(35 days)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.
Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:
Acceptance Criteria and Device Performance Table:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K150816, K153119) for diagnostic radiographic exposures of various body parts in adults and pediatrics, excluding mammography. | "Equivalent" to predicate devices. |
| Configuration of Digital Panels | Battery or AC operated wireless IEEE 802.11n or Wired Ethernet. | "Same" as predicate devices. |
| Digital Panel Models and their Clearance Numbers | Utilize previously cleared FDA digital flat panel detectors (specific K numbers listed in Note 1). | "Similar functionality" to predicate devices (Note 1 states the subject device uses different flat panel detectors that are previously FDA cleared, and testing demonstrates no increased safety concern or effect on effectiveness). |
| Image Acquisition Panel Specifications | Comparable pixel resolution and size range (e.g., 3,320 x 3,408 Pixels 125 µm, 3,072 x 3,072 Pixels 139 µm, etc.). | "Similar functionality" to predicate devices (Note 1). |
| DICOM Compliance | DICOM 3 compliant. | "Same" as predicate devices. |
| WiFi Wireless (if applicable) | Functionality similar to predicate wireless detectors. | "Similar functionality" to predicate devices (specific Canon, Varex, PerkinElmer, and DRTECH wireless detectors listed). |
| Image Acquisition Software | Utilize previously cleared FDA image processing software (specific K numbers listed in Note 2). | "Similar functionality" to predicate devices (Note 2 states Prognosys uses previously cleared FDA software and does not modify it). |
| Power Source | AC Line, various voltages available. | "Same" as predicate devices. |
| X-ray Generator | Range of power ratings (e.g., 32 kW to 80 kW, 125 kV/150 kV). | "Same or similar functionality" to predicate devices (Note 3 states the subject device uses similar X-ray generators with different power ratings and that these generators have been used in previously cleared 510(k) devices). |
| X-ray Tubes | Range of kV, focal spot sizes, and heat units (e.g., Toshiba E7239FX, Varex RAD14, etc.). | "Similar functionality" to predicate devices (Note 4 states both configurations provide similar imaging resolution and these tubes have been used in previously cleared 510(k) devices). |
| Collimator | Adequate inherent filtration. | "Similar functionality" to predicate devices (Note 5 states the inherent filtration is different but does not affect safety and effectiveness). |
| Performance Standard Compliance | Compliance with FDA 21 CFR 1020.30-31 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components). | "Same" as predicate devices. |
| Electrical Safety | Compliance with IEC 60601-1. | "Same" as predicate devices. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device complies with this standard. |
| Radiation Protection | Compliance with IEC 60601-1-3. | Device complies with this standard. |
| Specific Safety/Performance for X-ray Equipment | Compliance with IEC 60601-2-54. | Device complies with this standard. |
| Usability | Compliance with IEC 60601-1-6. | Device complies with this standard. |
| Risk Management | Compliance with ISO 14971. | Device complies with this standard. |
| Cybersecurity | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" guidance for device labeling. | Cybersecurity concerns were addressed based on the US FDA Guidance document. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
- Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist.
- Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.
3. Adjudication method for the test set:
- Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.
4. 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:
- MRMC Study: No. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
- Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Prognosys Medical Systems Private Limited % Dr. Shruti Sancheti Manager - Quality and Regulatory Affairs IZiel Healthcare 14. Hadapsar Industrial Estate Hadapsar, Pune, 411013 INDIA
January 24, 2019
Re: K183541
Trade/Device Name: ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 20, 2018 Received: December 21, 2018
Dear Dr.Sancheti:
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 mav, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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.
Michael D. O'Hara 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) K183541
Device Name
ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems
Indications for Use (Describe)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
510(k) summary of Safety and Effectiveness for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is provided in accordance with 21 CFR 807.92.
| Date: | October 5, 2018 |
|---|---|
| Submitter (Owner): | V. Krishna PrasadPresidentPrognosys Medical Systems Pvt. Ltd.No. 249, Ground Floor, Front Building, 4th MainRoad, Chamrajpet,Bangalore - 560 018, Karnataka, IndiaPhone: +91-8026621544E-mail Id: info@prognosysmedical.com |
| 510(k) Contact Person: | Dr. Shruti SanchetiManager-Quality & Regulatory AffairsIZiel Healthcare14, Hadapsar Industrial Estate,Hadapsar, Pune – 411013India.P: +91-72762 2555 M:+91-9518546814Email: shruti.sancheti@izielhealthcare.com |
| Device Trade Name: | ProRad 2FC and ProRad 3NC StationaryRadiographic Systems |
| Regulation Number: | 21 CFR 892.1680 |
| Regulation Description: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | KPR, MQB |
| Predicate Device: | 1. Jumong Series Stationary Radiographic System(K150816)2. Amrad Medical OTS Digital Radiography System,Amrad Medical DFMTS Digital RadiographySystem, Amrad Medical FRS Digital RadiographySystem (K153119) |
Indications for Use:
The ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Description of the Device:
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the
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mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices (respective approval numbers are discussed in Section 11, Table 1). Details of the various configurations of all the components are given in Table 1 below:
| ComponentCategory | Component Description andModel | ManufacturingLocation | ProRad2FC | ProRad3NC |
|---|---|---|---|---|
| DigitalImagingSystem | CANON Flat Panel Detector CXDI-401C Compact | Canon Inc., Japan | √ | √ |
| CANON Flat Panel Detector CXDI-410C Wireless | √ | √ | ||
| CANON Portable Detector CXDI-701C Wireless | √ | √ | ||
| CANON Portable Detector CXDI-710C Wireless | √ | √ | ||
| VAREX PAXSCAN 4343R v3 | Varian MedicalSystems, Inc. | √ | √ | |
| VAREX PAXSCAN 4336W v4Wireless | √ | √ | ||
| VAREX (PerkinElmer) Flat PanelDetector XRpad 4343F MED | Perkin-Elmer, Inc | √ | √ | |
| VAREX (PerkinElmer) Flat PanelDetector XRpad 4336 MEDWireless | √ | √ | ||
| DRTECH Digital Flat Panel X-rayDetector EVS 4343, EVS 4343G | DRTECHCorporation | √ | √ | |
| DRTECH Digital X-ray DetectorEVS 3643, EVS 3643G Wireless | √ | √ | ||
| ImageAcquisition | Canon CXDI NE | Canon Inc., Japan | √ | √ |
| Software | DROC (Digital RadiographyOperator Console) | E-COM TechnologyLtd. | √ | √ |
| Econsole1 | DRTECH Corp. | √ | √ |
Table 1: Available system configurations
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| ComponentCategory | Component Description andModel | ManufacturingLocation | ProRad2FC | ProRad3NC |
|---|---|---|---|---|
| X-rayGenerator | CPI CMP 200DR (32 kW, 40 kW, 50 kW, 65 kW, 80 kW) | Communications &Power Industries,Canada | √ | √ |
| X-ray Tube | TOSHIBA (E7239FX, E7242FX, E7252X, E7254X, E7869X, E7884X, E7843X) | TOSHIBAELECTRONTUBES &DEVICES CO.,LTD. | √ | √ |
| VAREX (RAD14, RAD60, RAD92) | Varian MedicalSystems, Inc. | √ | √ | |
| Collimator | Ralco (R221, R225ACS) | Ralco Italy | √ | √ |
| Daesung (M38) | DaesungCorporation, Korea | √ | √ | |
| MechanicalTube Stand | Ceiling Mounted Tube Stand- Full Auto- Single (SCS-FA)- Auto Tracking- Single (SCS-AT)- Manual- Single (SCS-MA)- Full Auto- Dual (DCS-FA)- Auto Tracking- Dual (DCS-AT)- Manual- Dual (DCS-MA)Floor Mounted Tube Stand | -- | √ | |
| - Full Auto- Single (SFT-FA)- Auto Tracking- Single (SFT-AT)- Manual- Single (SFT-MA)- Auto Tracking (FTC-AT)- Manual (FTC-MA)- Full Auto- Dual (DFT-FA)- Auto Tracking- Dual (DFT-AT)- Manual- Dual (DFT-MA) | √ | -- | ||
| MechanicalBuckyStand | Floor Mounted Vertical Bucky Stand- VB-MO- VB-MA- VBNTL-MO- VBNTL-MA | √ | √ | |
| PatientTable | Mobile Patient Table PRO-MT- Mobile Patient Table with 4-way movement PRO-MT4- Mobile Patient Table with 6-way movement PRO-MT6- Fixed Patient Table PRO-FT- Fixed Patient Table with 4-way movement PRO-FT4- Fixed Patient Table with 6-way movement PRO-FT6 | √ | √ |
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Safety and effectiveness, comparison to predicate device:
This combination device has the same indications for use, is similar in technological characteristics to the predicate devices and employs already 510(k) cleared digital panels and software. In addition, most of the other components employed in the device have already been used in previously cleared 510(k) devices. The device has also been adequately tested to the relevant performance standards to prove that the integrated device is safe and effective for the intended use.
| Predicate | Predicate | Comparison | ||
|---|---|---|---|---|
| Comparable | Subject Device | Device 1 | Device 2 | Results |
| Properties | (K150816) | (K153119) | ||
| Intended Use | ProRad Series StationaryRadiographic System isintended for use by aqualified, trained doctor ortechnician on both adult andpaediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying in theprone or supine position. Notfor mammography. | Jumong Seriesis intended foruse by aqualified,trained doctor ortechnician onboth adult andpediatricsubjects fortakingdiagnosticradiographicexposures ofthe skull, spinalcolumn, chest.abdomen,extremities, andother bodyparts.Applications canbe performedwith the patientsitting, standing,or lying in theprone or supineposition. Not formammography. | Theseradiographicsystems areintended foruse by aqualified/trained physicianor technicianon both adultand pediatricsubjects fortakingdiagnostic x-rays. Not formammography,angiography,interventional, orfluoroscopyuse. | Equivalent |
| ComparableProperties | Subject Device | PredicateDevice 1(K150816) | PredicateDevice 2(K153119) | ComparisonResults |
| Configurationof DigitalPanels | Battery or AC operatedwireless IEEE 802.11n orWired Ethernet | Battery or ACoperatedwireless IEEE802.11n orWired Ethernet | Battery orAC operatedwirelessIEEE802.11n orWiredEthernet | Same |
| Digital PanelModels andtheirClearanceNumbers | CANON Flat Paneldetector CXDI-401CCompact (K103591)CANON Flat Paneldetector CXDI-410CWireless (K171270)CANON Portable detectorCXDI-701C Wireless(K131106)CANON Portable detectorCXDI-710C Wireless(K170332)VAREX PAXSCAN4343R v3 (K172951)VAREX PAXSCAN4336W v4 (K161459)VAREX (PerkinElmer)XRpad 4343F MED FlatPanel Detector (K142698)VAREX (PerkinElmer)XRpad 4336 MED FlatPanel Detector (K140551)DRTECH EVS 4343, EVS4343G Digital Flat PanelX-ray Detector (K162555)DRTECH EVS 3643, EVS3643G Digital X-raydetector (K162552) | Vieworks- Vivix-SWireless(K122865)- Vivix-S withVxvue(K122866)- Vivix-S(K120020) | - VAREXPAXSCAN4343R(K130318) | Similarfunctionality(Note 1) |
| ImageAcquisitionPanelSpecificationS | 3,320 x 3,408 Pixels 125µm (CXDI 401CCompact)3,320 x 3,408 Pixels 125µm (CXDI 410CCompact)2,800 x 3,408 Pixels 125µm (CXDI 701C) | FXRD-1717SA,FXRD-1717SB)3,072 x3,072,140µm orFXRD-1417SA, | 3,072 x3,072 Pixels139 µm(PAXSCAN4343R)2,560 x3,072 Pixels139 µm | Similarfunctionality(Note 1) |
| ComparableProperties | Subject Device | Predicate | Predicate | Comparison |
| Device 1 | Device 2 | Results | ||
| (K150816) | (K153119) | |||
| 2,800 x 3,408 Pixels 125µm (CXDI 710C)3,072 x 3,072 Pixels 139µm (PAXSCAN 4343Rv3)3,072 x 2,560 Pixels 139µm (PAXSCAN 4336Wv4)4,318 x 4,320 Pixels 100µm (XRpad 4343F)3,556 × 4,320 Pixels 100µm (XRpad 4336)3,072 x 3,072 Pixels 140µm (EVS 4343, EVS4343G)2,560 x 3,072 Pixels 140µm (EVS 3643, EVS3643G) | FXRD-1417SB)2,560 x3,072,140µmWireless:FXRD-1417WA,FXRD1417WB, 2,560 x3,072,140µm | (PAXSCAN4336R) | ||
| DICOM | DICOM 3 | DICOM 3 | DICOM 3 | Same |
| WiFiWirelessIEEE802.11n(Allothers areEthernetTethered.) | CANON CXDI 701CWirelessVAREX PAXSCAN4336W v4PerkinElmer XRpad 4336MED Flat Panel DetectorDRTECH EVS 3643, EVS3643G Digital X-raydetector | K122865 Vivix-S Wireless | Wirelessdetector- Notapplicable | Similarfunctionality |
| ImageAcquisitionSoftware | CANON CXDI NE(K153312, K171270)DROC (DigitalRadiography OperatorConsole) (K130883)Econsole1 (K152172) | VieworksVivix-S WithVxvue(K122866)Vivix-S(K120020) | ECOMSoftware(K130883) | Similarfunctionality(Note 2) |
| PowerSource | AC Line, various voltagesavailable | AC Line,various voltagesavailable | AC Line | Same |
| X-rayGenerator | CPI CMP 200DR (32 kW, 40kW, 50 kW, 65 kW, 80 kW)(125 kV/150 kV for 32 kW, 40kW)(150kV for 50 kW, 65 kW, 80kW) | CPI CMP200DR | CPI CMP200DR HF,150kV(40kW,50kW, 65kW, 80 kW) | Same orsimilarfunctionality(Note 3) |
| ComparableProperties | Subject Device | PredicateDevice 1(K150816) | PredicateDevice 2(K153119) | ComparisonResults |
| X-ray Tubes | TOSHIBAE7239FX: 125kV, LF2.0,SF1.0, 140kHUE7242FX:125kV, LF1.5, SF0.6, 200kHUE7252X: 150kV, LF1.2,SF0.6, 300kHUE7254X: 150kV, LF1.2,SF0.6, 400kHUE7869X: 150kV, LF1.2,SF0.6, 600kHUE7884X: 150kV, LF1.2,SF0.6, 300kHUE7843X: 150kV, LF1.2,SF0.6,150kHUVAREXRAD14: 150kV, LF1.2, SF0.6,300kHURAD60: 150kV, LF1.2, SF0.6,400kHURAD92: 150kV, LF1.2, SF0.6,600kHU | -- | CPI CMP200DR HF,125kV(40kW)150 kVp0.6/1.2 mmfocal spots | Similarfunctionality(Note 4) |
| Collimator | Ralco R221, R225ACSDeasung M38 | Ralco R225 | Collimare | Similarfunctionality(Note 5) |
| PerformanceStandard | FDA 21 CFR 1020.30-31 | FDA 21 CFR1020.30-31 | FDA 21 CFR1020.30-31 | Same |
| ElectricalSafety | Electrical Safety as per IEC60601. | Electrical Safetyas per IEC60601 | ElectricalSafety as perIEC 60601 | Same |
Substantial equivalence:
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| Note | Description |
|---|---|
| Note 1 | The subject device utilizes a different X-Ray flat panel detector; however,the flat panel detectors used by the subject device are already previouslycleared by the FDA and the testing demonstrate that it does not raise thelevel of safety concern and affect any effectiveness. The relevant 510(k)approval numbers are K103591, K171270, K131106, K170332, K172951,K161459, K142698, K140551, K162555 and K162552. |
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| Note 2 | Prognosys utilizes image processing software that has been previouslycleared by the FDA. The respective 510(k) approval numbers are K153312,K171270, K130883 and K152172. Prognosys does not modify anysoftware utilized for image processing or display. |
|---|---|
| Note 3 | In addition to the various power ratings of x-ray generators used bypredicate device, the subject device also utilizes a similar X-ray generatorwith different power ratings which does not raise any level of safety concernand affect any effectiveness; the generator frequency does affect the X-rayexposure parameters. In addition, the X-ray generators used by the subjectdevice have also been used in previously cleared 510(k) devices withapproval numbers K150816 and K153119. |
| Note 4 | Both configurations (Toshiba and Varex) provide similar imaging resolutionon both focal spots. In addition, the X-ray tubes have been used inpreviously cleared 510(k) devices with approval numbers K152767,K173823, K103050 and K1881874. |
| Note 5 | The inherent filtration for the collimator in the subject device is different fromthe predicate device; this difference does not affect the safety andeffectiveness. |
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. This device utilizes previously cleared X-ray flat panel detectors and image processing software which are the main components of any X-Ray diagnostic system. The other components of the imaging system such as the X-Ray generator and X-Ray Tube are used in previously cleared 510(k) devices and are either identical or similar to the predicate devices. The remaining other components such as the Collimator, Mechanical Tube Stand, Mechanical Bucky Stand and Patient Table have no impact on the safety and effectiveness of the system. In addition, the subject device has been tested to the relevant performance standards as summarized below.
Summary of non-clinical testing:
The ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems comply with the following standards:
- . IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General ● requirements for basic safety Collateral standard: Electromagnetic compatibility requirements and tests
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- IEC 60601-1-3: General requirements for basic safety and essential ● performance - Collateral Standard: Radiation protection in diagnostic Xray equipment
- IEC 60601-2-54: Particular requirements for the basic safety and essential ● performance of X-ray equipment for radiography and radioscopy
- IEC 60601-1-6: Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
- ISO 14971: Medical devices. Application of risk management to medical ● devices
Furthermore, cybersecurity concerns were addressed based on the US FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" in the device labeling of these products.
Summary of clinical testing:
Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document. The following information was not necessary to demonstrate substantial equivalence but provides additional support that the device works as intended. Clinical images acquired by the device were reviewed by a radiologist. The images were found to be acceptable and allowed the radiologist to make an accurate diagnosis.
Conclusion:
Technological differences from the predicate devices include different detectors, some with wireless functionality, different collimators and x-ray tubes. Although some of the components differ from the predicate devices, the detectors and other components have been cleared as part of other 510(k) submissions. Despite the few differences, after analysis of all test information, including the indications for use and test data, it can be concluded that the devices "ProRad 2FC and ProRad 3NC Stationary Radiographic Systems" are as safe and effective as the predicate devices, thus rendering them substantially equivalent to the predicate devices,
§ 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.