(267 days)
Not Found
Yes
The device description mentions "Image predictive processing (DLServer)" and the performance studies describe "Standalone performance testing which included chest CT scans from patients who underwent lung cancer screening was performed to validate detection accuracy of InferRead Lung CT.AI." and "Results showed that InferRead Lung CT.AI had similar nodule detection sensitivity and FP/scan compared to those of the predicate device." This strongly suggests the use of deep learning (DL) or other predictive algorithms, which fall under the umbrella of AI/ML, for image analysis and nodule detection.
No.
The device is described as aiding in the detection of pulmonary nodules, not treating a condition or providing therapy.
Yes
Explanation: The device is described as "computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest". The detection of pulmonary nodules is a diagnostic activity.
Yes
The device is described as software provided as a Service (SaaS) via a URL, with modules for image reception, processing, storage, and display. While it interacts with hardware like CT scanners and PACS systems, the device itself is the software component that performs the analysis and provides annotations. The description focuses on the software architecture and modules, not on any specific hardware included with the device.
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.
- InferRead Lung CT.AI's Function: InferRead Lung CT.AI analyzes medical images (CT scans) of the chest. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to aid radiologists in the detection of pulmonary nodules during the review of CT examinations. This is an image analysis and interpretation tool, not a diagnostic test performed on a biological sample.
Therefore, InferRead Lung CT.AI falls under the category of medical imaging software or computer-assisted detection (CAD) software, not an in vitro diagnostic device.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series.
Product codes
OEB, LLZ
Device Description
InferRead Lung CT.AI uses the Browser/Server architecture, and is provided as Service (SaaS) via a URL. The system integrates algorithm logic and database in the same the simplicity of the system and the convenience of system maintenance. The server is able to accept chest CT images from a PACS system, Radiological Information System) or directly from a CT scanner, analyze the images and provide output annotations regarding lung nodules. Users are an existing PACS system to view the annotations. Dedicated servers can be located at hospitals and are directly connected to the hospital networks. The software consists of 4 modules which are Image reception (Docking Toolbox), Image predictive processing (DLServer), Image storage (RePACS) and Image display (NeoViewer).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
chest / lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist, hospital networks
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
A total of 10 board-certified radiologists and a collection of 249 scans were involved in the reader study.
Summary of Performance Studies
Non-clinical performance evaluation: Software testing was performed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002). Software testing which included unit testing, software integration testing and software system testing was performed on InferRead Lung CT.AI. It was demonstrated that InferRead Lung CT.AI, when used according to operating instructions, met all requirement specifications. All system functionalities were tested and passed. Measurement performance was validated on phantom and clinical data to assess reproducibility and accuracy. Standalone performance testing which included chest CT scans from patients who underwent lung cancer screening was performed to validate detection accuracy of InferRead Lung CT.AI. Results showed that InferRead Lung CT.AI had similar nodule detection sensitivity and FP/scan compared to those of the predicate device. Based on the results of verification and validation tests it is concluded that InferRead Lung CT.AI is effective and safe in the detection of nodules.
Clinical performance evaluation: A pivotal reader study which was a retrospective, fully crossed, multi-reader multi-case (MRMC) study was conducted to validate that the device conformed to the defined user needs and intended uses. A total of 10 board-certified radiologists and a collection of 249 scans were involved in the reader study. The purpose of the reader study was to validate that with the aided of InferRead Lung CT.AI radiologists' nodule detection performance could significantly improve without significantly increasing reading time at a significance level alpha of 0.05 (two-sided). The reader study measured the area under the curve (AUC) of the localization receiver operating characteristic (LROC) response when using InferRead Lung CT.AI relative to the unaided read. The study also measured the radiologists' interpretation time when using InferRead Lung CT.AI relative to unaided interpretations. Results showed that InferRead Lung CT.AI was found to significantly increase the AUC (Aided - Unaided: 0.073, 95%CI: 0.020, 0.125), indicating the detection performance through using the device is superior to the unaided read for detecting nodules. Moreover, InferRead Lung CT.AI was also found to decrease reading times (Aided - Unaided: -23s, 95%Cl: -42, -3). In conclusion, the pivotal study showed that with the aided of InferRead Lung CT.AI radiologists' nodule detection performance could significantly improve without significantly increasing reading time.
Key Metrics
AUC (Aided - Unaided): 0.073, 95%CI: 0.020, 0.125
Reading times (Aided - Unaided): -23s, 95%Cl: -42, -3
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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Beijing Infervision Technology Co., Ltd. % Matt Deng 1900 Market St., 8th Floor PHILADELPHIA, PA 19103
July 2, 2020
Re: K192880
Trade/Device Name: InferRead Lung CT.AI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: OEB, LLZ Dated: June 2, 2020 Received: June 3, 2020
Dear Matt Deng:
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 (OS) 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,
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
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Indications for Use
510(k) Number (if known)
K192880
Device Name InferRead Lung CT.AI
Indications for Use (Describe)
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series.
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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Summary of 510(k)
Beijing Infervision Technology Co., Ltd. K192880
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | Beijing Infervision Technology Co., Ltd.
Room B401, 4th Floor, Building 1,
No.12 Shangdi Information Road.
Haidian District, Beijing, 100085
Phone: +86 10-86462323 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Mr. Matt Deng
Email: dyufeng@infervision.com
Phone: 919-491-5457 |
| Company Contact: | Xiaoyan Fan
Project Leader |
| Date Prepared: | July 1, 2020 |
Device Name and Classification
| Trade Name: | InferRead Lung CT.AI |
|---|---|
| Classification: | Class II |
| Regulation Number: | 21 CFR 892.2050, Picture archiving and communications system |
| Classification Panel: | Radiology |
| Product Code: | OEB, LLZ |
Predicate Device:
| Trade Name | ClearRead CT |
|---|---|
| Classification | Class II |
| 510(k) Number | K161201 |
| Regulation Number | 21 CFR 892.2050, Picture archiving and communications system |
| Classification Panel | Radiology Panel |
| Product Code | OEB, LLZ |
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Device Description
InferRead Lung CT.AI uses the Browser/Server architecture, and is provided as Service (SaaS) via a URL. The system integrates algorithm logic and database in the same the simplicity of the system and the convenience of system maintenance. The server is able to accept chest CT images from a PACS system, Radiological Information System) or directly from a CT scanner, analyze the images and provide output annotations regarding lung nodules. Users are an existing PACS system to view the annotations. Dedicated servers can be located at hospitals and are directly connected to the hospital networks. The software consists of 4 modules which are Image reception (Docking Toolbox), Image predictive processing (DLServer), Image storage (RePACS) and Image display (NeoViewer).
Indications for Use
InferRead Lung CT.AI is comprised of computer assisted to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.Al provides adjunctive information and is not intended to be used without the original CT series.
Risk Analysis Method
The InferRead Lung CT.AI was assessed to determine risks to health associated with the use of the device. Risks related to safety and usability were considered. A risk analysis was conducted in accordance with ISO 14971:2007, Medical devices – Application of risk management to medical devices. Several risks were assessed, including, but not limited to device malfunction and improper use.
Substantial Equivalence
InferRead Lung CT.AI is substantially equivalent to the ClearRead CT (K161201) currently on the market.
The table below provides a detailed comparison of InferRead Lung CT.AI to the predicate device.
| Item | InferRead Lung CT.AI
(Subject Device) | ClearRead CT (K161201)
(Predicate Device) | Comparison |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | InferRead Lung CT.AI is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection
of pulmonary nodules | ClearRead CT™ is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection of
pulmonary nodules during | The indications for use of InferRead Lung
CT.AI are identical to the indications for
use of the previously cleared ClearRead
CT. |
| | | | |
| | during the review of CT examinations of the chest on an asymptomatic population. InferRead Lung CT.AI requires that both lungs be in the field of view. InferRead Lung CT.AI provides adjunctive information and is not intended to be used without the original CT series. | review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series. | |
| Intended Use | Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest. | Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest. | The intended use of InferRead Lung CT.AI is identical to the intended use of the previously cleared ClearRead CT. |
| Accessories/Tools
Required by the
User (Platform) | Must be used in conjunction with a PACS system or an Image Viewer that reads DICOM images. | Must be used in conjunction with a PACS system or an Image Viewer that reads DICOM images. | The accessories required by the user for InferRead Lung CT.AI are identical to the accessories required by the user for the previously cleared ClearRead CT. |
| User Access
Point | Post Processing Application | Post Processing Application | The user access point of InferRead Lung CT.AI is identical to the user access point of the previously cleared ClearRead CT. |
| Image Input | DICOM | DICOM | The image input of InferRead Lung CT.AI is identical to the image input of the previously cleared ClearRead CT. |
| Type of Scans | CT | CT | The type of scans for InferRead Lung CT.AI are identical to the type of scans for the previously cleared ClearRead CT. |
| Automatically
Locate and
Identify Lung | Yes | Yes | The function of automatically locating and identifying lung nodules for InferRead Lung CT.AI is identical to the function of |
| | | | |
| | | | lung nodules for the previously cleared
ClearRead CT. |
| Modifies the
Original CT
Scan | No | Yes | According to the device description of the
predicate device found in its 510K
summary, "ClearRead CT is a dedicated
post-processing application that generates
a secondary vessel suppressed Lung CT
series with CADe marks and associated
region descriptors intended to aid the
radiologist in the detection of pulmonarynodules." ClearRead CT modifies the
original scan by performing vessel
suppression. On the contrary, InferRead
Lung CT.AI does not modify the original
scan, only shows the locations of
pulmonary nodules.
This difference does not affect the
intended use or safety and effectiveness of
the device. |
| Requires a
Disjoint
Comparison with
the Original CT
Scan | No | Yes | Since ClearRead CT creates a secondary
vessel suppressed Lung CT series, it
requires the user to have an original CT
series on a separate window. There are 2
series open at the same time. We refer to
this setup as "disjoint comparison". On the
contrary, InferRead Lung CT.AI does not
require 2 series open, as its CADe marks
overlay with the original CT scan and can
be toggled on and off. Therefore,
InferRead Lung CT.AI does not require
"disjoint comparison"
This difference does not affect the
intended use or safety and effectiveness of
the device. |
| | | | InferRead Lung CT.AI display the original
CT scans. |
| Nodule Marking | A bounding box is provided
around nodules | A bounding box is provided
around nodules | The function of providing a bounding box
around nodules for InferRead Lung CT.AI
is identical to the indications for use of the
previously cleared ClearRead CT. |
| Provides Nodule
Characteristics | Yes, the maximum axial
plane longest diameter,
mean diameter and volume
information are provided. | Yes, the volume, maximum
axial plane diameter,
minimum axial plane
diameter, and average
density in Hounsfield units
are provided. (from website) | InferRead Lung CT.AI has mean diameter
measurement function that is not provided
by predicate device. Mean diameter is the
average of maximum axial plane diameter
and minimum axial plane diameter. And
this difference does not affect the safety
and effectiveness of the device. |
| Detection
Target(s) | Solid, Sub Solid (part solid
and ground glass) nodules | Solid, Sub Solid (part solid
and ground glass) nodules | The detection targets of InferRead Lung
CT.AI are identical to the detection targets
of the previously cleared ClearRead CT.
They have the same definition principles
for actionable nodules classification. |
| Size of Detection
Targets | 4mm and above, supports
visualization of nodules
smaller than 4mm | 5mm and above, supports
visualization of nodules
smaller than 5mm | The InferRead Lung CT.AI detects smaller
nodules. This difference does not affect
the intended use or safety and
effectiveness of the device. This difference
has been addressed with the completion of
stand-alone performance characteristics
testing. |
Detailed Comparison of the Subject and Predicate Devices
Infervision InferRead Lung CT.AI Traditional 510(k)
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Testing Summary
Non-clinical performance evaluation
Software testing was performed in accordance with General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002). Software testing which included unit testing, software integration testing and software system testing was performed on InferRead Lung CT.AI. It was demonstrated that InferRead Lung CT.AI, when used according to operating instructions, met all requirement specifications. All system functionalities were tested and passed. Measurement performance was validated on phantom and clinical data to assess reproducibility and accuracy. Standalone performance testing which included chest CT scans from patients who underwent lung cancer screening was performed to validate detection accuracy of InferRead Lung CT.AI. Results showed that InferRead Lung CT.AI had similar nodule detection sensitivity and FP/scan compared to those of the predicate device. Based on the results of verification and validation tests it is concluded that InferRead Lung CT.AI is effective and safe in the detection of nodules.
Clinical performance evaluation
A pivotal reader study which was a retrospective, fully crossed, multi-reader multi-case (MRMC) study was conducted to validate that the device conformed to the defined user needs and intended uses. A total of 10 board-certified radiologists and a collection of 249 scans were involved in the reader study. The purpose of the reader study was to validate that with the aided of InferRead Lung CT.AI radiologists' nodule detection performance could significantly improve without significantly increasing reading time at a significance level alpha of 0.05 (two-sided). The reader study measured the area under the curve (AUC) of the localization receiver operating characteristic (LROC) response when using InferRead Lung CT.AI relative to the unaided read. The study also measured the radiologists' interpretation time when using InferRead Lung CT.AI relative to unaided interpretations. Results showed that InferRead Lung CT.AI was found to significantly increase the AUC (Aided - Unaided: 0.073, 95%CI: 0.020, 0.125), indicating the detection performance through using the device is superior to the unaided read for detecting nodules. Moreover, InferRead Lung CT.AI was also found to decrease reading times (Aided - Unaided: -23s, 95%Cl: -42, -3). In conclusion, the pivotal study showed that with the aided of InferRead Lung CT.AI radiologists' nodule detection performance could significantly improve without significantly increasing reading time.
Substantial Equivalence Conclusions
In conclusion, the intended use for InferRead Lung CT.AI is the same as that of the previously cleared ClearRead CT (K161201). The technological characteristics demonstrate that the InferRead Lung CT.AI is substantially equivalent to the previously cleared ClearRead CT (K161201), and the testing shows that the InferRead Lung CT.AI is substantially equivalent to the previously cleared ClearRead CT (K161201) and assures that the InferRead Lung CT.AI is as safe and effective as the previously cleared ClearRead CT (K161201).
Conclusion
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The 510(k) Pre-market Notification for InferRead Lung CT.AI contains adequate information and data to determine that InferRead Lung CT.AI is as safe and effective as the legally marketed predicate device.