EXPLORER 4D TREATMENT PLANNING SYSTEM

K101220 · American Radiosurgery, Inc. · MUJ · Nov 5, 2010 · Radiology

Device Facts

• Record ID: K101220
• Device Name: EXPLORER 4D TREATMENT PLANNING SYSTEM
• Applicant: American Radiosurgery, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Nov 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed. The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Device Story

Explorer 4D™ Treatment Planning System (TPS) creates gamma radiation therapy treatment plans. Inputs include CT and MR images; operator registers fiducial markers for image alignment; annotates regions of interest (ROI); defines radiation 'shots' and dose levels relative to collimator size. System calculates dose delivery parameters. Output is a finalized treatment plan for export. Used in clinical settings by trained operators; requires physician approval of plans. Benefits include precise target localization and visualization of dose distribution to target and surrounding structures, facilitating accurate radiosurgical planning.

Clinical Evidence

Bench testing only. Functional coverage testing and accuracy comparison tests were performed. Physicist manual calculations verified that dose calculation results using MR images are equivalent to results generated using CT images.

Technological Characteristics

3D imaging software for radiation treatment planning. Supports CT and MR image import. Features include ROI annotation, fiducial marker registration, and dose visualization. Connectivity via TCP/IP network interface. Security via identification code and password. Software version 2.1.

Indications for Use

Indicated for patients with intracranial diseases requiring neurological radiosurgery.

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

• Explorer 4D™ Treatment Planning System version 2.0 (K093588)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for American Radiosurgery. The logo consists of a series of black dots arranged in a semi-circular pattern on the left side of the image. To the right of the dots, the words "AMERICAN RADIOSURGERY" are written in a bold, sans-serif font. The text is aligned horizontally and is the main element of the logo.

# 510(k) Summary

NOW - 5 2010

| 510(k) | K101220 |
|---------------------------|---------------------------------------------------------------|
| Submitter/Applicant Name: | American Radiosurgery, Inc. |
| Address: | 16776 Bernardo Center Drive, Suite 203<br>San Diego, CA 92128 |
| Phone number: | 858-451-6173 |
| Fax number: | 858-487-0662 |
| Contact: | John Clark |
| Contact person: | Dan Olivier (CCS, Inc.) |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Date prepared: | October 30, 2010 |
| Trade name: | Explorer 4D™ Treatment Planning System |
| Common name: | Radiation Therapy Treatment Planning System |
| Classification name: | System, Planning, Radiation Therapy Treatment |
| Classification: | 21 CFR Part 892.5050 Class II |

# Substantial equivalence claimed to:

Substantial equivalence thanks as: "Treament Planning System is functionally and
substantially equivalent to the K093588 Explorer 4D™ Treatment Planning System with the subsumitially equility to import MR as well as CT images. Both systems share the same user interface and dose calculation algorithms; the only difference is the ability to import both CT and MR images.

## Description

The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan.

Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.

When the plan definition is completed the operator can save or export the treatment plan.

Intended Use

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The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed.

The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

# Substantial Equivalence

Substantial Explorer 4D™ Treatment Planning System include the capability to prepare treatment plans using MR images as well as CT images cleared under submission K093588 (version 2.0). Functional testing has demonstrated that version 2.1 is safe and effective and accuracy comparison tests have demonstrated equivalent performance using MR images as obtained using CT images.

| Equivalence Comparison | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate |
| Name | Explorer 4DTM Treatment<br>Planning System version 2.1<br>(K101220) | Explorer 4DTM Treatment<br>Planning System version 2.0<br>(K093588) |
| Indications for<br>Use | The Explorer 4DTM Treatment<br>Planning System software is<br>intended for use in preparing<br>treatment plans for patients who<br>have intracranial diseases where<br>neurological radio surgery has<br>been prescribed.<br>The software is used to<br>electronically import CT and<br>MR images to determine the<br>precise location of the target, to<br>define and visualize treatment<br>beam locations, and to visualize<br>dose to the target and other<br>structures. | The Explorer 4DTM Treatment<br>Planning System software is<br>intended for use in preparing<br>treatment plans for patients who<br>have intracranial diseases where<br>neurological radio surgery has<br>been prescribed.<br>The software is used to<br>electronically import CT images<br>to determine the precise<br>location of the target, to define<br>and visualize treatment beam<br>locations, and to visualize dose<br>to the target and other<br>structures. |
| System<br>Functions | The Explorer 4DTM Treatment<br>Planning System (TPS) imports<br>patient images to determine the<br>precise location of the target for<br>gamma irradiation. | The Explorer 4DTM Treatment<br>Planning System (TPS) imports<br>patient images to determine the<br>precise location of the target for<br>gamma irradiation. |
| Technological<br>characteristics | Technological characteristics<br>include 3D imaging of<br>treatment beam locations to<br>visualize target dose overlaid on<br>CT and MR images. | Technological characteristics<br>include 3D imaging of<br>treatment beam locations to<br>visualize target dose overlaid on<br>CT images. |
| Import data | CT and MR images | CT |

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| Equivalence Comparison | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Item | Device | Predicate |
| Data interfaces | TCP/IP network interface | TCP/IP network interface |
| User access | Secured through identification<br>code and password | Secured through identification<br>code and password |
| Safety Features | Requires physician approval of<br>treatment plans | Requires physician approval of<br>treatment plans |
| Non-clinical<br>testing | Testing includes functional<br>coverage of all requirements<br>and accuracy comparison tests<br>using CT and MR images | Testing includes functional<br>coverage of all requirements |
| Test results | Test results have been verified<br>by physicist manual<br>calculations as accurate for CT<br>and MR images | Test results have been verified<br>by physicist manual<br>calculations as accurate for CT<br>images |
| Software version | 2.1 | 2.0 |

## Performance Data

Testing for the Explorer 4D™ Treatment Planning System is the same as was performed for the r esting for the Explorer 12 - Freativent Planning System) with the difference that production and of no 9500 Enpress ware version 2.1 using MR images instead of CT images. In an tests were concacted with comparison tests were also conducted showing the results using MR images are equivalent to the results generated using CT images.

> production : : : : : : :

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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 features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### 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

American Radiosurgery, Inc. c/o Mr. Dan Olivier President Certified Compliance Solutions. Inc. 11665 Avena Place, Suite 203 SAN DIEGO CA 92128

NOV - 5 2010

Re: K101220

> Trade Name: Explorer 4DTM Treatment Planning System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 24, 2010 Received: October 25, 2010

Dear Mr Oliver:

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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#### Page 2

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 vours.

Dan

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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American Radiosurgery Explorer 4D™ Treatment Planning System Premarket Submission

#### Indications for Use 4.

510(k) Number: K101220 510(K) Namber : R101220 TM Treatment Planning System

NOV - 5 2010

Indications for Use:

The Explorer 4D™ Treatment Planning System software is intended for use in preparing The Exploier 4D - Treamfell Tiaming System Scoranial diseases where neurological radio surgery has been prescribed.

The software is used to electronically import CT and MR images to determine the precise I he "software" is asour to "elections and visualize treatment beam locations, and to visualize dose to the target and other structures.

Prescription Use (Per 21 CFR 801 Subpart D)

"AND/OR ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

(Division Sign-Off)

510K K101220