(106 days)
Not Found
No
The description focuses on traditional image analysis routines and mathematical comparisons (like Gamma analysis) and does not mention AI, ML, or related concepts.
No
DoseLab Pro is described as a "software-only QA tool" used for quality assurance in radiation oncology, not for directly treating or diagnosing patients.
No
The device is described as a "quality assurance software intended to be used as part of a dosimetry verification system for linear accelerators" and an "analysis tool meant solely for quality assurance (QA) purposes". It compares measured and calculated dose distributions from radiation therapy, but does not diagnose patient conditions.
Yes
The device description explicitly states "DoseLab Pro is a software-only device".
Based on the provided information, DoseLab Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DoseLab Pro's Function: DoseLab Pro analyzes images related to radiation dose distributions from linear accelerators, measurement devices, and treatment planning systems. It compares calculated and measured dose distributions for quality assurance purposes in radiation oncology.
- No Patient Contact or Specimen Analysis: The description explicitly states that DoseLab Pro "never comes into contact with patients" and analyzes data from external sources (scanned film, measurement devices, treatment planning systems), not patient specimens.
Therefore, DoseLab Pro falls outside the scope of an In Vitro Diagnostic device. It is a software tool for quality assurance in radiation therapy.
N/A
Intended Use / Indications for Use
DoseLab Pro is quality assurance software intended to be used as part of a dosimetry verification system for linear accelerators. It can be used to import radiation-exposed images from scanned film, other measurement devices, and treatment to display differences between measured and calculated dose distributions.
Product codes
IYE
Device Description
DoseLab Pro is a software-only device that uses image analysis to perform radiation oncology quality assurance (QA) as part of a dosimetry verification system. Images are useful in radiation oncology QA because they can be analyzed qualitatively by viewing them and quantitatively using mathematical routines on the data that composes them. A variety of data sets can be analyzed as images in DoseLab Pro. They include radiation dose distributions calculated by treatment planning systems, measured dose distributions from arrays (diode and ion chamber), and radiation-exposed film images.
DoseLab Pro uses numerous built-in image analysis routines that have been developed to perform the tests and meet the standards of the medical physics QA community. In particular, these tools were designed to specifically support completing dose comparisons. Dose comparisons are made between two, two-dimensional images containing radiation dose and spatial information. The first image is exported from the dose calculation of a patient-specific computed treatment plan from treatment planning software, while the second image is the measured dose from delivery of that plan captured by film or a measurement array. DoseLab Pro assists in aligning the images spatially before performing several different comparisons including Gamma analysis and normalization. DoseLab Pro additionally contains tools for image editing, film image import, and film calibration.
It is important to note that while DoseLab Pro operates in the field of radiation therapy, it is neither a radiation delivery device (e.q. a linear accelerator), nor is it a treatment planning system (TPS). DoseLab Pro is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, DoseLab Pro never comes into contact with patients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiation-exposed images from scanned film, other measurement devices, and treatment planning systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / as part of a dosimetry verification system for linear accelerators.
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
Non-clinical performance testing was performed on DoseLab Pro as part of its validation. The software Test Plan, Testing Final Report, and Validation Test Records are all submitted as separate appendices to this 510(k) application. Testing involved the use of known good data for inputs into DoseLab Pro and execution of tests designed to confirm expected behavior and expected output. Validation testing was performed manually on the fully compiled software in conditions comparable to its intended clinical environment. All tests passed without defect.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
August 27, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mobius Medical Systems, LP Stan Eshelman Chief Operating Officer 5012 Tamarisk St. BELLAIRE TX 77401-2826
Re: K141230 Trade/Device Name: DoseLab Pro Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 24, 2014 Received: July 25, 2014
Dear Mr. Eshelman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DoseLab Pro
Indications for Use (Describe)
DoseLab Pro is quality assurance software intended to be used as part of a dosimetry verification system for linear accelerators. It can be used to import radiation-exposed images from scanned film, other measurement devices, and treatment to display differences between measured and calculated dose distributions.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5 510(k) Summary
5.1 510(K) Owner
Mobius Medical Systems, LP 5012 Tamarisk St Bellaire, TX 77401 Tel: (888) 263-8541 Fax: (888) 263-8541
5.2 Contact Person
Stan Eshelman
5.3 Preparation Date
May 12, 2014
5.4 Trade Name
DoseLab Pro
5.5 Common Name
Dosimetry QA Software
5.6 CLASSIFICATION NAME
Accelerator, Linear, Medical 21 CFR 892.5050 Product Code - IYE
5.7 Predicate Devices
- K935928 RIT 113 (Radiological Imaging Technology, Inc) .
5.8 Device Description
DoseLab Pro is a software-only device that uses image analysis to perform radiation oncology quality assurance (QA) as part of a dosimetry verification system. Images are useful in radiation oncology QA because they can be analyzed qualitatively by viewing them and quantitatively using mathematical routines on the data that composes them. A variety of data sets can be analyzed as images in DoseLab Pro. They include radiation dose distributions calculated by treatment planning systems, measured dose distributions from arrays (diode and ion chamber), and radiation-exposed film images.
DoseLab Pro uses numerous built-in image analysis routines that have been developed to perform the tests and meet the standards of the medical physics QA community. In particular, these tools were designed to specifically support completing dose
4
comparisons. Dose comparisons are made between two, two-dimensional images containing radiation dose and spatial information. The first image is exported from the dose calculation of a patient-specific computed treatment plan from treatment planning software, while the second image is the measured dose from delivery of that plan captured by film or a measurement array. DoseLab Pro assists in aligning the images spatially before performing several different comparisons including Gamma analysis and normalization. DoseLab Pro additionally contains tools for image editing, film image import, and film calibration.
It is important to note that while DoseLab Pro operates in the field of radiation therapy, it is neither a radiation delivery device (e.q. a linear accelerator), nor is it a treatment planning system (TPS). DoseLab Pro is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, DoseLab Pro never comes into contact with patients.
5.9 Intended Use
DoseLab Pro is quality assurance software intended to be used as part of a dosimetry verification system for linear accelerators. It can be used to import radiation-exposed images from scanned film, other measurement devices, and treatment planning systems to display differences between measured and calculated dose distributions.
5.10 TECHNOLOGICAL CHARACTERISTICS SUMMARY
The principle technological characteristic of DoseLab and its predicate device is to perform quality assurance comparisons between images exported from a radiation treatment planning system (TPS) and images from measurements taken during delivery by the radiation delivery system (e.g. linear accelerator). Detailed technological characteristics and indications for use presented within the full set of submitted documentation for this 510(k) application support the claim that DoseLab Pro is substantially equivalent to the predicate device.
5.11 Non-Clinical Performance Data
Non-clinical performance testing was performed on DoseLab Pro as part of its validation. The software Test Plan, Testing Final Report, and Validation Test Records are all submitted as separate appendices to this 510(k) application. Testing involved the use of known good data for inputs into DoseLab Pro and execution of tests designed to confirm expected behavior and expected output. Validation testing was performed manually on the fully compiled software in conditions comparable to its intended clinical environment. All tests passed without defect.
5.12Conclusions
As a result of the testing done and the comparisons made between technological characteristics, we conclude DoseLab Pro is substantially equivalent to the predicate device.