VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8

K092653 · Medcom GmbH · LHN · Sep 18, 2009 · Radiology

Device Facts

• Record ID: K092653
• Device Name: VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
• Applicant: Medcom GmbH
• Product Code: LHN · Radiology
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VeriSuite is an active therapeutic medical device for verification of the patient position and calculation of a correction vector for the treatment of turnors during a radiation therapy with photons, electrons (from a linear accelerator) or particles (protons, heavy ions). The VeriSuite system calculates digitally reconstructed radiographs (DRRs) based on a high-resolution CT data set for a treatment position. With these DRRs and Xray images acquired during the performance of the position verification procedure a correction vector for the patient position can be calculated. An authorized person must evaluate the correctness of the calculation and approve the result for further usage. The system shall only be used after correct installation in appropriate treatment rooms by trained personnel. Legal regulations especially regulation for the operation of X-ray devices must be regarded. VeriSuite must not be used for diagnostic purposes

Device Story

VeriSuite is an image processing system for radiation therapy patient position verification. It inputs X-ray images acquired during treatment and DRRs calculated from patient CT data/treatment planning. It calculates a correction vector for patient positioning by comparing acquired X-ray images to DRRs or by identifying implanted radio-opaque markers. Used in treatment rooms by trained personnel; requires authorized clinician evaluation and approval of calculated results. System components include a workstation (Windows XP), beam-limiting collimator (Ralco 302), X-ray generator (Sedecal XHF 835), X-ray tubes (Varian A277/A272), and flat panel digital imagers (Varian 4030E). Output assists clinicians in adjusting patient position to ensure accurate radiation delivery. Not for diagnostic use.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

System includes workstation, X-ray generator, X-ray tubes, flat panel digital imagers, and collimator. Software-based image processing system. Connectivity via Varian DLLs PaxScan API and Pleora Driver. Operates on Windows XP Professional. Hardware components are legally marketed devices.

Indications for Use

Indicated for verification and correction of patient position during radiotherapy treatment with external beams or charged particles (photons, electrons, protons, heavy ions).

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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

• VeriSuite 1.6 (K080742)

Reference Devices

• X-Ray Generator, Sedecal SHF 835
• X-Ray Tubes, Varian A277 / A272
• Flat Panel Digital Imager, Varian PaxScan 4030E
• Collimator, Ralco 302 (K946320)

Submission Summary (Full Text)

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VeriSuite 1.8 - 510(k) Submission

Page 4 of 25

#### III. Summary of Safety and Effectiveness

- A. Applicant
Name: Address: MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE 64283 Germany

# B. Device ·

Trade name: Common name Classification name: Classification Number: Classification: Product code:

# VeriSuite Patient position verification system System, Radiation Therapy, Charged-Particle, Medical 892.5050 Class II LHN

C. Device Trade Name

# VeriSuite also marketed as VeriSuite 1.8 and VeriSuite-Particle and VeriSuite-Particle 1.8

# D. Predicate device

Device trade name: 510(k) number: Company name: Classification Number: Classification: Product code:

VeriSuite 1.6 K080742 MedCom GmbH 892.5050 Class II · LHN

# X-Ray Generator, Sedecal SHF 835

Device trade name: Classification name:

Classification Number:

Registration Number:

Classification:

Product Code:

Manufacturer

Generator, High Voltage Xray, Diagnostic 892.1700 Class | Exempt IZO 9617251

# X-Ray Tubes, Varian A277 / A272

Classification name: Assembly, Tube, Housing X-ray, Diagnostic Classification Number: 892.1700 Classification: Class I Exempt Product Code: IZO Manufacturer Registration Number: 1717855 .

Document : File :

MC.5024.MSC.2100.0003.A mc.5024.msc.2100.0003.fda_completeadmission.doc

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#### Flat Panel Digital Imager, Varian PaxScan 4030E

،

Classification name: Solid State X-ray Imager Classification Number: 892.1630 Class II Classification: MQB Product Code: 510(k) Number: -

#### Collimator, Ralco 302

Classification name:

Classification Number: Classification: Product Code: 510(k) Number:

Device, Beam Limiting, X-ray Solid State X-ray Imager 892.1610 Class II KPW K946320

Document : File :

MC.5024.MSC.2100.0003.A mc.5024.msc.2100.0003.fda_completeadmission.doc

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© MedCom GmbH 2009 Printed 06.08.2009, 13:24

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# E. Description

VeriSuite is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of X-ray images that are acquired during the treatment with DRRs (digital reconstructed radiographs) calculated from a CT image series of the patient and information from the radiation therapy planning, The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient.

VeriSuite is a system of devices consisting of the VeriSuite software and a number of hardware devices:

- Beam limiting collimator device (Ralco 302)
- X-ray generator (Sedecal XHF 835) -
- X-ray tubes (Varian A277 or A272)
- Flat panel digital imager (Varian 4030E -

Optional:

All these hardware devices are legally marketed in the US as listed in previous section D.

Image /page/2/Figure/10 description: The image shows a diagram of a VeriSuite Workstation running on Windows XP Professional. The workstation is connected to a Sedecal Generator XHF 835 with 2-3 tubes, three Xray Tubes Varian A277, and two Digital Flat Panels Varian 4030E. The workstation also includes Varian DLLs PaxScan API L04 and Pleora Driver.

System Overview

Document : File :

MC.5024.MSC.2100.0003.A mc.5024.msc.2100.0003.fda_completeadmission.doc

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#### F. Intended Use

VeriSuite is an active therapeutic medical device for verification of the patient position and calculation of a correction vector for the treatment of turnors during a radiation therapy with photons, electrons (from a linear accelerator) or particles (protons, heavy ions).

The VeriSuite system calculates digitally reconstructed radiographs (DRRs) based on a high-resolution CT data set for a treatment position. With these DRRs and Xray images acquired during the performance of the position verification procedure a correction vector for the patient position can be calculated. An authorized person must evaluate the correctness of the calculation and approve the result for further usage.

The system shall only be used after correct installation in appropriate treatment rooms by trained personnel. Legal regulations especially regulation for the operation of X-ray devices must be regarded.

VeriSuite must not be used for diagnostic purposes

### G. Summary of Technical Considerations

VeriSuite is substantially equivalent to the predicate device.

I

Document : File ;

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

FP 1 8 2009

Mr. Stefan Walter Quality Manager MedCom GmbH Rundeturmstrasse 12 Darmstadt. Hessen 64283 GERMANY

Re: K092653

Trade/Device Name: VeriSuite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN/IYE Dated: August 20, 2009 Received: August 28, 2009

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting 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): 长092653

# Device Name: VeriSuite

The VeriSuite patient position system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

and Radiological Devices

510(k) Number

OR

Over-The-Counter Use

| Document : | MC.5024.MSC.2100.0003.A |
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| File : | mc.5024.msc.2100.0003.fda_completeadmission.doc |

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Division of Reproductive, Abdominal.© MedCom GmbH 2009 Printed 06.08.2009, 13:24