(37 days)
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremties and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical persomel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.
SKANRAD 400 is a high frequency radiography system with 32kW generator X-Ray power. It can be used with table (recumbent position) as well as chest stand (standing position) for general radiography purpose. Electronic circuits incorporated for control, user interface, feedback circuits to ensure accuracy & reproducibility of X-Ray output. lt consists of:
- Tube head and collimator assembly
- Floating table assembly
- Chest stand assembly
- HV generator assembly
SKANRAD 400 can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software.
The provided FDA 510(k) summary for the SKANRAD 400 describes performance testing for substantial equivalence to a predicate device, rather than explicit acceptance criteria for a new clinical indication or capability. The document focuses on demonstrating that the SKANRAD 400 X-ray system is as safe and effective as the predicate device (RADspeed Fit K173517) through non-clinical performance data and compliance with relevant standards.
Therefore, the response will interpret "acceptance criteria" as the performance aspects and standards the device must meet to demonstrate substantial equivalence, as indicated in the provided text.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for an X-ray system demonstrating substantial equivalence, the "acceptance criteria" are implied by the comparison to the predicate device and adherence to industry standards, rather than specific performance metrics for a novel clinical function. The reported device performance is primarily a statement of compliance with these standards and the successful validation of its components.
| Acceptance Criteria (Implied by Comparison/Standards) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate | kV Range: Subject device (40 kV–125 kV) is within the predicate device's range (40-150 kV). Claimed to cover all general-purpose diagnostic exposure needs without raising safety/efficacy concerns. mA Range: Subject device (10-400 mA) is within the predicate device's range (10-500 mA for 32 kW). Claimed to be within safety margins and meet required values for general diagnostic imaging. Time Range: Subject device (5ms to 5s) is within the predicate device's range (1ms to 10s). Claimed to cover all diagnostic imaging procedures without raising safety/efficacy concerns. Other Comparable Properties: Identical for product code, class, intended use (with minor non-impactful differences), target population, performance standard, duration of contact, generator type (high frequency), generator power level (32 kW), X-ray tube focal spot, type of installation, aluminum equivalence of table/chest stand, image acquisition (Digital), image receptor (Film/CR/DR), exposure method, user interface, device parts contact the patient, and power source. |
| Safety and Essential Performance (Standards Adherence) | SKANRAD 400 complies with the following standards: - IEC 60601-1 Ed. 3.1 (2012)+EN 60601-1:2006+A1:2013+A12:2014 (General requirements for basic safety and essential performance) - IEC 60601-1-2:2014 (EMC) - IEC 60601-1-3:2008 + A1:2013 (Radiation protection) - IEC 60601-2-54 Ed. 1.2 2018-06 (X-ray equipment for radiography and radioscopy) - IEC 60601-2-28:2017 (X-Ray tube assemblies) - IEC 60601-1-6:2010/AMD1:2013 (Usability) - IEC 62304:2006+A1:2015 (Software Life-Cycle processes) - ISO 10993-1:2018 (Biological evaluation of medical devices) - ISO 14971:2007 (Application of risk management) "The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks after risk control measures." "Design verification, design validation and performance testing activities have been documented and indicate that the subject device is as safe and effective as the predicate device." |
| Compatibility with Image Receptors | The device was tested and verified with Varex PaxScan 4336W v4 (K161459) and Varex PaxScan 4343RC (K172951) flat panel detectors and DROC image acquisition software (K130883) to meet required performance. The validation activity for the detector and software with SKANRAD 400 has been performed and documented. |
| Biocompatibility | Materials of both floor table and chest stand are evaluated for biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. The "tests" mentioned are primarily engineering verification and validation activities against standards and functional comparisons with the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for a diagnostic output. The study focused on engineering performance and substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document states: "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 difference when compared to the predicate device. Considering this, non-clinical data is sufficient to support the safety and performance of SKANRAD 400. Hence clinical studies are not required."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. The SKANRAD 400 is an X-ray generation system, not an AI algorithm for diagnostic interpretation. Its performance is related to generating X-rays and imaging capabilities, not standalone algorithmic interpretation.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" implicitly used in this 510(k) submission relates to established engineering standards for X-ray devices and the performance characteristics of the legally marketed predicate device (K173517). The performance tests would verify that the device meets its design specifications and standard requirements.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device requiring a training set.
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April 1, 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Skanray Technologies Limited % Ankur Naik Managing Director IZiel Healthcare 14, Hadapsar Industrial Estate, Hadapsar Pune, Maharashtra 411013 INDIA
Re: K220518
Trade/Device Name: SKANRAD 400 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: February 18, 2022 Received: February 23, 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
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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, Ph.D. Assistant 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
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Indications for Use
trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.
510(k) Number (if known)
K220518
Device Name SKANRAD 400
Indications for Use (Describe)
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremties and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical persomel or operators who have been
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) summary of safety and effectiveness for SKANRAD 400 is provided in accordance with 21 CFR 807.92.
| Date: | 31 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) Contact Person: | 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: | SKANRAD 400 |
| Regulation Number: | 892.1680 |
| Regulation Description: | A stationary x-ray system is a permanently installeddiagnostic system intended to generate and control x-rays for examination of various anatomical regions.This generic type of device may include signal analysisand display equipment, patient and equipment support,component parts, and accessories |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | KPR |
| Predicate Device: | RADspeed Fit (K173517)Regulation number: 21 CFR 892.1680Regulation name: Stationary X-ray systemDevice class: IIProduct code: KPR, MQB |
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Device description
SKANRAD 400 is a high frequency radiography system with 32kW generator X-Ray power. It can be used with table (recumbent position) as well as chest stand (standing position) for general radiography purpose. Electronic circuits incorporated for control, user interface, feedback circuits to ensure accuracy & reproducibility of X-Ray output. lt consists of:
-
- Tube head and collimator assembly
-
- Floating table assembly
-
- Chest stand assembly
-
- HV generator assembly
SKANRAD 400 can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software. Skanray recommends using 510(k) cleared detectors and image acquisition systems to maintain compliance and quality: either wired or wireless with 14"x17" or 17" x 17" panels. Table 1 indicates the flat panel detectors and associated software, which are tested and verified with SKANRAD 400 to meet the required performance.
Table 1: Flat panel detectors and image acquisition software
| Flat panel detector | Image Acquisition Software | Remarks |
|---|---|---|
| Varex PaxScan 4336W v4(K161459) | DROC (Digital RadiographyOperating Console) by E-COMTechnology Ltd. (K130883) | DROC softwarecompatible with all threedetectors. |
| Varex PaxScan 4343RC(K172951) |
Intended Use / Indications for Use
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremities and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system.
The system has been designed for indoor usage. It is intended for qualified medical personnel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography
Comparison to predicate devices
One predicate device is selected in this submission for the SKANRAD 400.
Predicate device: RADspeed fit (K173517)
The image quality of X-ray system depends on two main factors - the X-Ray generation and the Digital Radiography system. The X-Ray voltage generator, the
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technology, design of the subject device is substantially equivalent to the predicate device, with minor changes in the ranges of kV, mA, and exposure time which does not affect the safety and effectiveness of the device. Image receptors that can be used with SKANRAD 400 include film, computed radiography and digital radiography. Flat panel detector and image acquisition software are not provided with the SKANRAD 400. To demonstrate that the subject device functions as intended it is tested with Varex PaxScan 4336Wv4 and Varex PaxScan 4343RC detectors along with the E-COM DROC image viewing software. The validation of the detector and software with SKANRAD 400 has been performed and validation activity has been documented. It does not affect the safety and efficacy of the device.
The details of the substantial equivalence between the subject device and predicate devices are explained as below:
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Table 2: Comparison to Predicate Device
| ComparableProperties | Subject Device | Predicate Device (K173517) | Comparison Results |
|---|---|---|---|
| Product name | SKANRAD 400 | RADspeed fit | Not applicable |
| Manufacturer | Skanray Technologies Limited | Shimadzu Corporation | Not applicable |
| Regulation number | 892.1680 | 892.1680 | Identical |
| Product code | KPR | KPR, MQB | Identical |
| Product Class | II | II | Identical |
| Intended Use /Indications for Use | The SKANRAD 400 is intendedfor use in generating X-Rays &radiographic images of humananatomy including skull, spinalcolumn, chest, abdomen,extremities and other body partsin all general-purpose X-raydiagnostic procedures. Thedevice is intended for use inpaediatric and adult. It may beused in radiology departments,paediatrics, orthopaedics andclinics. Exposures may be takenwith the patient sitting, standing,or lying in the prone or supineposition. Device is designed tobe used with conventionalfilm/screen or ComputedRadiography (CR) cassettes/ DRsystem.The system has been designedfor indoor usage. It is intendedfor qualified medical personnel | The RADspeed fit is intended togenerate digital or conventionalradiographic images of the skull,spinal column, chest, abdomen,extremities, and other body partsof human anatomies in all routineradiography examinations. TheRADspeed fit enablesradiographic exposure of thewhole body of all ages includingpaediatric patients. Exposuresmay be taken with the patientsitting, standing, or lying in theprone or supine position. TheRADspeed fit uses portable orintegrated flat panel detectors togenerate diagnostic images byconverting x-rays into electronicsignals. The device is alsodesigned to be used withconventional film/screen orcomputed radiography (CR)cassettes. The device is notintended for mammographic | Substantially equivalent |
| ComparableProperties | Subject Device | Predicate Device (K173517) | Comparison Results |
| or Operators who have beentrained in the use of X-Rayequipment. SKANRAD400 is notintended for mammography. | applications or tomographictechniques. The indications foruse remain the same as thosefor the predicate, except for theremoval of tomographictechnique. WARNING: UnitedStates Federal Law restricts thisdevice to sale by or on the orderof a physician. | ||
| Target Population | Adult, paediatric | Adult, paediatric | Identical |
| Performance Standard | 1020.30 & 1020.31 | 1020.30 & 1020.31 | Identical |
| Duration ofContact | <10 min | <10 min | Identical |
| Generator type | High Frequency | High frequency | Identical |
| Generator power level | 32 kW | 32kW/56kW | Identical |
| kV Range | 40 kV–125 kV, 1 kV step | 40-150 kV, 1 kV step | Substantial equivalentkV range of the subject deviceis within the range of thepredicate device. The rangecovers all the general purposediagnostic exposure requiredfor the mentioned anatomiesand it does not raise anyconcerns of safety andefficacy of the device. |
| mA Range | 10-400 mA | 10-500 mA (32 kW) | Substantial equivalentmA range of the subjectdevice is within the range ofthe predicate device. This isconsidered as within thesafety margin. mA is part ofmAs (product of time and |
| ComparableProperties | Subject Device | Predicate Device (K173517) | Comparison Results |
| current), and exposure valuesmeets the required values forgeneral diagnostic imagingprocedure for all anatomicalrange, and it does not raiseany concerns of safety andefficacy of the device. | |||
| Time range | 5ms to 5 s | 1 ms to 10 s | Substantial equivalentTime range of the subjectdevice is within the range ofthe predicate device. Alldiagnostic imagingprocedures are covered withinthis exposure duration, and itdoes not raise any concernsof safety and efficacy of thedevice. |
| X-ray tube focal spot | 0.6 mm / 1.3 mm | 0.6 mm / 1.3 mm | Identical |
| Type of Installation | Fixed (Tube- Floor Mount) | Fixed (Tube - Floor mount) | Identical |
| AluminiumEquivalence of Tableand chest stand | < 1 mm Al | < 1 mm Al | Identical |
| Image acquisition | Digital | Digital | Identical |
| Image Receptor | Film/CR/DR | Film/CR/DR | Identical |
| Exposure method | Hand-switch/ Console | Hand-switch/ Console | Identical |
| UserInterface | Touch console (Tube head &Operator) | Touch console (Tube head &Operator) | Identical |
| Device parts contactthe patient | Patient table & chest bucky | Patient table & chest bucky | Identical |
| Power source | AC line | AC line | Identical |
| ComparableProperties | Subject Device | Predicate Device (K173517) | Comparison Results |
| Product Image | Image: Subject Device | Image: Predicate Device | N/A |
| Electrical safety andEMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-54 | IEC 60601-1IEC 60601-1-2IEC 60601-1-3 | Identical |
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Discussion of similarities and differences
SKANRAD 400 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 and is not intended for mammographic application. Both predicate and subject device are indoor floor mounded X-ray system where X-Ray can be taken in all positions with the help of floor table and chest X-ray can be taken with the support of chest stand. The ranges for kV, mA and exposure duration are found to be within the predicate device range limiting to slightly on the lower side, which does not impact the intended application of the subject device as compared to predicate device. Image receptors of the subject device are film, CR, and DR which are same as predicate devices. User can choose their modality based on their requirements. The components of X-ray system like an X-ray generator and an X-ray tube are either identical or similar to predicate devices. The other components like the floor table, chest stand have no impact on the safety and effectiveness of the system. Materials of both floor table and chest stand are evaluated for biocompatibility. In addition, the subject device has been tested to the relevant performance standards as summarized below.
Performance data
The risks identified during risk analysis were reduced by applying suitable risk control measures and it was noted that there were no unacceptable risks after risk control measures.
Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors. The design verification, design validation and performance testing activities have been documented and indicate that the subiect device is as safe and effective as the predicate device.
SKANRAD 400 complies with the following standards:
- IEC 60601-1 Edition 3.1 (2012)+EN 60601-1:2006+A1:2013+A12:2014 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 and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment -● Part 1: General requirements for safety -3. Collateral standard: General requirements for radiation protection in diagnostic X-Ray equipment.
- IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION Medical ● electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
- IEC 60601-2-28:2017 (Third Edition) 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: Usability
- IEC 62304:2006+A1:2015 Medical device software-Software Life-Cycle . processes.
- ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.
- ISO 14971:2007 Medical devices. Application of risk management to medical devices
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 difference when compared to the predicate device. Considering this, non-clinical data is sufficient to support the safety and performance of SKANRAD 400. Hence clinical studies are not required.
Conclusion
All the above details collectively demonstrate that SKANRAD 400 is safe and effective when the device is used as labelled and is substantially equivalent to the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.