EXOMIO, MODEL 2.0 SP1

K032550 · Medcom GmbH · KPQ · Sep 25, 2003 · Radiology

Device Facts

• Record ID: K032550
• Device Name: EXOMIO, MODEL 2.0 SP1
• Applicant: Medcom GmbH
• Product Code: KPQ · Radiology
• Decision Date: Sep 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Exomio 2.0 SP1 is a software-based virtual radiation therapy simulation system. It processes patient CT data sets, including skin registration markers, to enable virtual treatment planning without the physical patient present. Clinicians use the system to perform manual or automatic contouring and segmentation, edit radiation treatment fields, and generate 3D visualizations of anatomy and treatment beams. The system supports navigation tools for detailed investigation of tumor-beam relationships. Output includes treatment parameters and images exported via DICOM RT Plan and Structure Set standards to compatible medical devices. Used in clinical environments by physicians and medical staff to improve the efficiency and accuracy of the radiation therapy simulation process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based radiation therapy simulation system. Operates on patient CT data sets. Features include 3D visualization, manual/automatic contouring, segmentation, and treatment field editing. Connectivity via DICOM standard for export of RT Plan and Structure Sets.

Indications for Use

Indicated for physicians performing CT-based diagnostic image analysis and radiation treatment planning. Used for virtual simulation of radiation treatment setups in clinical settings.

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

• Exomio, Model 1.1 (K022219)

Submission Summary (Full Text)

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# SEP 2 5 2003

Exomio 2.0 SP1 - 510(k) Submission

Page 1 of 2

Page 4 of 25

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III. 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 Model 2.0 SP1 Radiation Therapy Simulation System Class II \$892.5840 KPQ

# C. Device Trade Name

Excimio

### D. Predicate device

Device trade name: Exomio, Model 1.1 510(k) number: K022219 Company name: MedCom GmbH

#### 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 reqistration 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 savinq even more time for the physician and the rest medical staff.

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### F. Intended 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.

#### G. Summary of Technical Considerations

Exomio 2.0 SP 1 is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Mr. Stefan Walter Quality Manager MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE64283 GERMANY

Re: K032550

Trade/Device Name: Exomio Model 2.0 SP1 Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: August 13, 2003

Received: August 26, 2003

Dear Mr. Walter:

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.

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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### VIII. Indications for Use Statement

510(k) Number (if known): Not Available

Device Name: Exomio 2.0 SP 1

队032550

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.

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number.

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

MC 5001 MSC 2130.0001.A Document : MC 5001 MSC 2130.FDA_CompleteAdmission.doc File

© MedCom GmbH 2003 Printed 12.08.2003, 16:34