(134 days)
Not Found
Unknown
The summary mentions "computer assisted reading tools" and "CADe marks," which are often associated with AI/ML, but it does not explicitly state that AI or ML is used in the device description or other sections.
No.
The device is a computer-assisted reading tool designed to aid radiologists in detecting pulmonary nodules, providing adjunctive information rather than directly treating or mitigating a disease or condition.
Yes
Explanation: The device is designed to "aid the radiologist in the detection of pulmonary nodules," which is a diagnostic function. It provides "adjunctive information" and "CADe marks and associated region descriptors" to assist in identifying a medical condition.
Yes
The device is described as a "dedicated post-processing application" that generates a secondary image series and CADe marks. This strongly indicates a software-only function operating on existing CT data. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: ClearRead CT processes medical images (CT scans of the chest) to aid in the detection of pulmonary nodules. It does not interact with or analyze biological samples.
The description clearly indicates that the device is a "dedicated post-processing application" that works with "CT examinations of the chest." This falls under the category of medical image analysis software, not IVD.
N/A
Intended Use / Indications for Use
ClearRead CTTM is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during 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.
Product codes (comma separated list FDA assigned to the subject device)
OEB, LLZ
Device Description
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 pulmonary nodules.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT examinations of the chest
Anatomical Site
Pulmonary / Lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologist
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation was conducted in a multi-reader multi-case (MRMC) study to validate that the device conformed to the defined user needs and intended uses. The reader study measured the area under the curve (AUC) of the localization receiver operating characteristic (LROC) response when using ClearRead CT relative to the unaided read. The study also measured the radiologists' interpretation time when using ClearRead CT relative to unaided interpretations. ClearRead CT was found to significantly increase the AUC, indicating use of the device is superior to the unaided read for detecting nodules. ClearRead CT was found to decrease read times with and without outliers.
Developmental testing was conducted to verify requirements according to the ClearRead CT device specifications. The Risk Analysis was completed and risk control measures implemented to mitigate hazards. Documentation required for software with a Moderate Level of Concern is included as part of the submission. Device labeling together with results from verification & validation testing demonstrate the device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Area Under the Curve (AUC), interpretation time
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Riverain Technologies, LLC % Ms. Jennifer Butsch Director of Regulatory Affairs & Quality Assurance 3020 South Tech Blvd. MIAMISBURG OH 45324
Re: K161201
Trade/Device Name: ClearRead CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB, LLZ Dated: September 6, 2016 Received: September 7, 2016
Dear Ms. Butsch:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ClearRead CT
Indications for Use (Describe)
ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during 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.
| 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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1.0 510(K) SUMMARY
| Submission Date: | April 25, 2016 |
|---|---|
| ------------------ | ---------------- |
Submitter Information:
| Company Name: | Riverain Technologies, LLC. |
|---|---|
| --------------- | ----------------------------- |
| Company Address: | 3020 South Tech Blvd., Miamisburg, OH 45342-4860 |
|---|---|
| Contact Person: | Jennifer Butsch |
| Director, Regulatory Affairs and Quality Assurance | |
| Riverain Technologies | |
| 800.990.3387 | |
| 937.425.6493 | |
| jbutsch@riveraintech.com |
Device Information:
| Trade Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code: | ClearRead CTTM
21 CFR §892.2050
Picture archiving and communications system
Class II
OEB/LLZ |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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 pulmonary nodules. |
| Indications for Use: | ClearRead CTTM is comprised of computer assisted reading tools
designed to aid the radiologist in the detection of pulmonary
nodules during 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. |
| Predicate Devices: | syngo.CT Lung CAD
(K143196)
Siemens AG Medical Solutions
Class II
syngo.PET&CT Oncology
(K093621) |
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Siemens AG Medical Solutions Class II
ClearRead Bone Suppression (SoftView) (K092363) Riverain Technologies, LLC Class II
Comparison to Predicate Device Technical Characteristics:
Riverain is of the opinion that the ClearRead CT is substantially equivalent, both in intended use and technical characteristics to the listed predicate devices. Differences in the design and performance from the cited predicate devices do not affect either the safety or the effectiveness of ClearRead CT for its intended use.
| | Predicate:
syngo.CT Lung
CAD (Siemens
AG Medical
Solutions)
K143196 | Predicate:
syngo.PET &
CT Oncology
(Siemens AG
Medical
Solutions)
K093621 | Predicate:
ClearRead
Bone
Suppression
(Riverain
Technologies)
K092363 | Subject Device:
ClearRead CT
(Riverain
Technologies) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OEB | LLZ | LLZ | OEB/LLZ |
| Intended Use | Computer-aided
detection tool
designed to
assist
radiologists in
the detection of
solid pulmonary
nodules during
review of
MDCT
examinations of
the chest | Viewing,
manipulation,
3D-
Visualization,
and
comparison
of medical
images from
multiple
imaging
modalities. | Generating
bone
suppressed
image from
an original
PA/AP chest
radiograph | Computer
assisted reading
tools designed to
aid the
radiologist in the
detection of
pulmonary
nodules during
review of CT
examinations of
the chest |
Testing Summary:
Clinical validation was conducted in a multi-reader multi-case (MRMC) study to validate that the device conformed to the defined user needs and intended uses. The reader study measured the area under the curve (AUC) of the localization receiver operating characteristic (LROC) response when using ClearRead CT relative to the unaided read. The study also measured the radiologists' interpretation time when using ClearRead CT relative to unaided interpretations. ClearRead CT was found to significantly increase the AUC, indicating use of the device is superior to the unaided read for detecting nodules. ClearRead CT was found to decrease read times with and without outliers.
Developmental testing was conducted to verify requirements according to the ClearRead CT device specifications. The Risk Analysis was completed and risk control measures
5
implemented to mitigate hazards. Documentation required for software with a Moderate Level of Concern is included as part of the submission. Device labeling together with results from verification & validation testing demonstrate the device is safe and effective.
Conclusion:
In preparing this 510(k) submission, Riverain has carefully considered the relevant statutory and regulatory requirements, and believes that the information contained within satisfies the requirements for demonstrating substantial equivalence.