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 for adults. 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.

Device Description

Rapid RV/LV software device is a radiological computer-assisted image processing software device. The Rapid RV/LV device is a CTPA processing module which operates within the integrated Rapid Platform to locate and measure the right and left ventricle diameters of the human heart to ultimately provide a ratio of the right ventricle diameter to the left ventricle diameter. The RV/LV software analyzes input CTPA images that are provided in DICOM format and provides both a visual output containing a color overlay image displaying where the ventricle diameter measurements were made along with the quantitative results of the measurements and a text file output (json format) containing the quantitative measurement results (the individual right and left ventricle diameters and their corresponding ratio).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on specific performance metrics rather than explicitly listing "acceptance criteria" in a separate table. However, the performance data section implies the following are the primary endpoints for proving the device's accuracy in measuring RV/LV ratios.

Acceptance Criteria (Implicit)	Reported Device Performance
Average slope of RV/LV ratio measurements between device and experts	1.1 (95% CI: 1.0, 1.2)
Average intercept of RV/LV ratio measurements between device and experts	-0.2 (95% CI: -0.1, -0.3)
Lower confidence level of the 95% CI of the slope	1.0
Lower confidence level of the 95% CI of the intercept	-0.1
Mean Bland-Altman bias (RV/LV ratio)	0.023 (95% CI: -0.04, 0.08)
Mean Absolute Error (MAE) between Rapid RV/LV and experts	3.8mm

2. Sample Size for the Test Set and Data Provenance

Sample Size: 124 CTPA cases.
Data Provenance: The cases were mixed from different scanner manufacturers (GE, Philips, Toshiba, and Siemens), suggesting data from various sources, likely clinical institutions. The document does not explicitly state the country of origin or if it was retrospective or prospective, though the mention of "cases with ground truth established" usually implies a retrospective approach where existing data is annotated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: 3 experts.
Qualifications of Experts: The document does not explicitly state the qualifications of the experts (e.g., "radiologist with 10 years of experience"). It only identifies them as "experts."

4. Adjudication Method for the Test Set

The document states "ground truth established by 3 experts." It does not specify the adjudication method used (e.g., 2+1, 3+1, or simple consensus).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the device against expert ground truth.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "Final device validation included standalone performance validation." This indicates the algorithm's performance was evaluated by itself, without human-in-the-loop assistance.

7. Type of Ground Truth Used

Expert Consensus: The ground truth was established by "3 experts."

8. Sample Size for the Training Set

The algorithm development used 516 CTPA cases. The text indicates that "training included 80% of cases for validation and 20% for training." This phrasing is a bit ambiguous, as typically the larger portion is for training and a smaller set for validation during development. However, if interpreted as 20% for pure training, then the training set size would be approximately 103 cases (20% of 516). If "validation" here refers to a development-phase validation set, then 80% would be 413 cases used in that stage. Given the context of "algorithm development" and allocation for "validation and training" within the 516, it's safe to say the total "training set" (including internal validation during development) was 516 cases.

9. How the Ground Truth for the Training Set Was Established

The document states that the 516 CTPA cases used for algorithm development were used with a "wide range of LV diameters." It does not explicitly detail the method for establishing ground truth for the training set, but it can be inferred that it would have been established by experts, similar to the test set, given that the final validation relied on expert ground truth.

Summary

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iSchema View Inc. % James Rosa SVP Regulatory and Quality 433 Park Point Drive, Suite 220 GOLDEN CO 80401

Re: K223396

February 1, 2023

Trade/Device Name: Rapid RV/LV Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: December 27, 2022 Received: December 27, 2022

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 (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

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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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223396

Device Name Rapid RV/LV

Indications for Use (Describe)

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)

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K223396

510(k) Summary

iSchemaView, Inc.'s Rapid RV/LV

This document contains the 510(k) summary for the iSchemaView Rapid RV/LV device. 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 200Golden, CO 80401
Official Contact:	Jim RosaPhone: (303) 704-3374Email: rosa@ischemaview.com

Summary Preparation Date: January 31, 2023

Device Name and Classification:

Trade Name:	Rapid RV/LV
Common Name:	Automated Radiological Image ProcessingSoftware
Classification:	II
Product Code:	Primary: QIH
Regulation No:	21 C.F.R. §892.2050
ClassificationPanel:	Radiology Devices

Predicate Devices:

The iSchemaView Rapid RV/LV Analysis Module is claimed to be substantially equivalent to the following legally marketed predicate devices:

Imbio's RV/LV Software (K203256)

Device Description:

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iSchemaView - Traditional 510(k) Rapid RV/LV

510(k) Summary

Indications for Use:

Technological Characteristics and Substantial Equivalence:

Rapid RV/LV does not raise new questions of safety or effectiveness compared to the previously cleared Imbio RV/LV Software (K203256). There are minor differences in intended use and technical characteristics with the predicate device; however, with the minor changes the clinical use for Rapid RV/LV device is the same with no additional risks. Thus, the Rapid RV/LV software device is substantially equivalent.

The following table summarizes and compares data on the Imbio RV/LV Software (K203256) to the Rapid RV/LV software device that is the subject of this Traditional 510(k) submission.

Parameter	Imbio RV/LV SoftwareK203256 - Predicate Device	Rapid RV/LV – Subject DeviceK223396
Product Code	QIH	QIH
Regulation	21 CFR §892.2050	21 CFR §892.2050
Intended Use/Indications forUse	The Imbio RV/LV Softwaredevice is designed to measurethe maximal diameters of theright and left ventricles of theheart from a volumetric CTPAacquisition and report the ratioof those measurements. RV/LVanalyzes cases using an artificialintelligence algorithm toidentify the location andmeasurements of the ventricles.The RV/LV software providesthe user with annotated imagesshowing ventricularmeasurements. Its results arenot intended to be used on astand-alone basis for clinicaldecision-making or otherwisepreclude clinical assessment ofCTPA cases.	The Rapid RV/LV softwaredevice is designed to measure themaximal diameters of the rightand left ventricles of the heartfrom a volumetric CTPAacquisition and report the ratio ofthose measurements for adults.Rapid RV/LV analyzes casesusing machine learningalgorithms to identify locationsand measurements of theventricles. The Rapid RV/LVdevice provides the user withannotated images showingventricular measurements. Itsresults are not intended to be usedon a stand-alone basis for clinicaldecision-making or otherwisepreclude clinical assessment ofCTPA cases.
Input DataRequirements	Non-gated, CTPulmonary	Same

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iSchemaView - Traditional 510(k) Rapid RV/LV

	Angiography images
DICOMCompliance	Yes, using CTPA	Same
LV Segmentation	Yes	Same
RV Segmentation	Yes	Same
DiameterMeasurements	Yes - Automated	Same
Fully AutomatedSegmentation	Yes	Same
Interface	Command Line	Command Line
Outputs	Reports, DICOM SecondaryCapture Series	Reports, DICOM SecondaryCapture Series

510(k) Summary

AI/ML Module Development:

Algorithm development was performed using 516 CTPA cases from multiple sites; training included 80% of cases for validation and 20% for training. Cases selected covered a wide range of LV diameters. Cases were obtained from Siemens, GE, Toshiba, and Philips scanners.

Clinical Characteristics:

The primary users of Rapid RV/LV software are medical professionals who use RV/LV ratio as a clinical metric quantifying the severity of right-heart strain.

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)

Performance Data:

Rapid RV/LV 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.

iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid RV/LV device. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid RV/LV device provides accurate representation of key processing parameters under a range of clinically relevant perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid RV/LV device met all design requirements and specifications.

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iSchemaView - Traditional 510(k) Rapid RV/LV

510(k) Summary

Final performance validation included 124 CTPA cases with ground truth established by 3 experts. The primary endpoint passed, the average slope was 1.1 (95% CI: 1.0, 1.2) and the average intercept was -0.2 (95% CI: -0.1. -0.3 The lower confidence level of the 95% CI of the slope and intercept were 1.0 and -0.1. The secondary endpoint (Bland-Altman bias) passes with mean bias of 0.023 (95% CI 0: -0.04. 0.08). Mean Absolute Error (MAE) between Rapid RV/LV and the experts was calculated at 3.8mm. 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.

Prescriptive Statement:

Caution: Federal law restricts this device to sale by or on the order of a physician.

Safety & Effectiveness:

Rapid RV/LV 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 RV/LV performance has been validated with case data.

Conclusion:

In conclusion, the iSchemaView Rapid RV/LV software device is substantially equivalent in intended use, technological characteristics, safety and performance characteristics to the legally marketed predicate device, Imbio RV/LV Software (K203256).

Regulation Number and Section

§ 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).