AIBOLIT 3D+

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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) | <span> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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<br>Albolit Technologies, LLC<br>9616 Moritz Way<br>Delray Beach, FL 33446<br>Telephone: 609-273-7350<br>hs.ss@lucidmedical.net | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | January 7, 2022 | | Device Trade Name: | AIBOLIT 3D+ | | Manufacturer: | Albolit Technologies, LLC<br>9616 Moritz Way<br>Delray Beach, FL 33446 | | Common Name: | Automated Radiological Image Processing Software<br>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+<br>Image Processing System | Ceevra Reveal 2.0<br>Image Processing System | | 510(k) Number | Subject Device - TBD | K173274 | | Type of Device/<br>Product Code / | Radiological Image<br>Processing System / QIH -<br>LLZ | Radiological Image Processing<br>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<br>medical imaging system that<br>allows the processing, review,<br>analysis, communication and<br>media interchange of multi-<br>dimensional digital images<br>acquired from CT imaging<br>devices. It is also intended as<br>software for preoperative<br>surgical planning, training,<br>patient information and as<br>software for the intraoperative<br>display of the multidimensional<br>digital images. Aibolit 3D+ is<br>designed for use by health<br>care professionals and is<br>intended to assist the clinician<br>who is responsible for making<br>all final patient management<br>decisions. | Ceevra Reveal 2.0 is intended as<br>a medical imaging system that<br>allows the processing, review,<br>analysis, communication<br>and media interchange of multi-<br>dimensional digital images<br>acquired from CT or MR imaging<br>devices. It is also intended as<br>software for preoperative surgical<br>planning, and as software for the<br>intraoperative display of the<br>aforementioned multidimensional<br>digital images. Ceevra Reveal 2.0<br>is designed for use by health care<br>professionals and is intended to<br>assist the clinician who is<br>responsible for making all final<br>patient management decisions. | | Mechanism of<br>Action | Capture and enhancement of<br>(DICOM) digital video images<br>via software-based conversion<br>to 2-D and 3-D anatomical<br>structure images that can be<br>manipulated for viewing | Capture and enhancement of<br>(DICOM) digital video images via<br>software-based conversion to 2-D<br>and 3-D anatomical structure<br>images that can be manipulated<br>for viewing | | Intended Users | Health care professionals | Health care professionals | | Intended Use<br>Environment | Healthcare facilities such as<br>hospitals and clinics | Healthcare facilities such as<br>hospitals and clinics | | Format of Captured<br>Images | DICOM | DICOM | | Intended Use | AIBOLIT 3D+ is intended for<br>use as a medical imaging<br>system that allows the<br>processing, review, analysis,<br>communication and media<br>interchange of multi-<br>dimensional digital images<br>acquired from CT imaging<br>devices. It is also intended as<br>software for preoperative<br>surgical planning, and as<br>software for the intraoperative<br>display of multi- dimensional<br>digital images. AIBOLIT 3D+<br>is designed for use by health<br>care professionals and is<br>intended to assist the clinician<br>who is responsible for making<br>patient management<br>decisions. | Intended as a medical imaging<br>system that allows the<br>processing, review, analysis,<br>communication and media<br>interchange of multi- dimensional<br>digital images acquired from CT<br>or MR imaging devices. It is also<br>intended as software for<br>preoperative surgical planning,<br>and as software for the<br>intraoperative display of the<br>aforementioned multi-<br>dimensional digital images.<br>Ceevra Reveal 2.0 is designed for<br>use by health care professionals<br>and is intended to assist the<br>clinician who is responsible for<br>making all final patient<br>management decisions. | | Security | Data coded and HIPAA<br>compliant | Data coded and HIPAA compliant | | Form of Device | AIBOLIT 3D+ is a software<br>only device that permits<br>electronic image uploads,<br>provides image conversion<br>and allows viewing on a<br>mobile device or standard<br>computer monitor. | The Ceevra Reveal 2.0 Video<br>Processor is a software only<br>device that permits electronic<br>image uploads, provides image<br>conversion and allows viewing on a<br>mobile device or standard<br>computer monitor. | | Image processing | High-definition digital images<br>up to 4K | High-definition digital images | | Functions | Generation of 2D and 3D<br>images from DICOM data<br>Organ segmentation and<br>structure identification<br>Dimensional and volume<br>references<br>Multi-axis image rotation<br>Organ transparency<br>Organ retraction animation | Generation of 2D and 3D images<br>from DICOM data<br>Organ segmentation and structure<br>identification<br>Dimensional and volume<br>references<br>Multi-axis image rotation | | Body contact | None | None | | User Interface and<br>System Work-Flow | Physician uploads DICOM<br>images and specifies desired<br>anatomical segments of<br>interest<br>Radiologist annotates sample<br>(segments) images<br>AI software facilitates<br>annotation of available images<br>under guidance and control by<br>the Radiologist<br>Imaging technician generates<br>multi-axis rotatable image and<br>retraction model<br>Radiologist reviews images<br>generated by imaging<br>technician and returns output<br>file to requesting physician | Physician uploads DICOM images<br>and specifies desired anatomical<br>segments of interest<br>Imaging technician annotates<br>sample (segments) images<br>Imaging technician generates<br>multi-axis rotatable image and<br>returns output file to requesting<br>physician | | External / Internet<br>Connections | Web-based software | Web-based software | | CT Image<br>Uploading | By requesting physician | By requesting physician | | Other User Inputs | List of organ structures to be<br>annotated and displayed,<br>patient ID and demographics | List of organ structures to be<br>annotated and displayed, patient<br>ID and demographics | | Image<br>Segmentation | By Radiologist (MD) – Manual<br>annotation is done for all CT<br>slices with optional use of<br>AI/ML algorithms as<br>determined by Radiologist and<br>with Radiologist's approval | By Imaging Technician – Manual<br>annotation done for all CT slices –<br>No software used for annotation | | Organ<br>identification | By Radiologist | Unknown proprietary method<br>used to identify organ structures | | 3D Image<br>generation | 3D image file generated by 3rd<br>party software (3D Slicer)<br>following Radiologist review<br>and approval of annotation | 3D image file generated by 3rd<br>party software | | Organ structure<br>identification | Proprietary software assigns<br>color coding to each structure<br>identified by Radiologist and<br>displays color-coded image<br>with labeled key to<br>color/structure identity | Proprietary software assigns color<br>coding to each structure identified<br>by imaging technician and<br>displays color-coded image with<br>key to color/structure identity | | Image editing<br>permission | Only the radiologist can alter<br>or edit images following review<br>- User physicians cannot edit<br>images - Physicians have<br>option to show or hide organs<br>on display | Imaging technician can edit<br>images generated by the system<br>software – User physicians<br>cannot edit images - Physicians<br>have option to show or hide<br>organs on display | | Device Output<br>Devices | 3D image can be displayed on<br>standard monitor | 3D image can be displayed on<br>standard monitor, smart phone<br>(with separate software) or Virtual<br>Imaging 3D headset | | Supplemental<br>outputs | Organ structure dimensions,<br>volume, organ labels, patient<br>ID, CT date and demographics | Organ structure dimensions,<br>volume, organ labels, patient ID<br>and demographics | | Output image<br>manipulation by<br>user | Physician user can show or<br>hide individual organ<br>structures, zoom capability,<br>rotational capability and<br>transparency capability | Physician user can show or hide<br>individual organ structures, zoom<br>capability, rotational capability,<br>transparency capability (current<br>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.