COLON VIEW, MODEL CSCV-001A

K090220 · Toshibamedical Systems Corporation · JAK · Feb 11, 2009 · Radiology

Device Facts

• Record ID: K090220
• Device Name: COLON VIEW, MODEL CSCV-001A
• Applicant: Toshibamedical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Feb 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

This application software is an image analysis package that allows for the visualization of the colon using volume datasets that provide 2D, 3D and MPR images. When employed by a qualified physician, this package can be used to observe polyps, masses and other lesions of the colon. Upon observation of the potential lesion the physician can mark and categorize the observed lesion. This package also allows for the generation of reports that can be exported to DICOM based PACS systems for the continued tracking of changes in the colon.

Device Story

Colon View CSCV-001A is a post-processing software package for CT colonography. It takes CT volume datasets as input to generate 2D, 3D, and multi-planar reconstruction (MPR) images of the colon. Used in clinical settings by physicians, the software enables the observation, manual marking, and categorization of potential polyps, masses, or lesions. It facilitates clinical decision-making by allowing physicians to track changes in the colon over time through generated reports exported to DICOM-based PACS systems. The device does not control the CT scanner and has no impact on radiation dose.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Post-processing software package for 3D image review. Operates on CT volume datasets. Does not control CT scanner hardware. DICOM-compliant for PACS integration.

Indications for Use

Indicated for use by qualified physicians to visualize colon volume datasets (2D, 3D, MPR) to observe, mark, and categorize polyps, masses, and other colon lesions.

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

• GE CT Colonography II (K041270)
• Siemens syngo Colonography (K042605)
• Siemens syngo Colonography (K030982)
• GE Ct Colonography (K023943)

Submission Summary (Full Text)

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# Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; Colon View CSCV-001A

K09020

# 510(k) Summary

Date:

Submitter's Name:

Submitter's Address:

Submitter's Contact:

October 24, 2008

TMSC: 9614698

TAMS: 2020563

Colon View CSCV-001A

CT Colonography Software

II (per 21 CFR 892.1750)

21 CFR Subchapter J.

Scanner, Computed Tomography, X-Ray [Fed. Reg. No. 892.1750, Pro. Code: 90JAK]

Federal Diagnostic X-ray Equipment Standard

GE CT Colonography II [k041270]

Siemens syngo Colonography [k042605] Siemens syngo Colonography [k030982]

GE Ct Colonography [k023943]

FEB 1 1 2009

Toshiba Medical System Corporation (TMSC)

1385 Shimoishigami, Otawara-shi, Tochigi-ken, Japan, 324-8550

Paul Biggins, Director Regulatory Affairs Toshiba America Medical Systems, Inc.(TAMS) 2441 Michelle Drive Tustin, CA 92780 T: [phone] F: [phone]

Establishment Registration Number:

Device Proprietary Name:

Common Name:

Regulatory Class:

Performance Standard:

Predicate Device(s):

Reason For Submission

New software package

#### Description of this Device:

Colon View is a post processing software package that allows for the review, annotation and reporting of 2D, 3D and MPR images, obtained from volume datasets, of colon images.

Summary of Intended Uses:

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## Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; Colon View CSCV-001A

This application software is an image analysis package that allows for the visualization of the colon using volume datasets that provide 2D, 3D and MPR images. When employed by a qualified physician, this package can be used to observe polyps, masses and other lesions of the colon. Upon observation of the potential lesion the physician can mark and categorize the observed lesion.

This package also allows for the generation of reports that can be exported to DICOM based PACS systems for the continued tracking of changes in the colon.

### Technological Characteristics:

This device is a post processing software package that enhances currently available #D image review software. The software does not control the CT scanner, thus has no effect on radiation dose, but allows for the processing of image data for the colon.

#### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR & 820.

### Substantial Equivalence:

This device is a software package that contains similar features of the predicate devices that are commercially available at this time.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K090220

: Trade/Device Name: Colon View CSCV-001A Regulation Number: 21 CFR 892,1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 28, 2008 Received: January 29, 2008

### Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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. This letter will allow you to begin marketing your device as described in your Section 510(k)

premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

### 510(k) Number (if known): Kego220

Device Name: Colon View CSCV-001A

Indications for Use:

This application software is an image analysis package that allows for the visualization of the colon using volume datasets that provide 2D, 3D and MPR images. When employed by a qualified physician, this package can be used to observe polyps, masses and other lesions of the colon. Upon observation of the potential lesion the physician can mark and categorize the observed lesion.

This package also allows for the generation of reports that can be exported to DICOM based PACS systems for the continued tracking of changes in the colon.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huls

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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