DOSEVIEW 3D

K103193 · Standard Imaging, Inc. · IYE · Dec 27, 2010 · Radiology

Device Facts

• Record ID: K103193
• Device Name: DOSEVIEW 3D
• Applicant: Standard Imaging, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include: - Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system. - Quality assurance measurements to identify and minimize the sources of uncertainty and error in the radiation therapy system, radiotherapy system or radiation treatment planning system. - Collection of dose depth data for radiation treatment planning system use. - Completion of clinical dosimetry protocols and calibrations.

Device Story

DoseView 3D is a 3-axis water phantom scanning system; measures/analyzes radiation dose from linear accelerators or radioactive sources. System components: water tank, electrometer, radiation detectors, motion controller, controlling software, master pendant, lift/reservoir cart. Operated by medical physicists in clinical settings for acceptance testing, commissioning, and quality assurance of radiation therapy systems. Inputs: radiation measurements from detectors. Outputs: dose depth data and dosimetry analysis. Data used to support radiation treatment planning systems; helps minimize uncertainty/error in radiation delivery; ensures accurate clinical dosimetry calibrations. Evolution of the DynaScan Radiation Beam Data Acquisition System.

Clinical Evidence

No clinical trials were required. Device performance was verified and validated through bench testing, including software testing, installation testing, acceptance testing, calibration, and shipment testing. Clinical evaluation was conducted at three sites: Turville Bay MRI & Radiation Oncology Center, UW Hospitals & Clinics, and ATC/Tokyo Metropolitan University to confirm design specifications and validation objectives.

Technological Characteristics

3-axis water phantom system. Components: water tank, electrometer, radiation detectors, motion controller, master pendant, lift/reservoir cart. Standards: ISO 13485, ISO 14971, IEC 60601-1 (Medical Electrical Equipment), IEC 60601-1-2 (EMC/EMI), IEC 60601-1-4 (Programmable Systems), IEC 60731 (Dosimeters), IEC 61217 (Radiotherapy Coordinates). Connectivity: controlling software for data acquisition and analysis. Sterilization: N/A.

Indications for Use

Indicated for use by trained medical physicists to measure and analyze pulsed photon/electron radiation from linear accelerators or continuous radiation from radioactive source-based radiotherapy systems for acceptance testing, commissioning, quality assurance, and clinical dosimetry protocols.

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

• DynaScan Radiation Beam Data Acquisition System (K854880)
• MP3 Automatic Water Phantom (K954165)

Submission Summary (Full Text)

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Image /page/0/Picture/11 description: The image shows the logo for Standard Imaging. The logo consists of the word "STANDARDIMAGING" in a stylized font, with a small dot above the "i". To the right of the word is a circular graphic with a lightning bolt design inside. The logo is black and white.

K103193 Subject: 510(k) Summary of Safety and Effectiveness Information for the Standard Imaging DoseView 3D Standard Imaging DoseView 3D Proprietary Name: DEC 2 7 2010 Device Name Classification(s): Primary: Medical Charged-Particle Radiation Therapy System (accessory to) Secondary: Radiologic Quality Assurance Instrument, Radiation Therapy Simulation System Device Panel: Radiology Device Classification(s): Primary: Class II - 21CFR892.5050 - IYE Secondary: Class II - 21CFR892.1940 - LHO Class II - 21CFR892.5840 - KPQ Predicate Devices: Computerized Medical Systems, Inc., DynaScan Radiation Beam Data Primary: Acquisition System -510(k) K854880 PTW - New York Corp., MP3 Automatic Water Phantom -Secondary: 510(k) Number K954165 Contact Person: Raymond Riddle, PE, RAC, Chief Regulatory Officer

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The DoseView 3D system is a 3-axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear accelerated based radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment plasot system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include:

- Acceptance testing and/or commissioning of a radiation therapy or . radiotherapy system.
- Quality assurance measurements to identify and minimize the sources . of uncertainty and error in the radiation therapy system, radiotherapy system or radiation treatment planning system.
- Collection of dose depth data for radiation treatment planning system use. .
- Completion of clinical dosimetry protocols and calibrations.

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..

STANDARDING, INC. 3120 Dening Way, Midleton, W 53562-1461 600-261-0025 HH 608-831-202 FAX www.standardimaging.com

ADVANCING RADIATION QA"

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Image /page/1/Picture/0 description: The image shows the logo for Standard Imaging. The logo consists of the words "STANDARD IMAGING" in a stylized font, with the word "STANDARD" in a lighter weight font than "IMAGING". To the right of the words is a circular graphic with a stylized sunburst design inside.

Standard Imaging acquired the product technology, controlling software and labeling for the Dose View 3D System from Computerized Medical Systems, Inc. Previously, Computerized Medical Systems had successfully distributed their DynaScan Radiation Beam Data Acquisition System and further supported their system until the company was acquired by Elekta A. Thus, the new Standard Imaging DoseView 3D is the logical update and evolution of the original Computerized Medical Systems DynaScan Radiation Beam Data Acquisition System. That system was cleared by FDA via a 510(k) premarket notification.

The Standard Imaging DoseView 3D was designed to comply with the applicable portions of the following voluntary product related standards:

- ISO 13485: Quality Management Systems .
- ISO 14971: Risk Management
- IEC 60601-1, plus amendments: Medical Electrical Equipment
- IEC 60601-1-2, plus amendments: EMC/EMI �
- IEC 60601-1-4: Programmable Systems ●
- IEC 60731: Dosimeters with Ionization Chambers as used in Radiotherapy .
- IEC 61217: Radiotherapy Equipment Coordinates, Movements and Scales .
- EN 980: Symbols ●
- . EN 1041: Manuals

The Standard Imaging DoseView 3D has been verified and validated at Standard Imaging. These activities addressed software testing, installation testing, acceptance testing maglify assurance testing, data collection, calibrations and shipment testing related to thing quant Additionally, the DoseView 3D was successfully evaluated by the following clinical heta sites:

- Turville Bay MRI & Radiation Oncology Center, Madison, WI .
- · UW Hospitals & Clinics, Madison, WI
- ATC/Tokyo Metropolitan University, Tokyo, Japan �

The Standard Imaging DoseView 3D has been deemed to meet its predetermined design specifications, risk analysis and validation objectives.

STANDARDING, INC. 3120 Deming Way, Middleton, W153562-1461 600-261-0025 HH 608-831-202 FM 608-831-202 FM www.standardina.goomag.com

Image /page/1/Picture/18 description: The image shows the words "ADVANCING RADIATION QA" in all caps. The words are white and the background is black. The letters are bolded and sans-serif.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, and two curved lines that form the legs and feet.

## 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

Mr. Raymond T. Riddle, PE, RAC Chief Regulatory Officer Standard Imaging, Inc. 3120 Deming Way MIDDLETON WI 53562-1461

0EC 2 7 2910

Re: K103193

Trade/Device Name: DoseView 3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy device Regulatory Class: II Product Code: IYE Dated: October 27, 2010 Received: October 29, 2010

Dear Mr. Riddle:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 remarketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premy aref notification" (21 CFR 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 tolloffree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): | <103193

Device Name:

DoseView 3D

DEC 2 7 2010

Indications For Use:

The DoseView 3D system is a 3 axis, water phantom scanning system intended to easily and accurately, measure and analyze pulsed photon and electron radiation from a linear acceleratedbased radiation therapy system or continuous radiation from a radioactive source-based radiotherapy system. This data is then often used in support of a radiation treatment planning system. It is comprised of a water tank, electrometer, radiation detector(s), motion controller, controlling software, master pendant and lift/reservoir cart. It is a prescription device intended to be used by a trained medical physicist. The general uses of the DoseView 3D include the following:

- Acceptance testing and/or commissioning of a radiation therapy or radiotherapy system. ◆
- Quality assurance measurements to identify and minimize the sources of uncertainty and . . error in the radiation therapy system, radiotherapy system or radiation treatment planning system.
- Collection of dose depth data for radiation treatment planning system use. ●
- . Completion of clinical dosimetry protocols and calibrations.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

and/or

Over-the-Counter-Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Radiological D Office of In Vitro Diagnostic Device Evaluat

610K K103/93

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