CLEARVIEW

K133373 · Neusoft Medical Systems Co., Ltd. · JAK · Dec 3, 2014 · Radiology

Device Facts

• Record ID: K133373
• Device Name: CLEARVIEW
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space. A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts. ClearView are not intended to be used in CCT and Pilot.

Device Story

ClearView is a CT reconstruction software module; operates on raw data acquired from CT scanners. User selects between ClearView or standard Filter Back-Projection (FBP) reconstruction. Employs iterative processing between image space and raw data space to reduce pixel noise and body streak artifacts. Allows for reduced mAs (radiation dose) while maintaining diagnostic image quality. Users select from 9 noise reduction levels (10% to 90%) based on clinical task, patient size, and anatomy. Used by radiologists/technicians in clinical settings to optimize image quality and dose. Benefits include potential patient radiation dose reduction and improved low-contrast resolution.

Clinical Evidence

Bench testing only. No clinical data. Evidence includes phantom measurements (MITA body and ACR head phantoms) comparing full-dose FBP to reduced-dose ClearView. Metrics included pixel noise, high contrast resolution, and low contrast detectability. Model Observer evaluation confirmed equivalent low contrast detectability at the highest noise reduction level for 0.625 mm reconstruction slices.

Technological Characteristics

CT reconstruction software; iterative algorithm; 9 selectable noise reduction levels (10-90%); operates on raw CT data; integrates with existing CT scanner image reconstruction modules; software-based.

Indications for Use

Indicated for use as a CT reconstruction software to assist in reducing radiation dose while maintaining image quality (pixel noise, low contrast detectability, high contrast resolution) and reducing body streak artifacts in CT imaging. Not intended for use in CCT and Pilot.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• NeuViz 64 Multi-Slice CT Scanner System (K121792)

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

Neusoft Medical Systems Co., Ltd. % Mr. Tian Yuehui No. 16, Shiji Road Hunnan Industrial Area Shenyang, Liaoning, 110179 CHINA

Re: K133373

Trade/Device Name: ClearView Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 30, 2014 Received: November 3, 2014

Dear Mr. Yuehui:

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.

December 3, 2014

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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/Resourcesfor You/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,

Robert A Ochs

for

Janine M. Morris 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 Form

K133373 510(k) Number (if known) :

Device Name: ClearView

Indications for use:

ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data.

Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.

A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.

ClearView are not intended to be used in CCT and Pilot.

Prescription Use Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Deices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510 (k) -

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Section 6

510(K) Summary

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## 510(K) Summary

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This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92

General Information:

| Trade Name: | ClearView |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | ClearView |
| Classification Name: | 21 CFR Part 892.1750<br>Computed Tomography X-ray System |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment<br>Standard |
| Manufacture: | Neusoft Medical Systems Co., Ltd.<br>No.16 Shiji Road, Hunnan Industrial Area, Shenyang,<br>Liaoning, China, 110179 |
| Distributor: | Neusoft Medical Systems Co., Ltd.<br>No.16 Shiji Road, Hunnan Industrial Area, Shenyang,<br>Liaoning, China, 110179 |
| Submitter: | Contact : Tian Yuehui<br>Title : Manager of Q&R Department<br>Tel : [phone]<br>Fax : [phone]<br>E-Mail : [e-mail] |

Summary prepared : November, 30, 2014

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## Safety and Effectiveness information

Intended Uses:

ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.

A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.

ClearView are not intended to be used in CCT and Pilot.

Device Description:

ClearView reconstruction technology may enable reduction in pixel noise standard deviation and improvement in low contrast resolution. ClearView reconstruction algorithm may allow for reduced mAs in the acquisition of image, thereby it can reduce the dose required.

In clinical practice, the use of ClearView reconstruction may reduce CT patient dose depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.

As a reconstruction option, ClearView can be selected before scanning or after scanning. There are 9 ClearView Levels from 10% to 90%. Users can select t.the level of ClearView that is appropriate for the clinical task being performed. According to the comparison based on the requirements of 21 CFR 807.87, we stated that ClearView reconstruction software is substantially equivalent to the FBP of NeuViz 64 Multi-Slice CT Scanner System.

ClearView is a moderate concern device.

Predicated Devices:

NeuViz 64 Multi-Slice CT Scanner System(K121792).

Statement of Substantial Equivalence:

ClearView is a CT reconstruction technology, which is of comparable type and substantially equivalent to the filter back-projection (FBP) that complies with the same or equivalent standards and has the same intended uses. The end user can choose to apply either

ClearView or the filter back-projection (FBP) to the acquired raw data within the image reconstruction module of the NeuViz 64 Multi-Slice CT Scanner System(K121792). Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution.

According to the comparison based on the requirements of 21 CFR 807.87, we stated

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that ClearView reconstruction software is substantially equivalent to the FBP of
NeuViz 64 Multi-Slice CT Scanner System.