QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
Device Facts
| Record ID | K013531 |
|---|---|
| Device Name | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 |
| Applicant | Impac Medical Systems, Inc. |
| Product Code | KPQ · Radiology |
| Decision Date | Nov 7, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5840 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.
Device Story
QwikSIM is a virtual simulation system for radiation therapy planning. It imports patient image data; provides tools for image adjustment, manual/automatic contouring of tumors and normal tissues, and beam placement visualization. Operators (radiation oncologists, physicists, dosimetrists) use the system to define treatment ports, isocenters, and laser centers. Output includes plan data for laser positioning systems and export to external treatment planning systems for dose calculation. Used in clinical settings to streamline radiotherapy planning, improve accuracy of target delineation, and facilitate treatment unit setup.
Clinical Evidence
No clinical data provided. Substantial equivalence determined via bench testing, hazard analysis, and verification/validation of software design controls.
Technological Characteristics
Radiation therapy simulation system; software-based image processing and contouring. Complies with ISO 9001:1994, ISO 13485:1996, EN 46001:1997, and EN 601-1-4:1996. Operates as a workstation-based application for image import, visualization, and planning data export.
Indications for Use
Indicated for radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import/review, tumor/tissue delineation, and virtual simulation of treatment unit setup for external beam radiotherapy planning.
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
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for IMPAC. The logo consists of the word "IMPAC" in a bold, serif font. Above the word is a geometric design that appears to be a square with a circle inside, divided into sections by lines. The overall design is simple and professional.
NOV 0 7 2001
IMPAC Medical Systems, Inc. www.impac.com
Corporate Office: 100 West Evelyn Avenue Mountain View, CA 94041-146. T 650-254 4700 F 650-428 0721
Eastern Region: 43 Thorndike Street Cambridge, MA 02141-1764 T 617-621 2557 F 617-494 6109
#### Friday, July 13, 2001
K013531/
# OwikSIM, Virtual Simulation System Premarket Notification (510(k)) Summary of Safety and Effectiveness
#### Introduction
This document summarizes the safety and effectiveness information within the QwikSIM Premarket Notification (510(k)). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution. For additional information, feel free to contact the submitter's Management Representative listed below.
#### Premarket Notification Information
- 1. Product Information:
- Product Name a.
- Release Version Number b.
#### Classification Information: 2.
- Classification Name a.
- b. Common/Usual Name
- Product Classification C.
- d. Product Code
- Reference e.
- f. Review Panel
- Establishment Information: ని.
- Submitter a.
- b. Submitter Address
- Establishment Number c.
- Contact d.
- Contact Phone e.
- f. Contact Fax
QwikSIM Virtual Simulation System Version 2.00
Radiation Therapy Simulation System
Virtual Simulation System
Class II
9 0 - KPQ 21 CFR 892.5840
Radiology
IMPAC Medical Systems, Inc. 100 West Evelyn Ave., Mountain View, CA 94041 2950347 Thomas H. Faris, Director RA/QA 650-623-8807 650-428-0721
### Predicate Device Information
QwikSIM is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. QwikSIM is substantially equivalent to these products in intended use and safety and effectiveness.
- Advantage Sim 1.
| Manufacturer | General Electric Co. |
|-----------------------------------|----------------------|
| Previous Premarket Notification # | K951830 |
| Previous Submission Date | 04/20/95 |
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K013531
#### ACQSIM Simulator/Localizer 2..
| | Manufacturer | Marconi Medical Systems |
|----|-----------------------------------|-------------------------|
| | Previous Premarket Notification # | K923851 |
| | Previous Submission Date | 07/31/92 |
| 3. | Somavision | |
| | Manufacturer | Varian Assoc., Inc. |
| | Previous Premarket Notification # | K992751 |
| | Previous Submission Date | 08/16/99 |
#### OwikSIM Intended Use
QwikSIM is a radiation therapy virtual simulation system for patient image review, target and critical structure delineation, and geometric treatment planning.
### QwikSIM Indications for Use
The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicsting and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup to support the radiother py treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.
### Description of the Product
The QwikSIM Virtual Simulation System provides fast and accurate visualization, contouring and beam definition I to streamline the radiation therapy planning process. QwikSIM imports image data, and provides an array of tools to straining and adjusting images. Manual and automatic contouring tools allow for anatomical and tumor contour definition. Beam placement and visualization tools facilitate treatment port definition, isocenter placement and laser center placement. The resulting plan data can then be used with laser positioning systems for patient marking and exported to therapy planning systems for dose calculation.
#### Clinical Demonstration of Efficacy
No additional or changed diagnostic or therapeutic claims arise as the result of the differences between QwikSIM and the predicate devices. Clinical performance data is not required for determination of substantial equivalence for this type and class of device.
#### Device Safety
The QwikSIM System Hazard Analysis was performed to determine and evaluate all areas that represent potential I fo wholen by hazards during QwikSIM system operation. For all system hazards, the hazards, effects, and suitigations have all been documented (SHA4901), reviewed, and implemented. This System Hazard Analysis is reviewed with every change and release of the product. Validation and verification activities trace the hazard identification and mitigation through evaluation, design, specification, implementation, and testing. The QwikSIM Tesign Review Team has reviewed the QwikSIM System Hazard Analysis and has determined that the QwikSIM product does not pose a greater health or safety risk to patients, users, or other third parties than predicate devices listed above.
Image /page/1/Picture/13 description: The image shows the logo for IMPAC. The logo consists of a square with a stylized globe inside it, above the word "IMPAC" in a bold, serif typeface. The globe is represented by lines dividing it into sections, suggesting a network or interconnectedness.
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# Substantial Equivalence Determination
IMPAC has determined and certified that:
- A. The intended use of QwikSIM is the same as that of the predicate devices.
- QwikSIM has the same technological characteristics as the predicate devices. B.
- C. Any differences in the functionality of QwikSIM compared to the predicate devices do not raise any new issues of safety or effectiveness, nor are novel verification or validation methods required to assure safety and effectiveness.
QwikSIM is substantially equivalent to the previously cleared predicate devices listed above. Although functionality is not identical, the use and operation of the QwikSIM product is substantially equivalent to the predicate devices, as demonstrated by the Feature Comparison Matrix included in the Premarket Notification.
### Quality System
The fundamental goal of IMPAC's quality program is to provide value to customers and internal operations by producing better and safer products that are less expensive to build and maintain, simpler to use, and easier to producing obtact and sales proved the IMPAC Quality System to operate in a manner that has proven to be the most efficient and effective. Organizational experience and expertise is built into the management system to ensure that each process consistently meets defined specifications and continuously seeks improvement. All employees receive extensive Quality System training and take pride in the value that they contribute to IMPAC products and processes and to the final customer and their patients.
QwikSIM was developed according to the IMPAC Software Design Control Procedure (SDCP). This procedure governs the process by which system and software development are to be planned, defined, implemented, tested, and released.
| DOC. ID | TITLE |
|------------------|----------------------------------------------------------------------------------------------------------------|
| 21 CFR 820 | Quality System Regulation |
| ISO 9001:1994 | Quality Systems-Model for Quality Assurance in Design, Development,<br>Production, Installation, and Servicing |
| ISO 13485:1996 | Quality Systems-Medical Devices-Particular Requirements for the Application of<br>ISO 9001 |
| 93/42/EEC | Medical Device Directive |
| EN 46001: 1997 | Application of EN ISO 9001 to the Manufacture of Medical Devices |
| EN 601-1-4: 1996 | General Requirements for Safety |
The IMPAC Quality System was developed in compliance with all of the following standards and regulations:
#### Verification and Validation Testing
A Traceability Matrix has been created, based upon the project plan, to ensure the completion of the specification, implementation, and testing of all requirements of the feature enhancement, including performance of full system hazard mitigation and basic operational testing. The System Test Plan defines the overall plan for completing full application, integration, and system testing of QwikSIM, while the Test Procedures capture the detailed testing parameters, results, and certification. The included Test Certification Statement certifies that the planned testing requirements were completed successfully. Design Reviews have been performed at the conclusion of each software design and development phase to review and validate the fulfillment of all of the phase requirements and deliverables. All of the above have been completed for QwikSIM and representative documents have been included in the Premarket Notification.
Image /page/2/Picture/13 description: The image shows the logo for IMPAC. The logo consists of a square with a circle inside, divided into sections by lines. Below the square is the word "IMPAC" in large, bold, sans-serif font.
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IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering testing was also performed to ensure that the QwikSIM product functions as intended and specified, according to design specifications and customer labeling. The testing demonstrated that the functionality of QwikSIM was successfully implemented.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 7 2001
IMPAC Medical Systems, Inc. c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K013531
Trade/Device Name: OwikSIM Virtual Simulation System, V2.00 Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: October 22, 2001 Received: October 23, 2001
Dear Mr. Job:
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 | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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NOV 0 7 2001
# QwikSIM Indications for Use Statement
510(k) Number (if known): 10 (3531
Device Name: QwikSIM Virtual Simulation System
Indications for Use:
The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Nancy C. borgdon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013531
**Prescription Use**
10/5/01
file://G:\DOCS\QSM49\Reg\010713\21 indicate.htm
10/5/01
