COLON CAR 1.2

K042674 · Medicsight · NWE · Oct 19, 2004 · Radiology

Device Facts

• Record ID: K042674
• Device Name: COLON CAR 1.2
• Applicant: Medicsight
• Product Code: NWE · Radiology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Colon CAR 1.2 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images. Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

Device Story

Colon CAR 1.2 is a PC-based software tool for CT colonography. It processes CT image data to assist radiologists in identifying and evaluating colonic polyps and lesions. Users define regions of interest (ROI) manually or via semi-automatic seed-point selection with boundary fine-tuning. The device provides 2D/3D visualization and measurement of polyp size and volume. A key feature is the Polyp Enhanced Viewing (PEV) filter, which identifies intra-colonic filling defects protruding into the lumen. The PEV filter is adjustable based on object sphericity, height-to-base ratio (flatness), and diameter range. Results are presented in a Joint Reader view, displaying enhanced and non-enhanced data simultaneously. The software supports simultaneous display of supine and prone images. By highlighting potential polyp candidates, the device aids the radiologist's diagnostic workflow, potentially improving the detection of colonic lesions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PC-based, stand-alone software application. Functions as an accessory to CT X-ray systems. Features include 2D/3D visualization, manual/semi-automatic ROI extraction, and Polyp Enhanced Viewing (PEV) filter for feature enhancement.

Indications for Use

Indicated for use by radiologists and clinicians to assist in the evaluation of polyps, cancers, and other lesions in the colon using 2D and 3D CT scan image data.

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

• MedicColon 1.0 (K033102)

Submission Summary (Full Text)

{0}------------------------------------------------

# MEDI@SIGHT

K042674

OCT 1 9 2004

Appendix E

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92( c ).

| Submitted by: | |
|---------------------|--------------------------------------------|
| Name: | Medicsight PLC. |
| Address: | 46 Berkeley Square<br>London W1J 5AT<br>UK |
| Telephone: | 44 (0) 207 598 4070 |
| Facsimile: | 44 (0) 207 598 4071 |
| Contact: | Carol MacDonald, RA QA Director |
| Date of summary: | 24th September 2004 |
| Device Information: | |

#### evice Information:

| Trade Name: | Colon CAR™ Release 1.2 |
|----------------------|---------------------------------------------|
| Common Name: | Medical imaging software for CT scanners |
| Classification Name: | Computed Tomography X-Ray System, Accessory |
| Regulation Number: | 892.1750 |

#### Predicate Device:

Medicsight Colon CAR 1.2 is substantially equivalent to the following commercially available device:

| Manufacturer | Device | 510(k) No. | Clearance Date |
|--------------|----------------|------------|-------------------|
| MEDICSIGHT | MedicColon 1.0 | K033102 | November 5th 2003 |

{1}------------------------------------------------

# MEDI®SIGHT

#### Device Description:

Colon CAR™ (Computer Assisted Reader) 1.2 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps and other lesions in the colon. The software allows the user to select regions of interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of polyps and measurement of polyp characteristics such as size and volume. The further feature of Colon CAR™ 1.2 as compared to the cleared device is a Polyp Enhanced Viewing Filter (PEV), the results of which are presented in a Joint Reader filter view (enhanced and non-enhanced data viewed simultaneously). The PEV filter identifies intra-colonic filling defects protruding into the colonic lumen, thereby highlighting potential polyp candidates for further interrogation by the reporting radiologist. This filter is fully adjustable and, in deciding the desired characteristics of the objects to be highlighted, the radiologist may specify the degree of object sphericity (or roundness), the height of the protruding object in relation to its base (object 'flatness') as well as select an approximate object diameter range.

#### Intended Use:

Colon CAR 1.2 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.

Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the nonenhanced view.

#### Comparison to Predicate Device:

As in the predicate device, MedicColon 1.0, Colon CAR 1.2 assists users in assessing CT images for the identification and evaluation of colonic polyps.

Test data are provided to validate the performance of the system and its substantial equivalence to the predicate device. The functional features and the intended use of Colon CAR 1.2 are substantially equivalent to the predicate device. The modifications to the original device did not introduce any new potential safety risks.

{2}------------------------------------------------

# MEDI@SIGHT

### Safety:

A comprehensive hazard analysis was carried out on Colon CAR 1.2, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system.

### Conclusion:

Colon CAR 1.2 does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed device. Colon CAR 1.2 is therefore substantially equivalent with respect to safety and effectiveness to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Public Health Service

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol MacDonald Regulatory & Quality Director Medicsight 46 Berkeley Square London W1J5AT UNITED KINGDOM

Re: K042674 Trade/Device Name: Medicsight Colon CAR 1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NWE Dated: September 27, 2004 Received: September 29, 2004

Dear Ms. MacDonald:

This letter corrects our substantially equivalent letter of October 19, 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, 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.

{4}------------------------------------------------

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 (OS) 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.

Heike Leuren

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

Enclosure

{5}------------------------------------------------

APPENDIX A

Page __ of _

510(k) Number (if known): Ko 4z 2 24

Device Name: Medicsight Colon CAR 1.2

Indications for Use:

Colon CAR 1.2 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.

Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C hogdon

Prescription Use_

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042674

3