(248 days)
No
The document describes a software product that performs dose calculations using Monte Carlo methods and compares them to TPS calculations and delivery log data. There is no mention of AI or ML algorithms being used for these calculations or comparisons.
No.
The device is a quality assurance software for radiation treatment plans, not a device that directly treats or diagnoses patients.
No
The device is described as a quality assurance tool for verifying radiation treatment plans, not for diagnosing medical conditions. It re-calculates dose parameters and compares them, which is a verification step, not a diagnostic one.
Yes
The device description explicitly states "Being a software-only QA tool, ArcherQA never comes into contact with patients." and describes it as a "standalone software product". While it uses data from other devices (TPS, linear accelerator log files), it does not include or control any hardware itself.
Based on the provided information, ArcherQA 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ArcherQA's Function: ArcherQA is a software product used for quality assurance of radiation treatment plans. It recalculates dose parameters based on existing treatment plans and compares them to the original calculations. It does not analyze biological specimens from a patient.
- Intended Use: The intended use clearly states it's for "quality assurance of a radiation treatment plan" and is used by "trained radiation oncology personnel for quality assurance purposes."
- Device Description: The description emphasizes its role as an "analysis tool meant solely for QA purposes" and that it "never comes into contact with patients."
Therefore, ArcherQA falls outside the scope of an In Vitro Diagnostic device. It is a software tool used in the clinical workflow for verifying the accuracy of radiation therapy planning.
N/A
Intended Use / Indications for Use
ArcherQA is a software product intended to provide quality assurance of a radiation treatment plan generated by a commercial treatment planning system (TPS) by allowing a clinician to re-calculate dose parameters with dose calculation algorithms independent from the commercial TPS and compare the two set of dose information. ArcherQA is not a TPS or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Product codes
IYE
Device Description
ArcherQA (v1.0) is a standalone software product used within a radiation therapy clinic for quality assurance ( Q A ) and treatment plan verification via recalculation of the dose with a GPU-based independent Monte Carlo dose calculation algorithm. ArcherQA is neither a radiation delivery device (e.g. a linear accelerator) nor a Treatment Planning System (TPS). ArcherQA cannot design or transmit instructions to a delivery device or control any other medical device. ArcherQA is an analysis tool meant solely for QA purposes when used by trained medical professionals. Being a software-only QA tool, ArcherQA never comes into contact with patients.
ArcherQA performs dose calculation verifications for radiation treatment plans by independently calculating radiation dose. Using both algorithm and hardware-enhanced Monte Carlo methods, ArcherQA can verify the final dose for radiotherapy plans. The calculation is based on read-in treatment plans that are initially calculated by a TPS. ArcherQA supports photon and electron dose calculation. The treatment modalities that can be evaluated by ArcherQA include: three-dimensional conformal radiotherapy (3D CRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT).
ArcherQA also performs dose delivery OA by using the measurement data recorded in a linear accelerator's delivery log files to compare with calculated the delivery dose. This is presented to the end user in a software component of ArcherQA called Fraction Check.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiation oncology personnel / within a radiation therapy clinic
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
Software verification and validation were conducted, and the process was documented per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Verification and Validation tests were executed to verify that the product performed to specifications and worked as designed. Test results demonstrate conformance to applicable requirements and specifications. Bench testing against the predicate device SciMoCa with 30 randomly selected samples from available database demonstrates good agreement, proving that both devices can be used as equivalent third-party independent software for clinical dose verification in radiotherapy. No animal studies or clinical tests were required for validation of the software.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
January 5, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Wisdom Technologies., Inc. % Wei Wang Consultant 11 Longstreet IRVINE, CA 92620
Re: K231273
Trade/Device Name: ArcherOA (V1.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 5, 2023 Received: December 5, 2023
Dear Wei Wang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Loca Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
ArcherQA (V1.0)
Indications for Use (Describe)
ArcherQA is a software product intended to provide quality assurance of a radiation treatment plan generated by a commercial treatment planning system (TPS) by allowing a clinician to re-calculate dose parameters with dose calculation algorithms independent from the commercial TPS and compare the two set of dose information. ArcherQA is not a TPS or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo for Wisdom Tech. The logo features a stylized human figure in blue, standing in front of a yellow and orange sunburst. To the right of the figure are the words "WISDOM TECH" in blue, with some Chinese characters above it. The logo is clean and modern, and the colors are bright and eye-catching.
510(k) Summary
The following information is provided as required by 21 CFR 807.92
I. SUBMITTER
Name: Wisdom Technologies., Inc.
Address: 4th Floor, Building F2, Phase II, Innovation Industrial Park, Hefei, Anhui, China 230088
Phone: +86-0551-65116387
Email: registration(@wisdom-tech.online
Contact Person: Wei Wang, Consultant, Regulatory Affairs Phone: 949-7849283
Date Prepared: April 26, 2023
II. DEVICE
Subject Device Name: ArcherQA v1.0 Common/Trade Name: ArcherQA Product Code and Classification: Medical charged-particle radiation therapy system IYE | 21 CFR 892.5050 | Class II
III. PREDICATE DEVICES
Primary: K180595 SciMoCa (Radialogica LLC) Reference: K203669 Mobius3D (Varian Medical Systems, Inc.)
DEVICE DESCRIPTION IV.
ArcherQA (v1.0) is a standalone software product used within a radiation therapy clinic for quality assurance ( Q A ) and treatment plan verification via recalculation of the dose with a GPU-based independent Monte Carlo dose calculation algorithm. ArcherQA is neither a radiation delivery device (e.g. a linear accelerator) nor a Treatment Planning System (TPS). ArcherQA cannot design or transmit instructions to a delivery device or control any other medical device. ArcherQA is an analysis tool meant solely for QA purposes when used by trained medical professionals. Being a software-only QA tool, ArcherQA never comes into contact with patients.
4
ArcherQA performs dose calculation verifications for radiation treatment plans by independently calculating radiation dose. Using both algorithm and hardware-enhanced Monte Carlo methods, ArcherQA can verify the final dose for radiotherapy plans. The calculation is based on read-in treatment plans that are initially calculated by a TPS. ArcherQA supports photon and electron dose calculation. The treatment modalities that can be evaluated by ArcherQA include: three-dimensional conformal radiotherapy (3D CRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic radiosurgery (SRS), stereotactic body radiotherapy (SBRT).
ArcherQA also performs dose delivery OA by using the measurement data recorded in a linear accelerator's delivery log files to compare with calculated the delivery dose. This is presented to the end user in a software component of ArcherQA called Fraction Check.
INDICATIONS FOR USE V.
ArcherQA is a software product intended to provide quality assurance of a radiation treatment plan generated by a commercial treatment planning system (TPS) by allowing a clinician to re-calculate dose parameters with dose calculation algorithms independent from the commercial TPS and compare the two set of dose information. ArcherQA is not a TPS or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
The primary technological components of ArcherQA and its predicate devices are independent dose calculation algorithms and functionalities that allow comparison between an independently-calculated dose information and those generated by a commercial TPS for the purpose of quality assurance. Both are software devices that receive inputs related to radiological images to estimate absorbed dose using the well-established algorithms; Both are software devices for prescription use in a professional environment with no patient contact.
There are no known differences in technological characteristics between the subject device and the predicate devices that raise any questions of safety or effectiveness. The technological characteristics of the subject device are believed to be substantially equivalent to the predicate devices.
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Substantial Equivalence Comparison Table
| Area of | Subject Device- | Primary- | Reference-Mobius3D |
|---|---|---|---|
| Comparison | ArcherQA | SciMoCa(K180595) | (K203669) |
| Regulation | |||
| Number/cod | |||
| e | 21 CFR 892.5050 IYE | 21 CFR 892.5050 IYE | 21 CFR 892.5050 IYE |
| Regulation | |||
| Name | Medical charged-particle | ||
| radiation therapy system | Medical charged-particle | ||
| radiation therapy system | Medical charged-particle | ||
| radiation therapy system | |||
| Indications | |||
| for Use | ArcherQA is a software | ||
| product intended to | |||
| provide quality assurance | |||
| of a radiation treatment | |||
| plan generated by a | |||
| commercial treatment | |||
| planning system (TPS) by | |||
| allowing a clinician to re- | |||
| calculate dose parameters | |||
| with dose calculation | |||
| algorithms independent | |||
| from the commercial TPS | |||
| and compare the two set of | |||
| dose information. | |||
| ArcherQA is not a TPS or a | |||
| radiation delivery device. It | |||
| is to be used only by | |||
| trained radiation oncology | |||
| personnel for quality | |||
| assurance purposes. | SciMoCa is a software | ||
| product intended to provide | |||
| quality assurance of a | |||
| radiotherapy dose | |||
| calculated by a treatment | |||
| planning system by allowing | |||
| a clinician to re-calculate the | |||
| dose with an independent | |||
| dose calculation algorithm | |||
| and compare the two doses. | |||
| SciMoCa is not a treatment | |||
| planning system or a | |||
| radiation delivery device. It | |||
| is to be used only by trained | |||
| radiation oncology | |||
| personnel for quality | |||
| assurance purposes. | Mobius3D software is used for | ||
| quality assurance, treatment | |||
| plan verification, and patient | |||
| alignment and anatomy | |||
| analysis in radiation therapy. It | |||
| calculates radiation dose | |||
| three-dimensionally in a | |||
| representation of a patient or | |||
| a phantom. The calculation is | |||
| based on read-in treatment | |||
| plans that are initially | |||
| calculated by a treatment | |||
| planning system and may | |||
| additionally be based on | |||
| external measurements of | |||
| radiation fields from other | |||
| sources such as linac delivery | |||
| log data. Patient alignment | |||
| and anatomy analysis is based | |||
| on read-in treatment planning | |||
| images (such as | |||
| computed tomography) and | |||
| read-in daily treatment | |||
| images (such as registered | |||
| cone beam computed | |||
| tomography). | |||
| Mobius3D is not a treatment | |||
| planning system. It is only to | |||
| be used by trained radiation | |||
| oncology personnel as a | |||
| quality assurance tool. | |||
| Algorithm | Monte Carlo | Monte Carlo | Collapsed Cone |
| Convolution/Superposition | |||
| Input | Plan parameters | Plan parameters | Plan parameters |
| Output | 3D dose calculation | 3D dose calculation | 3D dose calculation |
| Dose Map | |||
| Format | DICOM RT3.0 | DICOM RT3.0 | DICOM RT3.0 |
| types of dose | |||
| calculations | photon, electron | photon, electron | photon, electron |
| Types of | |||
| image files | |||
| supported | CT images | CT images | CT images |
| Treatment | |||
| types | 3D, IMRT, VMAT, | ||
| SBRT, SRS | 3D, IMRT, VMAT, | ||
| SBRT, SRS | IMRT, VMAT, dynamic / | ||
| virtual wedge, SRS | |||
| Analysis | |||
| modes | • DVH Graph | ||
| • Target Coverage | |||
| • DVH Limits | |||
| • 3D Gamma | |||
| • Beam Information | |||
| • ROI Overview | |||
| • Notes and Approvals | • DVH Graph | ||
| • Target Coverage | |||
| • DVH Limits | |||
| • 3D Gamma | |||
| • Beam Information | |||
| • ROI Overview | |||
| • Notes and Approvals | • DVH Graph | ||
| • Target Coverage | |||
| • DVH Limits | |||
| • 3D Gamma | |||
| • Beam Information | |||
| • ROI Overview | |||
| • Notes and Approvals | |||
| Usage | |||
| Environment | for prescription use in a | ||
| professional environment | |||
| by trained radiation | |||
| oncology personnel | for prescription use in a | ||
| professional environment by | |||
| trained radiation oncology | |||
| personnel | for prescription use in a | ||
| professional environment by | |||
| trained radiation oncology | |||
| personnel | |||
| Patient | |||
| Contact | None | None | None |
6
PERFORMANCE DATA VII.
Software verification and validation were conducted, and the process was documented per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Verification and Validation tests were executed to verify that the product performed to specifications and worked as designed. Test results demonstrate conformance to applicable requirements and specifications. Bench testing against the predicate device SciMoCa with 30 randomly selected samples from available database demonstrates good agreement, proving that both devices can be used as equivalent third-party independent software for clinical dose verification in radiotherapy. No animal studies or clinical tests were required for validation of the software.
VIII. CONCLUSION
ArcherQA is believed to be substantially equivalent to predicate devices in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates the subject device is as safe, is as effective, and performs as well as predicate devices. Therefore, it is in the opinion of Wisdom Technologies, Inc. that the medical device, ArcherOA, is substantially equivalent to predicate devices.