← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K211443 # AIBOLIT 3D+ (K211443) _Aibolit Technologies, LLC · LLZ · Jan 7, 2022 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K211443 ## Device Facts - **Applicant:** Aibolit Technologies, LLC - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Jan 7, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML, Software as a Medical Device ## Intended 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 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 Story Web-based, software-only medical imaging system; processes DICOM CT images to generate 3D anatomical models. Workflow: physician uploads CT data; radiologist performs manual segmentation/annotation of anatomical structures (vessels, ducts, lesions, calcifications) with optional AI/ML-assisted annotation; imaging technician generates rotatable 3D models; radiologist reviews and approves output. Output: 3D rotatable images with color-coded, labeled structures, volume/dimension metrics, and transparency/retraction animation features. Used in hospitals/clinics by physicians for surgical planning, case review, and intraoperative reference. Benefits: assists clinicians in visualizing anatomy, potentially reducing errors from misidentification of structures. ## Clinical Evidence Bench testing only. Documentation provided includes software design specifications, risk analysis, traceability analysis, software validation report, usability evaluation, and cybersecurity documentation. ## Technological Characteristics Web-based, software-only application. Processes DICOM CT images. Features: 3D reconstruction, organ segmentation, structure identification, multi-axis rotation, transparency, and retraction animation. Supports up to 4K resolution. Connectivity: internet-connected. Software includes optional AI/ML algorithms for annotation assistance under radiologist control. No patient-contacting materials. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - Ceevra Reveal 2.0 Image Processing System ([K173274](/device/K173274.md)) ## Reference Devices - Intuitive Surgical, Inc. IRIS 1.0 System ([K182643](/device/K182643.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. Albolit Technologies, LLC Howard Schrayer Official Correspondent 9616 Moritz Way Delray Beach, Florida 33446 #### Re: K211443 January 7, 2022 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: November 30, 2021 Received: December 2, 2021 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 {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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # INDICATIONS FOR USE DEPARTMENT OF HEALTH AND HUMAN SERVICES Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. | 510(k) Number (if known) | TBD K21143 | |--------------------------|-------------| | Device Name | AIBOLIT 3D+ | Indications for Use (Describe) 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 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Sarvices (301) 443-6740 {3}------------------------------------------------ K211443 # Exhibit E - 510(k) Summary (Per 21 CFR 807.92) | Contact: | Howard Schrayer
Albolit Technologies, LLC
9616 Moritz Way
Delray Beach, FL 33446
Telephone: 609-273-7350
hs.ss@lucidmedical.net | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | January 7, 2022 | | 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 | | Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System [510(k) K173274] Reference Predicate Intuitive Surgical, Inc. IRIS 1.0 System [510(k) K182643] {4}------------------------------------------------ ### 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 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 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 device was shown to be substantially equivalent to a previously cleared video image processing system, the Ceevra Reveal 2.0 Image Processing System [510(k) K173274]. {5}------------------------------------------------ | 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 893.2050 - 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 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 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 clinician
who is responsible for making
patient management
decisions. | 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 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
up to 4K | 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
Organ retraction animation | Generation of 2D and 3D images
from DICOM data
Organ segmentation and structure
identification
Dimensional and volume
references
Multi-axis image rotation | | 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
AI software facilitates
annotation of available images
under guidance and control by
the Radiologist
Imaging technician generates
multi-axis rotatable image and
retraction model
Radiologist reviews images
generated by imaging
technician and returns output
file to requesting physician | Physician uploads DICOM images
and specifies desired anatomical
segments of interest
Imaging technician annotates
sample (segments) images
Imaging technician generates
multi-axis rotatable image and
returns output file to requesting
physician | | External / Internet
Connections | Web-based software | Web-based software | | CT 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
slices with optional use of
AI/ML algorithms as
determined by Radiologist and
with Radiologist's approval | By Imaging Technician – Manual
annotation done for all CT 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 alter
or 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 | 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, CT 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) | # Predicate Comparison Table {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ### Performance Testing: The following documentation was submitted in the 510(k). 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 ### Conclusion AIBOLIT 3D+ is substantially equivalent to the previously cleared Ceevra Reveal 2.0 Image Processing System with respect to intended use, principle of operation, general technological characteristics and performance. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K211443](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K211443) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com