(83 days)
Not Found
No
The document describes image acquisition and processing but does not mention AI or ML technologies. The focus is on hardware modifications and software for workflow integration and control.
No
The device is an X-ray imaging system designed to support patient localization and image guidance during radiation therapy, but it does not directly deliver therapy or treat a disease.
No
The device is an imaging system designed to support patient localization and image guidance during radiation therapy. While it provides images of patient anatomy, its primary purpose is for treatment guidance, not for diagnosing medical conditions.
No
The device description explicitly states that the ImagingRing System on Rails (IRr) consists of both hardware (rails, ring gantry, detector, source, etc.) and software. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for image guidance in radiation therapy to support patient localization and positioning. This involves imaging the patient's anatomy in vivo (within the living body) using X-rays.
- Device Description: The device is described as an X-ray imager and its components are related to generating and detecting X-rays for imaging.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
The device is clearly designed for medical imaging of the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The ImagingRing System on rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of inaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.
IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support pationing, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement.
With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) - receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data. providing input for third party RTCS for repositioning of the patient).
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
This Traditional 510(k) describes modifications made to the medPhoton ImagingRing System. The kev differences are:
- In contrast to the existing ImagingRing System. where the ring (imager gantry) is mounted ● on the patient table, in the current system, the ring is mounted on a ceiling-mounted rail which allows longitudinal movement of the ring.
- Thus, the ImagingRing System on Rails does not include the patient table. ●
- The diameter of the gantry (ring structure carrying the imaging components X-ray generator ● and flat-panel detector) has been increased, providing bigger gantry clearance. This is facilitating positioning of the patient relative to the ImagingRing System on Rails using a Patient Positioning System (PPS) that is provided and controlled by a system integrator since not part of the ImagingRing System on Rails.
- A new control console, being used as human machine interface, has been developed to ● improve usability and to simplify imaging workflows (Control Console 2.0).
- In addition to the existing basic and slightly extended software (ImagingRing Software ● Suite), front-end software (medPhoton controls) was added to simplify imaging workflows and integration with overall radiation therapy workflow software that is provided and controlled by a svstem integrator.
The remaining characteristics and the basic technology have remained the same. The same essential components (X-ray generator and -detector, control system, etc.) are used.
Similar to the ImagingRing System, the ImagingRing System on Rails (Rr) is an X-ray imager that is intended to be integrated into a radiation therapy treatment system (e.g. a proton therapy system with its subsystems and workflows) by a system integrator. A major reason for the further development of the ImagingRing System has been to provide a simpler X-ray imager integration option for system integrators.
The medPhoton ImagingRing System on Rails (IRr) is an imaging system designed to obtain Two-Dimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment.
The IRr consists of
- . hardware called ImagingRing (IR) consisting of rails for longitudinal movement, ring gantry, flat-panel detector, X-ray source, generator, control cabinet, control console;
- software comprising the ImagingRing Software Suite (ImRiSS) and the medPhoton ● Controls (mPc) to orchestrate image acquisition and data processing;
- programmable logic controller (PLC) components and related software (ImagingRing ● Control System - ImRiCS), to execute and control motion and image acquisition.
The system is designed in a way such that it provides the following key features:
-
- The IR can be moved along the ceiling mounted rail in order to acquire images of any anatomical region of interest (the patient is positioned statically by the system integrator using a PPS).
-
- The X-ray source and detector can move independently in order to enable non-isocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the trans-axial Field Of View (FOV).
The independently moveable components allow for continuous acquisition of X-ray projective images. These provide the foundation for 2D planar imaging as well as acquisition and reconstruction of 3D Cone-Beam Computed Tomography (CBCT) images around customizable centers of interest.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
all areas of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician / hospital environment
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)
The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in chapter 9 (Declaration of Conformity and Summary Reports) which includes but not limited to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-68, IEC 62304, IEC 62366 and ISO 14971.
Testing was performed to evaluate the respective safety and performance requirements in the form of module and integration verification as well as system level validation. The results from verification and validation testing prove the conformance to applicable standards and demonstrate that safety & effectiveness have been achieved.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
August 1, 2019
MedPhoton GmbH % Daniel Schaffarzick Official Correspondent Strubergasse 16 SALZBURG, 5020 AUSTRIA
Re: K191267
Trade/Device Name: ImagingRing System on Rails Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: May 3, 2019 Received: May 10, 2019
Dear Daniel Schaffarzick:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
For
Thalia M. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191267
Device Name ImagingRing System on Rails
Indications for Use (Describe)
The ImagingRing System on rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of inaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.
IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support pationing, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement.
With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) - receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data. providing input for third party RTCS for repositioning of the patient).
| 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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
medPhoton GmbH
Traditional 510(k) Submission
Chapter 04 - 2/2
3
510(k) Summary
In accordance with the requirements of the Safe Medical Device Act, medPhoton GmbH herewith submits a 510(k) Summary.
This 510(k) summary for the ImagingRing System on Rails meets the requirements of 21 CFR 807.92.
| Date Prepared: | May 3rd, 2019 |
|---|---|
| Submitter Information: | medPhoton GmbH |
| Strubergasse 16 | |
| 5020 Salzburg | |
| Austria | |
| Phone: 0043 699 161 053 86 | |
| Registration Number: 3012631246 | |
| Owner/Operator Number: 10054933 | |
| Official Correspondent: | Dr. Daniel Schaffarzick |
| medPhoton GmbH | |
| Strubergasse 16 | |
| 5020 Salzburg | |
| Austria | |
| Phone: 0043 699 161 054 06 | |
| US Agent (Contact): | Michael Friedl |
| Österr. AußenwirtschaftsCenter New York | |
| 120 West 45th Street, 9th Floor | |
| New York, NY 10036 | |
| Phone: T +1 212 421 52 50 | |
| E-mail: newyork@wko.at | |
| Device(s) Identification: | |
| Device Trade Name: | ImagingRing System on Rails |
| Device common name: | ImagingRing System on Rails |
| Device Classification Name: | Accelerator, Linear, Medical |
| Regulation Description: | Medical charged-particle radiation therapy system |
| Product Code: | IYE |
| Reference: | per 21 CFR 892.5050 |
| Review Panel: | Radiology |
| Device Class: | II |
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 2/10 |
|---|
4
Image /page/4/Picture/2 description: The image shows the logo for medPhoton. The logo consists of a stylized, lowercase "m" in blue, followed by a Greek letter "Phi" in blue. Below the symbols, the word "medPhoton" is written in gray, with "med" in lowercase and "Photon" in uppercase.
Device Description:
This Traditional 510(k) describes modifications made to the medPhoton ImagingRing System. The kev differences are:
- In contrast to the existing ImagingRing System. where the ring (imager gantry) is mounted ● on the patient table, in the current system, the ring is mounted on a ceiling-mounted rail which allows longitudinal movement of the ring.
- Thus, the ImagingRing System on Rails does not include the patient table. ●
- The diameter of the gantry (ring structure carrying the imaging components X-ray generator ● and flat-panel detector) has been increased, providing bigger gantry clearance. This is facilitating positioning of the patient relative to the ImagingRing System on Rails using a Patient Positioning System (PPS) that is provided and controlled by a system integrator since not part of the ImagingRing System on Rails.
- A new control console, being used as human machine interface, has been developed to ● improve usability and to simplify imaging workflows (Control Console 2.0).
- In addition to the existing basic and slightly extended software (ImagingRing Software ● Suite), front-end software (medPhoton controls) was added to simplify imaging workflows and integration with overall radiation therapy workflow software that is provided and controlled by a svstem integrator.
The remaining characteristics and the basic technology have remained the same. The same essential components (X-ray generator and -detector, control system, etc.) are used.
Similar to the ImagingRing System, the ImagingRing System on Rails (Rr) is an X-ray imager that is intended to be integrated into a radiation therapy treatment system (e.g. a proton therapy system with its subsystems and workflows) by a system integrator. A major reason for the further development of the ImagingRing System has been to provide a simpler X-ray imager integration option for system integrators.
The medPhoton ImagingRing System on Rails (IRr) is an imaging system designed to obtain Two-Dimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment.
The IRr consists of
- . hardware called ImagingRing (IR) consisting of rails for longitudinal movement, ring gantry, flat-panel detector, X-ray source, generator, control cabinet, control console;
- software comprising the ImagingRing Software Suite (ImRiSS) and the medPhoton ● Controls (mPc) to orchestrate image acquisition and data processing;
- programmable logic controller (PLC) components and related software (ImagingRing ● Control System - ImRiCS), to execute and control motion and image acquisition.
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 3/10 |
|---|---|---|
| ---------------- | ------------------------------- | ------------------- |
5
Image /page/5/Picture/2 description: The image shows the logo for medPhoton. The logo consists of a stylized lowercase "m" in blue, followed by a Greek letter Phi, also in blue. Below the symbols, the word "medPhoton" is written in gray, with the "m" aligned under the left side of the blue "m" symbol.
The system is designed in a way such that it provides the following key features:
-
- The IR can be moved along the ceiling mounted rail in order to acquire images of any anatomical region of interest (the patient is positioned statically by the system integrator using a PPS).
-
- The X-ray source and detector can move independently in order to enable non-isocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the trans-axial Field Of View (FOV).
The independently moveable components allow for continuous acquisition of X-ray projective images. These provide the foundation for 2D planar imaging as well as acquisition and reconstruction of 3D Cone-Beam Computed Tomography (CBCT) images around customizable centers of interest.
Intended Use:
The ImagingRing System on Rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of imaging patient anatomy including the
therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.
IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support patient positioning, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement.
With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or RadioTherapy Control Systems (RTCS) - receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data, providing input for third party RTCS for repositioning of the patient).
Predicate device:
| Device Trade Name: | |
|---|---|
| Applicant: | |
| 510(k) No.: |
ImagingRing System medPhoton GmbH K161400
The ImagingRing System on Rails is considered substantial equivalent to the ImagingRing System (K161400).
| mediPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 4/10 |
|---|---|---|
| ----------------- | ------------------------------- | ------------------- |
6
Image /page/6/Picture/2 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'p' in a stylized, cursive font, with the 'p' resembling the Greek letter phi. Below the symbol is the word 'medPhoton' in a sans-serif font. The logo is blue against a white background.
-
- Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the ImagingRing System on Rails and the predicate device.
-
- There is no significant difference in intended use or technology.
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 - 5/10 |
|---|---|---|
| ---------------- | ------------------------------- | ------------------- |
7
Image /page/7/Picture/0 description: The image shows the logo for medPhoton. The logo consists of a stylized lowercase "m" connected to the Greek letter Phi (Φ), both in blue. Below the symbol, the word "medPhoton" is written in gray, with the "m" aligned with the left side of the symbol above.
Summary of Technological Characteristics:
| Characteristics | ImagingRing System on Rails | ImagingRing System |
|---|---|---|
| 510(k) | - | K161400 |
| Manufacturer | medPhoton GmbH | medPhoton GmbH. |
| Product code | IYE | IYE |
| Indications for use | ||
| Image guidance equipment as part of the | ||
| radiation therapy (RT) treatment | ||
| process, in all areas of the body where | ||
| such image guidance is determined by a | ||
| licensed physician. | ✓ | ✓ |
| Verification of patient setup position | ✓ | ✓ |
| Image acquisition | ||
| X-ray imaging with digital flat panel | ||
| detector | ✓ | ✓ |
| Stereoscopic acquisition | ✓ | ✓ |
| CBCT | ✓ | ✓ |
| Temperature | 15°C to 30°C | 15°C to 30°C |
| Humidity | 30 to 65 % | 30 to 65 % |
| Atmospheric Pressure | 80 kPa to 110 kPa | 80 kPa to 110 kPa |
| Clearance (inner diameter) | 102 cm | 77.1 cm |
| Outer diameter | 1254 cm | 938.35 cm |
| Motorized movements laterally and | ||
| longitudinally | ✓ | ✓ |
| Touchguard prevents collision | ✓ | ✓ |
| Touchguard prevents collision | ✓ | ✓ |
| Movements are continuously variable | ✓ | ✓ |
| Beam rotates radially through 360° in the | ||
| direction of the isocenter | ✓ | ✓ |
| Speed | 0 to 1 revolutions/min | 0 to 1 revolutions/min |
| Position Accuracy | ±0.2° | ±0.2° |
| Source Axis Distance (SAD) | 62.98 cm | 63.06 cm |
| Detector Axis Distance (DAD) | 52.81 cm | 40.71 cm |
| Source Detector Distance (SDD) | 115.79 cm | 103.86 cm |
| Source Collimator Distance (SCDx) x-jaw | 8.86 (v1); 9.22 (v2) | 8.86 (v1); 9.22 (v2) |
| Source Collimator Distance (SCDy) y-jaw | 10.18(v1); 10.39(v2) | 10.18(v1); 10.39(v2) |
| Inherent filtration | 1.4 | 1.4 |
| Added filtration | 5.2 | 5.2 |
| Total filtration at | ||
| 100 kV | 6.6 | 6.6 |
| Nominal voltage | 230 V | 230 V |
| Voltage variation | ±10% | ±10% |
| Phases | Single-phase and earth | Single-phase and earth |
| Frequency | 50 – 60 Hz | 50 – 60 Hz |
| Impedance | 0.2 Ohms | 0.2 Ohms |
| Fuse rating | 32 A | 32 A |
| confinement of extra focal radiation | extra focal radiation is not more | |
| than 15 cm on each side of the | ||
| largest X-ray field | extra focal radiation is not more | |
| than 15 cm on each side of the | ||
| largest X-ray field |
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 - 6/10 |
|---|
8
Image /page/8/Picture/0 description: The image shows the logo for medPhoton. The logo consists of a stylized lowercase "m" in blue, followed by the Greek letter Phi (Φ) in blue. Below the blue symbols, the word "medPhoton" is written in gray, with "med" on the first line and "Photon" on the second line.
| beam limits | Independently moveable X and
Y jaws to shape the x-ray field of
irradiation | Independently moveable X and Y
jaws to shape the x-ray field of
irradiation |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| leakage radiation in the loading state | 0.1979 mGy/h | 0.1979 mGy/h |
| leakage radiation when not in the loading
state | 0 mGy/h | 0 mGy/h |
| Relation between the X-ray field and
image receptor area | At the image receptor plane, the
X-ray beam must not be larger
than the boundaries by more
than 3% of the source-to-image
distance along the two major
axes | At the image receptor plane, the
X-ray beam must not be larger
than the boundaries by more than
3% of the source-to-image
distance along the two major axes |
| Radiation warning lamp | ✓ | ✓ |
| 80 kV | 4.4 mm Al | 4.4 mm Al |
| 120 kV | 6.3 mm Al | 6.3 mm Al |
| Generator operating range | 40 – 120 kVp | 40 – 120 kVp |
| Flat panel detector pixel size | 400 μm | 400 μm |
| Flat panel matrix | 1024 x 1024 | 1024 x 1024 |
| 2D low contrast visibility | ≥12 disks visible | ≥12 disks visible |
| 2D spatial resolution | ≥1.6 line/mm | ≥1.6 line/mm |
| CBCT spatial resolution | ≥10 lp/cm (up to 18) | ≥10 lp/cm (up to 18) |
| CBCT low contrast resolution | 1 The term FlexMap indicates a technique to compensate for the deflection of ring mounted components due to the difference in gravitational force along the rotation trajectory, leading to a difference between nominal and actual position values as a function of the position in the trajectory.
| medPhoton GmbH | Traditional 510(k) Submission | Chapter |
|---|
9
Image /page/9/Picture/0 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'Φ' in blue, with the word 'medPhoton' in gray underneath. The 'm' is stylized with a curved line extending from the top of the letter to the right, connecting to the 'Φ' symbol. The overall design is clean and modern.
| Inline visualisation | During a CBCT image acquisition, the volume will be reconstructed inline and it is visualized and presented to the user in transaxial, coronal and sagittal slices how the 3D dataset is created. Inline reconstructed slices can also be streamed to a third party Radiotherapy Control System. | During a CBCT image acquisition, the volume will be reconstructed inline and transaxial, coronal and sagittal slices can be streamed to a third party Radiotherapy Control System. |
|---|---|---|
| Intrafraction Imaging | The ImagingRing System, provided that no collision is detected, is capable of acquiring images while the treatment beam is ON. | The ImagingRing System, provided that no collision is detected, is capable of acquiring images while the treatment beam is ON. |
| Segmental Technique | The ImagingRing System is capable of interrupting image acquisitions using the proper command. | The ImagingRing System is capable of interrupting image acquisitions using the proper command. |
| Distributed Image Review | The ImagingRing System provides interfaces to a third party system (e.g. the Radiotherapy Control System of a treatment delivery device) called requestor, with the requested image dataset for image review and further processing. | The ImagingRing System provides interfaces to a third party system (e.g. the Radiotherapy Control System of a treatment delivery device) called requestor, with the requested image dataset for image review and further processing. |
| DICOM Connectivity | The ImagingRing System provides a DICOM Server supporting exchange of image data as SCU/SCP, including DICOM modality worklist support. | The ImagingRing System provides a DICOM Server supporting storage of image data (C-STORE as SCU). |
| IEC 60601-1 | ✓ | ✓ |
| IEC 60601-1-2 | ✓ | ✓ |
| IEC 60601-1-3 | ✓ | ✓ |
| IEC 60601-2-54 | ✓ | ✓ |
| IEC 60601-2-68 | ✓ | ✓ |
| IEC 62304 | ✓ | ✓ |
| IEC 62366 | ✓ | ✓ |
| ISO 14971 | ✓ | ✓ |
Table 1: Comparison of technological characteristics of IRS and the predicate XVI R5.0
The ImagingRing System on Rails and the predicate device, medPhoton´s couch mounted Imaging Ring System, target the same patient population, i.e., patients undergoing radiotherapy procedures in a hospital environment. Therefore, they are subject to the same human factors and are intended to be used in similar workflows in interaction with third
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 - 8/10 |
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10
Image /page/10/Picture/2 description: The image contains the logo for medPhoton. The logo features the letters 'm' and 'p' in a stylized, connected form, rendered in blue. Below the symbol, the word 'medPhoton' is written in a smaller, gray font.
party systems such as - but not limited to - patient setup and immobilization devices, radiotherapy treatment delivery systems and patient positioning systems.
The ImagingRing System on Rails, like the predicate device, can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies, prostate, and bone metastases.
Like its predicate device, the medPhoton ImagingRing System on Rails is intended to be used with a particle or photon Radiation Therapy Control System (RTCS) to support patient (re)-positioning on the basis of acquired 2D planar or 3D volumetric image datasets to be used with reference patient datasets, e.g. pre-interventional planning CT. The ImagingRing System on Rails produces image datasets comparable to the predicate device to visualize the anatomy of a patient. The ImagingRing System on Rails can generate projective (2D) or tomographic (3D) images whose parameters are comparable to those of the predicate device. These output datasets can be used by a third party system to calculate the (re)positioning vector and thus spatially align the treatment to the planned position. The predicate device provides the same or substantially equivalent functions, performance and characteristics.
| medPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 9/10 |
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Image /page/11/Picture/2 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'Φ' (phi) in blue, with 'medPhoton' written in gray below. The 'm' is stylized with a curved line, and the 'Φ' is a standard Greek letter.
Summary of performance testing:
The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in chapter 9 (Declaration of Conformity and Summary Reports) which includes but not limited to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-68, IEC 62304, IEC 62366 and ISO 14971.
Testing was performed to evaluate the respective safety and performance requirements in the form of module and integration verification as well as system level validation. The results from verification and validation testing prove the conformance to applicable standards and demonstrate that safety & effectiveness have been achieved.
Animal Testing:
medPhoton GmbH did not perform any animal testing for the ImagingRing System on Rails.
Clinical Testing:
medPhoton GmbH did not perform any clinical testing for the ImagingRing System on Rails.
Conclusion: medPhoton GmbH believes that the ImagingRing System on Rails is substantially equivalent to the currently legally marketed devices. The ImagingRing System does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
| medlPhoton GmbH | Traditional 510(k) Submission | Chapter 05 – 10/10 |
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