(117 days)
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. 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 90 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).
This document is a 510(k) summary for the Philips Zenition 90, which is an Image-Intensified Fluoroscopic X-Ray System. The summary asserts substantial equivalence to a predicate device (Zenition 70, K212813) rather than proving performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested details, such as those related to acceptance criteria for device performance, sample sizes for test and training sets for an AI algorithm, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) summary. The document does not describe a study proving the device meets acceptance criteria in the way one would for a software or AI/ML device. Instead, it demonstrates compliance with recognized standards and substantial equivalence to a predicate device.
However, I can extract the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the typical sense for a new AI/software function. Instead, it compares the proposed device (Zenition 90) features and specifications to those of the predicate device (Zenition 70) to establish substantial equivalence. The "acceptance criteria" here appear to be adherence to the predicate device's performance characteristics or recognized industry standards.
| Feature/Component | Acceptance (Predicate Zenition 70) | Reported Performance (Proposed Zenition 90) | Conclusion (Relative to Acceptance) |
|---|---|---|---|
| Indications for Use | Radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates. Used in health care facilities inside and outside the operating room, sterile and non-sterile. Applications: Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac. | Radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients (including neonates). Used in health care facilities inside and outside the operating room, sterile and non-sterile. Applications: Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac. | Substantially Equivalent. The inclusion of neonates is justified by compliance with FDA guidance "Pediatric information for x-ray imaging device premarket notifications." The device is deemed safe and effective despite this expanded indication. |
| C-arm motions and brakes | Manual | Motorized (3 axis: angulation, rotation, longitudinal) with electromagnetic brakes. | Similar and Substantially Equivalent. (Added advantage, simplifies workflow, no impact on safety/effectiveness). |
| X-ray Generator | Peak output power: 15 kW | Peak output power: 15kW/25kW options. kV range similar. | Similar and Substantially Equivalent. Different make of generators but similar technology, energy source, and output. No impact on safety and effectiveness. |
| X-ray tube | Model: RTM 780 H (Type RO-0306), Focal spot: dual (0.3 & 0.6), Target angle: 10°, Anode heat content: 225kJ, Max anode cooling rate: 550W, Nominal anode input power: 15kW. | Same model, focal spot, target angle, anode heat content, max anode cooling rate. Nominal anode input power: 15kW/25kW (for 25kW version). | Same and Substantially Equivalent. From the same supplier. |
| Monoblock: Oil circulation | Active oil circulation with AC Pump | Active oil circulation with DC Pump | Same and Substantially Equivalent. Similar heat performance, no significant difference in safety and clinical performance. DC pump helps with better oil circulation and lower power consumption. |
| Monoblock heat content | 1350kJ | 1350kJ | Same and Substantially Equivalent. |
| Safety mechanisms | Thermal Switch | Thermal Switch | Same and Substantially Equivalent. |
| Fluoro time | 296W for 60mins | 296W for 60mins | Same and Substantially Equivalent. |
| Flat Panel Detector | Frame rate: 30fps, Zoom modes: Overview + 2 zoom, Detector size: 207x207mm/301x301mm (square), Pixel pitch: 154µm, Image matrix: 1344x1344/1000x1000, DQE: 77% | Same frame rate, zoom modes, detector sizes, pixel pitch, image matrix, and DQE. | Same and Substantially Equivalent. Uses the same FPD cleared in the predicate device. |
| Imaging Processing | Xres-3 | Xres-3 | Same and Substantially Equivalent. |
| Anti Scatter Grid | Removable grid (square), Transmission: 70% | Removable grid (square), Transmission: 70% | Same and Substantially Equivalent. |
| Radiation safety features | Collimation, Anti-scatter grid, Fluoroscopy modes, Pulsed fluoroscopy, Recording and storing fluoro runs, Last image hold, Real-time dose monitoring. | Same radiation safety features. | Same and Substantially Equivalent. |
| Beam Limiting Device | Square (but round in zooming/rotation) | Square (but round in zooming/rotation) | Same and Substantially Equivalent. |
| Geometry | Hammerhead design, Size: 206x82x162 cm, Weight: 332 Kg, Stand-U/I: 15.3" touch screen. | New design stand. Size: 206x82x162 cm, Weight: 400 kg (Motorized) / 375 Kg (Non-motorized), Stand-U/I: 15.3" touch screen. | Similar and Substantially Equivalent. New stand design offers benefits like lower C-arm operating forces and provision for additional UI monitor, improving maneuverability and ease of use. Increased weight due to motorization is accepted as it simplifies workflow and improves user experience without impacting clinical workflow. |
| System architecture | PC Based Win 10 | PC Based Win 10 | Same and Substantially Equivalent. |
| Ionizing radiation | System uses X-ray for imaging | System uses X-ray for imaging | Same and Substantially Equivalent. Same X-ray technology. |
| Laser Alignment tool | Tube Laser Aiming Device (Model: 4598 008 4322x) | Tube Laser Aiming Device (Model: 4598 008 4322x) | Same and Substantially Equivalent. |
| DICOM connectivity | DICOM connectivity workflow | DICOM connectivity workflow | Same and Substantially Equivalent. |
| Security features | Various listed features including patient data export, network transfer, local user account management, audit trail, white listing, disk encryption, FIPS 140-2. | Same listed security features, potentially with different implementation for network time sync. | Same and Substantially Equivalent. |
| Room Interface | External x-ray Lamp and power indication interface | External x-ray Lamp and power indication interface | Same and Substantially Equivalent. |
| Audible signals | Speaker with volume control added in the Stand. | Speaker with volume control added in the Stand. | Same and Substantially Equivalent. |
| Wired Footswitch and remote control unit | Same | Same | Same and Substantially Equivalent. |
| Automatic Vascular Outlining (AVO) | Manual Outlining | Manual and automatic outlining | Similar and Substantially Equivalent. Automatic outlining is an added ease-of-use feature, with manual adjustment still available. No significant difference in safety and effectiveness. |
| Injector interface | Manual Injection with user-added X-ray delay from an injector device possible. | Integrated injector interface where user can add needed X-ray delay based on Injection volume. Manual Injection is also possible. | Similar and Substantially Equivalent. Added provision for external integrated injector interface. No change in clinical workflow or significant difference in safety and effectiveness. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses non-clinical performance testing and non-clinical validation testing for the device's intended use, claims, safety measures, instructions, and usability. It does not specify sample sizes of imaging data for a test set, nor the provenance of such data (e.g., country of origin, retrospective/prospective). This is because it is not a submission for a new AI/ML algorithm that requires clinical image data validation for its performance metrics. Instead, it relies on demonstrating compliance with recognized standards for the x-ray system as a whole.
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 this is not an AI/ML algorithm submission requiring ground truth for image interpretation, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of image interpretation that would require an adjudication method.
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
Not applicable. This is not an AI-assisted interpretation device that would involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm, but a complete x-ray system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth for image interpretation is described or required for this type of submission.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows 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.
May 22, 2024
Philips Medical Systems Nederlands B.V. % Rahul Kumar Sinha Regulatory Approbation Officer Veenpluis 6 Best. NB 5684 PC NETHERLANDS
Re: K240224
Trade/Device Name: Zenition 90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: January 25, 2024 Received: April 22, 2024
Dear Rahul Kumar Sinha:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
K240224
Device Name
Zenition 90
Indications for Use (Describe)
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. 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
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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PHILIPS - IGT Systems 510(k) Number: K240224
510 (k) Summary
The 510(k) Summary is given in the below pages.
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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 | January 25, 2024 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| PrimaryContactPerson: | Rahul Kumar SinhaRegulatory Approbation OfficerPhone: +91 9940259360E-mail: rahulkumar.sinha@philips.com | |
| SecondaryContactPerson: | Neena SonavaneRegulatory Affairs LeaderPhone: +91-8446020023E-mail: neena.sonavane@philips.com | |
| Device: | Trade Name: | Zenition 90 |
| 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: | Zenition 70 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K212813 | |
| 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 |
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Device The proposed Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for description: 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 proposed Zenition 90 is used for radiological guidance and visualization during diagnostic, Indications for interventional and surgical procedures on all patients. The device is to be used in health care facilities Use: 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 90 demonstrates substantial equivalence with predicate Zenition 70 in terms of intended use. and do not raise questions of safety and effectiveness.
| Table 1. Indications for use comparison of the proposed Zenition 90 versus the currentlymarketed and predicate device, Zenition 70 | ||
|---|---|---|
| Predicate Device Zenition 70 | Proposed Zenition 90 | Conclusion |
| Indications for Use | ||
| The Zenition 70 device isintended to be used andoperated by: adequatelytrained, qualified andauthorized health careprofessionals who have fullunderstanding of the safetyinformation and emergencyprocedures as well as thecapabilities and functions of thedevice.The device is used forradiological guidance andvisualization during diagnostic,interventional and surgicalprocedures on all patients,except neonates (birth to onemonth), within the limits of thedevice. The device is to be usedin health care facilities bothinside and outside the operatingroom, sterile as well as non-sterile environment in a varietyof procedures.Applications:● Orthopedic● Neuro● Abdominal | The device is used forradiological guidance andvisualization during diagnostic,interventional and surgicalprocedures on all patients. Thedevice is to be used in health carefacilities both inside and outsidethe operating room, sterile as wellas non-sterile environment in avariety of procedures.Applications:● Orthopedic● Neuro● Abdominal● Vascular● Thoracic● Cardiac | Substantially EquivalentSE analysis:SameThe proposed Zenition 90 isused for all patients includingneonates (birth to one month).The safety and effectiveness isin line with FDA guidance"Pediatric information for x-ray imaging device premarketnotifications"Therefore, proposed Zenition90 demonstrates substantialequivalence with predicateZenition 70 in terms ofintended use and is safe andeffective. |
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| • Vascular | ||
|---|---|---|
| • Thoracic | ||
| • Cardiac |
Fundamental Scientific Technology:
The proposed Zenition 90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Zenition 70. The technology used in the development of the major components of the proposed Zenition 90, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is similar to the currently marketed and predicate Zenition 70.
Table 2 shows that the proposed Zenition 90 is considered substantially equivalent to the currently marketed predicate, Zenition 70 in terms of major components and technological characteristics.
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| Component/feature | Currently marketZenition 70 | Proposed Zenition90 | Conclusion |
|---|---|---|---|
| C-armmotions andbrakes | Manual | Motorized | The c-arm movements are motorized inZenition 90 as against manual in Zenition 70.The Zenition 70 system provide manual brakelevers to release and lock the brakes whileZenition 90 system uses electromagneticbrakes to release or lock the c-arm axis tosimplify the workflow.Motorized movement and the electromagneticbrakes are an added advantage in Zenition 90compared to the equivalent devices Zenition70.Zenition 90 introduces motorized movement in3 axis (angulation, rotation, and longitudinal)that are manual in Zenition 70.Conclusion:Similar and substantially equivalent |
| X-rayGenerator | -Peak output power:15 kW | -Peak output power:15kW/25kW | The kV range of proposed Zenition 90 is thesame as compared to the predicate Zenition 70.The maximum mA of the Zenition 90 (15kW)is the same compared to the Zenition 70.While in Zenition 90 we also have a 25kWversion, where higher mA is possible.Make of Generators are different in both thedevices however, the technology, energysource and output are similar.This change does not impact the safety andeffectiveness of the device. Thus,demonstrating substantial equivalence.Conclusion:Similar and substantially equivalent |
| X-ray tube | -Rotating Anode(Model: RTM 780H (Type RO-0306) | - Rotating Anode(Model: RTM 780 H(Type RO-0306) | The design and characteristics of X-ray tube ofsubject device Zenition 90 and the predicatedevice Zenition 70 are the same and from samesupplier.Conclusion:Same and substantially equivalent |
| -Focal spot: dual(0.3 & 0.6)-Target angle: 10° | Focal spot: dual (0.3& 0.6)Target angle: 10° | ||
| -Anode heatcontent: 225kJ | Anode heat content:225kJ | ||
| -Maximum anodecooling rate: 550W | Maximum anodecooling rate: 550W | ||
| -Nominal anodeinput power: 15kW | -Nominal anode inputpower: 15kW | ||
| -Nominal anode inputpower: 25kW | |||
| Monoblock | The Monoblock is the combination of x-raytube, transformer, cooling oil and oil pump. | ||
| Oilcirculation | Active oilcirculation with ACPump | Active oil circulationwith DC Pump | The proposed device Zenition 90 has similarheat performance compared to the predicate |
| Monoblockheat content | Monoblock heatcontent: 1350kJ | Monoblock heatcontent: 1350kJ | device Zenition 70. There are no technologicalsignificant difference in the safety and clinicalperformance of the devices. |
| Safetymechanisms | Safety mechanisms:Thermal Switch | Safety mechanisms:Thermal Switch | Proposed device Zenition 90 uses DC oil pumpwhile the predicate Zenition 70 uses AC oil |
| Inherentfiltration | filtration | filtration | pump. DC Pump in Zenition 90 helps for betterOil circulation with lower power consumptionwhich results in lower energy losses. |
| Fluoro time | fluoro time: 296Wfor 60mins | fluoro time: 296Wfor 60mins | Both the devices Zenition 70 and Zenition 90use the same safety mechanism of thermalswitch to address undesirable overheatingscenarios. |
| Conclusion:Same and substantially equivalent | |||
| Flat PanelDetector /ImageIntensifier | The subject device Zenition 90 uses the sameflat panel detector which has been previouslycleared in predicate device Zenition 70(K212813) and sourced from the samesupplier. | ||
| - Frame rate | Frame rate: 30fps | Frame rate: 30fps | |
| - Zoommodes | Zoom modes:Overview mode + 2zoom modes | Zoom modes:Overview mode + 2zoom modes | |
| - Detectorsize ( x/y) | -Detector size (x/y):207mm x 207mm(square) | Detector size (x/y):207mm x 207mm(square) | |
| - Detector size (x/y):301mm x 301mm(square) | Detector size (x/y):301mm x 301mm(square) | ||
| - Pixel pitch- Imagematrix | pixel pitch: 154 $\mu$ mImage matrix:1344x1344DQE: 77% | pixel pitch: 154 $\mu$ mImage matrix:1344x1344DQE: 77% | |
| - "Detectorquantumefficiency(DQE) | Pixel pitch: 154 $\mu$ m | Pixel pitch: 154 $\mu$ m | |
| Image matrix:1000x1000DQE: 77% | Image matrix:1000x1000DQE: 77% | Conclusion:Same and substantially equivalent | |
| ImagingProcessing | Xres-3 | Xres-3 | The predicate device Zenition 70 and theproposed device Zenition 90 both use the same |
| Conclusion: | |||
| Same and substantially equivalent | |||
| Anti ScatterGrid | Removable grid(square) | Removable grid(square) | The proposed Zenition 90 has same as ofpredicate Zenition 70 |
| Transmission: 70% | Transmission: 70% | Conclusion:Same and substantially equivalent | |
| Radiationsafetyfeatures | Collimation | Collimation | Both the proposed device Zenition 90 and thepredicate device Zenition 70 share the sameradiation safety features. |
| Anti-scatter grid | Anti-scatter grid | ||
| Fluoroscopy modes | Fluoroscopy modes | ||
| Pulsed fluoroscopy | Pulsed fluoroscopy | ||
| Recording andstoring fluoroscopicruns | Recording andstoring fluoroscopicruns | ||
| Last image hold | Last image hold | Conclusion:Same and substantially equivalent | |
| Real-time dosemonitoring | Real-time dosemonitoring | ||
| BeamLimitingDevice(Collimator) | Square (but round inzooming androtation) | Square (but round inzooming androtation) | The proposed Zenition 90 system uses the samecollimator as is in predicate device Zenition 70.Conclusion:Same and substantially equivalent |
| Geometry | Hammerhead designLength : 206 x 82 x162 cm | New design standSize: 206 x 82 x 162cm | The proposed Zenition 90 new stand designcomes with lower C-arm operating forces,provision to mount additional User Interfacemonitor. This helps in maneuverability andease of use. |
| Weight: 332 Kg | Weight:400 kg (Motorized)375 Kg (Non-motorized) | The Proposed Zenition 90 stand brings higherweight (400 kg) due to motorization incomparison with Zenition 70 (<350), eventhough c-arm axis movements by Motorizationsimplify the workflow and improves userexperience, no impact on Clinical workflow. | |
| Stand-U/I: 15.3"touch screen display | Stand-U/I: 15.3"touch screen display | The stand UI display (15.3") is same in theproposed Zenition 90 and the predicateZenition 70. | |
| Conclusion:Similar and substantially equivalent | |||
| Systemarchitecture | PC Based Win 10 | PC Based Win 10 | Conclusion:Same and substantially equivalent |
| Ionizingradiation | System uses X-rayfor imaging | System uses X-rayfor imaging | Same X-ray technology usageConclusion:Same and substantially equivalent |
| LaserAlignmenttool | Tube Laser AimingDevice (Model:4598 008 4322x) | Tube Laser AimingDevice (Model: 4598008 4322x) | Conclusion:Same and substantially equivalent |
| DICOMconnectivity | DICOMconnectivityworkflow | DICOM connectivityworkflow | Conclusion:Same and substantially equivalent |
| Securityfeatures | -Easier selection ofpatient data forexport-Introducedunattended networktransfer of exportjobs-Integratedworkflow for exportto local media (USBand DICOM DVD)-Improvedworkflow formultimodalityviewer functionality- DICOM transferspeed-Local user accountmanagement-Function improvedto enable ausername/passwordcombination.-Network timesynchronization-Differentimplementation only-Audit trail-White listing-DIACAP hardening-Disk encryption-FIPS 140-2 | -Easier selection ofpatient data forexport-Introducedunattended networktransfer of exportjobs-Integrated workflowfor export to localmedia (USB andDICOM DVD)-Improved workflowfor multimodalityviewer functionality- Same DICOMtransfer speed-Local user accountmanagement-Function improvedto enable ausername/passwordcombination.-Network timesynchronization-Differentimplementation only-Audit trail-White listing-DIACAP hardening-Disk encryption-FIPS 140-2 | Conclusion:Same and substantially equivalent. |
| RoomInterface(XrayIndication +InputPower) | External x-ray Lampand powerindication interface | External x-ray Lampand power indicationinterface | Conclusion:Same and substantially equivalent. |
| Audiblesignals | Speaker withvolume controladded in the Stand | Speaker with volumecontrol added in theStand | Conclusion:Same and substantially equivalent. |
| WiredFootswitchand remotecontrol unit | Same | Same | Conclusion:Same and substantially equivalent. |
| AutomaticVascularoutlining(AVO) | Manual Outlining -User can manuallyget the vascularoutline for region ofinterest | Manual andautomatic | Both Zenition 90 and Zenition 70 providemanual vascular outlining. In addition,Zenition 90 introduces automatic vascularoutlining, where the user can get a vascularoutline by a single click on UI. The operator isable to manually adjust the outline, re-draw it,or hide it at any time. Additionally, manualvascular outlining is always available to theuser. Therefore, the change introduced inZenition 90 is aimed to improve ease of use.Clinical workflow is the same in both manual orautomatic vascular outlining.The Manual outlining in Zenition 90 is similar |
| The automatic vascular outlining is an addedadvantage for ease of use in Zenition 90.Thus, there is no significant difference in thesafety and effectiveness of the devices.Conclusion:Similar and substantially equivalent. | |||
| Injectorinterface | Manual Injectionpossible. User canmanually add X-raydelay from aninjector device | Integrated injectorinterface where usercan add needed X-raydelay based onInjection volume.Manual Injection isalso possible. | Manual Injector is always possible in both thesystems the proposed Zenition 90 as well as theequivalent device Zenition 70. In addition tomanual injector, Zenition 90 has provision toconnect an external injector, so the user can addX-ray start delay time based on injectionvolume. Hence, clinically, no change isintroduced in the workflow by using integratedInjector interface.Thus, there is no significant difference in thesafety and effectiveness of the devicesConclusion:Similar and substantially equivalent. |
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Based on the information provided above, the Zenition 90 is considered substantially equivalent to the currently marketed predicate Zenition 70 in terms of fundamental scientific technology.
Summary of Non-Clinical Performance Data:
Non-clinical performance testing has been performed on the proposed Zenition 90 and it demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.2 2020-08). FDA/CDRH recognition number 19-49.
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text) FDA/CDRH recognition number 19-4
- o IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.2, 2019). FDA/CDRH recognition number 12-329.
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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. The Subject device Zenition 90 meets the acceptance criteria and is adequate for its intended use.
Substantial The Zenition 90 is substantial equivalent to the currently marketed predicate device Zenition 70 Equivalence (K212813), in terms of indications for use, fundamental scientific technology, safety and effectiveness. Conclusion:
§ 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.