MEDIC COLON MODEL, RELEASE 1

K033102 · Medicsight · JAK · Nov 5, 2003 · Radiology

Device Facts

• Record ID: K033102
• Device Name: MEDIC COLON MODEL, RELEASE 1
• Applicant: Medicsight
• Product Code: JAK · Radiology
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MedicColon I 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 a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.

Device Story

MedicColon 1 is a PC-based, stand-alone software for visualizing and analyzing CT colonography images; assists radiologists/clinicians in identifying polyps, cancers, and lesions. Input: 2D/3D CT scan data of the colon. Operation: user selects regions of interest (ROI) manually or via seed-point selection with semi-automatic boundary detection; software allows interactive fine-tuning of ROI boundaries and simultaneous display of supine and prone images. Output: 2D/3D visualizations and quantitative measurements (size/volume) of lesions. Clinical use: aids diagnostic evaluation; supports clinical decision-making by providing enhanced visualization and measurement tools. Benefit: improved assessment of colonic pathology.

Clinical Evidence

Bench testing only. Performance validated through hazard analysis and functional testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

PC-based, stand-alone software application. Functions include 2D/3D visualization, manual ROI drawing, and semi-automatic ROI boundary detection via seed-point selection. Operates on CT scan image data. No specific hardware or connectivity standards mentioned.

Indications for Use

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

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

• VOXAR VC, MODEL 1.0 (K012072)
• SYNGO COLONOGRAPHY SOFTWARE PRODUCT (K030982)

Submission Summary (Full Text)

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Ko3 3/02

Image /page/0/Picture/1 description: The image shows a logo for a company called "medicsight". The logo consists of a grid of black squares with a white circle in the center. The top right square is curved. The word "medicsight" is written in a handwritten-style font below the grid.

NOV - 5 2003

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:<br>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 Manager |
| Date of summary: | 22 September 2003 |

#### Device Information:

| Trade Name: | MedicColon™ Release 1 |
|----------------------|---------------------------------------------|
| Common Name: | Medical imaging software for CT scanners |
| Classification Name: | Computed Tomography X-Ray System, Accessory |
| Regulation Number: | 892.1750 |

### Predicate Devices:

Medicsight MedicColon 1 is substantially equivalent to the following devices:

| Manufacturer | Device | 510(k) No. |
|--------------|----------------------------------------|------------|
| VOXAR | VOXAR VC, MODEL 1.0 | K012072 |
| SIEMENS | SYNGO COLONOGRAPHY<br>SOFTWARE PRODUCT | K030982 |

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Image /page/1/Picture/0 description: The image shows a logo for a company called "medicsight". The logo consists of a square divided into nine smaller squares, with the corners of the larger square rounded off. The central square is white, while the surrounding squares are black. The word "medicsight" is written in a sans-serif font below the square.

#### Device Description:

MedicColon™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of polyps, cancers 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 other lesions, and measurement of polyp characteristics such as size and volume.

#### Intended Use:

MedicColon I 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 a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images.

#### Comparison to Predicate Device:

As in the predicate devices, Voxar VC Model 1.0 and Siemens Syngo Colonography Product. MedicColon 1 assists users in assessing CT images for the identification and evaluation of polyps, cancers and other lesions in the colon.

Test data are provided to validate the performance of the system and its substantial equivalence to the predicate devices. The functional features and the intended use of MedicColon 1 are substantially equivalent to the predicate devices.

#### Safety:

A comprehensive hazard analysis was carried out on MedicColon 1, 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:

MedicColon 1 does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. MedicColon 1 is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.

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Image /page/2/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 image of an eagle or bird with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol MacDonald Regulatory & Quality Manager MedicSight PLC 46 Berkeley Square London W1J 5AT UNITED KINGDOM

Re: K033102

NOV - 5 2003

Trade/Device Name: MedicSight MedicColon 1.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system -Regulatory Class: II Product Code: 90 JAK Dated: September 23, 2003 Received: September 29, 2003

Dear Ms. Mac Donald:

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.

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.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### APPENDIX A

Page __ of ___

510(k) Number (if known): Ko3 3/6 Z

Device Name: Medicsight MedicColon 1.0

Indications for Use:

MedicColon I 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 a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device✓

Nancy C Brogdon

(Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033102