IKOENGELO, VERSION 2

K083591 · Ikoetech, LLC · KPQ · Dec 29, 2008 · Radiology

Device Facts

• Record ID: K083591
• Device Name: IKOENGELO, VERSION 2
• Applicant: Ikoetech, LLC
• Product Code: KPQ · Radiology
• Decision Date: Dec 29, 2008
• Decision: SESE
• Submission Type: Special
• 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 v2.0 is a software system for radiation therapy simulation. It accepts patient CT images as input. The device provides tools for contour delineation of tumors and normal tissues, improved image I/O performance, and multi-modality image fusion. It is used by radiation oncologists, physicists, and dosimetrists in a clinical setting to assist in the radiotherapy treatment planning process. The clinician reviews and approves contours, which are then exported to a treatment planning system for dose calculation. The device aims to improve the efficiency and versatility of the contouring workflow.

Clinical Evidence

Bench testing only. Validation test procedures were developed based on company standard test plans. Results demonstrated improved efficiency and versatility of contour modification tools, faster image loading/display, and successful implementation of image fusion functions comparable to the predicate device.

Technological Characteristics

Software-based radiation therapy simulation system. Features include contour modification tools, image I/O handling, and 3D image registration for multi-modality image fusion. Operates on DICOM3 image standards. Connectivity involves exporting data to external treatment planning systems.

Indications for Use

Indicated for 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)
• Image Fusion and Review System (K973233)

Reference Devices

• IKOEngelo version 1.0 (K061006)

Submission Summary (Full Text)

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## Experts at your Fingertips

6223 Richmond Avenue, Suite 303 HOUSTON, TX 77057

Tel. [phone] Fax: {713} 600-2411 E-MAIL: [e-mail] WER SITE: HTTP://www.ikoetech.com

DEC 2 9 2008

# Premarket Notification [510(k)] Summary

November 5, 2008

| Trade Name: | <i>IKOEngelo</i> ™ Software Version 2.0 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | 6223 Richmond Avenue, Suite 303<br>Houston, TX 77057 |
| Corresponding Official: | Ms. Huimin Chao, LLM |
| Title: | President |
| Telephone: | [phone] |
| Fax: | [phone] |
| Predicate Device for Previous Cleared Version 1.0: | IMPAC Medical Systems, Inc.<br>QwikSIM Virtual Simulation System, 510(k) #: K013531. |
| Predicate Device for Current Submitted Version 2.0: | ADAC Laboratories<br>Image Fusion and Review System, 510(k) #: K973233. |
| Device Description: | The <i>IKOEngelo</i> version 2.0 device is a software system upgraded from<br>version 1.0. This submitted new version has better contour modification<br>tool, faster image files loading and display, and a new function for image<br>fusion. For the same purpose of version 1.0, this software will assist<br>radiation oncologists with the assistance of physicists and dosimetrists to |

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6223 Richmond Avenue, Suite 303 HOUSTON, TX 77057

TEL: [phone] FAX: {713} 600-2411

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

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:

- Continuing from version 1.0 software with improved contouring tools. .
- Improved image I/O performance and display. .
- Multi-modality image fusion to assist contouring works. .

Continuing the same workflow as version 1.0 with the followings:

- Final review and approve patient's contours 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

### Technological Characteristics:

The improved functions in IKOEngelo version 2.0 for better contouring tools and faster image I/O handling/display are maintaining the same substantially equivalence to QwikSim (IMPAC Medical Systems, Inc., K013531) as IKOEngelo version 1.0 (K061006).

The new added Image Fusion function in IKOEngelo version 2.0 and Image Fusion and Review System (ADAC Laboratories, K973233) both have same process of importing DICOM3 images and then perform 3D image registration.

Although functionality is not identical, the use and operation of the IKOEngelo device is substantially equivalent to the previously cleared predicate devices and does not raise new issues of safety or effectiveness.

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### EXPERTS AT YOUR FINGERTIPS

6223 RICHMOND AVENUE, SUITE 303 Houston, TX 77057

TEL: [phone] Fax: [phone]

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

The verification and validation test procedures for IKOEngelo version 2.0 Verification and Validation: was developed based on IKOEtech company's standard test plans. The verification test procedures were executed and discrepancies were captured and evaluated with "criticality level", then the corresponding "correction actions" were generated.

> The validation test results have demonstrated that the contour modification tools were improved with efficiency and versatility, the image file loading and display were faster and the new image fusion functions were similar to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2008

Ms. Huimin (Helen) Chao President IKOEtech, LLC 6223 Richmond Avenue, Suite 303 HOUSTON TX 77057

Re: K083591

Trade/Device Name: IKOEngelo™ Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: KPQ Dated: November 20, 2008 Received: December 4, 2008

#### 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 (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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#### Page 2

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" (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 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,

hoque Mr. Whang

Joyce M. Whang, Ph.D. Acting 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

10835 510(k) Number (if known): Pending Device Name: IKOEngelo™

# 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.

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)

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K083591 |