(55 days)
Not Found
Unknown
The description mentions "deformable segmentation to auto-contour" and "automatically fuse the images," which are image processing techniques that could be implemented using AI/ML, but the summary does not explicitly state that AI/ML is used. There is no mention of AI, ML, DNN, training data, or performance metrics typically associated with AI/ML models.
No
The device aids in treatment planning by delineating contours, but it does not directly apply or administer therapy to the patient.
No
Explanation: The device is described as a system for "tumor and normal tissue contour delineation to support the radiotherapy treatment planning process." It helps in outlining areas, but it does not diagnose a condition or disease itself. Its function is to prepare data for treatment, not to identify a medical condition.
Yes
The device description explicitly states "The IKOEngelo device is a software system" and the entire workflow described involves software operations on imported image data, with no mention of accompanying hardware components or hardware-specific functions.
Based on the provided information, the IKOEngelo™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- IKOEngelo™ System's Function: The IKOEngelo™ System works directly with medical images (CT scans) of the patient's body. It processes these images to assist in contouring tumors and normal tissues for radiotherapy planning. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is to "support the radiotherapy treatment planning process" by assisting with contour delineation on images.
Therefore, the IKOEngelo™ System falls under the category of medical imaging software or radiotherapy planning software, not an IVD.
N/A
Intended Use / Indications for Use
The IKOEngelo™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. 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.
Product codes (comma separated list FDA assigned to the subject device)
KPQ, MUJ, IYE
Device Description
The IKOEngelo device is a software system that will assist radiation 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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologists, physicists and dosimetrists, medical physicists, medical dosimetrists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5840 Radiation therapy simulation system.
(a)
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.(b)
Classification. Class II.
0
Experts at your Fingertips
3000 Richmond Suite 200 Houston, TX 77908
TEL: (713) 600-2410 Fax: (713) 600-2411 E-MAIL: INFORMATION@IKOETECH.COM 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, |
| Product Code: KPQ (per 21 CFR 892.5840) | |
| Manufacturer's Name: | IKOEtech, LLC. |
| Address: | 3000 Richmond, Suite 200 |
| Houston, TX 77098 | |
| Corresponding Official: | Ms. Huimin Chao, LLM |
| Title: | President |
| Telephone: | (713) 600-2410 |
| Fax: | (713) 600-2411 |
| Predicate: | IMPAC Medical Systems, Inc. |
| 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.
1
Experts at your Fingertips
3000 Richmond Suite 200 Houston, TX 77908
Tel.: (713) 600-2410 Fax: (713) 600-2411
E-MAIL: INFORMATION@IKOETECH.COM 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.
QwikSIM (K013531) | IKOEtech
IKOEngelo ™ |
|---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | QwikSIM is a radiation therapy
virtual simulation system for patient
image review, target and critical
structure delineation, and geometric
treatment planning. | The IKOEngelo ™ System is intended
for use in tumor and normal tissue
contour delineation to support the
radiotherapy treatment planning
process. |
| 2 | Image Study
Import | Dicom3 | Dicom3 |
| 3 | Treatment
Planning
Connectivity | DICOM CT SCP and DICOM RT
Structure Set SCP/SCU interface
modalities. | DICOM CT SCP and DICOM RT
Structure Set SCP/SCU interface
modalities. |
2
Experts at your Fingertips
3000 Richmond Suite 200 Houston, TX 77908
Tel: (713) 600-2410 Fax: (713) 600-2411
E-Mail: Information@ikoetech.com Web Site: http://www.ikoetech.com
| 4 | Flexible Image
Display | Multiple-image views and allows
side-by-side views for comparison,
displaying the following perspectives:
Slice View, Orthogonal Multi-Planar
Reconstructed View, and Digital
Scout View. | Multiple-image views and allows
side-by-side views for comparison,
displaying the following perspectives:
Slice View, Orthogonal Multi-Planar
Reconstructed View. |
|----|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5 | Image Viewing
Tools | Tools for image review include zoom
and pan tools for reviewing
MPR/Slice planes, and tape measure
and protractor controls. | Tools for image review include zoom
and pan tools for reviewing
MPR/Slice planes, slice indicators,
tape measure, CT number displayer,
and isocenter lines. |
| 6 | Contour Source | Anatomy Templates | Expert Case Library |
| 7 | Automatic
Contouring | Based on pre-defined CT thresholds | Deformable registration and
segmentation. |
| 8 | Contour
Expansion | 2D inflation of anatomical objects
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
scroll through simultaneously. |
| 11 | Contour
Modification
Tools | Point-click draw contour tool. | Nudge contour, cut contour, draw
contour and create new contour tools. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 pattern around the bird symbol.
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
4
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" (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 Chrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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)