(150 days)
Not Found
Yes
The document explicitly states "The Al-based algorithm is based on a system that has been trained to identify organs/structures using a dataset..." and mentions "Mentions AI, DNN, or ML: Yes".
No
The device is described as an imaging system for processing, analysis, and display of images for surgical planning and reference, which is diagnostic and assistive, not therapeutic.
No
The device is intended for preoperative surgical planning, patient information, and intraoperative display of images, assisting clinicians in decision-making by creating 3D images from CT and MRI scans. While it aids in understanding anatomy, it does not provide a diagnosis itself.
Yes
The device description explicitly states "Aibolit 3D+ is a software only device".
Based on the provided information, Aibolit 3D+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that Aibolit 3D+ is a medical imaging system for processing, reviewing, analyzing, communicating, and interchanging digital images acquired from CT and MRI devices. It is intended for preoperative surgical planning, patient information, and intraoperative display of these images.
- Nature of IVDs: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. Aibolit 3D+ does not involve the analysis of such specimens.
- Device Description: The device description focuses on processing and manipulating medical images (CT and MRI) to create 3D representations and highlight anatomical structures. This is consistent with medical imaging software, not an IVD.
The device's function is centered around the visualization and analysis of in vivo (within the living body) images, not in vitro (in glass, or outside the body) specimens.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ
Device Description
Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference.
Aibolit 3D+ is a software only device, which processes CT and MR images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest.
The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship.
Mentions image processing
Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MR imaging devices.
Mentions AI, DNN, or ML
For image segmentation, the device includes optional artificial intelligence including machine learning followed by review by a radiologist. The Al-based algorithm is based on a system that has been trained to identify organs/structures using a dataset of 108 anatomical structures as obtained from medical images (MRI scans) and their corresponding segmentation.
Input Imaging Modality
CT and MR imaging devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals / Healthcare facilities such as hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
The Al-based algorithm is based on a system that has been trained to identify organs/structures using a dataset of 108 anatomical structures as obtained from medical images (MRI scans) and their corresponding segmentation.
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 was included in the 510(k) submission to demonstrate that the Aibolit software has been validated for its intended use and to support substantial equivalence to the predicate device.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility (R&R) study on the segmentation of multiple internal organ/structure anatomies and 3) accuracy study on 3D model generation for multiple organ structures.
Expansion of Software Validation to include MRI validation using multiple organ structures, multiple radiologists and multiple view perspectives. The validation was conducted in accordance with a written protocol with pre-determined acceptance criteria. The validation demonstrated conservation of shape dimensions, volume of the structures in a side-by-side testing comparison with a "ground truth" accepted standard independent of radiologist, organ structure and view perspective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aibolit Technologies, LLC % Howard Schrayer Regulatory Consultant Howard Schrayer 8 Lookout HILTON HEAD ISLAND SC 29928
Re: K222458
Trade/Device Name: Aibolit 3D+ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ, Dated: December 5, 2022 Received: December 5, 2022
January 12, 2023
Dear Howard Schrayer:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222458
Device Name AIBOLIT 3D+
Indications for Use (Describe)
Arbolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K222458
| Contact: | Howard Schrayer
Albolit Technologies, LLC
9616 Moritz Way
Delray Beach, FL 33446 |
|---------------------|----------------------------------------------------------------------------------------------------|
| | Telephone: 609-273-7350
hs.ss@lucidmedical.net |
| Date Prepared: | January 11, 2023 |
| Device Trade Name: | AIBOLIT 3D+ |
| Manufacturer: | Albolit Technologies, LLC
9616 Moritz Way
Delray Beach, FL 33446 |
| Common Name: | Automated Radiological Image Processing Software
Medical image management and processing system |
| Classification: | Class II |
| Product Code: | QIH - LLZ |
| Regulation: | 21 CFR 892.2050 |
| Predicate Devices: | |
| Primary Predicate | Aibolit Technologies, LLC 3D+ System
[510(k) K211443]. |
| Reference Predicate | Ceevra, Inc.
Ceevra Reveal 2.0
Image Processing System
[510(k) K173274] |
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Indications for Use:
Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MR imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Device Description:
Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference.
Aibolit 3D+ is a software only device, which processes CT and MR images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest.
The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship.
Substantial Equivalence and Predicate Devices:
The reason for this submission was to add the processing of images derived from MRI DICOM files to the functioning of the primary Aibolit predicate. This functionality is present in the referenced Ceevra predicate. The device was shown to be substantially equivalent to itself [510(k) K211443] and a previously cleared video image processing system, the Ceevra Reveal 2.0 Image Processing System [510(k) K173274].
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Predicate Comparison Table
| Manufacturer | Albolit Technologies, LLC | Ceevra |
|---|---|---|
| Trade Name | AIBOLIT 3D+ | |
| Image Processing System | Ceevra Reveal 2.0 | |
| Image Processing System | ||
| 510(k) Number | Subject Device - TBD | K173274 |
| Type of Device/ | ||
| Product Code / | Radiological Image Processing | |
| System / QIH - LLZ | Radiological Image Processing | |
| System / LLZ | ||
| Regulation / Class | 21 CFR 892.2050 – Class II | 21 CFR 892.2050 – Class II |
| Indications for | ||
| Use | Aibolit 3D+ is intended as a | |
| medical imaging system that | ||
| allows the processing, review, | ||
| analysis, communication and | ||
| media interchange of multi- | ||
| dimensional digital images | ||
| acquired from CT or MR | ||
| imaging devices. It is also | ||
| intended as software for | ||
| preoperative surgical planning, | ||
| training, patient information and | ||
| as software for the | ||
| intraoperative display of the | ||
| multidimensional digital images. | ||
| Aibolit 3D+ is designed for use | ||
| by health care professionals and | ||
| is intended to assist the clinician | ||
| who is responsible for making all | ||
| final patient management | ||
| decisions. | Ceevra Reveal 2.0 is intended as | |
| a medical imaging system that | ||
| allows the processing, review, | ||
| analysis, communication | ||
| and media interchange of multi- | ||
| dimensional digital images | ||
| acquired from CT or MR imaging | ||
| devices. It is also intended as | ||
| software for preoperative surgical | ||
| planning, and as software for the | ||
| intraoperative display of the | ||
| aforementioned multidimensional | ||
| digital images. Ceevra Reveal | ||
| 2.0 is designed for use by health | ||
| care professionals and is | ||
| intended to assist the clinician | ||
| who is responsible for making all | ||
| final patient management | ||
| decisions. | ||
| Mechanism of | ||
| Action | Capture and enhancement of | |
| (DICOM) digital video images | ||
| via software-based conversion | ||
| to 2-D and 3-D anatomical | ||
| structure images that can be | ||
| manipulated for viewing | Capture and enhancement of | |
| (DICOM) digital video images via | ||
| software-based conversion to 2- | ||
| D and 3-D anatomical structure | ||
| images that can be manipulated | ||
| for viewing | ||
| Intended Users | Health care professionals | Health care professionals |
| Intended Use | ||
| Environment | Healthcare facilities such as | |
| hospitals and clinics | Healthcare facilities such as | |
| hospitals and clinics | ||
| Format of | ||
| Captured Images | DICOM | DICOM |
| Intended Use | ||
| AIBOLIT 3D+ is intended for use as a medical imaging system | ||
| that allows the processing, review, analysis, communication | ||
| and media interchange of multi-dimensional digital images | ||
| acquired from CT or MR imaging devices. It is also intended as software for | ||
| preoperative surgical planning, and as software for the | ||
| intraoperative display of multi-dimensional digital images. | ||
| AIBOLIT 3D+ is designed for use by health care professionals | ||
| and is intended to assist the | Intended as a medical imaging system that allows the | |
| processing, review, analysis, communication and media | ||
| interchange of multi- dimensional digital images acquired from CT | ||
| or MR imaging devices. It is also intended as software for | ||
| preoperative surgical planning, and as software for the | ||
| intraoperative display of the aforementioned multi- | ||
| dimensional digital images. | ||
| Ceevra Reveal 2.0 is designed for use by health care | ||
| professionals and is intended to | ||
| clinician who is responsible for | ||
| making patient management decisions. | assist the clinician who is | |
| responsible for making all final | ||
| patient management decisions. | ||
| Security | Data coded and HIPAA | |
| compliant | Data coded and HIPAA | |
| compliant | ||
| Form of Device | AIBOLIT 3D+ is a software only | |
| device that permits electronic | ||
| image uploads, provides image | ||
| conversion and allows viewing | ||
| on a mobile device or standard | ||
| computer monitor. | The Ceevra Reveal 2.0 Video | |
| Processor is a software only | ||
| device that permits electronic | ||
| image uploads, provides image | ||
| conversion and allows viewing on | ||
| a mobile device or standard | ||
| computer monitor. | ||
| Image processing | High-definition digital images | High-definition digital images |
| Functions | Generation of 2D and 3D | |
| images from DICOM data | ||
| Organ segmentation and | ||
| structure identification | ||
| Dimensional and volume | ||
| references | ||
| Multi-axis image rotation | ||
| Organ transparency | Generation of 2D and 3D images | |
| from DICOM data | ||
| Organ segmentation and | ||
| structure identification | ||
| Dimensional and volume | ||
| references | ||
| Multi-axis image rotation | ||
| Organ transparency | ||
| Body contact | None | None |
| User Interface and | ||
| System Work-Flow | Physician uploads DICOM | |
| images and specifies desired | ||
| anatomical segments of interest | ||
| Radiologist annotates sample | ||
| (segments) images | Physician uploads DICOM | |
| images and specifies desired | ||
| anatomical segments of interest | ||
| Imaging technician annotates | ||
| sample (segments) images | ||
| Radiologist may use add-on | ||
| software to facilitate annotation | ||
| of DICOM images under | ||
| guidance and full control of the | ||
| Radiologist |
Radiologist generates multi-axis
rotatable image and returns
output file to requesting
physician | Imaging technician generates
multi-axis rotatable image and
returns output file to requesting
physician |
| External / Internet
Connections | Web-based software | Web-based software |
| CT / MRI Image
Uploading | By requesting physician | By requesting physician |
| Other User Inputs | List of organ structures to be
annotated and displayed, patient
ID and demographics | List of organ structures to be
annotated and displayed, patient
ID and demographics |
| Image
Segmentation | By Radiologist (MD) – Manual
annotation is done for all CT and
MRI slices with optional use of
software as determined by
Radiologist and with
Radiologist's approval and
control | By Imaging Technician – Manual
annotation done for all CT and
MRI slices - No software used
for annotation |
| Organ
identification | By Radiologist | Unknown proprietary method
used to identify organ structures |
| 3D Image
generation | 3D image file generated by 3rd
party software (3D Slicer)
following Radiologist review and
approval of annotation | 3D image file generated by 3rd
party software |
| Organ structure
identification | Proprietary software assigns
color coding to each structure
identified by Radiologist and
displays color-coded image with
labeled key to color/structure
identity | Proprietary software assigns
color coding to each structure
identified by imaging technician
and displays color-coded image
with key to color/structure identity |
| Image editing
permission | Only the radiologist can edit
images following review – User
physicians cannot edit images –
Physicians have option to show
or hide organs on display | Imaging technician can edit
images generated by the system
software – User physicians
cannot edit images - Physicians
have option to show or hide
organs on display |
| Device Output
Devices | 3D image can be displayed on
standard monitor or another
appropriate display | 3D image can be displayed on
standard monitor, smart phone
(with separate software) or
Virtual Imaging 3D headset |
| Supplemental
outputs | Organ structure dimensions,
volume, organ labels, patient ID,
image date and demographics | Organ structure dimensions,
volume, organ labels, patient ID
and demographics |
| Output image
manipulation by
user | Physician user can show or hide
individual organ structures,
zoom capability, rotational
capability and transparency
capability | Physician user can show or hide
individual organ structures, zoom
capability, rotational capability,
transparency capability (current
version) |
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Performance Testing:
Non-clinical performance data was included in the 510(k) submission to demonstrate that the Aibolit software has been validated for its intended use and to support substantial equivalence to the predicate device.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility (R&R) study on the segmentation of multiple internal organ/structure anatomies and 3) accuracy study on 3D model generation for multiple organ structures.
For image segmentation, the device includes optional artificial intelligence including machine learning followed by review by a radiologist. The Al-based algorithm is based on a system that has been trained to identify organs/structures using a dataset of 108 anatomical structures as obtained from medical images (MRI scans) and their corresponding segmentation. The images were evaluated from 3 perspectives by 4 radiologists. After a radiologist establishes contours. the system produces additional seqmentations for review by the radiologist.
The following documentation was previously submitted.
- Hardware Requirements Level of Concern Statement Software Description Architecture Design User Manual and Instructions for Use Software Design Specification Risk Analysis Traceability Analysis Software Validation Report Usability Evaluation Software Development Lifecycle Unresolved Anomalies Cybersecurity
Additional Testing
Expansion of Software Validation to include MRI validation using multiple organ structures, multiple radiologists and multiple view perspectives. The validation was conducted in accordance with a written protocol with pre-determined acceptance criteria. The validation demonstrated conservation of shape dimensions, volume of the structures in a side-by-side testing comparison with a "ground truth" accepted standard independent of radiologist, organ structure and view perspective.
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Conclusion
AIBOLIT 3D+ is substantially equivalent to the previously cleared Aibolit 3D+ system (K211443) and to the Ceevra Reveal 2.0 Image Processing System (K173274) with respect to intended use, principle of operation, general technological characteristics and performance.