RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

K101038 · Acceletronics Digital Imaging, LLC · KPQ · Aug 17, 2010 · Radiology

Device Facts

• Record ID: K101038
• Device Name: RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
• Applicant: Acceletronics Digital Imaging, LLC
• Product Code: KPQ · Radiology
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2

Intended Use

The RAD II KV Imager device is used for verification of correct patient position in relation to the Radiation Therapy Machine Isocenter; and verification of the treatment fields in relation to anatomical and or fiducial landmarks prior to radiation therapy treatment. The RAD II Simulator device is intended for use in developing and verifying patient treatment positioning protocols for radiation therapy treatment of cancer.

Device Story

RAD II KV Imager and RAD II Simulator are therapy-attached diagnostic imaging devices mounted to linear accelerators or cobalt therapy units. RAD II KV Imager uses a digital imager (NAOMI) to capture images for IGRT protocols; RAD II Simulator uses standard x-ray film. Both systems include positioning software (Theraview) running on a PC. Operated by therapists or oncologists in a clinical radiation therapy setting. The device provides images of patient anatomy and fiducial landmarks relative to the machine isocenter. Healthcare providers review these images to verify or adjust patient positioning before radiation delivery. This process ensures accurate treatment field alignment, potentially improving therapeutic precision and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison and performance characteristics relative to predicate devices.

Technological Characteristics

System includes X-ray generator (SEDECAL SHF-320), X-ray tube (Varian Rad-60), collimator, and imaging components. RAD II KV Imager uses NAOMI digital imager; RAD II Simulator uses Kodak T-Mat-H film. Software: Theraview patient positioning software on Dell PC. Connectivity: Standalone workstation at therapist console. Mounting: Fixed or retractable arm design for linear accelerators/cobalt units.

Indications for Use

Indicated for cancer patients undergoing radiation therapy. Used as diagnostic imaging devices for patient positioning verification prior to treatment. RAD II KV Imager uses digital imaging; RAD II Simulator uses x-ray film. Both are permanently mounted to linear accelerators or cobalt teletherapy devices. Use is prescribed by a radiation oncologist.

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

• Varian Medical Systems On-Board Imager (K040192)
• Varian Medical Systems Portal Vision (K003636)
• Elekta Synergy (K032996)
• Oldelft Simulux-HP (K946128)
• Haynes Radiation Ltd., Inc. RAD II Simulator (K834281)

Reference Devices

• Theraview (K960510)

Submission Summary (Full Text)

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K101038

AUG 1 7 2010

510(k) Summarv May 10, 2010, revised 7/03/10

The following submission is provided following the format of 21CFR 807.92 for the RAD II Simulator & RAD II KV Imager.

- 1. Submitter: ACCELETRONICS, INC. 602 Gordon Drive Exton, PA. 19341 USA Contact: Stephen E. Havnes Phone: [phone] Fax: [phone] Email: [e-mail]
- 2. Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:

RAD II Simulator & RAD II KV Imager RAD II Simulator & RAD II KV Imager Therapy Attached Simulator/verification device System Simulator, Radiation Therapy 21CFR 892.5840 Class II Product Code: KPQ

## 3. Predicate Devices to claim substantial equivalence:

| A) Varian Medical Systems On-Board Imager | K040192 |
|-------------------------------------------------|---------|
| B) Varian Medical Systems Portal Vision | K003636 |
| C) Elekta Synergy | K032996 |
| D) Oldelft Simulux-HP | K946128 |
| E) Haynes Radiation Ltd., Inc. RAD II Simulator | K834281 |

- Description of the device: The RAD II KV Imaging device is mounted directly to the 4. head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.
Substantial Equivalence = The RAD II is substantially equivalent in name to predicated devices A-E as a "Simulator" or "On Board Imager" device.

- 5. Intended Use Statement:
A) The RAD II KV Imager device is used for verification of correct patient position in relation to the Radiation Therapy Machine Isocenter; and verification of the treatment fields in relation to anatomical and or fiducial landmarks prior to radiation therapy treatment.

Substantial Equivalence: The RAD II KV Imager is substantially equivalent in usage as an "On Board Imager" when compared to the predicated devices A-C.

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Image /page/1/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left and the word "Acceletronics" on the right. The symbol is a combination of a target-like design and vertical bars. The word "Acceletronics" is written in a stylized font, and the letters are connected.

- B) The RAD II Simulator device is intended for use in developing and verifying patient treatment positioning protocols for radiation therapy treatment of cancer.
Substantial Equivalence: The RAD II Simulator is substantially equivalent in usage as a "Radiation Therapy Simulator" when compared to the predicated devices D&E.

- 6. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart on Exhibit C-4 provides a comparison of the technological characteristics and componentry to those of the predicate devices. The RAD II Simulator and the RAD II KV Imager are detailed in this chart Exhibit C-4 showing substantial equivalence of componentry to the predicate devices listed.
A) The predicate devices use:

X-Ray Generator X-Ray Tube Collimator & Bearing Gantry Imaging Via X-ray Film Imaging Via Digital Imager Imaging Via Image intensifier Positioning Software Computer

RAD II Simulator and KV Imager Use:

X-Ray Generator X-ray Tube Collimator & Bearing Mounted to a Gantry Imaging Via X-ray Film Imaging Via Digital Imager lmaging via X-ray film Positioning Software Computer

- . The RAD II Simulator & RAD II KV Imager are substantially equivalent to the predicate RAD II Simulator device in almost all of its predicate capabilities. The differences exist in the RAD II KV Imager which has no delineator, but has advanced digital imaging,
- The RAD II Simulator & RAD II KV Imager are substantially equivalent to the . Oldelft Standalone Simulator in their ability to create relevant Patient positioning lmages for Radiation Therapy Treatment protocols, while using the Therapy gantry they are mounted to, and the Therapy couch, which is part of the Therapy System assembly.
- . The RAD II KV Imager is substantially equivalent to the predicate Varian On-Board lmager as a Therapy attached diagnostic device using digital imaging and Patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.
- The RAD II KV Imager is substantially equivalent to the predicate Portal Vision . Devices as a Therapy attached digital imaging Device using Digital Imaging and patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.

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| Exhibit C-4<br>RAD II Make, Model &<br>Operational Prd. | X-Ray Tube<br>Model & Make | X-Ray<br>Generator<br>Model & Make | Tube Mount<br>Model & Make | X-Ray Film<br>Model & Make | Film Cassette<br>Model & Make | Imager Model<br>& Make | Cassette &<br>Imager Mount<br>Model & Make | Patient<br>Positioning<br>software | Imager Comp.<br>Model & Make | Application<br>Comp. Model &<br>Make | 510K<br>Number |
|-----------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------|------------------------------|-------------------------------------------------|----------------|
| HRL RAD II<br>MODEL<br>Phantom-HF<br>2003-Present | Phantom Hd.,<br>Superior by<br>Dynarad & Del<br>Global 50-<br>100kVp | Phantom<br>Generator<br>Dynarad & Dell<br>Global, 12.5mA<br>fixed | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | Kodak<br>T-Mat-H. | Kodak Lannex<br>Regular & Fast | None | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | None | None | None | K834283 |
| HRL RADII Rad<br>Only MODEL 2001-<br>HF 1994-1999 | Rad-74, Eureka<br>50-125kVp | Futurus 2001<br>Generator by<br>Innerscan 50-<br>500mA | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | Kodak<br>T-Mat-H | Kodak Lannex<br>Regular | None | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | None | None | None | K834281 |
| HRL RAD II<br>Rad Only MODEL<br>2001-HF 1999-<br>Present | Rad-74, Varian<br>50-125kVp | SHF-320<br>Generator by<br>SEDECAL<br>25-300mA | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | Kodak<br>T-Mat-H | Kodak Lannex<br>Regular | None | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | None | None | None | K834281 |
| Single<br>Headed RAD<br>II KV Imager<br>MODEL 2001-HF<br>2009-Present | Qty. 1<br>Rad-60, Varian<br>50-150kVp | (1) SHF-320<br>Generator by<br>SEDECAL<br>25-300mA | HRL Shut Down in 2006, purchased bu Acceletronics in 2007. RAD II KV Imager product developed from 2008-2009 | | | QTY.1<br>NAOMI Imager<br>by RF<br>SYSTEMS<br>LAB | Fixed or<br>Retractable<br>Arm Design by<br>Acceletronics<br>for<br>Accelerators | Theraview<br>Software by<br>Cablon | Mini Computer<br>by Cablon | DELL PC<br>Loaded with<br>Theraview<br>software | K101038 |
| Dual Headed<br>RAD II KV<br>Imager MODEL<br>2001-HF 2009-<br>Present | Qty. 2<br>Rad-60, Varian<br>50-150kVp | (2) SHF-320<br>Generator by<br>SEDECAL<br>25-300mA | Retractable<br>Design by<br>Acceletronics<br>for<br>Accelerators | None | None | QTY.2<br>NAOMI Imager<br>by RF<br>SYSTEMS<br>LAB | Retractable<br>Arm Design by<br>Acceletronics<br>for<br>Accelerators | Theraview<br>Software by<br>Cablon | Mini Computer<br>by Cablon | DELL PC<br>Loaded with<br>Theraview<br>software | K101038 |
| Varian O.B.I.<br>2004-Present | Qty. 1<br>Rad-60, Varian<br>50-150kVp | (1) CPI Indico<br>100 Generator<br>by CPI 25-<br>300mA | Retractable<br>Head Design<br>by Varian<br>mounts to | None | None | Varian 4030<br>Amorph<br>Silicone<br>Imaging Panel | Retractable<br>Arm Design by<br>Varian mounts<br>to middle of<br>RetractablE | Proprietary<br>Software | Unknown? | PC at<br>Therapist<br>Console Area | K040192 |
| Elekta Synergy<br>Imager 2003<br>to present | Qty. 1 Rotating<br>Anode Tube 50<br>125kVp | (1) Generator<br>make/model<br>unknown | Retractable Head<br>Design mounts to<br>mid-gantry of<br>Clinac | None | None | Amorph<br>Silicone<br>Imaging Panel | Arm Design by<br>Elekta mounts<br>to middle of<br>RetractablE | Proprietary<br>Software | Unknown? | PC at<br>Therapist<br>Console Area | K032996 |
| Varian Portal<br>Vision 2004-<br>Present | | | | None | None | Varian 4030<br>Amorph<br>Silicone<br>Imaging Panel | Retractable<br>Arm Design by<br>Varian mounts<br>to Ctwt, Ass. | Proprietarg<br>Software | Unknown? | PC at<br>Therapist<br>Console Area | K003636 |
| Theraview | | | | None | None | CCD Camera<br>Imaging Panel | Theraview Rot. Arm<br>Darian mounts to<br>Gantry Chut. Arry. | Proprietary<br>Software | Unknown? | PC at<br>Therapist<br>Console Area | K960510 |
| Oldelft Simulux-HP | Qty. 1 R/F<br>Rotating<br>Anode Tube 50<br>150kVp | (1) R/F<br>X-Ray<br>Generator<br>25-500mA | Standalone<br>Gantry<br>Simulates an<br>Accelerator | None | None | Glass Image<br>Intensifier -<br>Variable sizes | Variable imager<br>Arm Design by<br>Oldelft mounts<br>to lower Gantry | Proprietary<br>Software | Unknown? | PC at<br>Therapist<br>Console Area | K945128 |
| RAD II<br>Simulator | Qty. 1 Fixed<br>Anode Tube 50<br>125kVp | (1) Generator<br>make by Porta<br>Ray/Dynarad | Typically fixed<br>Adapter mounts<br>to Head of<br>Accelerator | None | Kodak<br>Lannex Fast<br>Cassettes | | Variable<br>Design by HRL<br>for Clinac &<br>Cobalt | | | | K834281 |

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight or flowing lines, stacked vertically.

## 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. Stephen Haynes Project Design & Engineering Acceletronics Digital Imaging, LLC 602 Gordon Drive EXTON PA 19341

AUG 1 7 2010

Re: K101038

Trade/Device Name: Rad II KV Imager & RAD II Simulator Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulator system Regulatory Class: II Product Code: KPQ . Dated: July 29, 2010 Received: July 30, 2010

## Dear Mr. Haynes:

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 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 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 premarket 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 toll-free number

[phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. St.Pierre 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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Image /page/5/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol to the left of the company name. The symbol is made up of concentric arcs intersected by vertical and horizontal lines, resembling a target or radar screen. The text "Acceletronics" is written in a stylized font to the right of the symbol, with the letters slightly slanted and connected.

K101038

Indications for Use Revised 7/03/10

510(k) Number (if known): K101038

Device Name: Rad II KV Imager & RAD II Simulator

Indications for use:

- 1. Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
- 2. Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
- 3. The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
- 4. The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
- 5. The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
- 6. The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

Prescription Use YES AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OIVD

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101038

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Acceletronics Digital Imaging, LLC. · 602 Gordon Drive · Exton, PA 19341 Toll Free 800-543-5144 · Service Dispatch 800-626-8704 · Fax [phone] · www.acceletronics.com