(54 days)
The Zenition 50 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Applications:
Orthopedic
Neuro
Abdominal
Vascular
Thoracic
Cardiac
The proposed Zenition 50 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station(MVS)
The provided text describes the Philips Medical Systems Nederland BV Zenition 50, an image-intensified fluoroscopic X-ray system. The document is a 510(k) summary indicating substantial equivalence to a predicate device, the BV Pulsera.
Based on the provided document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence by showing compliance with various recognized standards and guidance documents. This largely forms the acceptance criteria for safety and performance.
| Acceptance Criteria (from International and FDA Recognized Standards & Guidance) | Reported Device Performance (Zenition 50) |
|---|---|
| Safety and Essential Performance Specific Standards: | |
| IEC 60601-2-43 (X-Ray equipment for interventional procedures) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-2-54 (X-Ray Equipment for Radiography and Radioscopy) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-2-28 (X-ray tube assemblies for medical diagnosis) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1 (General requirements for basic safety and essential performance) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-3 (Radiation Protection in Diagnostic X-Ray Equipment) | Complies (stated in "Non-clinical verification and validation test results") |
| Software and Usability Specific Standards/Guidance: | |
| IEC 62304 (Medical device software Software life cycle processes) | Complies (stated in "Non-clinical verification and validation test results") |
| ISO 14971 (Application of risk management to medical devices) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 60601-1-6 (Usability) | Complies (stated in "Non-clinical verification and validation test results") |
| IEC 62366 (Application of Usability Engineering to Medical Devices) | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Content of Premarket Submissions for Software | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Applying Human Factors and Usability Engineering | Complies (stated in "Non-clinical verification and validation test results") |
| Guidance for Management of Cybersecurity in Medical Devices | Complies (stated in "Non-clinical verification and validation test results") (Note: "Introduction of the security features" is described as not impacting clinical functionality and demonstrating substantial equivalence.) |
| Other: | |
| FDA Performance Standard for Diagnostic X-Ray Systems (21 CFR 1020.30 & 1020.32) | Complies ("Image processing performance is compared by means of an image quality performance comparison with the predicate device and found equal or improved, see Appendix A38. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.") |
| Pediatric information for x-ray imaging device premarket notifications | Complies (stated as a guidance document the device complies with) |
| Radio frequency wireless technology in medical devices guidance | Complies (for wireless footswitch, stated that "The change does not introduce new risks, but only minor update to existing risks compared to the predicate device. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.") |
| Effectiveness of Safety Measures & Intended Use | Non-clinical validation testing performed to cover intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users. Results demonstrate the device "Meets the acceptance criteria and is adequate for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical performance testing (verification and validation) against recognized standards. There is no mention of a clinical study or a specific "test set" of patient data for the Zenition 50 itself. The performance comparison is done against a predicate device, and improvements are assessed through non-clinical means.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical study or specific "test set" with a ground truth established by experts is described for the Zenition 50, this information is not provided. The evaluation relies on compliance with technical standards and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or adjudication process for image interpretation (which would be typical for AI/algorithm performance) is described.
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 is mentioned. The device is a fluoroscopic X-ray system, and the submission focuses on its safety and performance equivalence to a predicate device through non-clinical testing, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe the Zenition 50 as an AI/algorithm-only device or an algorithm with standalone performance. It is a medical imaging system. Its image processing performance was compared to the predicate device and found "equal or improved" through non-clinical means (Appendix A38, not provided here).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Zenition 50, the "ground truth" for demonstrating safety and effectiveness relies on compliance with established international and FDA-recognized consensus standards and guidance documents, and by demonstrating substantial equivalence to a legally marketed predicate device (BV Pulsera). This primarily involves technical specifications, risk management, and performance testing against defined engineering and regulatory requirements, rather than clinical ground truth like pathology or outcomes data for a novel diagnostic claim.
8. The sample size for the training set
Not applicable. The document does not describe the Zenition 50 as being developed using a training set of data in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning/AI.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 31, 2018
Philips Medical Systems Nederland BV Sumit Kumar Regulatory Approbation Officer Veenpluis 4-6 BEST, NL 5684PC
Re: K183101
Trade/Device Name: Zenition 50 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: November 1, 2018 Received: November 7, 2018
Dear Sumit Kumar:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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,
Hole 2. Nils
for Robert A. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K183101 |
| Device Name | Zenition 50 |
| Indications for Use (Describe) | The Zenition 50 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. |
| Applications: | OrthopedicNeuroAbdominalVascularThoracicCardiac |
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. |
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
PSC
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510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Date Prepared: November 1, 2018
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277 | |
|---|---|---|
| PrimaryContactPerson: | Sumit KumarRegulatory Approbation OfficerPhone: +91 7028039288E-mail: sumit.kumar_3@philips.com | |
| SecondaryContactPerson: | Sonavane, Neena SandeepRegulatory Affairs ManagerPhone: +91 8446020023E-mail: neena.sonavane@philips.com | |
| Device: | Trade Name: | Zenition 50 |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | OWB | |
| Secondary Product Code: | JAA, OXO | |
| PrimaryPredicateDevice: | Trade Name: | BV Pulsera |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K010435 | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB; JAA; OXO | |
| Referencedevice: | Trade Name: | Veradius Unity |
| Manufacturer | Philips Medical Systems Nederland B.V | |
| 510(k) Clearance: | K142708 | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | 90-Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB; JAA; OXO | |
| Device description: | The proposed Zenition 50 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station(MVS) | |
| Indications for Use: | The proposed Zenition 50 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.Applications:Orthopedic Neuro Abdominal Vascular Thoracic Cardiac | |
| Fundamental Scientific Technology: | The proposed Zenition 50 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate BV Pulsera. The technology used in the development of the major components of the proposed Zenition 50, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is identical to the currently marketed and predicate BV Pulsera. See the below table for the comparison of the major components of the proposed Zenition 50 and the currently marketed and predicate BV Pulsera. | |
| The outcome of this comparison demonstrates that the minor differences in the technological |
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characteristics do not affect the safety or effectiveness of the Zenition 50 when compared to the currently marketed and predicate BV Pulsera.
| Technological characteristics comparison of the currently marketed predicate device, BVPulsera versus the proposed Zenition 50 | |||
|---|---|---|---|
| Component/feature | Currentlymarket BVPulsera | Proposed Zenition 50 | Conclusion |
| X-rayGenerator | iXion HFGeneratorModel: 10359400 | iXion HF GeneratorModel: 10359400 | Identical. |
| X-ray tube | Model: RTM 780H (Type RO-0306) | Model : RTM 780 H(Type RO-0306) | Identical. |
| X-ray housing assembly | iXion Monoblock IV with X-ray tube RO-0306 | iXion Monoblock V with X-ray tube RO-0306 | |
| Similar with minor change inmonoblock design for providingmore clearance to the floor.The monoblock design has beenupdated to reduce the height with3.5cm, and thus improves clearancebetween the tank and the floor whichresulting in more space to move. Inaddition, the filtration has beenreduced to lower the amount ofpower necessary for the same dose.The updated monoblock is evaluatedin risk management. The changedoes not introduce new risks. Thischange was shown to be compliantwith the international and FDArecognized standards IEC60601-1,IEC60601-2-43 and IEC60601-2-54for basic safety and essentialperformance. Hence, this changedoes not impact the safety andeffectiveness of the Device. Thus,demonstrating substantialequivalence. | |||
| Image Intensifier 9" | 23HRC | 23HRC | Identical. |
| Image Intensifier 12" | 31GG | 31GG | Identical |
| II Laser alignment tool | Z-LAD 9 InchZ-LAD 12 Inch | Z-LAD 9 InchZ-LAD 12 Inch | Identical |
| Beam Limiting Device | CoRa9890 010 23201 | Collimator IITV459801200241 | A new collimator has been designedsuch that it reuses the design ofexisting reference device VeradiusUnity (K142708) FD15 (PX2630Sv)collimator with the only exceptionthe square fixed diaphragm isremoved to match the format forIITV9" and IITV12". There is nochange in the functionalspecification compared to predicatedevice. All other parts of thecollimator are identical.This change was shown to becompliant with the international andFDA recognized |
| LaserAlignmenttool | Tube LaserAiming Device | Tube Laser AimingDevice | essential performance. Hence, thisdoes not impact safety oreffectiveness of the device Thus,demonstrating substantiallyequivalent. |
| Changed to fit in new collimator.Functional specification are similarcompared to predicate device. Thistube laser unit is reused from thereference device Veradius Unity(K142708).Hence, this change do not impactthe safety or effectiveness of theDevice. Thus, demonstratingsubstantial equivalence | |||
| Mobile C-armStand | BV Pulsera Stand | Pulsera R3.1 Stand | The mechanical interfaces havebeen updated for the updatedmonoblock and the standtouchscreen. These changes areassessed in risk management, andthey did not introduce new risks.The changes was also shown to becompliant with the FDA recognizedstandard IEC60601-1 for basicsafety and essential performance.Therefore, the change does notimpact safety and effectiveness.Thus, demonstrating substantialequivalence. |
| MobileViewingStation | MVS BV FamilyR2 | MVS BV Family R3 | The MVS has been changed tomatch the updated interfaces fromthe System architecture and roominterface changes. These changesare assessed in risk management,and they did not introduce new risks.The changes was also shown to becompliant with the FDA recognizedstandard IEC60601-1 for basicsafety and essential performance.Therefore, the change does notimpact safety and effectiveness.Thus, demonstrating substantialequivalence |
| Systemarchitecture | Current Systemarchitecture | Improved systemarchitecture with PCplatform• Solved obsolescence | These changes were assessed in riskmanagement, and they did notintroduce new risks. This changewas shown to be compliant with theinternational and FDA recognized |
| hardware and software by moving to state of the art computing hardware and corresponding interconnects. Migrated system software to the new computing hardware Migrated image processing from hardware to software implementation Integrated internal distributed components related to power functions into the mains control unit to simplify the design Integrated wireless network connection design to simplify configuration and setting to work by service engineers | standards IEC60601-1, IEC60601-2-43 and IEC60601-2-54 for basic safety and essential performance, IEC60601-1-2 for Electromagnetic compatibility, IEC62366 for application of usability engineering and the FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21 CFR 1020.30 / 1020.32). Image processing performance is compared by means of an image quality performance comparison with the predicate device and found equal or improved, see Appendix A38 .This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence. | ||
| ClearGuide and color coding | Not Present | Introduction of ClearGuide and color coding | These visual aids are ease-of-use improvements and improve communication in the OR between surgeon and operator. These features are reused from the reference device Veradius Unity (K142708).The changes do not introduce new risks or change any of the existing risks compared to the predicate device.This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence. |
| C-arm Stand user interface | C-arm Stand user interface based on hard keys and a small monochrome display | C-arm Stand touch screen user interface | The hard-key based interface on the predicate device has been replaced with a touch-screen based stand user interface This feature is reused from the reference device Veradius Unity (K142708). This change was shown to be compliant with the international and FDA recognized standards IEC60601-1, IEC60601- |
| 2-43 and IEC60601-2-54 for basicsafety and essential performance,IEC60601-1-2 for Electromagneticcompatibility,IEC62366forapplication of usability engineering.This change does not affect safety oreffectiveness of the device. Thus,demonstratingsubstantial | |||
| ManualOutline | Not Present | Manual outlining | equivalenceWith this so-called Manual Outlinefunction, it is possible to draw linesand dots on an overlay of the clinicalimage with help of the finger, styluspen or mouse. It is not related todiagnostics. This feature is reusedfrom the reference device VeradiusUnity (K142708).The changes do not introduce newrisks or change any of the existingrisks compared to the predicatedevice. |
| This change does not affect safety oreffectiveness of the device. Thus,substantialdemonstratingequivalence. | |||
| Wirelessfootswitch | Not Present | Wireless footswitch | Next to the wired footswitch andoptional wireless footswitch can beused with the system. This wirelessfootswitch is reused from referencedevice Veradius Unity (K142708).The change does not introduce newrisks, but only minor update toexisting risks compared to thepredicate device.This change does not affect safety oreffectiveness of the device. Thus,demonstratingsubstantialequivalence. |
| DICOMconnectivity | Current DICOMconnectivity | Improved DICOMconnectivity workflow· Easier selection ofpatient data forexport• Introducedunattended networktransfer of exportjobs• Integrated workflowfor export to local | The improvements are ease-of-useimprovements, fully compliant withthe DICOM standard and do notimpact clinical functionality. Thechanges are shown to be compliantwith the international and FDArecognized standard IEC62366 forapplication of usability engineering.Therefore, this change does notimpact safety or effectiveness of the |
| media (USB andDICOM DVD)• Improved workflowfor multimodalityviewer functionality• Improved DICOMtransfer speed | demonstratingdevice.Thus,substantially equivalent | ||
| X-ray tubeheatmanagement | Current X-raytube heatmanagement | • Improvedpresentation to theuser of tube and oilheating information· Reduced · ·energywaste in non-x-ray(pump, stator) | Theseimprovementsallowminimizingwastedenergy by updating the controlfunctions for the oil pump and statorcontrol and improve feedback to theuser on tube and oil heat status. Thechanges have been evaluated in riskmanagement, and they do not lead tonew risks. The changes are shown tobe compliant with the internationaland FDA recognized standardIEC62366 for application ofusability engineering. This changeimpactclinicaldoesnotfunctionality.Therefore, this change does not |
| impact safety or effectiveness of thedevice.Thus, demonstratingsubstantial equivalence. | |||
| User InterfaceMobileviewingstation | Current UserInterface Mobileviewing station | New identity look forMVS-UI. TheGraphical UserInterface look and feelof the mobile viewingstation is changed tothe Philips NewExperience Identitylook and feel. | These features are to improve thelook and feel of the device and doesnot impact clinical functionality.The changes have been evaluated inrisk management, and they do notlead to new risks. The changes areshown to be compliant with theinternational and FDA recognizedstandard IEC62366 for applicationof usability engineering.Therefore, this change does not |
| impact safety or effectiveness of theThus. demonstratingdevice.substantially equivalent. | |||
| WiredFootswitchand remotecontrol unit | Current WiredFootswitch andremote controlunit | The current wiredremotefootswitch, footswitch,unitcontrolarereplaced with a newwired footswitch andremote controlnew | The current wired footswitch andremote control unit are replacedwith a new wired footswitch andnew remote control with identicalfunctionality. This change does notimpact clinical functionality. Thesefeatures are to improve the look and |
| with identicalfunctionality | feel of the device and does notimpact clinical functionality. Thechanges have been evaluated in riskmanagement, and they do not lead tonew risks. The changes are shown tobe compliant with the internationaland FDA recognized standard IEC62366 for application of usabilityengineering. Therefore, this changedoes not impact safety oreffectiveness of the device. Thus,demonstratingsubstantialequivalence. | ||
| RAD(radiography) | RAD support(Optional) | RAD not supported | The removal of RAD (radiography)is evaluated in risk management Thechange does not introduce new risksTherefore; this change does notimpact safety or effectiveness of thedevice. Thus, demonstratingsubstantial equivalence. |
| Live DVDRecording | Live DVDrecording support(Optional) | Live DVD recordingoption not supported | The removal of Live DVD recordingis evaluated in risk management Thechange does not introduce new risksTherefore; this change does notimpact safety or effectiveness of thedevice. Thus, demonstratingsubstantial equivalence. |
| Securityfeatures | Current Securityfeatures | Introduction of thesecurity features• Local user accountmanagemento Function improvedto enable ausername/password combination.• Network timesynchronizationo Differentimplementation only• Audit trail• White listing• DIACAP hardening• Disk encryption• FIPS 140-2 | These features are to improvesecurity of the device and do notimpact clinical functionality.Therefore, this change does notimpact safety or effectiveness of thedevice.Thus, demonstrating substantialequivalence. |
| Introduction ofmetalexclusion | Not present | Metal exclusion added | The feature is to minimize theimpact of added metal in the X-rayimage by excluding metal (black |
| exclusion) from the automaticexposure control. It has the samedesign as the currently availableBodySmart (white exclusion)function of the predicate device.This change was shown to be | |||
| compliant with the international andFDA recognized standardsIEC60601-2-43 and IEC60601-2-54for basic safety and essentialperformance. Thus, demonstratingsubstantial equivalence | |||
| System servicefunctions | Current Systemservice functions | • BV-scope fieldservice infrastructureis replaced by PhilipsSupport Connect fieldservice infrastructure.• Introduction of PSCimplies also that theService UI is locatedon the target machineitself, and thusenabling access tofield servicefunctionality via theMVS-UI.• Using CAT tool toview logging.• All field serviceprocedures aremigrated to the PSCbased field serviceinfrastructure | The change is only impacting theservice interface and has no clinicalimpact. Therefore this change doesnot impact safety or effectiveness ofthe deviceThus, demonstrating substantialequivalence |
| RoomInterface | Not Present | External x-ray andpower indicationinterface | This feature is to optionally allowconnecting an external x-ray andpower lamp to the system and doesnot impact clinical functionality.Therefore, this change does notimpact safety or effectiveness of thedevice.Thus, demonstratingsubstantialequivalence. |
| Audiblesignals | Audible signalswith fixed volume | Speaker with volumecontrol added in theStand | This feature is to allow control of thevolume produced by the system foraudible signals. This change doesnot impact clinical functionality.Therefore, this change does not |
| Analogue video out | original | Analogue video out no longer supported | The analog video-out was used to connect external monitors. This is an outdated video interface and has been removed. This change does not impact clinical functionality. Therefore, this change does not impact safety or effectiveness of the device. Thus, demonstrating substantial equivalence. |
| impact safety or effectiveness of the device.Thus, demonstrating substantial equivalence. |
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Non-clinical performance testing has been performed on the proposed Zenition 50 and demonstrates Summary of Non-Clinical compliance with the following International and FDA-recognized consensus standards and FDA Performance guidance documents. Data:
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1, 2015). FDA/CDRH ● recognition number 13-79.
- ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, . corrected version, 2007). FDA/CDRH recognition number 5-40.
- IEC 60601-2-43 Particular requirements for the safety of X-Ray equipment for interventional . procedures (Edition 2.1, 2017). FDA/CDRH recognition number 12-308.
- IEC 60601-2-54, Medical Electrical Equipment- Part 2-54: Particular Requirements for the Basic . Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
- IEC 60601-2-28-Medical electrical equipment Part 2-28: Particular requirements for the basic ● safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 2.0 2010) FDA/CDRH recognition number 12-204.
- IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.1). FDA/CDRH recognition number 19-4.
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
- IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and ● Essential Performance .- Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and ● Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
- IEC 62366 IEC Application of Usability Engineering to Medical Devices (Edition 1.0 2015). FDA/CDRH recognition number 5-114
- Guidance for Industry and FDA Staff -Pediatric information for x-ray imaging device premarket notifications (document number 1771)
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for . Software Contained in Medical Devices, May 11, 2005 (document number 337).
- Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices(document number (1757)
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and FDA Staff (document number 1825).
- Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff (document number 1618).
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users
Non-clinical verification and validation test results demonstrate that the Zenition 50 :
- Complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use.
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| Summary ofClinicalPerformanceData: | The Zenition 50 did not require clinical study since substantial equivalence to the primary currentlymarketed and predicate device BV Pulsera was demonstrated with the following attributes: |
|---|---|
| Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness. | |
| SubstantialEquivalenceConclusion: | The Zenition 50 is substantial equivalent to the currently marketed predicate device BV Pulsera K010435 in terms of indications for use, fundamental scientific technology and safety and effectiveness.Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that Zenition 50 complies with the requirements specified in the international and FDA-recognized consensus standards and guidance, and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. |
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.