(170 days)
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
- Tube head
- SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
- Touchscreen operator console.
- Modified brake mechanism for wheels
- Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices.
The provided text does not contain information about specific acceptance criteria or an internal study demonstrating that the device meets those criteria. Instead, it focuses on the device's substantial equivalence to predicate devices, compliance with regulatory standards, and summarizes non-clinical performance data.
Therefore, I cannot populate the table of acceptance criteria or provide details about a study proving the device meets acceptance criteria as described in your request. The document explicitly states that "clinical studies are not required" for this submission, further indicating the absence of a study focused on proving specific performance metrics against pre-defined acceptance criteria in a clinical setting.
However, I can extract information related to the device's performance, testing, and ground truth establishment in a general sense based on the provided text, especially concerning the evaluation of the flat panel detectors which are a key component.
Here's an analysis of what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, explicit acceptance criteria are not presented in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to various electrical, safety, and image quality standards (DQE, MTF).
| Acceptance Criteria (Not explicitly stated as such, but derived from performance evaluations) | Reported Device Performance (Subject Device) |
|---|---|
| Detective Quantum Efficiency (DQE) of Digital Panel | Paxscan 4336Wv4: 0.242 @ 1cycle/mm, 0.125 @ 2cycles/mm, 0.04 @ 3cycles/mm CareView1500P: ~65% @ (0 lp/mm), ~20% @ (3 lp/mm) |
| Modulation Transfer Function (MTF) of Digital Panel | Paxscan 4336Wv4: 0.521 @ 1cycle/mm, 0.206 @ 2cycles/mm, 0.08 @ 3cycles/mm CareView1500P: ~70% @ (1 lp/mm), ~40% (@2 lp/mm), ~22% (@3 lp/mm) |
| Image Quality (Readability by Radiologist/Radiographer) | "Images were of good quality which were easily read by the radiologist" |
| Electrical Safety | Complies with IEC-60601, IEC-60601-1-2, IEC-60601-1-3, IEC-60601-2-54, IEC-60601-2-28, IEC 60601-1-6 |
| Electromagnetic Compatibility (EMC) | Complies with IEC-60601-1-2 |
| Software Life Cycle Processes | Complies with IEC 62304:2006 |
| Risk Management | Complies with ISO 14971:2012 |
| Exposure Index of Digital X-ray systems | Complies with IEC 62494-1 |
| Determination of Detective Quantum Efficiency | Complies with IEC 62220-1-1 |
| Digital Imaging and Communications in Medicine (DICOM) | Complies with NEMA PS 3.1 - 3.20 (2016) and supports DICOM |
| Radiation Dose Documentation | Complies with IEC 61910-1 |
| Characteristics of Focal Spots | Complies with IEC 60336 |
| Determination of quality equivalent filtration and permanent filtration | Complies with IEC 60522:1999 |
| Biological evaluation of medical devices | Complies with ISO 10993-1:2009 |
| Information supplied by the manufacturer of medical devices | Complies with EN 1041:2008+A1:2013 |
| Medical devices - Symbols to be used with medical device labels | Complies with ISO 15223-1 |
| Performance Testing of Shipping Containers and Systems | Complies with ASTM D4169-16 |
| Performance Standard for Radiation Safety for Diagnostic X-Ray Systems | Complies with 21 CFR 1020.30 and 1020.31 |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of images/patients.
- Data Provenance: Not specified. It mentions testing was done "both in-house and by outsourcing to appropriate third-party vendors." The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that "The quality of the images obtained from the subject devices were analysed by a radiographer and a radiologist and it was found the images were of good quality which were easily read by the radiologist".
- Number of experts: At least one radiographer and at least one radiologist ("a radiographer and a radiologist").
- Qualifications: "radiographer" and "radiologist." No specific years of experience are mentioned.
4. Adjudication method for the test set:
- Not specified. The text simply says "analysed by a radiographer and a radiologist." It does not describe a formal adjudication process (e.g., 2+1, 3+1).
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:
- No MRMC comparative effectiveness study was done. The device described is a mobile X-ray system, not an AI-assisted diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is an X-ray imaging system, not an algorithm for image interpretation. The "software/firmware" described primarily controls the operation of the device and integrates with image acquisition software.
7. The type of ground truth used:
- For image quality, the ground truth was "expert consensus" implicitly, as it was determined by the analysis of a radiographer and a radiologist who found the images to be of "good quality" and "easily read."
- For technical specifications (DQE, MTF, electrical safety, etc.), the "ground truth" or reference was compliance with various international standards (IEC, ISO, NEMA, ASTM, 21 CFR).
8. The sample size for the training set:
- Not applicable. The document discusses a physical X-ray device and its control software. There is no mention of a "training set" for an AI or machine learning algorithm. The software development "has been executed as per the requirements of ISO 62304" and undergone "software validation & verification," not machine learning training.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm mentioned.
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March 4, 2022
Image /page/0/Picture/1 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Skanray Technologies Limited % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 INDIA
Re: K212940
Trade/Device Name: SKANMOBILE, SKANMOBILE-DR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: January 12, 2022 Received: January 18, 2022
Dear Ankur Naik:
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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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
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Indications for Use
510(k) Number (if known) K212940
Device Name SKANMOBILE and SKANMOBILE-DR
Indications for Use (Describe)
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
| ☒ Remediation Use (Part 264 CFR 90 Subpart D) | ☐ Gas Treatment Use (264 CFR 90 Subpart O) |
|---|---|
| ------------------------------------------------------------------------------------------------ | -------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Attachment 2-1: 005_510(k) Summary
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510(k) Summary - K212940
510(k) summary of safety and effectiveness for SKANMOBILE and SKANMOBILE-DR is provided in accordance with 21 CFR 807.92.
| Date: | 12 January 2022 |
|---|---|
| Submitter (Owner): | Vasundhara RRegulatory HeadSkanray Technologies LimitedPlot# 15-17, Hebbal Industrial Area, HebbalMysore, Karnataka 570016, IndiaP: +91 821 2415559Email: vasundhara.r@skanray.com |
| 510(k) ContactPerson: | Ankur NaikManaging DirectorIZiel Healthcare14, Hadapsar Industrial Estate,Hadapsar, Pune – 411013, India.P: +91 72762 2555 M: +91 7069553814Email: ankur.naik@izielhealthcare.com |
| Device Trade Name: | SKANMOBILESKANMOBILE-DR |
| Regulation Number: | 892.1720 |
| Regulation Name: | Mobile X-Ray System |
| RegulationDescription: | A mobile x-ray system is a transportable device systemintended to be used to generate and control x-ray fordiagnostic procedures. This generic type of device mayinclude signal analysis and display equipment, patientand equipment support, component parts, andaccessories. |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | IZLMQB |
| Predicate Device(s): | ● AMADEO M-DR mini, AMADEO M-AX mini (K182317)Regulation number: 892.1720Regulation name: Mobile X-Ray systemDevice class: IIProduct code: IZL, MQBReview Panel: Radiology |
| • DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299) | |
| Regulation number: 892.1720 | |
| Regulation name: Mobile X-Ray system | |
| Device Class: II | |
| Product code: IZL, MQB | |
| Review Panel: Radiology |
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Device description
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
Device variants
The following table lists the details of the variants of SKANMOBILE and SKANMOBILE-DR:
Table 1: List of Device Variants
| Product Name | Part # |
|---|---|
| SKANMOBILE - HF diagnostic X-ray system, 230 VAC | 303-000018-0 |
| SKANMOBILE - HF diagnostic X-ray system, 110 VAC | 303-000018-3 |
| SKANMOBILE-DR – HF diagnostic X-Ray system, 230 VAC | 303-000018-15 |
| SKANMOBILE-DR – HF diagnostic X-Ray system, 110 VAC | 303-000018-16 |
Device design
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
-
- Tube head
-
- SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
{6}------------------------------------------------
-
- Touchscreen operator console.
-
- Modified brake mechanism for wheels
-
- Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices. The design and development of the software has been executed as per the requirements of ISO 62304. User interface is provided via UART interface from Console System. Software Control System of Control Firmware is of Master – Slave in nature. The programming language adopted is ANSI C and the software architecture follows a simple Call and Return flow of statements and modules.
Flat panel detectors and image acquisition software integration details
Table 2 explains the compatibility between available options of flat panel detectors and image acquisition software used in the X-ray systems.
| Flat Panel Detector | Image AcquisitionSoftware | Remarks |
|---|---|---|
| CE certified / FDAcleared Compatible FlatPanel Detector VarexPaxscan 4336Wv4 canbe used with the X-Raysystem | FDA cleared ImageAcquisition System withcompatible Flat PanelDetector can be used. | SKANMOBILE-DR isverified and validated withVarex Flat Panel DetectorPaxscan 4336Wv4 andECOM Image AcquisitionSoftware with customizedOEM title |
| CE certified / FDAcleared Compatible FlatPanel Detector CareView1500P can be used withthe X-ray system | FDA cleared ImageAcquisition System withcompatible Flat PanelDetector can be used. | SKANMOBILE-DR isverified and validated withCareView 1500P detectorand ECOM ImageAcquisition Software withcustomized OEM title |
Table 2: Flat panel detectors and image acquisition software integration
The above-mentioned specific combinations of flat panel detectors and image acquisition software are compatible with all types/configurations of other components (x-ray generator, x-ray tube, collimator, and mechanicals).
The device is packaged inside a corrugated box with, appropriate labels and the user manual after cleaning the entire unit. The device is secured to the wooden pallet and covered for adequate safety.
The device is packed appropriately as required by the mode of transportation.
Intended Use / Indications for Use
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology
{7}------------------------------------------------
departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Comparison to predicate devices
Two predicate devices are selected in this submission for the SKANMOBILE and SKANMOBILE-DR.
Predicate device 1: AMADEO M-DR mini, AMADEO M-AX mini (K182317)
Predicate device 2: DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299)
The details of the substantial equivalence between the subject device and predicate devices are explained in Table 3:
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Table 3: Comparison to Predicate Devices
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
|---|---|---|---|---|
| Productname | SKANMOBILE andSKANMOBILE-DR | AMADEO M-DR mini,AMADEO M-AX mini | DRAGON X SPSL4HC;DRAGON X SPSL8HC | Not applicable |
| Manufacturer | Skanray Technologies Limited | Oehm Und RehbeinGmbh | Sedecal SA | Not applicable |
| Regulationnumber | 892.1720 | 892.1720 | 892.1720 | Identical |
| Product code | IZL, MQB | IZL, MQB | IZL, MQB | Identical |
| ProductClass | II | II | II | Identical |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Intended Use/ Indicationsfor Use | SKANMOBILE andSKANMOBILE-DR areintended for use in generatingradio graphic images of humananatomy in all general-purposex-ray diagnostic procedures forall patient population includingpaediatrics and adults. It maybe used in radiologydepartments, emergencyrooms, intensive care units,operating rooms, orthopaedicsclinics, military camps,paediatric clinics, medicalcamps and small hospitals.SKANMOBILE andSKANMOBILE-DR areindicated for takingradiographic exposures of theskull, spinal column, chest,abdomen, extremities andother body parts with thepatient sitting, standing or lyingin the prone or supine position.The device has been designedfor indoor usage andused/operated only by thetrained & qualified physiciansor x-ray technologist.SKANMOBILE andSKANMOBILE-DR are notintended for mammographicapplications. | These PortableDiagnosticRadiographicSystems are intendedfor use by aqualified/traineddoctor or technicianon both adult andpediatric subjects fortaking diagnosticradiographicexposures of the skull,spinal column, chest,abdomen, extremities,and other body parts.Applications can beperformed with thepatient sitting,standing, or lying inthe prone or supineposition. (Not formammography). | These PortableDiagnosticRadiographicSystems are intendedfor use by aqualified/trained doctoror technicianon both adult andpediatric subjects fortaking diagnosticradiographicexposures of the skull,spinal column,chest, abdomen,extremities, and otherbody parts.Applications can beperformed with thepatient sitting,standing, or lying in theprone or supineposition. (Not formammography). | Substantially Equivalent |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Line powerrequirements | 230 VAC / 110 VAC | 100-240 VAC | 100-240 VAC / 220 -240 VAC | Substantially EquivalentMains power voltagerange are country specific.Devices are designed toaccept either230VAC/220VAC or100VAC/110VAC,depending on where theyare placed. The mainsinput labelling will bedeclared to indicate thedevice compliance to themains input meetingspecified country mainsregulation and hence doesnot raise the level ofsafety concern and affectperformance. |
| Generatortype | High Frequency | High frequency | High frequency | Identical |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Generatorpower level | 4 KW | 5KW | 4KW, 8KW | Substantially equivalentMaximum generatorpower is the maximumpower derived from themaximum kV and mAdrawn. The devicegenerates kV and mAoptimal for the differentanatomy as defined by theaccepted anatomicallyprogrammed radiography(APR) table, which areindependent of powerdrawn by the system.Thus, minor difference inthe power does notchange the intendedapplication. Additionally,electrical safety and EMCtesting has beenperformed on the subjectdevices and it has beenobserved that the deviceperforms as intended andhence does not raise thelevel of safety concernand affect performance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Peak voltage | 100 kV | 110 kV | 125 kV | Substantially equivalentMinor difference in thepeak voltage appliedacross the x-ray tubeindicates differences in thedevice construction andthe object distance fromthe source. However,these changes do notchange the intendeddevice application. Thequality of the imagesobtained from the subjectdevices were analysed bya radiographer and aradiologist and it wasfound the images were ofgood quality which wereeasily read by theradiologist and hencedoes not raise the level ofsafety concern and affectperformance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| High voltage range | 40 kV–100 kV, 1 kV step | 40-100 kV, 1 kV step | 40-125 kV, 1 kV step | Substantially equivalentX-ray tube voltage settingrange is 40kV to maximumpeak X-ray voltage, whichthe tube can handle.Range is a minor element,which can be different butit still maintains the sameintended application andhence does not raise thelevel of safety concernand affect performance. |
| mAs range | 0.1 mAs to 250 mAs | 0.4 –100 mAs | 0.1 mAs to 250 mAs | Substantially equivalentProduct of X-ray tubecurrent and time is termedas mAs, which is adependent parameter ofpower rating and voltagerating which as mentionedabove does not changethe intended application.APR table recommendsthe user to use referredvalue or user can set avalue which is appropriatefor that examination. Itdoes not raise the level ofsafety concern and affectperformance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Collimator | Manually operated, LED lightsource, Maximum light field of48 X 48 cm at 1 m SID, 30 Sectimer. | POSKOM PCMAX-100CAH: LED lamp,Maximum light field of47 X 47 cm @ 100 cmSID, 30 Sec timer. | Ralco R72S:Manual, white LED,Single layer squarefield of 43 X 43 cm at100 cm SID, 125 kVp.(K030487) | Substantially equivalentCollimator is the devicewhich restricts the X-raybeam within the specifieduseful area avoidingunintended radiation onthe body. Different lightfield indicates the area ofdetector that can be usedwith the system and does |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| ImageReceptor | DR | DR | DR | Substantially EquivalentSKANMOBILE variantsupports image receptionthrough film /computedradiography (CR)/digitalradiography (DR)technologies and user canuse any of these imagereception technologieswhich can integrate withSKANMOBILE with thesoftware inbuilt in theimage receptors.SKANMOBILE-DR variantsupports DR with its owncustomized Skanviewsoftware. |
| Digital PanelModels andtheirClearanceNumbers | Nexus DR™ Digital X-rayImaging System with PaxScan4336Wv4 (K161459)CareView 1500P X-ray FlatPanel Detectors (K162178) | PerkinElmer XRpad24336 detector(K161966) orthe XenOR 35CW(CareRayCareView1500CW)(K150929) | Toshiba FDX3543RPorFDX3543RPW(K130883) | Substantially EquivalentThe subject device utilizesa different X-ray flat paneldetector; however, the flatpanel detectors used bythe subject device arealready previously clearedby the FDA and the testingdemonstrates that it doesnot raise the level ofsafety concern and affectperformance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Digital PanelSpecifications | PaxScan® 4336Wv4: Pixelpitch: 139 μmDetector Element Matrix: 3072x 2560CareView 1500P:Pixel pitch 154 μmImage Matrix Size: 2304 x2816 pixels | XRpad2 4336: 100 μ,3524 × 4288 pixelsXenOR 35CW(CareView1500CW):154 μ 2304 x 2816pixels | FDX3543RP: 143 μmpixel pitch, 2448 ×2984pixelsFDX3543RPW: 140 μ,2466 ×3040pixels | Substantially EquivalentThe resolution of thenumber of horizontal andvertical sensing elementon the detector anddifference in the size doesnot change the intendedapplication. Thisparameter is definedunder the limited spatialresolution or detectablesize of anatomy. Spatialresolution for generalradiography is generalizedat 1.6 lp/mm. This doesnot raise the level ofsafety concern and affectperformance. |
| DetectorTechnology | Direct Deposition CsI | Direct Deposition CsI | Direct Deposition CsI | Identical |
| DetectiveQuantumEfficiency(DQE) ofDigital Panel | Paxscan 4336Wv4:0.242 @ 1cycle/mm0.125 @ 2cycles/mm0.04 @ 3cycles/mmCareView1500P (@RQA5,30μGy):~ 65% @ (0 lp/mm)~ 20% @ (3 lp/mm) | XRpad2 4336:75% (0 cy/mm)60% (1 cy/mm)40% (3 cy/mm)CareView1500CW:~ 65% @ (0 lp/mm)~ 20% @ (3 lp/mm) | FDX3543RP: >70%FDX3543RPW: >70%@ 0 lp/mm | Substantially EquivalentThe performance of theflat panel detectors withrespect to the claimedDQE was evaluated and itwas demonstrated that theDQE values measuredwere comparable to thevalues claimed by thedetector manufacturer.This does not raise thelevel of safety concernand affect performance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| ModulationTransferFunction(MTF) ofDigital Panel | Paxscan 4336Wv4:0.521 @ 1cycle/mm0.206 @ 2cycles/mm0.08 @ 3cycles/mmCareView1500P:~ 70 % @ (1 lp/mm)~ 40% (@ 2 lp/mm)~ 22% (@ 3 lp/mm) | XRpad2 4336:70% (1 cy/mm)40% (2 cy/mm)15% (4 cy/mm)CareView1500CW:~ 70 % @ (1 lp/mm)~ 40% (@ 2 lp/mm)~ 22% (@ 3 lp/mm) | FDX3543RP: 36% typ.(2.0 lp/mm, 70kVp,1x1)FDX3543RPW:Unknown | Substantially EquivalentThe performance of theflat panel detectors withrespect to the claimedMTF was evaluated and itwas demonstrated that theMTF values measuredwere comparable to thevalues claimed by thedetector manufacturer.This does not raise thelevel of safety concernand affect performance. |
| Communication interface | Wireless Data Interface: DualBand (2.4GHz and/or5GHz) 802.11a/b/g/n/ac | Gb Ethernet or802.11n WiFi | Unknown | Identical |
| Focal spot | 1.8 mm | 1.8 mm | 0.5 – 1.8 mm, 0.6 – 2.8mm | Identical |
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| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
|---|---|---|---|---|
| Software | CustomizedE-COM Software calledSkanView, a digitalradiography operationalsoftware | DICOMPACS DX-R | ECOM software ascleared in K130883 | Substantially EquivalentSKANMOBILE andSKANMOBILE-DR utilizescustomized E-COMsoftware. The E-COMsoftware is 510(k) clearedin K193644. Thecustomization of the510(k) cleared softwarehas been validated anddocumented as part ofsoftware validation &verification. It has beendemonstrated that thecustomization of the E-COM software does notraise the any newquestions of safety orperformance. |
| ComparableProperties | Subject Device | Predicate Device 1(K182317) | Predicate Device 2(K173299) | Comparison Results |
| Connection | Wi-Fi | Ethernet or Wi-Fi | Ethernet or Wi-Fi | Substantially EquivalentEthernet and Wi-fi are theconnectivity modules withexternal devices for thetransmission of data.Ethernet needs cableconnectivity for datatransfer whereas Wi-fi iswireless data transfer (nocable is required). Bothhave the samefunctionality of datatransmission. This doesnot raise the level ofsafety concern and affectperformance. |
| DICOM | Yes | Yes | Yes | Identical |
| Powersource | AC line | AC line | AC line | Identical |
| PerformanceStandard | 21 CFR 1020.30 and 1020.31 | 21 CFR 1020.30 | 21 CFR 1020.30 | Substantially EquivalentIn addition to 21 CFR1020.30, subject devicealso shows compliance to21 CFR 1020.31 and thetest report is available inSection 18 (Att-18-9). |
| Electricalsafety andEMC | IEC-60601IEC-60601-1-2IEC-60601-1-3IEC-60601-1-28IEC-60601-2-54 | IEC-60601IEC-60601-1-2IEC-60601-1-3IEC-60601-2-54 | IEC-60601 IEC-60601-1-2IEC-60601-1-3IEC-60601-2-54 | Identical |
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Discussion of similarities and differences
SKANMOBILE and SKANMOBILE-DR is intended for generating radiographic images of human anatomy for all general-purpose X-Ray diagnostic procedures in all patient population including pediatrics and adults. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The device shall be used or operated only by the trained & qualified physicians or X-ray technologists. This device is not intended for Mammography application. This device utilizes FDA cleared X-ray flat panel detectors and image processing software which are the associated components of any digital X-Ray diagnostic system. The other components of the imaging system such as the X-Ray generator and X-Ray tube are either identical or similar to the predicate devices. The remaining other components have no impact on the safety and performance of the system. In addition, the subject device confirms to the following performance standards as summarized below.
Performance data
SKANMOBILE and SKANMOBILE-DR are developed by implementing various design control activities including design verification, design validation and risk analvsis.
The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks remained after applying risk control measures. Though the X-Ray is harmful to the patient or user during intended use, the clinical benefit in terms of image quiding for diagnosis and treatment outweighs the risk caused by X-ray. The device is intended to be used in hospitals and clinics by trained operators.
Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors. A summary of the design verification, design validation and performance testing activities is elaborated in section 18 of this submission.
The SKANMOBILE and SKANMOBILE-DR comply with following standards:
- IEC 60601-1:2005+AMD1:2012 (Edition 3.1) Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests
- IEC 60601-1-3:2008 (Edition 2) General requirements for basic safety and ● essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54:2018 Particular requirements for the basic safety and ● essential performance of X-ray equipment for radiography and radioscopy
- IEC 60601-2-28:2010 Medical electrical equipment Part 2-28: Particular ● requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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- IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment Part 1-6: ● General requirements for basic safety and essential performance - Collateral standard: Usabilitv
- . IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices
- IEC 62304:2006 Medical device software Software life cycle processes ●
- ISO 14971:2012 Medical devices. Application of risk management to medical devices.
- IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment Exposure ● index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography.
- IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment-● Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging.
- NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.
- IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment Radiation ● dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy.
- . IEC 60336 Fourth edition 2005-04 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]
- IEC 60522:1999: B: 2003 Medical electrical equipment Diagnostics X-rays -● Part 1: Determination of quality equivalent filtration and permanent filtration.
- . ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices.
- ISO 15223-1 Third Edition 2016-11-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
Summary of clinical testing
As per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices document, subject device does not have major modifications when compared to predicate devices. Additionally, the flat panel detector used in the subject device has been previously cleared by US FDA. Considering this, nonclinical data is sufficient to support the safety and performance of SKANMOBILE and SKANMOBILE DR. Hence clinical studies are not required.
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Conclusion
Technological differences from the predicate devices include different detectors. Although some of the components differ from the predicate devices, the subject device utilizes previously cleared X-ray flat panel detectors and image processing software. The other components of the imaging system such as the X-ray generator and X-ray tube are either identical or similar to the predicate devices. Despite the few differences, after analysis of all test information, including the indications for use and test data it is collectively demonstrated that the SKANMOBILE and SKANMOBILE-DR are as safe and effective as the predicate devices when used as labelled and are substantially equivalent to predicate devices.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.