(90 days)
No K/DEN numbers listed for Reference Device(s)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not contain any language suggesting the use of AI or ML in the device description or intended use. While it mentions "automatic" contouring and segmentation, this functionality is not necessarily indicative of AI/ML and could be based on traditional image processing algorithms.
No
The device is a virtual simulation system for radiation treatment planning and diagnostic image analysis, not a device that directly administers therapy or performs a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "CT-based diagnostic image analysis."
Yes
The device description explicitly states "Exomio is a Programmable (Software) Medical Device" and describes its function as providing visualization and image manipulation tools based on patient CT data, without mentioning any accompanying hardware components that are part of the device itself.
Based on the provided information, the Exomio Radiation Treatment Simulation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Exomio system uses CT data sets of the patient, which are images, not biological specimens.
- The intended use of Exomio is for diagnostic image analysis and treatment planning. While it uses diagnostic images (CT scans), its primary function is to assist physicians in planning radiation treatment, not to perform diagnostic tests on biological samples.
- The device description focuses on image manipulation, visualization, and treatment setup. This aligns with the workflow of radiation therapy planning, not in vitro diagnostics.
In summary, Exomio is a medical device used in the field of radiation oncology for treatment planning and simulation, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment planning tools to the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3D visualization of the virtual treatment setup. Moreover, it includes useful treatment setup export capabilities to enable the communication with compatible medical devices.
Product codes
KPQ
Device Description
Exomio is a Programmable (Software) Medical Device aiming to fully provide the physicians with necessary visualisation and image manipulation tools to prepare the patient's RT simulation virtually in absence of the physical patient and the physical simulator. This is done using the patient's CT data set, including the attached on the patient's skin registration markers, instead of the physical patient. This process it called virtual simulation and Exomio, as well as other similar systems, is called CT-based or Virtual Radiation Treatment Simulation System.
Exomio provides tools to support clinician's decision making through the use of enhanced visualization of the patient data set and treatment parameters. 3-D visualization provides an excellent overview of the patient's anatomy. In addition, the relation between treatment beams and tumor can be investigated in detail using Exomio's navigation tools. All this unique functionality is provided to the clinics with aim the overall improvement of the RT simulation process.
Exomio is able, using the DICOM standard, to export all parameters necessary for the treatment of the patient as well as the images to other devices supporting DICOM RT Plan and Structure Set. This way the whole procedure becomes a lot faster saving even more time for the physician and the rest medical staff.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data set
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Clinics
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1022219
IV. Summary of Safety and Effectiveness
A. Applicant
MedCom GmbH Name: Address: 12 Rundeturmstrasse Darmstadt, HE 64283 Germany
B. Device
Trade name: Classification name: Classification: Product code:
Exomio Radiation Therapy Simulation System Class II §892.5840 KPQ
C. Device Trade Name Exomio
D. Predicate device
Device trade name: Somavision 510(k) number: K992751 Varian Inc. Company name:
E. Description
Exomio is a Programmable (Software) Medical Device aiming to fully provide the physicians with necessary visualisation and image manipulation tools to prepare the patient's RT simulation virtually in absence of the physical patient and the physical simulator. This is done using the patient's CT data set, including the attached on the patient's skin registration markers, instead of the physical patient. This process it called virtual simulation and Exomio, as well as other similar systems, is called CT-based or Virtual Radiation Treatment Simulation System.
Exomio provides tools to support clinician's decision making through the use of enhanced visualization of the patient data set and treatment parameters. 3-D visualization provides an excellent overview of the patient's anatomy. In addition, the relation between treatment beams and tumor can be investigated in detail using Exomio's navigation tools. All this unique functionality is provided to the clinics with aim the overall improvement of the RT simulation process.
Exomio is able, using the DICOM standard, to export all parameters necessary for the treatment of the patient as well as the images to other devices supporting DICOM RT Plan and Structure Set. This way the whole procedure becomes a lot faster saving even more time for the physician and the rest medical staff.
F. Intended Use
The Exomio Radiation Treatment Simulation System is used for CT-based diagnostic image analysis, while also providing treatment
1
planning tools to the physician, such as: contouring and segmentation (manual or automatic), radiation treatment field editing and 3D visualization of the virtual treatment setup. Moreover, it includes useful treatment setup export capabilities to enable the communication with compatible medical devices.
G. Summary of Technical Considerations
Exomio is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The logo is black and white.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. Ioannis Nomikos Quality Manager MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE 64283
Re: K022219
Trade/Device Name: Exomio Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system
Regulatory Class: II Product Code: 90 KPQ Dated: June 20, 2002 Received: July 9, 2002
OCT 0 7 2002
Dear Mr. Nomikos:
GERMANY
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 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.
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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K022219
Device Name: Exomio
Indications For Use:
The Exomic Radiation Treatment Simulation
System is used for CT-based diagnostic image
analysis, while also: providing treatment planning
tods to the pliysician, such as: contouring and
segmentation (manual or automatic), radiation treatment
field editing and 3D visualization of the virtual
treatment setup. Moreover, it includes useful
treatment setup export capabilities to enable the
communication with compatible medical
devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801, 109)
OR
Over-The-Counter Use
Page _
(Optional Formal 1-2-96)
David A. Ingram
Division of Reproductive, Abdominal and Radiological Devices 510(k) Numbe