(229 days)
The Intelli-C is indicated for use as a multipurpose diagnostic X-ray system for universal radioscopic and fluoroscopic studies. With its C-arm and digital flat detector, it can perform a range of applications including interventional procedures, vascular procedures, specialized applications including angiographic studies of the entire body on adults and paediatrics.
The Intelli-C system is only indicated for use by trained professionals. The Intelli-C is not intended for mammography studies.
The Intelli-C device that we wish to bring to market is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies.
This type of device is typically used in departments with a single fluoroscopy installation that benefit from the versatility of multi-purpose systems that allow a wider range of examinations than a standard fluoroscopy unit. In larger departments such systems can provide backup for other fluoroscopy installations, for example in case of breakdown.
As with most multi-purpose systems, the Intelli-C has the patient tabletop and C-arm assembly supported on a main column from which the complete unit can be elevated and tilted. The tabletop is supported only at the foot end providing good, all round access to the patient.
The C-arm supports the X-ray tube and image detector assembly and patient coverage is achieved through a combination of C-arm movements and table top movements. The C-arm has angulation and rotational movements, and the source to detector distance is variable. The image detector can be positioned above or below the tabletop depending on the specific examination requirement.
The control room control panel for gantry movements, imaging system, generator and collimator are located in the control room. To facilitate interventional studies to be performed on this type of system, most controls are duplicated on a mobile tableside control panel. The imaging system is normally connected to PACS and Hospital Information System, e.g. patient lists, through the hospital network.
The Intelli-C device will be offered in two main variants:
NRT REF No.: 03400000 Device name: Intelli-C, Right side suspended table
NRT REF No.: 03400010 Device name: Intelli-C, Left side suspended table
The main systems will be offered with a range of options and accessories as listed in section 11 of this application.
The provided text describes the NRT Intelli-C, an all-digital multipurpose tilt-C X-ray system. The submission is a 510(k) premarket notification, indicating the intent to market the device based on substantial equivalence to a legally marketed predicate device.
The document does not contain explicit "acceptance criteria" and "reported device performance" in the format of a table as requested. Instead, it argues for substantial equivalence by comparing the Intelli-C with its predicate device, the GE Precision MPi, and by citing scientific literature supporting the technological advancements.
Therefore, the following information is extracted and presented based on the available content:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria or device performance metrics against those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adopting established technology. The "performance" is implicitly deemed acceptable due to the use of a previously cleared digital X-ray receptor and "adequate verification and validation testing results document[ing] adequate image quality and integration."
| Acceptance Criteria (Implied) | Reported Device Performance/Argumentation |
|---|---|
| Safety and Effectiveness | The Intelli-C is believed to perform "as safe and as effective or better than the predicate device." This conclusion is based on a substantial equivalence discussion and literature summary, documenting technological differences including a digital X-ray receptor, user interfaces, X-ray generation component upgrades, and other minor modifications. No new issues of safety or effectiveness are perceived with the introduction of the Intelli-C. |
| Image Quality and Integration | "adequate verification and validation testing results document adequate image quality and integration." The use of a previously cleared digital X-ray receptor is cited. |
| Regulatory Compliance | The device is tested to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54) and FDA performance standards 21 CFR 1020.30, 31, and 32. Design and production controls are under a Quality Management System compliant with 21 CFR 820 and ISO 13485 requirements. |
| Technological Equivalence | The Intelli-C incorporates a digital flat panel detector (FPD) as an upgrade from the Image Intensifier (II) of the predicate device. Scientific literature is provided to support the benefits of FPD technology (improved patient access, lower patient radiation doses, wider dynamic ranges, better stability, lower radiation dose rates, improved dynamic range, elimination of glare and geometric distortions, more flexible positioning, more stable performance, zero geometrical distortion and vignetting, less physical dimensions with great versatility). |
2. Sample size used for the test set and the data provenance:
The document does not provide information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to a predicate device and citing peer-reviewed literature regarding the FPD technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document as there is no mention of a specific test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document as there is no mention of a specific test set or an adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to the provided document. The Intelli-C is an X-ray system, not an AI-powered diagnostic tool, and therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to the provided document. The Intelli-C is an X-ray system and not an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document as there is no mention of a specific ground truth establishment for a diagnostic test. The device itself is a diagnostic imaging system.
8. The sample size for the training set:
This information is not provided in the document. The Intelli-C is an X-ray imaging system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
This information is not provided in the document, as it is not relevant for the type of device described.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 11th, 2018
NRT X-ray A/S % Mr. Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane LITTLETON CO 80127
Re: K173631
Trade/Device Name: Intelli-C Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: June 30, 2018 Received: July 5, 2018
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Rogero
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Intelli-C
Indications for Use (Describe)
The Intelli-C is indicated for use as a multipurpose diagnostic X-ray system for universal radioscopic and fluoroscopic studies. With its C-arm and digital flat detector, it can perform a range of applications including interventional procedures, vascular procedures, specialized applications including angiographic studies of the entire body on adults and paediatrics.
The Intelli-C system is only indicated for use by trained professionals. The Intelli-C is not intended for mammography studies.
| 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/0 description: The image shows the logo for NRT. The logo consists of a circular icon to the left of the letters "NRT". The circular icon is made up of concentric circles. The letters "NRT" are in a sans-serif font and are blue in color.
This summary document has been prepared to meet the conditions of 21 CFR 807.92.
Date of summary:
June 25, 2018
Submitter information:
| 510(k) owner: | NRT X-Ray A/SBirkegaardsvej 168361 HasselagerDENMARK |
|---|---|
| Establishment Registration no.: | 1000188474 |
| Contact person: | Jan Malling, Quality Manager |
| Phone: | +4586283500 |
| E-mail: | jm@nrtxray.com |
New device:
| Trade name: | Intelli-C |
|---|---|
| Common name: | Multi-purpose tilt C |
| Classification name: | Interventional Fluoroscopic X-Ray System |
| Classification: | Class II |
| CFR Section: | 892.1650 |
| Product Code (primary): | OWB |
| (secondary): | JAA |
Predicate device:
Trade name: Premarket Notification No.: Manufacturer:
GE Precision MPi K033486 NRT X-Ray A/S Birkegaardsvej 16 8361 Hasselager DENMARK
Device description for new device:
The Intelli-C device that we wish to bring to market is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies.
This type of device is typically used in departments with a single fluoroscopy installation that benefit from the versatility of multi-purpose systems that allow a wider range of examinations than a standard fluoroscopy unit. In larger departments such systems can provide backup for other fluoroscopy installations, for example in case of breakdown.
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Image /page/4/Picture/0 description: The image shows the logo for NRT. The logo consists of a circular icon on the left and the text "NRT" on the right. The circular icon is made up of concentric circles, and the text "NRT" is in a sans-serif font and is blue in color.
As with most multi-purpose systems, the Intelli-C has the patient tabletop and C-arm assembly supported on a main column from which the complete unit can be elevated and tilted. The tabletop is supported only at the foot end providing good, all round access to the patient.
The C-arm supports the X-ray tube and image detector assembly and patient coverage is achieved through a combination of C-arm movements and table top movements. The C-arm has angulation and rotational movements, and the source to detector distance is variable. The image detector can be positioned above or below the tabletop depending on the specific examination requirement.
The control room control panel for gantry movements, imaging system, generator and collimator are located in the control room. To facilitate interventional studies to be performed on this type of system, most controls are duplicated on a mobile tableside control panel. The imaging system is normally connected to PACS and Hospital Information System, e.g. patient lists, through the hospital network.
The Intelli-C device will be offered in two main variants:
| NRT REF No.: | Device name: |
|---|---|
| 03400000 | Intelli-C, Right side suspended table |
| 03400010 | Intelli-C, Left side suspended table |
The main systems will be offered with a range of options and accessories as listed in section 11 of this application.
Electrical safety, EMC and QMS:
The Intelli-C device is tested to the below listed international standards, including FDA performance standards 21 CFR 1020.30, 31 and 32. Design and production controls are carried under a Quality Management System in compliance with 21 CFR 820 and ISO 13485 requirements.
| Standard | Title | Revision | Date |
|---|---|---|---|
| IEC 60601-1 | Medical electrical equipment –Part 1: General requirements for basic safety and essential performance(including US national differences) | Edition 3.1 | (2012-08) |
| IEC 60601-1-2 | Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performanceCollateral standard: Electromagnetic disturbances - Requirements and tests | Edition 4.0 | (2014-02) |
| IEC 60601-1-3 | Medical electrical equipment –Part 1-3: General requirements for basic safety and essential performanceCollateral Standard: Radiation protection in diagnostic X-ray equipment | Edition 2.1 | (2013-04) |
| IEC 60601-2-43 | Medical electrical equipment –Part 2-43: Particular requirements for basic safety and essential performanceof X-ray equipment for interventional procedures | Edition 2.0 | (2010-03) |
| IEC 60601-2-54 | Medical electrical equipment –Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | Edition 1.1 | (2015-04) |
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Image /page/5/Picture/0 description: The image shows the logo for NRT. The logo consists of a circular design on the left and the letters "NRT" on the right. The circular design has concentric circles, and the letters "NRT" are in a sans-serif font. The logo is in blue.
Comparison with predicate device:
The Intelli-C and GE Precision MPi are very similar on all comparable parameters. The predicate device comparison in section 12 of this application, contains a detailed discussion of all differences between the Intelli-C and its predicate device, the GE Precision MPi.
For the purpose of this 510(k) Summary, please find a comparison of the Intended Use, Indications for Use, target population and selected technology aspects below:
Comparison table, Intended Use, Indications for Use and target population:
| Intelli-C | Precision MPi | |
|---|---|---|
| Intended use: | The Intelli-C is an all-digital multipurpose tilt-C X-ray system, intendedfor a multitude of diagnostic procedures, including: universalradiographic, radioscopic and fluoroscopic diagnostic X-ray,interventional procedures, vascular and non-vascular procedures, andspecialized applications including angiographic studies of the entirebody on adults and pediatrics. | The GE Precision MPi is an all-digital multipurposetilt-C X-ray system, intended for a multitude ofdiagnostic procedures, including: R&F, radiology,fluoroscopy, interventional procedures, vascularand non-vascular procedures, and specializedapplications including angiographic studies |
| Indications foruse: | The Intelli-C is indicated for use as a multipurpose diagnostic X-raysystem for universal radiographic, radioscopic and fluoroscopic studies.With its C-arm and digital flat detector, it can perform a range ofapplications including interventional procedures, vascular and non-vascular procedures, specialized applications including angiographicstudies of the entire body on adults and pediatrics.The Intelli-C is not indicated for mammography studies. | The GE Precision MPi is a multi-purpose systemthat can perform general R&F, radiography,fluoroscopy, interventional and angiographyprocedures/applications. |
| Targetpopulation: | Adults and pediatrics | All, no limitations |
Technological differences:
The Intelli-C is the successor to the predicate device, GE Precision MPi, which was also manufactured by NRT X-ray A/S. The main difference between the Intelli-C and the Precision MPi is the introduction of a digital flat panel detector (FPD). The FPD adds benefits such as improved patient access, lower patient radiation doses, and wider dynamic ranges when compared to the Image Intensifier, utilized in the predicate device.
The difference in other X-ray critical components from when the predicate device was produced are reflecting the current state-of-the-art developments from the manufacturers of X-ray High Voltage Generator, X-ray tube and Beam Limiting Device. As it can be seen from the comparison table below, the manufacturers of the X-ray critical components are the same as for the Precision MPI.
| Component | Intelli-C | Precision MPi |
|---|---|---|
| High VoltageGenerator | Model:Indico IQ, 80kWManufacturer:Communications & Power Industries Canada Inc. | Model:Indico 100, 100kWManufacturer:Communications & Power Industries Canada Inc. |
| X-ray tube | Model:G1592/B180 or G1092/B160Manufacturer:Varex Imaging Corporation | Model:G1592/B180 or G1092/B160Manufacturer:Varex Imaging Corporation |
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Image /page/6/Picture/0 description: The image shows the logo for NRT. The logo consists of a circular icon to the left of the letters "NRT". The circular icon is made up of concentric circles, with the innermost circle being solid and the outer circles being broken into segments. The letters "NRT" are in a sans-serif font and are a similar color to the circular icon.
| Imaging system | Model:Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB).Manufacturer:Varex Imaging Corporation | Model:Platinum One Imaging SystemManufacturer:Infimed Inc. (now Varex Imaging Corporation) |
|---|---|---|
| Collimator | Model:R 806QManufacturer:Ralco S.R.L. | Model:R 806ASFLManufacturer:Ralco S.R.L. |
The Intelli-C is by no means an early mover into the FPD technology. We believe that the use of FPD technology is the state-of-the-art standard of today and since the majority of transitions from II to FPD took place years ago, we have decided to provide scientific literature that supports the transition from the II based systems to FPD systems. In this search we found the following peer reviewed articles, discussing the advantages and disadvantages using an FPD in place of an II:
Peer reviewed articles supporting FPD technology:
| ID | Article title | Author(s) | Published in | Assessment remarks and conclusion |
|---|---|---|---|---|
| 1 | AAPM/RSNA Physics Tutorialfor Residents: Physics of Flat-Panel Fluoroscopy SystemsSurvey of Modern FluoroscopyImaging: Flat-Panel Detectorsversus Image Intensifiers andMore | Edward LeeNickoloff,DSc | radiographics.rsna.org | The author concludes that Solid-state FPD image receptorshave better stability, lower radiation dose rates, andimproved dynamic range, and they eliminate glare andgeometric distortions such as vignetting and defocusingeffects. It is concluded that the fact that FPDs are smallerthan image intensifiers allows for more flexible positioning ofthe angiography and cardiac fluoroscopy systems.The few disadvantages of FPD systems include higher costsand lower spatial resolution with very small and very largeFOVS. |
| 2 | The design and imagingcharacteristics of dynamic,solid-state, flat-panel x-rayimage detectors for digitalfluoroscopy and fluorography | A.R. Cowen,A.G. Davies,M.U.Sivananthan | The Royal College ofRadiologists.Published by ElsevierLtd. | The authors conclude that the use of FPD technology bringsa range of advantages over the II-TV system such as morestable performance, zero geometrical distortion andvignetting, less physical dimensions with great versatility. |
Materials and control elements used for the Intelli-C and the predicate device are comparable and not significantly different.
Conclusions:
We believe that the Intelli-C will perform as safe and as effective or better than the predicate device. We base our conclusions on the Substantial Equivalence Discussion and Literature summary, documenting the technological differences which include the digital x-ray receptor, user interfaces, x-ray generation component upgrades, and other minor modifications.
The use of a previously cleared digital x-ray receptor and adequate verification and validation testing results document adequate image quality and integration.
We do not see that new issues of safety or effectiveness are raised with the introduction of the Intelli-C Xray device.
§ 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.