VERISUITE 1.6, VERISUITE-PARTICLE 1.6

K080742 · Medcom GmbH · IYE · May 9, 2008 · Radiology

Device Facts

• Record ID: K080742
• Device Name: VERISUITE 1.6, VERISUITE-PARTICLE 1.6
• Applicant: Medcom GmbH
• Product Code: IYE · Radiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The VeriSuite patient position verification 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.

Device Story

VeriSuite is a patient position verification system for radiotherapy. It inputs stereoscopic X-ray images and Digitally Reconstructed Radiographs (DRRs) derived from patient CT scans and treatment planning data. The system compares live X-ray images against planned DRRs to determine patient alignment. It is used in clinical radiotherapy settings by radiation oncology staff. The output provides positional verification and correction data, allowing clinicians to adjust patient positioning to ensure accurate radiation delivery. This process improves treatment precision and minimizes radiation exposure to healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the system components.

Technological Characteristics

System comprises X-ray generator (Sedecal SHF 835), X-ray tubes (Varian A277/A272), flat panel digital imager (Varian PaxScan 4030R), and collimator (Ralco 302). Operates via stereoscopic X-ray imaging and DRR calculation. Software-based image registration for patient positioning. Class II device.

Indications for Use

Indicated for verification and correction of patient positioning during external beam or charged-particle radiotherapy treatment.

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

• EXACTRAC 5.5 / ExacTrac X-RAY 6D (K072506)

Reference Devices

• X-Ray Generator, Sedecal SHF 835
• X-Ray Tubes, Varian A277 / A272
• Flat Panel Digital Imager, Varian PaxScan 4030R (K024147)
• Collimator, Ralco 302 (K946320)

Submission Summary (Full Text)

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# MAY - 9 2008

K080742

Page 4 of 26

# III. Summary of Safety and Effectiveness

### A. Applicant

Name: Address: MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE 64283 Germany

VeriSulte 1.6 and VeriSuite-Particle and VeriSuite-Particle 1.6

### 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

D. Predicate device

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

EXACTRAC 5.5 / ExacTrac X-RAY 6D K072506 BRAINLAB AG 892.5050 Class II LHN

### X-Ray Generator, Sedecal SHF 835

| Device trade name: | |
|------------------------|-------------------------------|
| Classification name: | Generator, High Voltage Xray, |
| | Diagnostic |
| Classification Number: | 892.1700 |
| Classification: | Class I Exempt |
| Product Code: | IZO |
| Manufacturer: | |
| Registration Number: | 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

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## Flat Panel Digital Imager, Varian PaxScan 4030R

Classification name: Solid State X-ray Imager Classification Number: 892.1630 Classification: Class II Product Code: MQB 510(k) Number: K024147

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

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K080742

Trade/Device Name: VeriSuite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 14, 2008 Received: March 17, 2008

### 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy Burgdon

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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구, 대학

일본

代表示范

ිනු ක්‍රියා ක්‍රියා ලෙස හැකියා විශ්වය විය. මෙම ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධාන බව ප්‍රධ

## VIII. Indications for Use Statement

### 510(k) Number (if known): K080742

### Device Name: VeriSuite

The VeriSuite patient position verification 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)

OR

Over-The-Counter Use

| Document : | MC.5024.MSC.2100.0002.A |
|------------|-------------------------------------------------|
| File : | mc.5024.msc.2100.0002.fda_completeadmission.doc |

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

| 510(k) Number | K080742 |
|---------------|---------|
|---------------|---------|

© MedCom GmbH 2008
Printed 05.06.2008, 13:24