CT COLONOGRAPHY II

K041270 · General Electric Medical Systems · LLZ · May 27, 2004 · Radiology

Device Facts

• Record ID: K041270
• Device Name: CT COLONOGRAPHY II
• Applicant: General Electric Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.

Device Story

CT Colonography II is a software package for analysis of DICOM 3.0 compliant CT colon images. It transforms raw CT data into 2D and 3D renderings, including an object-oriented endoluminal display. Used by radiologists and clinicians in clinical settings to process, review, and archive colon studies. Features include bookmarking of suspected lesions and synchronized viewing of 2D, 3D, and 360-degree dissection views. The device assists clinicians in identifying polyps, masses, and cancers, offering improved depth visualization compared to traditional colonoscopy. Output is used by healthcare providers to support diagnostic decision-making and clinical review.

Clinical Evidence

No clinical data provided; safety and effectiveness supported by software development, validation, and verification processes.

Technological Characteristics

Software-based image analysis package; DICOM 3.0 compliant; provides 2D/3D rendering, endoluminal display, and lesion bookmarking. Operates on CT image data. No hardware components described.

Indications for Use

Indicated for screening of the colon to detect polyps, masses, cancers, and other lesions in patients undergoing CT colonography. Intended for use by radiologists, clinicians, and referring physicians.

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

• CT Colonography (K023943)

Submission Summary (Full Text)

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1270

MAY 27 2004

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GE Medical Systems

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Programs Manager Tel: [phone] Fax: [phone] GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: February 20, 2004.

## PRODUCT IDENTIFICATION

| Name: | CT Colonography II |
|----------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography System |
| Manufacturer : | General Electric Medical Systems<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Buc, France. |
| Marketed Devices | The CT Colonography II is substantially equivalent to the devices listed below |
| Model: | CT Colonography |

General Electric Medical Systems, Buc, France Manufacturer: K023943 510(k) #:

#### Device Description:

CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose

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#### Indications for Use:

CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.

### Comparison with Predicate:

The functional features of the CT Colonography II software package are substantially equivalent to that of the following device:

| Device Name<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and answer of the control of change of channer of consection of the | FDA Clearance Number |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CT Colonography | Comments of the first and the commended to the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the<br>K023943 |

#### Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.

#### Conclusions:

The CT Colonography II does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CT Colonography II to be equivalent to those of CT Colonography (K023943).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical System % Mr. Tamas Borsai Program Manager 510(k) Review TUV Rheinland of North America, Inc. Medical Division, Newton Office 12 Commerce Road NEWTON CT 06470

Re: K041270 Trade/Device Name: CT Colonography II Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NWE Dated: May 3, 2004 Received: May 12, 2004

Dear Mr. Borsai:

This letter corrects our substantially equivalent letter of May 27, 2004.

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. Iisting 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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1. machine1/FDA1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 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,

Habd Leeman

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

Enclosure

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K04/27d

General Electric Medical Systems

## STATEMENT OF INDICATION FOR USE

Device name: CT Colonography II

#### Indication for Use:

CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.

(PL)EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) -OR-Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) Division Sinn. Division of Reprod and Radiological Dev 510(k) Number 3

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