic purposes, not for providing direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that it is a "software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization." It also mentions "display monitors used for reading medical images for diagnostic purposes" and that the software is "indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians." While it specifies that images viewed on a wireless stereoscopic head-mounted display are "for informational purposes only and not intended for diagnostic use," the overall description of its use for image review and manipulation by medical professionals for diagnostic purposes on traditional displays indicates it is primarily a diagnostic device.
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and its functions are solely related to the visualization and manipulation of medical images and data. While it can be used with hardware like monitors and HMDs, the device itself is the software.
Based on the provided information, CarnaLife® Holo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- CarnaLife® Holo's Function: CarnaLife® Holo is a software device that displays and manipulates medical images (like CT, MR, PET, USG scans). It works with imaging data acquired from the body, not with specimens taken from the body.
- Intended Use: The intended use clearly states it's for "display of medical images and other healthcare data," "image review, image manipulation, basic measurements, annotations, and 3D visualization," and "surgical planning activities." These are all related to interpreting and interacting with medical images, not analyzing biological samples.
Therefore, CarnaLife® Holo falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CarnaLife® Holo is a Software as a Medical Device (SaMD) to be used by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians for the visualization of medical images in 3D to allow for surgical planning activities. The device makes it possible to visualize 3D Digital Imaging and Communications in Medicine (DICOM) files using volume and surface rendering in 3D to be viewed on a classic display or on a stereoscopic, holographic display. CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD). The images can be viewed on desktop PCs with a monitor allowing the interaction with CarnaLife® Holo to be performed with a mouse and/or keyboard; and on an HMD, where the interaction with CarnaLife® Holo is performed using hand gestures, voice commands and virtual menus.
CarnaLife® Holo is used to:
- Load patient DICOM data;
- . Image review, image manipulation, basic measurements, annotations, and 3D visualization; and
- . View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT/angio CT MR/4D MR 3DRA ECHO PET USG
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD).
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design validation and verification activities were performed for CarnaLife® Holo as a result of the risk analysis assessment and product requirements.
Accuracy of the Measuring function: This testing was conducted using two data sets characterized by different voxel sizes (isotropic and anisotropic data). For each set, points P1, P2, P3 and P4 were defined for both Axial and Coronal projections. Measurement accuracy met specified requirements for the below measurements of distance:
X - distance of P1-P2 and P3-P4
Y - distance of P1-P3 and P2-P4
Angles defined by points P1-P2-P3
Diagonals defined by P1-P4 and P3-P2.
Accuracy of Volume Rendering: This testing was conducted by performing Volume Rendering on CT scans of two different geometric objects of known size and dimensions. The accuracy of Volume Rendering meeting specified requirements was demonstrated by comparing the size and dimensions of resulting displayed holograms to the known size and dimensions of the two geometric objects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SurgicalAR (K190764)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MedApp S.A. % Albert Pacheco Alliance Network Independent Consultant PAREXEL International 8 Federal Street BILLERICA, MASSACHUSETTS 01821
May 1, 2023
Re: K221870
Trade/Device Name: CarnaLife® Holo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 21, 2023 Received: March 22, 2023
Dear Albert Pacheco:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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, 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
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Indications for Use
510(k) Number (if known) K221870
Device Name CarnaLife® Holo
Indications for Use (Describe)
CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary as Required by 21 CFR 807.92(c)
For CarnaLife® Holo
| Date Prepared: | April 26, 2023 |
|---|---|
| Submitter: | MedApp,S.A. |
| Armii Krajowej 25 | |
| 30-150 Kraków, Poland | |
| Official Contact: | Al Pacheco |
| Independent Consultant | |
| Parexel International | |
| 2520 Meridian Parkway, Suite 200 | |
| Durham, NC 27713, USA | |
| Phone: +1 760 421 2919 | |
| Email: albert.pacheco@parexel.com | |
| Proprietary Name: | CarnaLife® Holo |
| Classification: | Class II |
| Medical Image Management and Processing System | |
| 21 CFR 892.2050 | |
| Product Code: LLZ | |
| Predicate Device: | SurgicalAR (K190764) |
| Reason for Submission: | New Device |
Device Description
CarnaLife® Holo is a Software as a Medical Device (SaMD) to be used by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians for the visualization of medical images in 3D to allow for surgical planning activities. The device makes it possible to visualize 3D Digital Imaging and Communications in Medicine (DICOM) files using volume and surface rendering in 3D to be viewed on a classic display or on a stereoscopic, holographic display. CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD). The images can be viewed on desktop PCs with a monitor allowing the interaction with CarnaLife® Holo to be performed with a mouse and/or keyboard; and on an HMD, where the interaction with CarnaLife® Holo is performed using hand gestures, voice commands and virtual menus.
CarnaLife® Holo is used to:
- Load patient DICOM data; ●
- . Image review, image manipulation, basic measurements, annotations, and 3D visualization; and
- . View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).
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Indications for Use
CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.
Substantial Equivalence Discussion
CarnaLife® Holo is substantially equivalent to the predicate device, SurgicalAR (K190764), as both devices have the same intended use and similar technological characteristics. While both devices do not have the same software features, the differences do not raise different questions of safety and effectiveness.
| Device
Characteristic | Subject Device:
CarnaLife® Holo (K221870) | Predicate Device:
SurgicalAR (K190764) | Comparison |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Same |
| Product Code | LLZ | LLZ | Same |
| Indications for
Use | CarnaLife® Holo is a software
device for display of medical
images and other healthcare
data. It includes functions for
image review image
manipulation, basic
measurements, and 3D
visualization.
Lossy compressed
mammography images and
digitized film screen images
must not be reviewed for
primary image interpretations.
Mammographic images may
only be interpreted using an
FDA- cleared display that meets
technical specifications
reviewed and accepted by FDA
or displays accepted by the
appropriate regulatory agency | SurgicalAR is a software device for
display of medical images and
other healthcare data. It includes
functions for image review image
manipulation, basic
measurements, and 3D
visualization (MPR reconstructions
and 3D volume rendering).
Lossy compressed mammography
images and digitized film screen
images must not be reviewed for
primary image interpretations.
Mammographic images may only
be interpreted using an FDA-
cleared display that meets
technical specifications reviewed
and accepted by FDA or displays
accepted by the appropriate
regulatory agency for the country
in which it is used. | Same |
| Device
Characteristic | Subject Device:
CarnaLife® Holo (K221870) | Predicate Device:
SurgicalAR (K190764) | Comparison |
| | for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians.
When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use. | Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
SurgicalAR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technologists.
When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use. | |
| Prescription
Use or OTC
Use | Prescription use | Prescription use | Same |
| Annotation and
Measurement
Tools | Line Angle Ruler Arrow | Line Angle Ruler Arrow | Same |
| Data Type
Supported | DICOM Non-DICOM | DICOM Non-DICOM | Same |
| Image Input
Types
Supported | CT/angio CT MR/4D MR 3DRA ECHO PET USG | CT MR | Different:
The
difference
does not alter
intended use
and is
supported by
software
verification
and
validation. |
| Image View/
Manipulation | Image Zoom/Zoom Pan Window Level AutoWindow/Presets | Image Zoom Pan Window Level AutoWindow | Different:
The
predicate
device does |
| Device
Characteristic | Subject Device:
CarnaLife® Holo (K221870) | Predicate Device:
SurgicalAR (K190764) | Comparison |
| | Level Reset Scout Lines/Intersection Lines Image Rotate Image Flipor Intersection Image Invert Magnify | Level Reset Scout Lines Image Rotate Image Flip Magnify | not have the
"Image
Invert"
functionality. |
| Data Encryption | HTTPS SSL | HTTPS SSL | Same |
| Patient
Demographic
Display | Capable of displaying patient
demographic information | Capable of displaying patient
demographic information | Same |
| Data Security | Stored locally on the workstation
(PC) | Stored on server | Same |
| Audit Trail | Audit trail logged | Audit trail logged | Same |
| File Type Used | JPEG for lossy data PNG for lossless data | JPEG for lossy data PNG for lossless data | Same |
| MPR Viewing | This viewing feature enables the
display of reformatted CT and
MR images into axial, coronal,
and sagittal orientations. | This viewing feature enables the
display of reformatted CT and MR
images into axial, coronal, and
sagittal orientations. | Same |
| 3D Volume
Rendered
Viewing | This viewing feature enables the
display of 3D perspective views
of CT and MR image sets that
have been transformed into
volumes. It also provides presets
to enable users to alter the
visualization parameters of the
3D views to highlight features. | This viewing feature enables the
display of 3D perspective views of
CT and MR image sets that have
been transformed into volumes. It
also provides presets to enable
users to alter the visualization
parameters of the 3D views to
highlight features. | Same |
| Crosshair
Navigation and
Synchronization | This viewing feature provides a
facility to synchronize and scroll
through multiple views at the
same time. | This viewing feature provides a
facility to synchronize and scroll
through multiple views at the same
time. | Same |
| Ability to close
an image by
clicking an "X"
in the upper-left
portion of the
view port | Ability to close an image by
clicking an "X" in the examination
tab. | Ability to close an image by clicking
an "X" in the upper-left portion of
the viewport. | Same |
| Support for TIF
Files | Yes | Yes | Same |
| Support for
BMP Files | Yes | No | Different:
The
difference
does not alter
intended use
and is
supported by
software
verification |
| Device
Characteristic | Subject Device:
CarnaLife® Holo (K221870) | Predicate Device:
SurgicalAR (K190764) | Comparison |
| | | | and
validation. |
| Support of
Stored ECHO
Data | Yes | No | Different:
The
difference
does not alter
intended use
and is
supported by
software
verification
and
validation. |
| HMD support
for
informational
purposes only
(not for
diagnostic use) | This viewing feature provides
access of CarnaLife® Holo
software on consumer, off-the-
shelf wireless, Wi-Fi enabled,
stereoscopic head-mounted
display with minimum of 2GB
RAM. | This viewing feature provides
access of SurgicalAR software on
consumer, off-the-shelf wireless,
Wi-Fi enabled, stereoscopic head-
mounted display with minimum of
2GB RAM. | Same |
| Diagnostic
quality medical
image review | Ability to provide diagnostic
quality medical image review for
multi-dimensional digital images
acquired from a variety of
imaging devices. | Ability to provide diagnostic quality
medical image review for multi-
dimensional digital images acquired
from a variety of imaging devices. | Same |
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Performance Data
Design validation and verification activities were performed for CarnaLife® Holo as a result of the risk analysis assessment and product requirements. The purpose of software design verification activities was to ensure that the design output specifications met the design input requirements. It is concluded that the design verification was successful in that the design output specifications satisfactorily met the design input requirements.
Design validation was successfully completed, and testing met all predetermined acceptance criteria based on user needs and intended use. Human factors activities were completed per ANSI/AAMI/IEC 62366.
Performance testing included:
- . Accuracy of the Measuring function: This testing was conducted using two data sets characterized by different voxel sizes (isotropic and anisotropic data). For each set, points P1, P2, P3 and P4 were defined for both Axial and Coronal projections. Measurement accuracy met specified requirements for the below measurements of distance:
- o X - distance of P1-P2 and P3-P4
- o Y - distance of P1-P3 and P2-P4
- Angles defined by points P1-P2-P3 o
- Diagonals defined by P1-P4 and P3-P2. o
8
- Accuracy of Volume Rendering: This testing was conducted by performing Volume Rendering on . CT scans of two different geometric objects of known size and dimensions. The accuracy of Volume Rendering meeting specified requirements was demonstrated by comparing the size and dimensions of resulting displayed holograms to the known size and dimensions of the two geometric objects.
Conclusion
The performance data demonstrate the CarnaLife® Holo is as safe, as effective, and performs as well as or better than the predicate device, SurgicalAR (K190764). In conclusion, the subject device, CarnaLife® Holo, is substantially equivalent to the predicate device, SurgicalAR (K190764).