(46 days)
No
The summary describes a robotic X-ray system with 2D and 3D imaging capabilities and integration with image guidance systems. It does not mention any AI or ML components for image processing, analysis, or other functions.
No.
Explanation: The device is described as an imaging system used for diagnostic and image-guided procedures, not for direct therapeutic treatment. While it can be combined with therapy devices, it is not a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to be used where 2D and 3D information of anatomic structures such as bony and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required." The "Device Description" also explicitly mentions that the system "can be used for diagnostic and interventional purposes."
No
The device description clearly states it is a "robotic, digital X-ray system" with physical components like a ring-gantry, arms, X-ray source, collimator, and flat-panel detector. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IRm is an X-ray imaging system. It acquires images of the internal structures of the body using X-rays. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for 2D planar, fluoroscopic, and 3D imaging of anatomical structures. This is a diagnostic imaging function, not an in vitro diagnostic function.
The device is a medical imaging device used for diagnostic and interventional purposes by visualizing internal anatomy.
N/A
Intended Use / Indications for Use
The IRm is a mobile X-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required.
The IRm provides an interface that can be used by system integration of the IRm with image guidance systems such as surgical navigation systems.
Product codes
OWB
Device Description
The Mobile ImagingRing System (IRm, "Loop-X" or "Loop-X mobile Imaging Robot") is a robotic, digital X-ray system which supports both 2D planar and fluoroscopic X-ray and 3D Cone-Beam Computed Tomography (CBCT) image acquisition and reconstruction of a patient's anatomical regions of interest (ROI).
The design of the Mobile ImagingRing is based on a ring-gantry ("ring") with two arms mounted: the first arm on gantry carries a monoblock X-ray source and a collimator, the second holds a flat-panel detector. The two arms are independently moveable to accommodate individual patient setups and off-center imaging of regions of interest.
The ImagingRing m / Loop-X Imaging Robot is intended for mobile use on patients in general and interventional radiology, in sterile and non-sterile areas. The system can be used for diagnostic and interventional purposes by volumetric or planar X-ray imaging and enables image-quided maneuvers and operations in medical fields such as general surgery. traumatology, orthopedics, neurology or radiotherapy. The system is designed for flexible examinations and treatments with patients lying, sitting or standing, with and without contrast agent. It can also be combined with therapy devices such as linear accelerators, particle beam delivery systems or other irradiation devices with active sources and patient positioning systems in Image Guided Radiation Therapy, Intraoperative Radiation Therapy, Brachytherapy or surqical navigation and assistance systems as well as in combination with surgical robots in lmage Guided Surgery, in which the image data provided by the ImagingRing IRm / Loop-X m can be used directly with patient in situ to control the respective therapy maneuvers. Using additional equipment, such as external tracking cameras or the built-in optical cameras, the position of objects such as tracked surgical instruments or pointer tools, for example, can also be determined in the imaging coordinate system. This position data, in combination with the patient's pre- and intra-interventional imaging data, can be used in guided or navigated workflows. The internal cameras of the IRm can also be used to capture pictures and film sequences of the medical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D planar X-ray, fluoroscopic X-ray, 3D Cone-Beam Computed Tomography (CBCT)
Anatomical Site
anatomic structures such as bony and soft tissue, objects with high X-ray attenuation such as (metallic) implants, patient's anatomical regions of interest (ROI)
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Mobile use on patients in general and interventional radiology, in sterile and non-sterile areas.
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)
Bench Testing: Non-clinical bench performance testing has been conducted to further support substantial equivalence of the subject device and the predicate device. A system level validation has been conducted, which provides evidence that the Mobile ImagingRing System (IRm, Loop-X Mobile Imaging Robot, Loop-X) meets all customer and system requirements and is able to perform according to its intended use. Clinical use of the device in general and its clinical imaging performance in particular have been tested using phantoms and cadavers. Those clinical imaging tests were conducted with the subject device as well as the predicate device. Results suggest that the subject device performs at least as good as the predicate device (in terms of resolution capabilities) or better (in terms of a larger dynamic range) and therefore support the demonstration of substantial equivalence. Additional bench testing pertaining to a variety of different mechanical characteristics of the device design were conducted. Results demonstrate the safety and effectiveness of the subject device in terms of its design. Voluntary consensus standards applied during design and development include but are not limited to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, IEC 62304, IEC 62366 and ISO 14971. Standard compliance has been demonstrated in a variety of tests conducted internally (by medPhoton) and by an external accredited testing laboratory.
Animal Testing: medPhoton GmbH did not perform any animal testing for the Mobile ImagingRing System.
Clinical Testing: medPhoton GmbH did not perform any clinical testing for the Mobile ImagingRing System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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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December 22, 2020
medPhoton GmbH % Daniel Schaffarzick Ouality and Regulatory Affairs Manager Karolingerstraße 16 Salzburg, Salzburg 5020 AUSTRIA
Re: K203281
Trade/Device Name: Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB Dated: October 30, 2020 Received: November 6, 2020
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Thalia T. 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)
K203281
Device Name Mobile ImagingRing System, IRm Loop-X Mobile Imaging Robot, Loop-X
Indications for Use (Describe)
The IRm is a mobile X-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required.
The IRm provides an interface that can be used by system integration of the IRm with image guidance systems such as surgical navigation systems.
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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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 Mobile ImagingRing System meets the requirements of 21 CFR 807.92.
| Date Prepared: | December 22, 2020 |
|---|---|
| Submitter Information: | medPhoton GmbH |
| Karolingerstraße 16 | |
| 5020 Salzburg | |
| Austria | |
| Phone: 0043 699 161 053 86 | |
| Registration Number: 3012631246 | |
| Owner/Operator Number: 10054933 | |
| Official Correspondent: | Dr. Daniel Schaffarzick |
| medPhoton GmbH | |
| Karolingerstraße 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(s): | Mobile ImagingRing System, IRm, |
| Loop-X Mobile Imaging Robot, Loop-X | |
| Device common name: | Interventional Fluoroscopic X-Ray System |
| Device Classification Name: | Interventional Fluoroscopic X-Ray System |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Product Code: | OWB |
| Reference: | per 21 CFR 892.1650 |
| Review Panel: | Radiology |
| Device Class: | 2 |
| medPhoton GmbH | Traditional 510(k) Submission | Page 1 of 9 |
|---|
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Image /page/4/Picture/2 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.
Device Description:
The Mobile ImagingRing System (IRm, "Loop-X" or "Loop-X mobile Imaging Robot") is a robotic, digital X-ray system which supports both 2D planar and fluoroscopic X-ray and 3D Cone-Beam Computed Tomography (CBCT) image acquisition and reconstruction of a patient's anatomical regions of interest (ROI).
The design of the Mobile ImagingRing is based on a ring-gantry ("ring") with two arms mounted: the first arm on gantry carries a monoblock X-ray source and a collimator, the second holds a flat-panel detector. The two arms are independently moveable to accommodate individual patient setups and off-center imaging of regions of interest.
The ImagingRing m / Loop-X Imaging Robot is intended for mobile use on patients in general and interventional radiology, in sterile and non-sterile areas. The system can be used for diagnostic and interventional purposes by volumetric or planar X-ray imaging and enables image-quided maneuvers and operations in medical fields such as general surgery. traumatology, orthopedics, neurology or radiotherapy. The system is designed for flexible examinations and treatments with patients lying, sitting or standing, with and without contrast agent. It can also be combined with therapy devices such as linear accelerators, particle beam delivery systems or other irradiation devices with active sources and patient positioning systems in Image Guided Radiation Therapy, Intraoperative Radiation Therapy, Brachytherapy or surqical navigation and assistance systems as well as in combination with surgical robots in lmage Guided Surgery, in which the image data provided by the ImagingRing IRm / Loop-X m can be used directly with patient in situ to control the respective therapy maneuvers. Using additional equipment, such as external tracking cameras or the built-in optical cameras, the position of objects such as tracked surgical instruments or pointer tools, for example, can also be determined in the imaging coordinate system. This position data, in combination with the patient's pre- and intra-interventional imaging data, can be used in guided or navigated workflows. The internal cameras of the IRm can also be used to capture pictures and film sequences of the medical procedures.
Intended Use / Indications for Use:
The intended use / indications for use statement has been specified as follows:
"The IRm is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The IRm provides an interface that can be used by system integrators for integration of the IRm with image guidance systems such as surgical navigation systems."
The interface between the subject device and other systems is twofold:
- A standard DICOM interface for communication with picture archiving and . communication systems (PACS), radiological information systems (RIS) or hospital
| medPhoton GmbH | Traditional 510(k) Submission | Page 2 of 9 |
|---|---|---|
| ---------------- | ------------------------------- | ------------- |
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Image /page/5/Picture/2 description: The image shows the logo for medPhoton. The logo consists of the letters 'm' and 'Φ' (phi) in blue, with the word 'medPhoton' written in gray below. The 'm' is stylized with a curved shape, and the 'Φ' is a Greek letter.
information systems (HIS) facilitates import and export of DICOM files from the subject device to an external DICOM server as well as the import of patient data (using DICOM Modality Worklist) from an external DICOM server to the subject device.
- In parallel, a proprietary navigation network-interface for communication of the subject . device with external systems (such as surgery planning and support systems or radiation therapy control systems in brachytherapy) is provided. External optical tracking systems can be used to track the position of the IRm's gantry based on passive reflectors (markers) that are attached to it. The IRm's imaging coordinate system can then be registered with an external reference coordinate system and based on this the external system can, for example, visualize tracked surgical instruments on the images provided by the IRm.
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Image /page/6/Picture/2 description: The image shows the logo for medPhoton. The logo consists of a stylized lowercase "m" connected to a Greek letter Phi (Φ), both in blue. Below the symbols, the word "medPhoton" is written in gray, with the "m" aligned under the stylized "m" above.
Predicate device:
Device Trade Name: Applicant: 510(k) No .: Device common name: Device Classification Name: Regulation Description: Classification Product Code: Reference: Review Panel: Device Class:
Ziehm Vision RFD 3D Ziehm Imaging GmbH K142740 Interventional Fluoroscopic X-Ray System Interventional Fluoroscopic X-Ray System Image-intensified fluoroscopic x-ray system OWB 21CFR892.1650 Radiology 2
Reference device1:
Device Trade Name: ImagingRing System on Rails Applicant: medPhoton GmbH 510(k) No .: K191267 Device common name: ImagingRing System on Rails Device Classification Name: Accelerator, Linear, Medical Regulation Description: Medical charged-particle radiation therapy system Classification Product Code: IYE Reference: 21CFR892.5050 Review Panel: Radiology Device Class: 2
The Mobile ImagingRing System is considered substantial equivalent to the Ziehm Vision RFD 3D (K142740).
-
- Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the Mobile ImagingRing System and the predicate device.
-
- There is no significant difference in intended use or technology.
1 As proposed in the FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (December 27, 2011), a reference device is used to support the scientific methods used to evaluate the different technological characteristics' effect on safety and effectiveness.
| medPhoton GmbH | Traditional 510(k) Submission | Page 4 of 9 |
|---|---|---|
| ---------------- | ------------------------------- | ------------- |
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Image /page/7/Picture/0 description: The image shows the logo for medPhoton. The logo features a stylized lowercase "m" connected to the Greek letter Phi (Φ) in blue. Below the symbol, the word "medPhoton" is written in gray, with "med" and "Photon" appearing on the same line.
Summary of Technological Characteristics:
| Characteristics | Ziehm Vision RFD 3D
(predicate device) | Mobile ImagingRing System
(IRm or "Loop-X mobile
imaging robot")
(subject device) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| 510(k) | K142740 | (K-number not yet assigned) |
| Manufacturer | Ziehm Imaging GmbH | medPhoton GmbH |
| Product code | OWB | OWB |
| Intended Use / Indications for Use | The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, interventional electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of | The IRm is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The IRm provides an interface that can be used by system integrators for integration of the IRm with image guidance systems such as surgical navigation systems. |
| medPhoton GmbH | Traditional 510(k) Submission | Page 5 of 9 |
|---|
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Image /page/8/Picture/0 description: The image contains the logo for medPhoton. The logo consists of the letters 'm' and 'p' connected in a stylized, cursive font, with the Greek letter 'Phi' (Φ) placed to the right of the 'p'. The text 'medPhoton' is written in a smaller, gray font below the symbol.
| | neurological,
intra-operative | |
|------------------------------|------------------------------------------|-----------------------------|
| | surgical procedures and where the | |
| | clinician benefits from 3D | |
| | visualization
complex | |
| | anatomical structures, such as but | |
| | not limited to those of high contrast | |
| | objects, and
bones, bones,
joints, | |
| | maxillofacial, cervical, thoracic, | |
| | and lumbar regions of the spine, | |
| | pelvis, acetabulum and joint | |
| | fractures of the upper and lower | |
| | extremities, and where digital | |
| | image and C-arm positioning data | |
| | is required for Computer-Assisted | |
| | Surgery procedures. | |
| | The visualization of of
such | |
| | anatomical structures assists the | |
| | clinician in the clinical outcome. At | |
| | the discretion of a physician, the | |
| | device may be used for other | |
| | imaging applications. This device | |
| | does not support d direct | |
| | radiographic film exposures and is | |
| | not intended for use in performing | |
| | mammography. The system is not | |
| | intended
for use near
MRI | |
| | systems. | |
| System Design | C-arm | Gantry |
| Imaging Modes | | |
| Isocentric imaging | > | く |
| Non-isocentric imaging | V | V |
| 2D planar imaging mode | V | V |
| 2D Fluoroscopic imaging mode | √ (pulsed and continuous) | V (pulsed and continuous) |
| | | |
| 3D imaging mode | V | V |
| СВСТ | イ | イ |
| X-ray System | | |
| Power Rating [kW@100kVp] | max. 25 | max. 15 |
| Voltage Range [kV] | 40-120 | 40-120 |
| Current Range [mA] | 0.2-250 | 5-80 |
| Pulse length [ms] | 4-40 | 2-35 |
| Tube Type | Rotating anode | Rotating anode |
| Anode Material | Tungsten rhenium molybdenum | Tungsten rhenium molybdenum |
| Fixed Filtration | ≥ 4.3 mm Al eq. | 4.4 mm Al eq. |
| Image Detector | | |
| medPhoton GmbH | Traditional 510(k) Submission | Page 6 of 9 |
|---|---|---|
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Image /page/9/Picture/0 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 these symbols, the word "medPhoton" is written in gray, with the 'm' aligned under the stylized 'm' above.
| Detector Technology | Amorphous silicon flat panel detector (aSi) | Amorphous silicon flat panel detector (aSi) |
|---|---|---|
| Panel Size [cm²] | 30 x 30 | 43.2 x 43.2 |
| Max. detector resolution [pixels] | 1536 x 1536 | 2880 x 2880 |
| User Interface | ||
| Remote Control Panels (incl. radiation buttons, radiation warning lamps and emergency stop buttons) | ✓ | ✓ |
| Wired footswitch | ✓ | ✓ |
| Other Components | ||
| Anti-Scatter Grids | ✓ | ✓ |
| Beam Limiter / Collimator | ✓ | ✓ |
| Lasers | ✓ (class 2M) | ✓ (class 1) |
| Monitor(s) | ✓ | -- |
| Collision protection | ✓ | ✓ |
| Electrical requirements | ||
| Input specification | 100-240 VAC (± 10%), 50/60 Hz | 120-230 VAC (± 10%), 50/60 Hz |
| Environmental Conditions | ||
| Operation | ||
| Temperature [°C] | 10 - 35 | 15 - 32 |
| Humidity [%] (non-condensing) | 20 - 70 | 30 - 60 |
| Atmospheric Pressure [mbar] | 790 - 1060 | 800 - 1100 |
| Storage | ||
| Temperature [°C] | -5 - 55 | 0 - 40 |
| Humidity [%] (non-condensing) | 20 - 70 | 10 - 75 |
| Atmospheric Pressure [mbar] | 790 - 1060 | 750 - 1100 |
| Transport | ||
| Temperature [°C] | -5 - 55 | -10 - 50 |
| Humidity [%] (non-condensing) | 20 - 70 | 5 - 75 |
| Atmospheric Pressure [mbar] | 790 - 1060 | 750 - 1100 |
| Other system specifications | ||
| Opposing source detector distance (SDD) [cm] | 104.5 | 126 |
| Max. rotational speed [°/s] | 15 | 16 (7 for certain IGRT applications) |
Table 1: Comparison of technological characteristics of IRS and the predicate XVI R5.0
| medPhoton GmbH |
|---|
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Image /page/10/Picture/2 description: The image contains a logo for a company called medPhoton. The logo features the letters 'm' and 'p' in a stylized, cursive font, with the 'p' resembling the Greek letter phi (Φ). The letters are in blue, and the word "medPhoton" is written in gray below the symbol.
Like the listed predicate device, the medPhoton Mobile ImagingRing System (IRm) is a mobile x-ray system intended to be used for 2D fluoroscopic and 3D imaging (adult and pediatric patients). Both devices are intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and objects with high X-ray attenuation such as (metallic) implants is required. Also, both devices are prepared for (equipped with respective interfaces) integration with image guidance systems, such as surgical navigation systems.
The technological characteristics (materials, energy sources, other features) of the subject device are not significantly different - i.e. can be considered the same - as those of the predicate device.
The device design of the subject device and the predicate device (gantry vs. C-arm) is significantly different, however, this difference raises no new questions of safety and effectiveness. The existing questions of safety and effectiveness have been addressed and answered in the submission of the reference device (K191267) which has the same design as the subject device. The Mobile ImagingRing System does not introduce new potential hazards or safety risks.
Since the subject device can therefore be considered to be as safe and effective as the predicate device and since they also have the same intended use, medPhoton is certain that the devices are substantially equivalent.
Summary of performance testing:
Bench Testing:
Non-clinical bench performance testing has been conducted to further support substantial equivalence of the subject device and the predicate device. The main aspects in determining substantial equivalence are the intended use of the devices, their technological characteristics as well as safety and effectiveness of the devices.
A system level validation has been conducted, which provides evidence that the Mobile ImagingRing System (IRm, Loop-X Mobile Imaging Robot, Loop-X) meets all customer and system requirements and is able to perform according to its intended use.
Clinical use of the device in general and its clinical imaging performance in particular have been tested using phantoms and cadavers. Those clinical imaging tests were conducted with the subject device as well as the predicate device. Results suggest that the subject device performs at least as good as the predicate device (in terms of resolution capabilities) or better (in terms of a larger dynamic range) and therefore support the demonstration of substantial equivalence.
Although safety and effectiveness of the subject device's design have been demonstrated for a
| medPhoton GmbH | Traditional 510(k) Submission | Page 8 of 9 |
|---|---|---|
| ---------------- | ------------------------------- | ------------- |
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Image /page/11/Picture/2 description: The image shows the logo for medPhoton. The logo features the letters 'm' and 'p' in a stylized, connected design. The 'm' is rendered in a flowing, cursive style, while the 'p' is represented by the Greek letter Phi, which is in blue. Below the symbol, the word 'medPhoton' is written in a sans-serif font, with 'med' in gray and 'Photon' in a slightly darker shade of gray.
reference device (with the same design), additional bench testing pertaining to a variety of different mechanical characteristics of the device design were conducted. Results demonstrate the safety and effectiveness of the subject device in terms of its design.
Voluntary consensus standards applied during design and development include but are not limited to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, IEC 62304, IEC 62366 and ISO 14971. Standard compliance has been demonstrated in a variety of tests conducted internally (by medPhoton) and by an external accredited testing laboratory.
In summary, the results of all non-clinical bench performance tests support substantial equivalence of the subject device and the predicate device and demonstrate safety and effectiveness of the subject device.
Animal Testing:
medPhoton GmbH did not perform any animal testing for the Mobile ImagingRing System.
Clinical Testing:
medPhoton GmbH did not perform any clinical testing for the Mobile ImagingRing System.
Conclusion: medPhoton GmbH believes that the Mobile ImagingRing System is substantially equivalent to the currently legally marketed devices. The Mobile ImagingRing System does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
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