EXOMIO, MODEL 1.1

K022219 · Medcom GmbH · KPQ · Oct 7, 2002 · Radiology

Device Facts

• Record ID: K022219
• Device Name: EXOMIO, MODEL 1.1
• Applicant: Medcom GmbH
• Product Code: KPQ · Radiology
• Decision Date: Oct 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Exomio is a software-based virtual radiation therapy simulation system; inputs patient CT data sets with registration markers; enables virtual simulation in absence of physical patient/simulator. Provides tools for 3D visualization of anatomy, manual/automatic contouring, segmentation, and radiation treatment field editing. Used by clinicians in clinical settings to support decision-making; facilitates investigation of relationship between treatment beams and tumors. Outputs treatment parameters and images via DICOM RT Plan and Structure Set standards to compatible medical devices; streamlines simulation workflow; improves RT simulation process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to the predicate device.

Technological Characteristics

Software-based medical device; operates on standard computing hardware; utilizes DICOM standard for data import/export (RT Plan and Structure Set). Features include 3D visualization, manual and automatic contouring/segmentation tools, and treatment field editing. Standalone software application.

Indications for Use

Indicated for use by physicians for CT-based diagnostic image analysis and radiation treatment planning, including contouring, segmentation, field editing, and 3D visualization of virtual treatment setups.

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

• Somavision (K992751)

Submission Summary (Full Text)

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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

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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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 | [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" (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 [phone] or [phone] 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

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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

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(Optional Formal 1-2-96)

David A. Ingram

Division of Reproductive, Abdominal and Radiological Devices 510(k) Numbe