HELAX-VISIR

K972617 · Helax AB · IYE · Oct 1, 1997 · Radiology

Device Facts

• Record ID: K972617
• Device Name: HELAX-VISIR
• Applicant: Helax AB
• Product Code: IYE · Radiology
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Helax-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy. It will help administrating patient sessions through the booking functionality and activity reports. It will fetch data from dose planning systems and simulators automatically or by manual input. At each individual treatment Helax-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Helax-VISIR can monitor the progress of both monitor values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded. Helax-VISIR is intended to be operated by physiciats, physicians and radiographers skilled in radiation therapy and trained in using the system. Thus the functionality of VISIR is to a large extent based on warnings instead of inhibiting actions. Absolute inhibition is used in situations where e.g. inconsistencies could be introduced. The overall philosophy is not to take control but to help the staff detecting unintentional actions.

Device Story

Helax-VISIR is a radiotherapy verification and information system; manages scheduling, setup, delivery, and recording of radiation therapy. Inputs include data from dose planning systems and simulators (manual or automatic). System presents setup data to operators and linear accelerators (linacs) via interface; verifies actual setup against plan; monitors treatment progress (monitor values and in vivo dosimetry). Operated by physicians and radiographers in clinical settings. Philosophy emphasizes warnings over inhibiting actions, except where inconsistencies pose risks. Assists staff in detecting unintentional actions; improves treatment management and quality assurance.

Clinical Evidence

Bench testing only. Performance tests confirmed the system consistently performed within design parameters and equivalently to the predicate device.

Technological Characteristics

Radiotherapy verification and information system. Complies with IEC 601-1 (safety), IEC 601-1-4 (programmable electrical medical systems), IEC 1217 (coordinates/movements), and IEC 878 (graphical symbols). Quality system certified to ISO 9001 and EN 46001. Software development follows FDA Reviewer Guidance for Computer Controlled Medical Devices (1991).

Indications for Use

Indicated for patients undergoing radiation treatment according to a prescribed treatment plan.

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

• Philips Veriflex (K902849)

Submission Summary (Full Text)

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Date: 1997-07-04

Helax AB

510(k) summary of safety and effectiveness

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K972617

# Submitter's information 1.

Helax AB PO Box 1704 S-751 47 Uppsala Sweden

Contact person Jan Törnqvist, Vice President RA/QM int 46 18 565017 Phone: int 46 18 565017 Fax: [e-mail] E-mail

Submission dated: 1997-07-04

#### 2. Device Name

Common or Usual name:

Verification and Information System in Radiotherapy (VISIR)

Proprietary Name:

Helax-VISIR

Classification Names:

Medical Linear Accelerator 21 CFR & 892,5050 Class II Product Code: RA IYE

## Predicate Device 3.

# Philips Veriflex

Verification and record system in Radiotherapy K902849 Philips Medical Systems, Inc. Currently owned by Nucletron Corporation

# Description of the Device 4.

The Helax-VISIR system is a modern product for improved treatment management and quality assurance in Radiotherapy. The increasing complexity of treatment techniques and equipment requires a flexible and vendor-independent system for the booking, set-up, verification and documentation of the radiotherapy process.

# Statement of Intended Use 5.

Helax-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy. It will help administrating patient sessions through the booking functionality and activity reports. It will fetch data from dose planning systems and simulators automatically or by manual

OCT ========================================================================================================================================================================== 1997

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input. At each individual treatment Helax-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Helax-VISIR can monitor the progress of both monitor values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.

Helax-VISIR is intended to be operated by physiciats, physicians and radiographers skilled in radiation therapy and trained in using the system. Thus the functionality of VISIR is to a large extent based on warnings instead of inhibiting actions. Absolute inhibition is used in situations where e.g. inconsistencies could be introduced. The overall philosophy is not to take control but to help the staff detecting unintentional actions.

The intended use is the same as the predicate devices.

## Statement of Technological Characteristics 6.

The predicate device is presently in commercial distribution in the United States. The Helax-VISIR has the same technological characteristics and is similar in design, function, and application to the predicate device.

The Technological Characteristics are the same as the predicate device.

### Differences 7.

M

There are no differences between the technology of the predicate device and the Helax-VISIR and only minor differences in configuration and specifications as noted in the predicate device comparison chart in Section X of Attachment E. These differences do not alter the intended use or affect the safety and effectiveness of the Helax-VISIR system when used as labelled.

## Special controls 8.

Although there are no performance standard established by the FDA for these devices the Helax-VISIR is designed, and manufactured to meet, the following standards:

- Electrical medical equipment General requirements for safety · IEC 601-1
- · IEC 601-1-4 Electrical medical equipment -Part 1 : General requirements for safety - 4. Collateral Standard: Programmable electrical medical sys-

tems.

- IEC 1217 Radiotherapy equipment - Coordinates, movements and scales .
- · IEC 878 Graphical symbols for electrical equipment in medical practice

Helax AB is certified according to European EG Medical Device Directive, Annex II Section 3.2 - Full Quality Assurance System, per 1997-01-08, The scove of the certification is: Design, development, production, installation and servicing of based systems in oncology in class IIb. This implies that Helax AB Quality System fulfils the requirements in ISO 9001 and EN 46001.

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A large part of the development, verification and validation of the Helax-VISIR medical device was performed by Helax-VISIR A/S in Oslo, Norway, a fully owned subsidiary to Helax AB. The development was performed according to Helax AB Quality System and controlled by Helax AB.

The device and its development process also comply with the FDA, CDRH, ODE, August 23, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review

Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

> OCT - I 1997

Jan Tornavist Vice President, Regulatory Affairs and Quality Management Helax AB Klostergatan 12 Uppsala, Sweden

Re:

K972617 Helax-VISIR (Verification and Information System in Radiotherapy) Dated: July 4, 1997 Received: July 9, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Tornqvist:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 marked 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 and additionally 809.10 for in ying diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.J. Liao Yin

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page

510(k) Number (if known):_K972617

Helax-VISIR Device Name:_

Indications For Use:

4:

radiation treatment Patients undergoing according to prescribed treatment plan.

(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
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972617