(262 days)
Not Found
No
The summary describes image analysis software that performs geometric and HU measurements and creates an "unfolded cylindrical projection" visualization. There is no mention of AI, ML, deep learning, or any training/inference process that would indicate the use of these technologies. The performance study focuses on the clinical utility and effectiveness of the visualization and measurement tools, not on the performance of an AI/ML algorithm.
No.
Open Rib is image analysis software for chest CT images, providing visualization and measurement tools. It is intended to assist physicians in viewing full rib anatomy as an additional view, not to provide therapy.
Yes
Explanation: The device is image analysis software for chest CT images that helps physicians view rib anatomy and offers measurement tools, which are used to aid in the diagnosis of medical conditions.
Yes
The device description explicitly states "Open Rib is image analysis software for chest CT images" and "The software resides on the Vitrea Advanced Visualization (AV) platform." There is no mention of any accompanying hardware developed or included as part of the Open Rib device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Open Rib is image analysis software that processes medical images (chest CT scans). It does not analyze biological samples from the patient.
- Intended Use: The intended use is to provide an additional visualization and measurement tools for physicians reviewing chest CT images of the rib cage. This is a diagnostic aid based on imaging, not on the analysis of biological specimens.
The description clearly indicates that the software works with chest CT images, which are generated by an imaging modality, not from a biological sample.
N/A
Intended Use / Indications for Use
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
Product codes
JAK
Device Description
Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform.
Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
The images can be directly exported to PACS and batch saved.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
chest CT images
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
Open Rib was tested on 30 chest CT cases with volume ≤ 1mm and reconstructed with a bone kernel. The 30 cases all met the following inclusion criteria:
• CT chest images with most of the ribs
• Slice thickness ≤ 1mm
• Bone reconstruction kernel
with the following excluded:
• Significant motion artifacts from patient breathing present on image
• Severe kyphosis
• Reconstruction kernel other than bone used
The datasets included were representative of most routine chest CT protocols and applied to a variety of clinical including routine diagnostic chest, oncologic chest studies and emergency/trauma studies.
The 30 cases included 12 normal cases (40%) and 18 abnormal cases such as rib fracture(s) and bony lesions and kyphosis (60%). 20 cases were non-contrast images (66.7%) and 10 cases were contrast images (33.3%). 30 cases acquired with various CTs were used. (Canon:17, Siemens:8, GE:4, Philips:1).
The evaluators were U.S. board-certified radiologists. Each evaluator reviewed 10 cases were evenly distributed between evaluators.
The evaluators were subsequently presented a list of questions asking about the clinical utility and effectiveness of the unfolded rib view, the measurement tools, and the overall application and workflow. A "pas" result required positive answers to all guestions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualitative study by three US board-certified radiologists, sample size of 30 cases. All three radiologist readers completed the questionnaire and responded "yes" to each of the device thus met pass criteria for visualization of the rib cage. The results device successfully generates unfolded cylindrical projections of the ribs that are an adjunct to a conventional MPR view.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
July 13, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Canon Medical Informatics, Inc. % Dr. Jay Vaishnav Principal Regulatory Affairs Strategist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K223261
Trade/Device Name: Open Rib Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 6, 2023 Received: June 6, 2023
Dear Dr. Jay Vaishnav:
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 medical devices and radiation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
| Submission Number ( if known ) | |
|---|---|
| --------------------------------------- | -- |
Device Name
Open Rib
Indications for Use (Describe)
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
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
"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."
3
510(k) #: K223261
510(k) Summary
Prepared on: 2023-07-07
Contact Details
Applicant Name
Applicant Address
Applicant Contact
Applicant Contact Email
Correspondent Address
Correspondent Name
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(2)
21 CFR 807.92(a)(4)
Canon Medical Informatics, Inc.
5850 Opus Parkway, Suite 300 Minnetonka MN 55343 United States
(952) 487-9548 Applicant Contact Telephone
Vincent Swenson
vincent.swenson@mi.medical.canon
Jay Vaishnav, PhD, RAC
Canon Medical Informatics, Inc.
5850 Opus Parkway, Suite 300 Minnetonka MN 55343 United States
Correspondent Contact Telephone (952) 487-9769
Correspondent Contact
Correspondent Contact Email
Device Name
Open Rib Device Trade Name Common Name Computed tomography x-ray system Classification Name System, X-Ray, Tomography, Computed Regulation Number 892.1750 Product Code JAK Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code SYNGO, CT BONE READING K123584 JAK
Device Description Summary
Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform.
Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
The images can be directly exported to PACS and batch saved.
HOW THE DEVICE FUNCTIONS
4
The device is a software device that operates on chest CT images in order to generate an unfolded cylindrical projection view of the rib The user has the ability to edit the segmentation of the ribs. cage.
SCIENTIFIC CONCEPTS THAT FORM THE BASIS OF THE DEVICE
The main algorithms used to generate the UCP view involve rib cage on standard (non-Al based) segmentation methods, and rib cage unfolding performed by mathematical projection of the rib caresian coordinates into unfolded cylindrical coordinates.
PHYSICAL AND PERFORMANCE CHARACTERISTICS OF THE DEVICE
The device is a software algorithm that operates on thoracic CT images. Device performance was validated on thirty cases, in a qualitative study by three US board-certified radition to this testing, software verification and validation activities were completed to ensure that the Open Rib software functions remained consistent with the software achieved all product release criteria.
Intended Use/Indications for Use
Open Rib is image analysis software for ches. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
Indications for Use Comparison
The device has different indications for use in comparison to the predicate device. The differences follow:
• Both the subject and predicate devices offer a visualization of the rib cated only for visualization of the ribs, whereas the predicate device is indication of the rib and spine. Limiting the device indications to ribs only does not constitute a new intended use.
• The subject device uses an unfolded projection instead of curved MPR to generate unfolded rib views. The indications have been modified to reflect the difference. As the device output remains the use of a different method to obtain it does not affect the device's intended use.
ı While the subject device offers similar measurement and visualization capabilities, the IFU is being and brevity. This change does not create a new intended use.
• Any indications related to pathologies or improvements in user workflow have been removed. Reducing the scope of the indications does not create a new intended use.
Technological Comparison
The device has different technological characteristics from the predicate device. The following is a summary comparison:
· Both devices operate on chest CT images and output unfolded views of the algorithms used to generate the unfolded rib views are different. The subject device uses an unfolded cylindrical projection instead of curved MPR to generate unfolded rib views.
v Both devices offer similar visualization tools. All views that the subject device offers are offered by the predicate device offers one additional visualization tool, inverted MIP view, that is not present in the subject device. Inverted MIP view is not necessary for visualization of the rib cage.
• The subject device offer distance line, marker and a pixel lens HU tool. The predicate offers polyline and angle geometric tools and ROI circle, ROI freehand, & VOI sphere HU tools but the subject device does not.
• Both devices offer manual editing capability for the unfolded rib view.
• The predicate device offers inverted MIP view and automated rib labeling. The subject device does not.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(a)(5)
21 CFR 807-92(b)
21 CFR 807.92(a)(5)
5
Open Rib was tested on 30 chest CT cases with volume ≤ 1mm and reconstructed with a bone kernel. The 30 cases all met the following inclusion criteria:
• CT chest images with most of the ribs
• Slice thickness ≤ 1mm
• Bone reconstruction kernel
with the following excluded:
• Significant motion artifacts from patient breathing present on image
• Severe kyphosis
• Reconstruction kernel other than bone used
The datasets included were representative of most routine chest CT protocols and applied to a variety of clinical including routine diagnostic chest, oncologic chest studies and emergency/trauma studies.
The 30 cases included 12 normal cases (40%) and 18 abnormal cases such as rib fracture(s) and bony lesions and kyphosis (60%). 20 cases were non-contrast images (66.7%) and 10 cases were contrast images (33.3%). 30 cases acquired with various CTs were used. (Canon:17, Siemens:8, GE:4, Philips:1).
The evaluators were U.S. board-certified radiologists. Each evaluator reviewed 10 cases were evenly distributed between evaluators.
The evaluators were subsequently presented a list of questions asking about the clinical utility and effectiveness of the unfolded rib view, the measurement tools, and the overall application and workflow. A "pas" result required positive answers to all guestions.
Al three radiologist readers completed the questionnaire and responded "yes" to each of the device thus met pass criteria for visualization of the rib cage. The results device successfully generates unfolded cylindrical projections of the ribs that are an adjunct to a conventional MPR view.
In addition to this testing, software verification activities were completed to ensure that the Open Rib software functions remained consistent with the software requirements. The software achieved all product release criteria.