(85 days)
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "analyzes cases using machine learning algorithms".
No
The device is described as a diagnostic tool that provides measurements and annotated images for medical professionals, not a device that directly treats or prevents a condition. Its results are explicitly stated not to be used on a stand-alone basis for clinical decision-making.
Yes
The device measures anatomical parameters (ventricle diameters and their ratio) which are used in the diagnosis of certain heart conditions. Although its results are not for standalone clinical decision-making, it provides quantitative data for assessment.
Yes
The device description explicitly states it is a "software device" and a "radiological computer-assisted image processing software device" that operates within an integrated platform and processes DICOM images. There is no mention of accompanying hardware components.
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: The Rapid RV/LV software device analyzes medical images (CTPA scans) of the heart. It does not perform tests on biological samples.
- Intended Use: The intended use is to measure anatomical structures (ventricle diameters) from images and provide a ratio, which is a form of image analysis and measurement, not a diagnostic test on a biological sample.
- Device Description: The description explicitly states it is a "radiological computer-assisted image processing software device."
Therefore, while it is a medical device used in the diagnostic process, it falls under the category of medical image processing software rather than an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 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.
Product codes
QIH
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
volumetric CTPA acquisition
Non-gated, CT Pulmonary Angiography images
Anatomical Site
ventricles of the heart
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professionals who use RV/LV ratio as a clinical metric quantifying the severity of right-heart strain.
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
Final performance validation included 124 CTPA cases with ground truth established by 3 experts. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Absolute Error (MAE) between Rapid RV/LV and the experts was calculated at 3.8mm.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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 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)
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.
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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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 200 |
| Golden, CO 80401 | |
| Official Contact: | Jim Rosa |
| Phone: (303) 704-3374 | |
| Email: rosa@ischemaview.com |
Summary Preparation Date: January 31, 2023
Device Name and Classification:
| Trade Name: | Rapid RV/LV |
|---|---|
| Common Name: | Automated Radiological Image Processing |
| Software | |
| Classification: | II |
| Product Code: | Primary: QIH |
| Regulation No: | 21 C.F.R. §892.2050 |
| Classification | |
| Panel: | 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:
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).
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iSchemaView - Traditional 510(k) Rapid RV/LV
510(k) Summary
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 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.
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 Software
K203256 - Predicate Device | Rapid RV/LV – Subject Device
K223396 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | QIH | QIH |
| Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 |
| Intended Use/
Indications for
Use | The Imbio 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. RV/LV
analyzes cases using an artificial
intelligence algorithm to
identify the location and
measurements of the ventricles.
The RV/LV software 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 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. |
| Input Data
Requirements | Non-gated, CT
Pulmonary | Same |
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iSchemaView - Traditional 510(k) Rapid RV/LV
| Angiography images | ||
|---|---|---|
| DICOM | ||
| Compliance | Yes, using CTPA | Same |
| LV Segmentation | Yes | Same |
| RV Segmentation | Yes | Same |
| Diameter | ||
| Measurements | Yes - Automated | Same |
| Fully Automated | ||
| Segmentation | Yes | Same |
| Interface | Command Line | Command Line |
| Outputs | Reports, DICOM Secondary | |
| Capture Series | Reports, DICOM Secondary | |
| Capture 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).