(25 days)
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.
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 provided document is a 510(k) summary for the IKOEngelo™ Software Version 2.0. It describes the device's intended use and technological characteristics, and importantly, highlights the verification and validation aspects. However, it does not contain a detailed study proving the device meets explicit acceptance criteria in the format requested.
The document states that "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." This is a general statement about meeting validation goals rather than specific acceptance criteria with quantitative performance metrics.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here is an attempt to structure the available information, with clear indications where information is not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Validation Statement) | Reported Device Performance (from "The validation test results have demonstrated that...") |
|---|---|
| Improved efficiency and versatility of contour modification tools | Contour modification tools were improved with efficiency and versatility |
| Faster image file loading and display | Image file loading and display were faster |
| New image fusion functions are similar to the predicate device (ADAC Laboratories Image Fusion and Review System, K973233) | New image fusion functions were similar to the predicate device |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not specified or implied. The device is a software system to assist radiation oncologists, physicists, and dosimetrists, but no comparative effectiveness study with human readers (with vs. without AI assistance) is mentioned.
- Effect Size: Not applicable, as no MRMC study is detailed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not explicitly stated as a standalone evaluation. The validation statement indicates "The validation test results have demonstrated that...", suggesting an evaluation of the software's functionality, but it's unclear if this was algorithm-only or if it involved human interaction/evaluation of the output. The device's intended use is to "assist" human experts, implying it's not a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified. The document mentions "contour delineation of the tumor target and normal tissue on patient's CT images" as the core function, but how the "truth" for these contours was established for validation is not described.
8. The sample size for the training set
- Sample Size: Not specified. (The document describes validation, not specifically training of a machine learning model, though the term "improved" tools could imply some form of iterative development and testing).
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not specified. (As above, training set details are not provided).
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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 303Houston, 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 LaboratoriesImage Fusion and Review System, 510(k) #: K973233. |
| Device Description: | The IKOEngelo version 2.0 device is a software system upgraded fromversion 1.0. This submitted new version has better contour modificationtool, faster image files loading and display, and a new function for imagefusion. For the same purpose of version 1.0, this software will assistradiation oncologists with the assistance of physicists and dosimetrists to |
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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.
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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.
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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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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
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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 |
§ 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.