(84 days)
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.
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.
The DVH Evaluator is provided to the customer on a CD or downloaded from www.DiversiLabs.com. A PC is not provided with the product. The PC requires Microsoft Windows XP or Windows Server 2003 Operating System, a minimum of 500 MHz microprocessor speed, a minimum of 256 MB RAM and 1 GB available hard drive space. Display requirements include 1024 x 768 minimum resolution with 1280 x 1024 preferred.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DiversiLabs Dose Volume Histogram (DVH) Evaluator:
Summary of Acceptance Criteria and Device Performance Study for the DiversiLabs Dose Volume Histogram (DVH) Evaluator
The provided 510(k) summary for the DiversiLabs Dose Volume Histogram (DVH) Evaluator focuses on establishing substantial equivalence to predicate devices through a design and development process that included software verification and validation. However, it does not contain explicit performance acceptance criteria or a detailed clinical study demonstrating the device's ability to meet them in the traditional sense of diagnostic accuracy metrics (e.g., sensitivity, specificity).
The device, being a software accessory for radiation therapy treatment planning systems, aims to aid in comparing treatment plans to dose tolerance limits and recording patient response. Its performance is evaluated primarily through software testing to ensure it functions as intended and accurately displays information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Accuracy: Correctly import Dicom-RT or vendor-specific files containing dose volume information. | The DVH Evaluator "imports a file produced by a radiation TPS in the format of an industry standard Dicom-RT™ or vendor specific file." |
| Functional Accuracy: Accurately display user-selected dose tolerance limits overlaid on dose volume information. | "DVH Evaluator allows the user to select dose tolerance limits and overlay them on the dose volume information." |
| Functional Accuracy: Correctly identify and display warnings if dose to critical anatomical structures exceeds tolerance limits. | "If the dose to any contoured critical anatomical structures exceeds any of the tolerance limits, warnings are displayed on the plots. Simple numerical interpolation is used to determine if any of the specified limits are violated." |
| Functional Accuracy: Enable recording of patient response and symptoms in the optional Followup Evaluator module. | The "Followup Evaluator... enables the user to record any response or symptoms that the patient experiences... This information is stored in the same database along with the DVH data for each patient for subsequent analysis." |
| Software Reliability & Robustness: Compliance with predetermined specifications. | "Software for the DVH Evaluator was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the DVH Evaluator complies with its predetermined specification." (Specific metrics not provided) |
| System Compatibility: Operate on specified PC environment. | "The PC requires Microsoft Windows XP or Windows Server 2003 Operating System, a minimum of 500 MHz microprocessor speed, a minimum of 256 MB RAM and 1 GB available hard drive space. Display requirements include 1024 x 768 minimum resolution with 1280 x 1024 preferred." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for evaluating diagnostic accuracy. The performance testing section mentions "Software Testing" but does not detail the nature or size of data used for verification and validation. It's implied that various radiation treatment plans (potentially synthetic or real, but not specified in terms of quantity or origin) were used to test the software's functionality.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the device is a software tool for displaying and comparing data rather than making a diagnosis or independent clinical decision, the "ground truth" for its testing would primarily be the correct output given a specific input, verifying the algorithms and display. This would typically be established by software engineers and medical physicists ensuring the calculations and warnings are accurate according to established tolerance limits.
4. Adjudication Method for the Test Set
Not applicable. The document describes software verification and validation, not a study requiring adjudication of clinical outcomes or expert readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing human performance with and without AI assistance. The device is an "aid" and its primary function is to present data, not to interpret it in a way that would replace human judgment or directly improve human reader performance in a controlled study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, implicitly. The "Software Testing" described is essentially a standalone evaluation of the algorithm's functionality and accuracy in generating plots and warnings based on input data and defined dose tolerance limits. The description states, "Test results indicated that the DVH Evaluator complies with its predetermined specification," implying evaluation of the software's outputs independent of human interpretation efficacy.
7. The Type of Ground Truth Used
For the software testing, the ground truth would be:
- Algorithmic Correctness: Verification that the software correctly imports DICOM-RT data, accurately applies user-selected dose tolerance limits, performs numerical interpolation correctly, and generates warnings when limits are violated, according to its design specifications.
- Display Accuracy: Verification that the graphical representations (DVH plots) and warnings are displayed accurately and as intended.
This is a technical ground truth based on the software's specifications and medical physics principles, rather than a clinical ground truth like pathology, expert consensus on images, or patient outcomes.
8. The Sample Size for the Training Set
Not applicable. This device is not described as a machine learning or AI-driven system that requires a "training set" in the conventional sense. It's an analytical software tool that applies predefined rules and calculations to input data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (for machine learning) is mentioned. The "ground truth" for the software's development (its design specifications and correctness criteria) would have been established by the software development team, likely in consultation with medical physicists and clinicians, based on established medical physics principles and industry standards for dose evaluation.
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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, LLCPO Box 107Huntingdon Valley, PA 19006 |
| DEC 1 6 2009 | |
| Submitter Contact: | Dr. Jimm Grimm, Ph.D., DABRMedical PhysicistDiversiLabs, LLCPO Box 107Huntingdon Valley, PA 19006+1 (215) 694-5598jimmgrimmjr@yahoo.com |
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 |
| Manufacturing Site: | DiversiLabs, LLCPO Box 107Huntingdon 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 |
| ClassificationRegulation: | 21 CFR §892.5050 |
| Product Code: | MUJ |
100 - 100
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Substantially Equivalent Devices: DiversiLabs Model
Predicate 510/k) Number
Predicate Manufacturer / Model
Dose Volume Histogram (DVH) Evaluator
Accuray, Inc MultiPlan v2.1 Radiation Treatment Planning System
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(cont.): | The DVH Evaluator is provided to the customer on a CD ordownloaded from www.DiversiLabs.com. A PC is not provided withthe product. The PC requires Microsoft Windows XP or WindowsServer 2003 Operating System, a minimum of 500 MHzmicroprocessor speed, a minimum of 256 MB RAM and 1 GB availablehard drive space. Display requirements include 1024 x 768 minimumresolution with 1280 x 1024 preferred. |
|---|---|
| Intended Use: | The DVH Evaluator system is intended to aid with comparing radiationtherapy treatment plans to applicable dose tolerance limits, and forrecording followup patient response and symptoms. |
| TechnologyComparison: | The DVH Evaluator is based on the same DVH data that all modernTPSs already support. The dose tolerance limits are stored in a textASCII file. The DVH Evaluator imports the DVH information from theTPS, imports the dose tolerance limits from the ASCII file, and plotsthe user-selected limits on the same graph. Simple numericalinterpolation is used to determine if any of the specified limits areviolated. |
| It is the responsibility of the medical physicist, physician or dosimetristto determine whether the dosimetric accuracy is adequate for a.particular patient, and to make the final decision regarding treatment.The benefit of the DVH Evaluator is to make quick, comprehensiveassessment of a treatment plan during the iterative planning process. | |
| Performance Testing: | |
| Software Testing | Software for the DVH Evaluator was designed and developed accordingto a robust software development process, and was rigorously verifiedand validated. Test results indicated that the DVH Evaluator complieswith its predetermined specification. |
| Conclusion | Based upon a comparison of the devices and performance testingresults, the DiversiLabs DVH Evaluator is substantially equivalent tothe 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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Page 2 -
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 (800) 638-2041 or (301) 796-7100 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:
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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices Haulogical Beviloco LCG2928
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.