(146 days)
Not Found
No
The description focuses on traditional algorithms (Collapsed Cone convolution, CUDA parallel algorithms) for dose calculation and verification, with no mention of AI or ML techniques.
No.
The device is described as a "quality assurance (QA) tool" that "outputs the dose distribution" and "calculates and checks the dose distribution," but it does not directly apply a therapeutic intervention to a patient.
No
Explanation: The device is described as an "independent quality assurance (QA) tool for the treatment planning system" that "verif[ies] that the treatment plan is in fact successfully delivered to the patient" and "check[s] the accuracy of the delivery." It calculates and checks dose distribution. This clearly indicates a quality assurance and verification function for radiation therapy delivery, not a diagnostic function for identifying medical conditions.
No
The device description mentions "By using the specific measuring device" and "By using the specific measuring device, the product can output the dose distribution... based on treatment field image data". This implies the device relies on a separate, specific hardware measuring device to acquire the initial data, making it not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that EDOSE is used for quality assurance of radiotherapy treatment planning and delivery, using treatment field image data, CT images, and fused image sets. It does not involve the analysis of biological samples from a patient.
- The purpose is to verify treatment delivery accuracy. The primary function is to check the accuracy of the dose distribution delivered by a linear accelerator, not to diagnose a disease or condition based on biological markers.
The device is a software tool used in the field of radiotherapy for quality assurance and verification of treatment plans.
N/A
Intended Use / Indications for Use
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are plamed to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
With technological development, precise radiotherapy has become the primary means of radiotherapy techniques. However, due to higher requirements that Radiation therapy technology refinement purposed, it also produced a greater risk of potential treatment failure. The greater the level of potential therapeutic accident, which makes quality assurance become a necessary step to ensure that radiotherapy can implement, but also for the quality assurance the work presents a higher demand. EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT image, treatment field image data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oncologist, radiotherapy physicist and/or radiotherapy dosimetrist
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)
Since EDOSE is a software product, the software system test and the product design verification are performed as the same single testing activity. During the system test period, all of the product level and software requirements have been tested and verified.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2015
Guangzhou Raydose Software Technology, LLC % Mr. Dennis Dong Sales & Marketing Director No.850 East Dongfeng Road, Guangzhou City Guangdong Province, Room 502, Glorious Tower Guangzhou, 510060 P. R. CHINA
Re: K150767
Trade/Device Name: EDOSE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 6, 2015 Received: July 10, 2015
Dear Mr. Dong:
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.
1
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/ResourcesforYou/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 D.'Hara For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150767
Device Name
EDOSE
Indications for Use (Describe)
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are plamed to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 13, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Guangzhou Raydose Software Technology., LLC. |
|---|---|
| Address: | Room 502, Glorious Tower, No.850 East Dongfeng Road, |
| Guangzhou city, Guangdong Province, P.R.China | |
| Contact Name: | Dennis Dong |
| Telephone No.: | +86-20-87764746-8020 |
| Fax No.: | +86-20-87764746-8024 |
| Email Address: | dennis.dong@raydose.com |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | EDOSE |
|---|---|
| Common Name: | Standalone Software Quality Control System |
| Classification: | Medical Charged-particle Radiation Therapy System |
| Product code: | IYE |
| Classification Panel: | Radiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows:
Math Resolutions, LLC, Dosimetry Check with Exit Dose has been cleared by FDA through 510(k) No.K101503 (Decision Date – August 04, 2010),
4
5. Description of the Device [21 CFR 807.92(a) (4)]
With technological development, precise radiotherapy has become the primary means of radiotherapy techniques. However, due to higher requirements that Radiation therapy technology refinement purposed, it also produced a greater risk of potential treatment failure. The greater the level of potential therapeutic accident, which makes quality assurance become a necessary step to ensure that radiotherapy can implement, but also for the quality assurance the work presents a higher demand. EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.
6. Indications for Use [21 CFR 807.92(a)(5)]
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
5
7. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
7.1 Intended uses:
| ID | Comparison
Item | Proposed Device
EDOSE | Predicate Device
Dosimetry Check with Exit
Dose |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended
Use | EDOSE is indicated to be
used as an independent
quality assurance (QA) tool
for the treatment planning
system, to verify that the
treatment plan is in fact
successfully delivered to the
patient. EDOSE is used by
oncologist, radiotherapy
physicist and/or radiotherapy
dosimetrist to check the
accuracy of the delivery by
high energy linear accelerator
that are planned to be applied
or have been applied to a
patient. By using the specific
measuring device, the
product can output the dose
distribution of the patient or
phantom based on treatment
field image data and
theoretical calculation. The
product can calculate and
check the dose distribution to
be or has been delivered. In
addition, the product may be
used to display the dose
distribution on other fused
image sets which could
provide additional clinical
information to the radiation
oncologist regarding the
treatment | The product is to be used by
radiation oncologist, dosimet-
rist, and radiation therapy
physicist to check the
correctness of the x-ray
treatment fields from high energy
treatment machines that are
planned to be or have been
applied to a patient. This product
is to be used in addition to the
treatment planning system to
provide a means for additional
and redundant verification that
the plan is in fact successfully
accomplished. This product is
not a treatment planning system
and is not to be used as one. This
product only checks the applied
dose based on the measurement
of each x-ray field and a
theoretical calculation. This
product does not provide any
quality assurance that the fields
are. in fact correctly applied to
and correctly aligned with the
patient anatomy a planned. In
addition, the product may be
used to display the above dose
on other fused image sets which
could provide additional clinical
information to the radiation
oncologist regarding the
treatment |
| ID | Comparison
Item | Proposed
Device
EDOSE | Predicate Device
Dosimetry Check
with Exit Dose |
| 2 | General | | |
| 2.1 | Classification Name | Quality Control for
Medical Charged-
particle Radiation
Therapy Systems. | Quality Control for
Medical Charged-
particle Radiation
Therapy Systems. |
| 2.2 | Product Code | IYE | IYE |
| 2.3 | Regulation Number | 892.5050 | 892.5050 |
| 2.4 | Panel | General & Plastic
Surgery | General & Plastic
Surgery |
| 2.5 | Class | Class II | Class II |
| 3 | Performance | | |
| 3.1 | Pre-treatment images | Yes | Yes |
| 3.2 | Exit images | Yes | Yes |
| 3.3 | Compute dose to patient | Yes | Yes |
| 3.4 | Compare to planning system dose | Yes | Yes |
| 3.5 | Used for verifying the correctness of
radiation therapy treatments | Yes | Yes |
| 3.6 | Uses a line in the transverse plane
through the radiation field measurement
provided to Dosimetry Check. A prior
measured longitudinal profile is applied
to each detector signal to complete the
radiation field. | No | No |
| 3.7 | Generates a report as described in the
Dosimetry Check manual using either
the auto-report feature, or the user may
construct their own report using the
evaluate tools. | Yes | Yes |
| 3.8 | Photons (x-ray) | Yes | Yes |
Table 1 Intended Use Comparison
6
7.2 Comparison table
7
| ID | Comparison
Item | Proposed
Device
EDOSE | Predicate Device
Dosimetry Check
with Exit Dose |
|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------|
| 3.9 | Electrons | No | No |
| 3.10 | Protons | No | No |
| 3.11 | Ability to use the TomoTherapy detector
data measured in a pretreatment dry run
without the patient and the detector data
taken during treatment | No | No |
| 3.12 | Operating Systems | Microsoft
Windows XP,
Windows 7,
Windows 8 | Microsoft Windows
XP, Windows Vista.
Windows 7, and
Ubuntu 9.04 (Linux) |
7.3 Discussion of Differences:
It is reasonable that there are some differences between our new device and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
Review of ID 1 - Intended use, both of them are used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy Linear accelerator that are planned to be applied or have been applied to a patient. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected
Review of ID 2 - General, both are the same, so the SE is not affected.
Review of ID 3 - Performance, both are the same, so the SE is not affected.
8. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Guangzhou Raydose Software Technology., LLC. concludes that EDOSE is substantially equivalent to predicate devices with regard to safety and effectiveness.
8
Since EDOSE is a software product, the software system test and the product design verification are performed as the same single testing activity. During the system test period, all of the product level and software requirements have been tested and verified.