(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional software improvements like contour modification tools, faster loading, and image fusion, without mentioning any AI/ML-specific functionalities or performance metrics.
No.
The device is indicated for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process, which is a diagnostic/planning function, not a therapeutic intervention itself.
No
The device is used for contour delineation to support radiotherapy treatment planning, which is a part of treatment, not diagnosis.
Yes
The device description explicitly states it is a "software system" and describes software functionalities like contour modification, image loading/display, and image fusion. There is no mention of accompanying hardware components.
Based on the provided information, the IKOEngelo™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IKOEngelo™ System Function: The IKOEngelo™ System is a software system used for image processing and contour delineation on medical images (specifically CT images and multi-modality image fusion) to support radiotherapy treatment planning. It works with images of the patient's anatomy, not with samples taken from the body.
- Intended Use: The intended use clearly states it's for "tumor and normal tissue contour delineation to support the radiotherapy treatment planning process." This is a function related to medical imaging and treatment planning, not laboratory testing of biological samples.
Therefore, the IKOEngelo™ System falls under the category of medical imaging software or radiotherapy planning software, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KPQ
Device Description
The IKOEngelo version 2.0 device is a software system upgraded from version 1.0. This submitted new version has better contour modification tool, faster image files loading and display, and a new function for image fusion. For the same purpose of version 1.0, this software 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:
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images, multi-modality image
Anatomical Site
Tumor target and normal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologists, medical physicists, and 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)
The verification and validation test procedures for IKOEngelo version 2.0 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.
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
6223 Richmond Avenue, Suite 303 HOUSTON, TX 77057
Tel. (713) 600-2410 Fax: {713} 600-2411 E-MAIL: HCHAO@IKOEMED.COM WER SITE: HTTP://www.ikoetech.com
DEC 2 9 2008
Premarket Notification [510(k)] Summary
November 5, 2008
| Trade Name: | IKOEngelo ™ Software Version 2.0 |
|---|---|
| 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: | 6223 Richmond Avenue, Suite 303 |
| Houston, TX 77057 | |
| Corresponding Official: | Ms. Huimin Chao, LLM |
| Title: | President |
| Telephone: | (713) 600-2410 |
| Fax: | (713) 600-2411 |
| Predicate Device for Previous Cleared Version 1.0: | IMPAC Medical Systems, Inc. |
| QwikSIM Virtual Simulation System, 510(k) #: K013531. | |
| Predicate Device for Current Submitted Version 2.0: | ADAC Laboratories |
| Image Fusion and Review System, 510(k) #: K973233. | |
| Device Description: | The IKOEngelo version 2.0 device is a software system upgraded from |
| version 1.0. This submitted new version has better contour modification | |
| tool, faster image files loading and display, and a new function for image | |
| fusion. For the same purpose of version 1.0, this software will assist | |
| radiation oncologists with the assistance of physicists and dosimetrists to |
1
6223 Richmond Avenue, Suite 303 HOUSTON, TX 77057
TEL: (713) 600-2410 FAX: {713} 600-2411
E-MAIL: HCHAO@IKOEMED.COM 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.
2
EXPERTS AT YOUR FINGERTIPS
6223 RICHMOND AVENUE, SUITE 303 Houston, TX 77057
TEL: (713) 600-2410 Fax: (713) 600-2411
E-Mail: HCHAO@IKOEMED.COM 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.
3
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 (800) 638-2041 or (240) 276-3150 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
5
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 |