(84 days)
Not Found
No
The description focuses on importing standard data formats, comparing values to user-selected limits, and displaying warnings. There is no mention of learning, prediction, or adaptive algorithms characteristic of AI/ML.
No
This device is a software application intended to aid in comparing radiation therapy treatment plans and recording patient responses; it does not directly deliver or control therapy.
No
The device is intended to aid with comparing radiation therapy treatment plans and recording patient responses and symptoms, not to diagnose a disease or condition. It helps evaluate existing treatment plans rather than making a diagnosis.
Yes
The device is explicitly described as a "stand alone software application product for use on a personal computer (PC)" and is provided on a CD or downloaded. It does not include any hardware components.
Based on the provided information, the DiversiLabs Dose Volume Histogram (DVH) Evaluator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DVH Evaluator's Function: The DVH Evaluator works with data generated by radiation treatment planning systems (TPS). This data is derived from imaging and treatment planning, not from the analysis of biological specimens taken from the patient.
- Intended Use: The intended use is to aid in comparing radiation therapy treatment plans to dose tolerance limits and recording patient response/symptoms. This is related to treatment planning and follow-up, not the diagnosis or monitoring of a disease through the analysis of biological samples.
- Input Data: The input is a file from a radiation TPS (Dicom-RT or vendor specific), which contains information about radiation dose volume for anatomical structures. This is not biological specimen data.
In summary, the DVH Evaluator is a software tool used in the context of radiation therapy treatment planning and follow-up, operating on data generated by other medical devices (TPS). It does not perform tests on biological specimens, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The DVH Evaluator is intended for use by trained medical physicists, physicians, or dosimetrists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| PO Box 107 | |
| Huntingdon Valley, PA 19006 | |
| DEC 1 6 2009 | |
| Submitter Contact: | Dr. Jimm Grimm, Ph.D., DABR |
| Medical Physicist | |
| DiversiLabs, LLC | |
| PO Box 107 | |
| Huntingdon Valley, PA 19006 | |
| +1 (215) 694-5598 | |
| jimmgrimmjr@yahoo.com | |
| Official Contact: | Thomas Kroenke |
| Principal Consultant | |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@speedtomarket.net | |
| 303 956 4232 | |
| Manufacturing Site: | DiversiLabs, LLC |
| PO Box 107 | |
| 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 | |
| Regulation: | 21 CFR §892.5050 |
| Product Code: | MUJ |
100 - 100
1
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.
2
| Device Description
(cont.): | 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. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Technology
Comparison: | The DVH Evaluator is based on the same DVH data that all modern
TPSs already support. The dose tolerance limits are stored in a text
ASCII file. The DVH Evaluator imports the DVH information from the
TPS, imports the dose tolerance limits from the ASCII file, and plots
the user-selected limits on the same graph. Simple numerical
interpolation is used to determine if any of the specified limits are
violated. |
| | It is the responsibility of the medical physicist, physician or dosimetrist
to 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, comprehensive
assessment of a treatment plan during the iterative planning process. |
| Performance Testing: | |
| Software Testing | 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. |
| Conclusion | Based upon a comparison of the devices and performance testing
results, the DiversiLabs DVH Evaluator is substantially equivalent to
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
4
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
5
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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