IKOENGELO

K061006 · Ikoetech, LLC · KPQ · Jun 5, 2006 · Radiology

Device Facts

• Record ID: K061006
• Device Name: IKOENGELO
• Applicant: Ikoetech, LLC
• Product Code: KPQ · Radiology
• Decision Date: Jun 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

Device Story

IKOEngelo is a software system for radiation therapy simulation; assists radiation oncologists, physicists, and dosimetrists in contouring tumors and normal tissues. Input: patient CT images (DICOM). Operation: imports patient CT; selects 'Expert Case' (pre-existing CT/contour data); performs automatic image fusion to align patient data with Expert Case; executes deformable segmentation for auto-contouring. Output: contoured CT images exported to treatment planning systems. Used in clinical settings; operated by oncology staff. Benefits: improves efficiency of contour delineation process; supports radiotherapy planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based radiation therapy simulation system. Connectivity: DICOM CT SCP and DICOM RT Structure Set SCP/SCU interfaces. Features: deformable registration and segmentation, image fusion, and manual contour modification tools. Operates on standard clinical workstations.

Indications for Use

Indicated for use by radiation oncologists, medical physicists, and medical dosimetrists to perform tumor and normal tissue contour delineation on patient CT images to support radiotherapy treatment planning.

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• QwikSIM Virtual Simulation System (K013531)

Submission Summary (Full Text)

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### Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

TEL: [phone] Fax: [phone] E-MAIL: [e-mail] WEB SITE: HTTP://www.iKOETECH.COM

JUN - 5 2006

# Premarket Notification [510(k)] Summary

K06/006

March 31, 2006

| Trade Name: | IKOEngelo™ |
|-------------------------|------------------------------------------------------------------------------------|
| Common Name: | Radiation Therapy Simulation accessory |
| Classification Name: | Radiation Therapy Simulation System,<br>Product Code: KPQ (per 21 CFR 892.5840) |
| Manufacturer's Name: | IKOEtech, LLC. |
| Address: | 3000 Richmond, Suite 200<br>Houston, TX 77098 |
| Corresponding Official: | Ms. Huimin Chao, LLM |
| Title: | President |
| Telephone: | [phone] |
| Fax: | [phone] |
| Predicate: | IMPAC Medical Systems, Inc.<br>QwikSIM Virtual Simulation System, 510(k) #: K01353 |

The IKOEngelo device is a software system that will assist radiation Device Description: oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.

> The sequence of events is illustrated in the following bullet items and diagram:

- Import patient's CT images. .
- Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT.

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#### Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

Tel.: [phone] Fax: [phone]

E-MAIL: [e-mail] WEB SITE: HTTP://www.ikoetech.com

061006

- Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case.
- Run deformable segmentation to auto-contour on the patient's CT . images.
- Review patient's contours and modify them if necessary. .
- Approval by qualified radiation oncologist. .
- Export patient's CT with its contours to the treatment planning system . used by the facility.

The IKOEngelo™ System is intended for use in tumor and normal tissue Intended Use: contour delineation to support the radiotherapy treatment planning process See the attached "Predicate Comparison Table". Technological Characteristics:

## Predicate Comparison Table

| # | Feature | IMPAC Medical Systems, Inc.<br>QwikSIM (K013531) | IKOEtech<br><i>IKOEngelo</i> ™ |
|---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | QwikSIM is a radiation therapy<br>virtual simulation system for patient<br>image review, target and critical<br>structure delineation, and geometric<br>treatment planning. | The <i>IKOEngelo</i> ™ System is intended<br>for use in tumor and normal tissue<br>contour delineation to support the<br>radiotherapy treatment planning<br>process. |
| 2 | Image Study<br>Import | Dicom3 | Dicom3 |
| 3 | Treatment<br>Planning<br>Connectivity | DICOM CT SCP and DICOM RT<br>Structure Set SCP/SCU interface<br>modalities. | DICOM CT SCP and DICOM RT<br>Structure Set SCP/SCU interface<br>modalities. |

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## Experts at your Fingertips

3000 Richmond Suite 200 Houston, TX 77908

Tel: [phone] Fax: [phone]

E-Mail: [e-mail] Web Site: http://www.ikoetech.com

K061006

| 4 | Flexible Image<br>Display | Multiple-image views and allows<br>side-by-side views for comparison,<br>displaying the following perspectives:<br>Slice View, Orthogonal Multi-Planar<br>Reconstructed View, and Digital<br>Scout View. | Multiple-image views and allows<br>side-by-side views for comparison,<br>displaying the following perspectives:<br>Slice View, Orthogonal Multi-Planar<br>Reconstructed View. |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5 | Image Viewing<br>Tools | Tools for image review include zoom<br>and pan tools for reviewing<br>MPR/Slice planes, and tape measure<br>and protractor controls. | Tools for image review include zoom<br>and pan tools for reviewing<br>MPR/Slice planes, slice indicators,<br>tape measure, CT number displayer,<br>and isocenter lines. |
| 6 | Contour Source | Anatomy Templates | Expert Case Library |
| 7 | Automatic<br>Contouring | Based on pre-defined CT thresholds | Deformable registration and<br>segmentation. |
| 8 | Contour<br>Expansion | 2D inflation of anatomical objects<br>with specified margins. | N/A |
| 9 | Image Fusion | N/A | Auto and manual fusion |
| 10 | Contours Review | Side-by-side only | Side-by-side with image linking to<br>scroll through simultaneously. |
| 11 | Contour<br>Modification<br>Tools | Point-click draw contour tool. | Nudge contour, cut contour, draw<br>contour and create new contour tools. |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Huimin Chao President IKOTech, LLC 3000 Richmond, Suite 200 HOUSTON TX 77098

JUN - 5 2006

Re: K061006

Trade/Device Name: IKOEngelo TM Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy simulation system Product Code: KPQ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Product Code: MUJ and IYE Regulatory Class: II Dated: April 1, 2006 Received: April 11, 2006

Dear Ms. Chao:

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/3/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a stylized font. The logo is surrounded by text that follows the circular shape.

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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Chrogdon

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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### Indications For Use

Kollool 510(k) Number (if known): Rending IKOEngelo™ Device Name:

#### Indications for Use:

The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

David A. Ayres

(Division Si of Reproductive A

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)