KOALA

{0}------------------------------------------------ November 5, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. IB Lab GmbH % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004 Re: K192109 Trade/Device Name: KOALA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: October 11, 2019 Received: October 11, 2019 Dear Dr. Smith: 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 510(k) Number (if known) K192109 Device Name KOALA #### Indications for Use (Describe) IB Lab KOALA is a radiological fully-automated image processing software computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians. | 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}------------------------------------------------ ### Submitter IB Lab GmbH Hietzinger Hauptstrasse 50/10 1130 Vienna, Austria Phone: +43 1 9051206 Contact Person: Dr. Richard Ljuhar Date Prepared: October 11, 2019 Name of Device: KOALA Classification Name: Picture archiving and communications system (21 C.F.R. 892.2050) Regulatory Class: Class II Product Code: LLZ/892.2050, JAK/892.1750 Predicate Device: Ortho Kinematics, Inc.'s VMA™ System version 3.0 (K172327) Reference Device: Zebra Medical Vision Ltd.'s HealthCCS (K172983) #### Device Description The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the ioint space width and indicators for presence of radiographic features of osteoarthritis (OA) on posterior-anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. #### Intended Use / Indications for Use IB Lab KOALA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians. {4}------------------------------------------------ # Summary of Technological Characteristics The following technological similarities and differences exist between the subject and predicate devices. The predicate and subject software utilize computer vision and machine learning algorithms trained on medical images. The machine-learning algorithms allow for high accuracy in the detection and measurement of OA related symptoms visible on knee radiographs. | Feature | IB Lab's KOALA Software<br>(Subject Device) | Ortho Kinematics,<br>Inc.'s VMA System<br>(K172327, Predicate<br>Device) | Zebra Medical Vision Ltd.'s<br>HealthCCS Software<br>(K172983, Reference Device) | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Classification<br>Name and<br>Product Code | System, Image Processing,<br>Radiological (LLZ) | System, Image<br>Processing, Radiological<br>(LLZ) | Computed Tomography X-Ray<br>System (JAK) | | Runs on Server | Yes | Yes | Yes | | Image Input | DICOM compliant images<br>collected in other devices in<br>either digitally computed (CR) or<br>directly digital (DX) formats | DICOM compliant<br>images inputted from<br>cleared PACS | DICOM | | Anatomical Area | Joint (knee) | Spine | Heart (coronary artery) | | Image<br>Processing | Knee detection;<br>Landmark detection;<br>Joint space detection | Semi-automated<br>vertebral body<br>templating and tracking | Calcification location marking | | Measurements | Yes | Yes | Yes | | Grading based<br>on<br>measurements | Yes, cutoffs on grades | No | Yes | | Human<br>Intervention for<br>interpretation | Required | Required | Required | | Intended User | Trained professionals | Physicians and clinical<br>professionals | Health care professionals | A table comparing the key features of the subject and predicate devices is provided below. ## Performance Data Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected. The company performed standalone clinical performance validation on a dataset of images from a large longitudinal US study, Osteoarthritis Initiative (OAI) study. This dataset contained a total of 6597 radiographs, representing 1149 individuals for which ground truth grading for Kellgren {5}------------------------------------------------ Lawrence grades, as well as osteophyte, sclerosis and joint space narrowing grades according to the OARSI (Osteoarthritis Research Society International) guidelines, was established by three physicians following adjudication procedures for discrepancies. The quality of the joint space width (JSW) measurements was quantified by orthogonal linear regression against reference measurements. The performance of the indicators was assessed by calculating its accuracy matrix) aqainst the reference standard and calculating sensitivity and specificity. The status indicator outputs of KOALA performed as follows | Status Indicator | Sensitivity<br>(95% CI) | Specificity<br>(95% CI) | |-------------------------------------------------------|-------------------------|-------------------------| | Kellgren-Lawrence status<br>(KL ≥ 2) | 0.87<br>(0.84, 0.9) | 0.83<br>(0.8, 0.86) | | Joint Space Narrowing Status<br>(JSN OARSI grade > 0) | 0.83<br>(0.8, 0.86) | 0.8<br>(0.76, 0.83) | | Osteophytosis status<br>(Ost OARSI grade > 0 ) | 0.86<br>(0.81, 0.9) | 0.79<br>(0.76, 0.83) | | Sclerosis status<br>(Scl OARSI grade > 0 ) | 0.82<br>(0.8, 0.87) | 0.8<br>(0.76, 0.83) | In addition, the accuracy of the joint space width measurements was compared to equivalent measurements also provided as part of the outputs from the longitudinal study mentioned above, using orthogonal linear regressions. | | Slope | Intercept<br>[mm] | |---------|-----------------------|-------------------------| | Medial | 1.02<br>(0.99 ; 1.05) | -0.08<br>(-0.22 ; 0.03) | | Lateral | 0.97<br>(0.93 ; 1.00) | 0.08<br>(-0.15 ; 0.30) | The analysis supports good agreement between the two sets of measurements. In summary, performance validation data establish that KOALA is an effective image processing device that provides reliable measurements and accurate indicators for presence/absence of radiographic features relevant for the diagnosis and classification of osteoarthritis. Thus, the device performs as intended and is substantially equivalent to the predicate device. ## Conclusions KOALA is as safe and effective as the predicate device. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences between subject and predicate device in indications do not alter the intended use of the device and do not raise new or different questions regarding its safety and effectiveness when used as labeled. Performance data demonstrate that the device performs as intended. Thus, KOALA is substantially equivalent.