Rapid MLS

{0} FDA U.S. FOOD & DRUG ADMINISTRATION iSchemaview Inc. James Rosa SVP Regulatory and Quality 1120 Washington Ave., Suite 200 Golden, CO 80401 May 28, 2025 Re: K243378 Trade/Device Name: Rapid MLS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: April 28, 2025 Received: April 28, 2025 Dear James Rosa: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243378 - James Rosa Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K243378 - James Rosa Page 3 Sincerely,  Jessica Lamb, Ph.D. Assistant Director, Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K243378 Device Name Rapid MLS Indications for Use (Describe) The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases. 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.” {4} K243378 Summary # K243378 Summary ## iSchemaview, Inc.'s Rapid MLS This document contains the 510(k) summary for the iSchemaview Rapid MLS device (K243378). The content of this summary is based on the requirements of 21 CFR Section 807.92(c). ## Applicant Name and Address: Name: iSchemaview, Inc. Address: 1120 Washington St., Suite 200 Golden, CO 80401 Official Contact: Jim Rosa Phone: (303) 704-3374 Email: rosa@ischemaview.com ## Summary Preparation Date: May 26, 2025 ## Device Name and Classification: Trade Name: Rapid MLS Common Name: Medical image management and processing system Classification: II Product Code: Primary: QIH Regulation No: 21 C.F.R. §892.2050 Classification Panel: Radiology Devices ## Predicate Devices: The iSchemaview Rapid MLS Analysis Module is claimed to be substantially equivalent to the legally marketed predicate, iSchemaview Rapid RV/LV (K223396). ## Device Description: Rapid MLS software device is a radiological computer-assisted image processing software device using AI/ML. The Rapid MLS device is a non-contrast CT (NCCT) processing module which operates within the integrated Rapid Platform to provide a measurement of the brain midline. The Rapid MLS software analyzes input NCCT images that are provided in DICOM format and provides both a visual output containing a color overlay image displaying the difference between the expected and indicated brain midline at the Foramen of Monro; and a text file output (json format) containing the quantitative measurement. ## Indications for Use: The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and {5} K243378 Summary any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases. # Technological Characteristics and Substantial Equivalence: Rapid MLS does not raise new questions of safety or effectiveness compared to the previously cleared Rapid RV/LV Software (K223396). There are minor differences in intended use and technical characteristics with the predicate device; however, with the minor changes the clinical use for Rapid MLS device is the same with no additional risks. Thus, the Rapid MLS software device is substantially equivalent. The following table summarizes and compares data on the predicate device (K223396) to the Rapid MLS software device that is the subject of this Traditional 510(k) submission. | Parameter | Rapid RV/LV (K223396) Predicate Device | Rapid MLS – (K243378) | | --- | --- | --- | | Product Code | QIH | QIH | | Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 | | Intended Use/Indications for Use | The Rapid RV/LV software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles. The Rapid RV/LV device provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases. | The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases. | | Input Data Requirements | Non-gated, CT Pulmonary Angiography images | Non-Contrast CT images | | DICOM Compliance | Yes, using CTPA | Yes, using NCCT | | Measurements | Heart RV, LV diameter | Brain midline measures | | SW | AI ML | AI ML | | Interface | Command Line | Command Line | | Outputs | Reports, DICOM Secondary Capture Series | Reports, DICOM Secondary Capture Series | {6} K243378 Summary ## AI/ML Module Development: Algorithm development was performed using 162 cases from multiple sites; training included 24 cases for validation and 138 for training. Cases selected covered 0-18.6 mm offsets from expected midline. Cases were from GE, Toshiba, Siemens, Philips, and PNMS. ## Clinical Characteristics: The primary users of Rapid MLS software are medical professionals who use midline shift as a clinical metric to determine extent of affect of indications including intracranial hemorrhage, tumor, and TBI. ## Performance Standards: Rapid PE has been developed in conformance with the following standards, as applicable: - EN ISO 14971:2019 (R2021) Application of Risk Management to Medical Devices - IEC 62304:2006 (R2015) Medical device software – Software lifecycle processes - IEC 62366:2015 (R2020) Application of Usability Engineering to Medical Devices - NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) - UL 2900-1 (2017) Standard for Safety for Cybersecurity Network-Connected Products ## Performance Data: Rapid MLS complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20; and was tested in accordance with the 820.20 Verification and Validation requirements and successfully passed. iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid MLS device. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid MLS device provides accurate representation of key processing parameters under a range of clinically relevant conditions associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid MLS device met all design requirements and specifications. Final performance validation included 153 NCCT cases with ground truth established by 3 experts. The primary endpoint analysis demonstrated the mean absolute error (MAE), based on validation data, of Rapid MLS is non-inferior to the MAE of experts. The Rapid MAE is 0.7 mm, and the experts average pairwise MAE is 1.0 mm. A Passing-Bablok fit to compare Rapid MLS to the reference MLS provided intercept = 0.12 (0, 0.2) and slope = 0.95 (0.9, 1.0) supporting the methods (Rapid vs Experts) are comparable. The difference plot shows no bias (paired t-test p-value = 0.1800. The cases were split Male: 44%, Female 56% with an age range or 26-93 years. The samples were mixed from GE, Philips, Toshiba and Siemens scanners. Validation data was sourced and blinded independent of the development cases through the data management team to ensure generalizability of the device. Thirteen (13) sites (2 OUS, 11 US); demographic split for age and gender, and four (4) manufacturers were used to test for broad demographic representation and avoidance of overlap bias with development. Page 3 of 4 {7} K243378 Summary ## Prescriptive Statement: Caution: Federal law restricts this device to sale by or on the order of a physician. ## Substantial Equivalence: Rapid MLS has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid MLS performance has been validated with case data. ## Conclusion: In conclusion, the iSchemaView Rapid MLS software device is substantially equivalent in intended use, technological characteristics, safety and performance characteristics to the legally marketed predicate device, Rapid RV/LV Software (K223396). Page 4 of 4