ClearRead CT

K161201 · Riverain Technologies, LLC · OEB · Sep 9, 2016 · Radiology

Device Facts

• Record ID: K161201
• Device Name: ClearRead CT
• Applicant: Riverain Technologies, LLC
• Product Code: OEB · Radiology
• Decision Date: Sep 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

ClearRead CT is a post-processing application for chest CT examinations; inputs are original CT series; device generates secondary vessel-suppressed lung CT series with CADe marks and region descriptors; used by radiologists in clinical settings to assist in pulmonary nodule detection; provides adjunctive information to original CT series; aids clinical decision-making by highlighting potential nodules; benefits patients through improved detection accuracy and potentially reduced interpretation time.

Clinical Evidence

Multi-reader multi-case (MRMC) study conducted. Primary endpoints: localization receiver operating characteristic (LROC) area under the curve (AUC) and interpretation time. Results: ClearRead CT significantly increased AUC compared to unaided read; interpretation time decreased with and without outliers.

Technological Characteristics

Post-processing software application; generates vessel-suppressed CT images; includes CADe marks and region descriptors; software-based; Moderate Level of Concern.

Indications for Use

Indicated for radiologists to aid in the detection of pulmonary nodules during review of chest CT examinations in asymptomatic populations; requires both lungs in field of view; adjunctive use only with original CT series.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• syngo.CT Lung CAD (K143196)
• syngo.PET&CT Oncology (K093621)
• ClearRead Bone Suppression (SoftView) (K092363)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K161201

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) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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<br>Director, Regulatory Affairs and Quality Assurance<br>Riverain Technologies<br>800.990.3387<br>937.425.6493<br>[e-mail] |

# Device Information:

| Trade Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code: | ClearRead CTTM<br>21 CFR §892.2050<br>Picture archiving and communications system<br>Class II<br>OEB/LLZ |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | ClearRead CT is a dedicated post-processing application that<br>generates a secondary vessel suppressed Lung CT series with<br>CADe marks and associated region descriptors intended to aid the<br>radiologist in the detection of pulmonary nodules. |
| Indications for Use: | ClearRead CTTM is comprised of computer assisted reading tools<br>designed to aid the radiologist in the detection of pulmonary<br>nodules during review of CT examinations of the chest on an<br>asymptomatic population. The ClearRead CT requires both lungs<br>be in the field of view. ClearRead CT provides adjunctive<br>information and is not intended to be used without the original CT<br>series. |
| Predicate Devices: | syngo.CT Lung CAD<br>(K143196)<br>Siemens AG Medical Solutions<br>Class II<br><br>syngo.PET&CT Oncology<br>(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:<br>syngo.CT Lung<br>CAD (Siemens<br>AG Medical<br>Solutions)<br>K143196 | Predicate:<br>syngo.PET &<br>CT Oncology<br>(Siemens AG<br>Medical<br>Solutions)<br>K093621 | Predicate:<br>ClearRead<br>Bone<br>Suppression<br>(Riverain<br>Technologies)<br>K092363 | Subject Device:<br>ClearRead CT<br>(Riverain<br>Technologies) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | OEB | LLZ | LLZ | OEB/LLZ |
| Intended Use | Computer-aided<br>detection tool<br>designed to<br>assist<br>radiologists in<br>the detection of<br>solid pulmonary<br>nodules during<br>review of<br>MDCT<br>examinations of<br>the chest | Viewing,<br>manipulation,<br>3D-<br>Visualization,<br>and<br>comparison<br>of medical<br>images from<br>multiple<br>imaging<br>modalities. | Generating<br>bone<br>suppressed<br>image from<br>an original<br>PA/AP chest<br>radiograph | Computer<br>assisted reading<br>tools designed to<br>aid the<br>radiologist in the<br>detection of<br>pulmonary<br>nodules during<br>review of CT<br>examinations of<br>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

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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.