The Rendoscopy Gentle Colon, revision 2.0 is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software: - 3D visualization (3D detection, 2D assessment) . - No blind areas behind colonic folds due to splitting colon techniques . - Multipath Tracking System allows path-finding over collapsed or liquid-filled . parts of the colon - . The software provides full presentation of cross sectional imaging, such as axial, sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware. The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.
Device Story
Gentle Colon 2.0 is a software-based virtual colonoscopy system; processes DICOM-compliant 2D CT slice data. Operates on PC hardware; used by radiologists and clinicians to generate 3D/2D visualizations of the colon. Features include automated multipath tracking, colonic mucosa surface calculation, and colon splitting to visualize areas behind folds. System handles collapsed or liquid-filled segments automatically. Outputs include cross-sectional, intraluminal, and external views; provides automated report creation. Assists clinicians in colonic mucosa assessment; intended as an adjunct to standard diagnostic practices like barium enema. Benefits include improved visualization of colonic folds and reduced manual interaction during path planning.
Clinical Evidence
Clinical validation performed on 30 patient cases. A radiologist compared Gentle Colon 2.0 against the predicate device (GE Navigator) using both 2D and 3D reconstructions. Evaluated normal anatomy and pathologic findings in well-distended and partially collapsed colons. Results showed images were equivalent in all 30 cases.
Technological Characteristics
Software-based 3D visualization system; runs on PC hardware. Utilizes DICOM-compliant CT scan data. Features automated segmentation, multipath tracking, and direct volume rendering. Connectivity via standard PACS integration. No specific hardware materials or energy sources defined as it is a software-only device.
Indications for Use
Indicated for adult patients undergoing CT colonography for colonic mucosa assessment. Used as an adjunct to standard radiology practices for diagnosis of the colon.
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).
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EXHIBT #1 4 pages
SEP 1 8 2006
## 510(K) SUMMARY
This summary of 510(k) safety and effective4ness information is being submitted in accordance with the requirements of SMDA 0990 and 21 CFR § 807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
#### Submitter's Identification 1.
Rendoscopy, Inc. 66, Sixth Avenue Holtsville, NY 11742 Contact: Mira Pattanayak, Regulatory Associate, Tel # 631-586-2086, Fax # 631-289-5753
# Date Summary Prepared:
April 29, 2006
### 2. Name of Device:
Rendoscopy Gentle Colon, revision 2.0
- 3. Predicate Device Information:
G.E. Navigator , 510(k) # K 954355 This system is an add-on to the Advantage Windows Workstation.
#### 4. Device Description:
The Gentle Colon contains all of the required software components to provide interactive 3D views from diagnostic CT scan 2D slice cut images of the colon utilizing PC hardware. The views include cross sectional imaging such as axial, sagittal, frontal, oblique, intraluminal, split colon, topogram view, external view of the colon and double contrast visualization. After the CT scan , axial cuts scanned colon image data are transferred to the Rendoscopy work station. The software loads the data from the CT without the need of
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manual interaction with the application, enabling the track through the colon including over collapsed parts or over liquid closed lumen.
Surface calculation of the colonic mucosa and splitting of the colon along the track follow automatically. The clip plane is oriented by the maximum curvature of the track, which ensures a free view of the colonic loops or folds.
Rendoscopy's 3D imaging algorithms create surfaces with almost no partial volume effect. Therefore, the 3D images have the highest possible technical contrast resolution, higher than 2D axial cuts.
By splitting the colon the user can get a free view behind the colonic folds, with no distortion. If the gas filled colon tube is interrupted by fluid, or by a collapsed colon part, the user will not run into trouble examining the adjacent colonic part. The Multipath Tracking System will find each path in the 3D dataset without any manual interaction.
This software device provides complete information on cross sectional imaging of any colon location and the information is updated at each step along the track. It is a user friendly, interactive automated Virtual Colonscopy (VC) that uses DICOM data from today's advanced multislice scanners from reputed manufacture. It has been tested and found to work smoothly with different PACS system produced by various manufacturers.
### ડ. Intended Use:
The Rendoscopy Gentle Colon, revision 2.0 is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software:
- 3D visualization (3D detection, 2D assessment) .
- No blind areas behind colonic folds due to splitting colon techniques .
- Multipath Tracking System allows path-finding over collapsed or liquid-filled . parts of the colon
- . The software provides full presentation of cross sectional imaging, such as axial, sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization
It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware.
The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.
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#### Comparison to Predicate Devices: 6.
The Rendoscopy Gentle Colon System utilizes the same technological characteristics as the predicate device, GE Navigator. Both provide multi-view user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. Both provide measurement tools for analysis of the observed structures: allow adjustment to virtual lighting parameters to emphasize details, and provide window/level adjustment of the 2D Views to enhance features.
The predicate device and Gentle Colon both provide external 3D views and endo lunimal 3D views. Gentle Colon system utilizes direct volume rendering for the split colon images. While the endo luminal view is surface extraction performed in a couple of seconds. GE Navigator utilizes surface extraction techniques for all 3D views.
With Gentle Colon, the user may choose between automatic path planning or interactive flight control. The G.E. Navigator also automatically plans a path, but requires the user to build the path in many short segments by pressing a button for each step. In essence, the Gentle Colon system performs the Navigator "auto step and align" function multiple times until the end of the organ is found. Gentle Colon finds all gas filled cylindrical structures automatically, means multi-path segments in the data set are found without manual interaction.
The Gentle Colon system performs a full automated segmentation without manual interaction. The only interaction can be necessary to increase the minimum number of path segments.
G.E. Navigator and Gentle Colon are specifically designed to streamline the typical colon examination. They both provide the ability to load both supine and prone datasets at the same time, even if in loading the dataset in two separate applications. Thy also allow the setting of landmarks (points of interest) and the entering of comments specific to each landmark.
We conclude that the Gentle Colon, is as safe and effective as its predicate device and poses no new questions of safety and effectiveness.
#### 7. Discussion of Non-Clinical Tests Performed
Laboratory testing at unit level and system level were performed in accordance with test scripts/protocol to assure that the Gentle Colon meets all the design specification, performance requirements and intended use of the software, device The Gentle Colon passed all final acceptance test/verification.
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The Gentle Colon has been developed in a manner consistent with accepted standards for software development. The software was designed, developed, tested and validated according to established procedures and protocols. The product has shown itself to be reliable, easy to use and capable of rendering useful 3D medical images like the predicate device.
### Discussion on Clinical Validation Performed 8.0
Clinical validation on thirty patients cases were performed by a radiologist to verify that the system performs as intended. The validation results were compared to the results of predicate device as to determine its quality and effectiveness. The radiologist evaluated both normal anatomy and pathologic findings in well distended and partially collapsed colons with both 2D and 3D reconstructions. The evaluating radiologist found the images are equivalent in all 30 cases using both Gentle Colon and the predicate device.
#### 9.0 Conclusions:
We conclude from the tests and clinical validation that the Gentle Colon is substantially equivalent to its predicate device in its ability to render 3 D images for use in medical diagnostics. The Gentle Colon is as safe and effective as its predicate device, the GE Navigator.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
# SEP 1 8 2006
Ms. Mira Pattanayak Regulatory Associate Rendoscopy, Inc. 8 Croydon Court DIX HILLS NY 11746
Re: K061532
Trade/Device Name: Gentle Colon, Revision 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2006 Received: September 5, 2006
# Dear Ms. Pattanayak:
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 (Premarket Approval), 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.
Image /page/4/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.
Protecting and Promoting Public Health
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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 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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Exhibit B
### INDICATIONS FOR USE
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: Gentle Colon, revision 2.0
Indications for Use:
Rendoscopy's Gentle Colon, revision 2.0, is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software:
- 3D visualization (3D detection, 2D assessment) .
- No blind areas behind colonic folds due to splitting colon techniques .
- Multi-path tracking system allows path finding over collapsed or liquid- filled . parts of the colon
- The software provides full presentation of cross sectional imaging, such as axial, . sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization
It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware.
The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (C
Carolyn Y. Newbold for N. Broydon
and Radiological Device 510(k) Number
