(242 days)
Yes
The "Mentions AI, DNN, or ML" section explicitly states the use of AI/ML algorithms for image annotation.
No
This device is for medical imaging and surgical planning, which assists clinicians and provides information, but does not directly treat a disease or condition.
No
Explanation: While the device processes medical images from CT scans and assists in surgical planning and intraoperative display, its primary stated purpose is not to provide a diagnosis but rather to support healthcare professionals in their decision-making by enhancing visualization and identification of anatomical structures. It explicitly states that it "is intended to assist the clinician who is responsible for making all final patient management decisions."
Yes
The device description explicitly states "Aibolit 3D+ is a software only device".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Aibolit 3D+ Function: Aibolit 3D+ processes and analyzes medical images (CT scans) acquired from the human body. It does not examine biological specimens. Its purpose is to aid in surgical planning, training, and intraoperative display based on anatomical visualization.
- Intended Use: The intended use clearly states its function is related to processing and analyzing digital images from CT devices for surgical planning and visualization, not for analyzing biological samples for diagnostic information.
Therefore, Aibolit 3D+ falls under the category of medical imaging software, not an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text indicates "Control Plan Authorized (PCCP) and relevant text: Not Found."
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 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.
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 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
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
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
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.
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 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) | 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:
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Sarvices (301) 443-6740
3
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.