DOSE VOLUME HISTOGRAM (DVH) EVALUATOR

K092928 · Diversilabs, LLC · MUJ · Dec 16, 2009 · Radiology

Device Facts

• Record ID: K092928
• Device Name: DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
• Applicant: Diversilabs, LLC
• Product Code: MUJ · Radiology
• Decision Date: Dec 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DVH Evaluator system is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.

Device Story

DVH Evaluator is standalone PC software for radiation therapy treatment planning. It imports DICOM-RT or vendor-specific files containing radiation dose volume data for patient anatomical structures. Users define dose tolerance limits via ASCII text files; software overlays these limits onto DVH plots. If dose exceeds limits, visual warnings appear. An optional 'Followup Evaluator' module records patient symptoms/responses in a database for offline analysis to optimize dose tolerance limits. Operated by medical physicists, physicians, or dosimetrists in clinical settings. Output assists clinicians in evaluating treatment plan adequacy during iterative planning. Does not control radiation delivery or export dose limit information.

Clinical Evidence

Bench testing only. Software verification and validation were performed to ensure compliance with predetermined specifications. No clinical data provided.

Technological Characteristics

Standalone software application for PC. Requires Windows XP or Server 2003, 500 MHz processor, 256 MB RAM, 1 GB disk space. Inputs: DICOM-RT or vendor-specific TPS files, ASCII text files for dose limits. Processing: Numerical interpolation for limit violation detection. Connectivity: CD or web download. No hardware provided.

Indications for Use

Indicated for use by trained medical physicists, physicians, or dosimetrists to compare radiation therapy treatment plans against dose tolerance limits and to record patient response/symptoms for radiation therapy patients.

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

• Accuray, Inc MultiPlan v2.1 Radiation Treatment Planning System (K000478)
• Varian Medical Systems, Inc. Eclipse Treatment Planning System (K091492)

Submission Summary (Full Text)

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## 510(k) Summary

and the comments of the comments of the comments of the comments of

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| Submission Date: | 18 September 2009 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | DiversiLabs, LLC<br>PO Box 107<br>Huntingdon Valley, PA 19006 |
| | DEC 1 6 2009 |
| Submitter Contact: | Dr. Jimm Grimm, Ph.D., DABR<br>Medical Physicist<br>DiversiLabs, LLC<br>PO Box 107<br>Huntingdon Valley, PA 19006<br>[phone]<br>[e-mail] |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 |
| Manufacturing Site: | DiversiLabs, LLC<br>PO Box 107<br>Huntingdon Valley, PA 19006 |
| Trade Name: | Dose Volume Histogram (DVH) Evaluator |
| Common Name: | Accessory to a Radiation Therapy Treatment Planning System |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification<br>Regulation: | 21 CFR §892.5050 |
| Product Code: | MUJ |

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Substantially Equivalent Devices: DiversiLabs Model

Predicate 510/k) Number

Predicate Manufacturer / Model

Dose Volume Histogram (DVH) Evaluator

K000478

Accuray, Inc MultiPlan v2.1 Radiation Treatment Planning System

K091492

Varian Medical Systems. Inc. Eclipse Treatment Planning System

## Device Description:

The Dose Volume Histogram (DVH) Evaluator is a stand alone software application product for use on a personal computer.(PC) intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.

The DVH Evaluator is intended for use by trained medical physicists, physicians, or dosimetrists. The results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physicist, physician or dosimetrist to determine whether the displayed limits and dose is adequate for a particular patient.

The DVH Evaluator imports a file produced by a radiation TPS in the format of an industry standard Dicom-RT™ or vendor specific file. which contains information about a treatment. The file contains information related to the radiation dose volume for patient anatomical structures.

After importing the TPS information, DVH Evaluator allows the user to select dose tolerance limits and overlay them on the dose volume information. If the dose to any contoured critical anatomical structures exceeds any of the tolerance limits, warnings are displayed on the plots. This enables clinical users to conveniently and comprehensively compare treatment plans to the user- selected dose tolerance limits. The DVH Evaluator does not control any radiation delivery devices and does not allow the export of dose limit information.

The Followup Evaluator is an optional module of the DVH Evaluator which conveniently enables the user to record any response or symptoms that the patient experiences, either prior to or following treatment. This information is stored in the same database along with the DVH data for each patient for subsequent analysis. This enables convenient offline feedback to assess whether the dose tolerance limits are optimal for each clinic.

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| Device Description<br>(cont.): | The DVH Evaluator is provided to the customer on a CD or<br>downloaded from www.DiversiLabs.com. A PC is not provided with<br>the product. The PC requires Microsoft Windows XP or Windows<br>Server 2003 Operating System, a minimum of 500 MHz<br>microprocessor speed, a minimum of 256 MB RAM and 1 GB available<br>hard drive space. Display requirements include 1024 x 768 minimum<br>resolution with 1280 x 1024 preferred. |
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| Intended Use: | The DVH Evaluator system is intended to aid with comparing radiation<br>therapy treatment plans to applicable dose tolerance limits, and for<br>recording followup patient response and symptoms. |
| Technology<br>Comparison: | The DVH Evaluator is based on the same DVH data that all modern<br>TPSs already support. The dose tolerance limits are stored in a text<br>ASCII file. The DVH Evaluator imports the DVH information from the<br>TPS, imports the dose tolerance limits from the ASCII file, and plots<br>the user-selected limits on the same graph. Simple numerical<br>interpolation is used to determine if any of the specified limits are<br>violated. |
| | It is the responsibility of the medical physicist, physician or dosimetrist<br>to determine whether the dosimetric accuracy is adequate for a.<br>particular patient, and to make the final decision regarding treatment.<br>The benefit of the DVH Evaluator is to make quick, comprehensive<br>assessment of a treatment plan during the iterative planning process. |
| Performance Testing: | |
| Software Testing | Software for the DVH Evaluator was designed and developed according<br>to a robust software development process, and was rigorously verified<br>and validated. Test results indicated that the DVH Evaluator complies<br>with its predetermined specification. |
| Conclusion | Based upon a comparison of the devices and performance testing<br>results, the DiversiLabs DVH Evaluator is substantially equivalent to<br>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 stylized eagle with three curved lines representing its wings and tail. The eagle is facing to the right. 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

DiversiLabs, LLC % Mr. Thomas Kroenke Official Correspondent Speed to Market, Inc. 2235 East Flamingo Road, Suite 201G LAS VEGAS NV 89119

## DEC 1 6 2009

Re: K092928

Trade/Device Name: DiversiLabs Dose Volume Histogram (DVH) Evaluator Regulation Number: 21 CFR 892.5050

4 7- 24

Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ

Dated: December 4, 2009 Received: December 9, 2009

Dear Mr. Kroenke:

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); medical device reporting (reporting of medical

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Enclosure

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

K092928

DiversiLabs Dose Volume Histogram (DVH) Evaluator

The DiversiLabs Dose Volume Histogram (DVH) Evaluator is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(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 Reproductive, Abdominal and Radiological Devices Haulogical Beviloco LCG2928

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