(189 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 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 30 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 K232420 submission for the Philips Zenition 30, a mobile X-ray imaging system, and compares it to a predicate device, Zenition 70 (K212813). The submission argues for substantial equivalence based on non-clinical performance data and compliance with various standards and guidance documents. There is no multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance data mentioned, as the device is an imaging system and not an AI-powered diagnostic tool. The ground truth concept is not directly applicable in the context of validating an X-ray imaging system for substantial equivalence; rather, the focus is on meeting specified performance criteria and demonstrating that the new device operates similarly and as safely and effectively as its predicate.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and compliance with various international and FDA-recognized consensus standards and guidance documents. The reported device performance is demonstrated by the technical characteristics listed in the comparison tables and the declaration of compliance with these standards.
Table 1: Key Performance Characteristics and Comparison (Derived from Section 7, Table 2)
| Component/Feature | Acceptance Criteria (Implied from Predicate Zenition 70 and Standards) | Reported Zenition 30 Performance | Conclusion on Equivalence |
|---|---|---|---|
| X-ray Generator | - Peak output power: 15 kW (max) | - Peak output power: 4kW | - Subset of predicate's performance in terms of peak power, kV range, mA, and pulse rate. - Continuous X-ray mode at 30 fps is equivalent to 30pps pulsed mode of predicate. - Clinically acceptable image quality for intended use. - No impact on safety and effectiveness. Substantially Equivalent. |
| - kV range: 40-120 kV | - kV Range: 40 to 110kV | ||
| - Mode of operation: Pulse (with 30 pps max) | - Pulse/ Continuous: Pulsed and Continuous (15 pps max pulsed) | ||
| - Maximum mA: 125 mA | - Maximum mA: 36mA | ||
| X-ray Tube | - Rotating Anode (e.g., RTM 780 H) | - Fixed Anode (e.g., OX 125 -0612) | - Similar target angle leads to similar field of view. - 0.6 mm focal spot used for most applications, similar to predicate. - No clinically significant difference in safety and clinical performance. Similar and substantially equivalent. |
| - Focal spot: dual (0.3 & 0.6) | - Focal spot: dual (0.6 & 1.2) | ||
| - Target angle: 10° | - Target angle: 9° | ||
| X-ray Housing Assembly | - Minimum limiting resolution: >= 2.2 lp/mm | - Minimum limiting resolution: >= 2.2 lp/mm | - Supports minimum limiting resolution of >=2.2 lp/mm. - Similar heat performance and safety mechanisms (thermal switch). - Better inherent filtration. - Complies with applicable X-ray safety standards (e.g., IEC 60601-1-3). Similar and substantially equivalent. |
| Flat Panel Detector | - Frame rate: 30fps | - Frame rate: 30fps | - Same design, scientific technology, and image acquisition workflow. - Similar physical size and zoom modes. - Similar DQE (Zenition 30 slightly higher). - Final system resolution >= 2.2 lp/mm due to similar anode angle and focal spot. - No change in clinically relevant characteristics. Similar and substantially equivalent. |
| - Detector size: approx. 207mm x 207mm | - Detector size: approx. 204mm x 204mm | ||
| - Pixel pitch: 154 μm | - Pixel pitch: 200 μm | ||
| - DQE: 77% | - DQE: 80% | ||
| Imaging Processing Technology | Xres-3 (PC-based platform and algorithm) | Xres-3 (PC-based platform and algorithm) | Same. Substantially equivalent. |
| Anti Scatter Grid | Removable square grid, 70% transmission | Removable square grid, 70% transmission | Same technology. Similar and substantially equivalent. |
| Radiation Safety Features | Collimation, anti-scatter grid, fluoroscopy modes, pulsed fluoroscopy, recording/storing runs, last image hold, real-time dose monitoring. | Collimation, anti-scatter grid, fluoroscopy modes, pulsed fluoroscopy, recording/storing runs, last image hold, real-time dose monitoring. | Same features. Same and substantially equivalent. |
| Beam Limiting Device (Collimator) | Square (round in zooming/rotation) | Square (round in zooming/rotation) | Reuses predicate's collimator; minor modification for mounting. Performance and safety parameters remain the same. Similar and substantially equivalent. |
| C-arm Motions and Brakes | 4 axis movements (Angulation, Rotation, Longitudinal, Wigwag), 4 axis manual brakes. | 4 axis movements, 3 axis electromagnetic brakes, 1 axis manual brake. | Electromagenetic brakes improve workflow and ease of use. Usability studies and product safety assessment confirm no new risks. Similar and substantially equivalent. |
| Geometry | Hammerhead design, 206x82x162 cm, 332 Kg (FD12), 15.3" touch screen. | New design stand, 185x82x172 cm (without push bar/surgeon arm), 210x82x162 cm (with), 295 kg, 12.1" touch screen. | Improved maneuverability, lower operating forces, slimmer UI (12.1"). Improves workflow and ease of use. Similar and substantially equivalent. |
| System Architecture | PC Based Win 10 | PC Based Win 10 | Same. Same and substantially equivalent. |
| Ionizing Radiation | System uses X-ray for imaging | System uses X-ray for imaging | Same X-ray technology usage. Same and substantially equivalent. |
| Detector Laser Aiming Device | Specific model, Wavelength: 635 nm, Max output: 10mW, Beam divergence: 34 degrees. | Specific model, Wavelength: 635 nm, Max output: 10mW, Beam divergence: 34 degrees. | Same. Same and substantially equivalent. |
| Tube Laser Aiming Device | Specific model (4598 008 4322x) | Specific model (4598 008 4322x) | Same. Same and substantially equivalent. |
| DICOM Connectivity | Features for patient data export, unattended network transfer, local media export, multimodality viewer, improved transfer speed. | Same features for patient data export, unattended network transfer, local media export, multimodality viewer, improved transfer speed. | Same. Same and substantially equivalent. |
| Security Features | Local user account management, username/password combination, network time synchronization, audit trail, white listing, DIACAP hardening, disk encryption, FIPS 140-2. | Same features including local user account management, username/password combination, network time synchronization, audit trail, white listing, DIACAP hardening, disk encryption, FIPS 140-2. | Same. Same and substantially equivalent. |
| Room Interface | External x-ray and power indication interface. | External x-ray and power indication interface. | Same. Same and substantially equivalent. |
| Audible Signals | Speaker with volume control in the Stand. | Speaker with volume control in the Stand. | Same. Same and substantially equivalent. |
| Wired Footswitch and remote control unit | Same as predicate | Same as predicate | Same. Same and substantially equivalent. |
| Product Name | Zenition 70 | New Product name Zenition 30 | Labeling change only; no impact on system features, safety, and effectiveness. Substantially equivalent. |
Study Information
The document describes a non-clinical performance testing study to demonstrate compliance and substantial equivalence, rather than a clinical study focused on diagnostic accuracy or AI performance.
- Sample size used for the test set and the data provenance: Not applicable in the context of this submission, which relies on non-clinical testing and comparison to a predicate device's established performance parameters. The "test set" consisted of the physical device and its components undergoing engineering verification and validation tests. The provenance is internal to Philips Medical Systems Nederland B.V.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the performance of an X-ray imaging system is established through adherence to recognized international and FDA consensus standards (e.g., IEC 60601 series) and physical measurements, rather than expert consensus on medical images. The expertise would be in medical device engineering, physics, and regulatory affairs, not clinical interpretation of images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Device performance is evaluated against quantitative engineering specifications and standard requirements, which do not typically involve an adjudication process like those used for expert review of images.
- 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 study was done. This device is a new iteration of an X-ray imaging system, not an AI-assisted diagnostic tool or an image interpretation algorithm. The focus is on the fundamental performance and safety of the hardware and integrated software for image acquisition and display, not on assisting human readers with interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Zenition 30 is an X-ray imaging system, not an AI algorithm. Its performance is as a complete medical device intended for radiological guidance and visualization.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in this context, refers to the established technical specifications, safety standards (e.g., radiation dose, image resolution), and functional requirements for an X-ray imaging system. It is established through recognized international standards (e.g., IEC), FDA guidance documents, and the validated performance of the predicate device. For example, a "limiting resolution of >=2.2 lp/mm" is a measurable technical specification, not something derived from expert consensus on clinical images in this submission.
- The sample size for the training set: Not applicable. The Zenition 30 is a hardware system with integrated software, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/machine learning model. The validation and verification process involves testing the physical device and its components against predefined engineering requirements and regulatory standards.
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February 16, 2024
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Philips Medical Systems Nederland B.V. Gyanendra Mani Tripathi Regulatory Approbation Officer Veenpluis 6 5684 PC Best The Netherlands
Re: K232420
Trade/Device Name: Zenition 30 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: August 4, 2023 Received: August 11, 2023
Dear Gyanendra Mani Tripathi:
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,
Gabriela M. Rodal -S
Digitally signed by Gabriela M. Rodal -S for
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
Enclosure
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Indications for Use
510(k) Number (if known) K232420
Device Name
Zenition 30
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 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K232420
510 (k) Summary
The 510(k) Summary is given in the below pages.
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510(k) Summary
K232420
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Date Prepared: August 25, 2023
Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277
Primary Gyanendra Mani Tripathi Contact Regulatory Approbation Officer Person: Phone: +91 9873846827 E-mail: gyanendramani.tripathi@philips.com
| Secondary | Sumit Kumar |
|---|---|
| Contact | Manager Regulatory Affairs |
| Person: | Phone: +91 7028039288E-mail: sumit.kumar_3@philips.com |
| Device: | Trade Name: | Zenition 30 |
|---|---|---|
| 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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The proposed Zenition 30 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for Device 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).
Indications for The device is used for radiological guidance and visualization during diagnostic, interventional and Use: 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 Philips Zenition 30 has same indications to the currently marketed and predicate device Zenition 70 (K212813, Oct 1, 2021).
Table 1 shows that the proposed Zenition 30 is substantially equivalent to the currently marketed and predicate device, Zenition 70, in terms of indications for use.
| Table 1 Indications for use comparison of the proposed Zenition 30 versus the currentlymarketed and predicate device, Zenition 70 | ||
|---|---|---|
| Predicate Device Zenition 70(K212813) | Proposed Zenition 30(K232420) | Conclusion |
| Indications for Use | ||
| The Zenition 70 device isintended to be used and operatedby: adequately trained, qualifiedand authorized 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, exceptneonates (birth to one month),within the limits of the device.The device is to be used in healthcare facilities both inside andoutside the operating room,sterile as well as non-sterile | 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:SameBoth the proposedZenition 30 and currentlymarketed predicate deviceZenition 70 are intendedfor radiological guidanceand visualization duringdiagnostic, interventionaland surgical procedures.The clinical applicationareas for both predicateZenition 70 and the subjectdevice Zenition 30 are thesame.The proposed Zenition 30is equipped with dedicated |
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| environment in a variety ofprocedures. | pediatric mode and capableof automatic dose controlbased on the subject size. |
|---|---|
| Applications:• Orthopedic• Neuro• Abdominal• Vascular• Thoracic• Cardiac | The moment user selectsthe pediatric mode foracquisition, a popupmessage will appear on thescreen to remove the gridfrom the flat detector tooptimize the dose. TheGrid is placed in such away that it can be easilyremoved without use oftools. |
| Zenition 30 has beenvalidated on different typesof phantom representingthe pediatric and adultpopulation. | |
| Therefore, Zenition 30demonstrates substantialequivalence with predicateZenition 70 in terms ofintended use. and do notraise questions of safetyand effectiveness. |
Fundamental The proposed Zenition 30 employs the same basic construction and fundamental scientific technology Scientific as the currently marketed and predicate Zenition 70. The technology used in the development of the Technology: major components of the proposed Zenition 30, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is similar to the currently marketed and predicate Zenition 70. Modifications implemented in the proposed Zenition 30 include:
- State of the art flat panel detector px2020S ●
- . New Scalable X-segment (Supports 2.1kW and 4.0kW modes)
- Introduction of the compact stand assembly
- Introducing Electro Magnetic Brakes
- Table Side UI
- Introduction of the light weight C-arc ●
- SCU changes ●
- Modification of Brake between wheels
- Introduction of general purpose I/O board(GPIO) ●
The risks associated with these changes were assessed and found to be acceptable. The minor differences between the Zenition 30 and the predicate device Zenition 70 do not raise any new questions regarding safety or effectiveness. The Zenition 30 is considered substantially equivalent to the currently marketed predicate Zenition 70 (K212813, Oct 1, 2021) in terms of fundamental scientific technology.
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Table 2 shows that the proposed Zenition 30 is considered substantially equivalent to the currently marketed predicate, Zenition 70 in terms of major components and technological characteristics.
| Table 2 Technological characteristics comparison of the currently marketed predicate device, Zenition 70 versus the proposed Zenition 30 | Conclusion | ||
|---|---|---|---|
| Component /feature | Predicate Device Zenition 70 (K212813) | Proposed Zenition 30 (K232420) | |
| X-ray Generator | -Peak output power: 15 kW | -Peak output power: 4kW | The X-ray generator characteristics of proposed Zenition 30 is subset of predicate Zenition 70 in terms of peak output power, kV range, mode of operation, maximum mA and pulse rate.The maximum pulse rates supported by predicate Zenition 70 and proposed Zenition 30 are different, however, the Zenition 30 system provides a continuous x-ray mode that works at 30 fps, this is treated as equivalent to the 30pps pulsed mode of Zenition 70.The X-ray power levels of the Zenition 70 and Zenition 30 are different. However, the image quality of Zenition 30 for the proposed intended use is clinically acceptable.This change does not impact the safety and effectiveness of the device. Thus, demonstrating substantial equivalence. |
| -kV range: 40-120 kV | -kV Range: 40 to 110kV | ||
| -Mode of operation: Pulse | -Pulse/ Continuous: Pulsed and Continuous. | ||
| -Maximum mA: 125 mA | -Maximum mA: 36mA | ||
| -Pulse Rate : 30 pps (max) | -Pulse rate: 15 pps (max) | ||
| -iXion HF Generator | -HF Generator | ||
| -Model : 10359400 | -Model : IRI.37.216.001 (HF1 4.0 kW ESU) | ||
| Conclusion: | |||
| Similar and substantially equivalent | |||
| X-ray tube | -Rotating Anode (Model: RTM 780 H (Type RO-0306) | -Fixed Anode (model: OX 125 -0612) | The target angle affects the focal spot size and field of view. As target angle of proposed Zenition 30 and predicate Zenition-70 are similar, the field of view is also similar.Focal spot size is contributing to resolution of the image. The predicate Zenition 70 uses the 0.6 focal spot for all application modes, and in proposed Zenition 30, 0.6 mm focal spot is used for all the applications except for single shot at 1.2 mm focal spot for the max power demonstration. |
| -Focal spot: dual (0.3 & 0.6) | -Focal spot: dual (0.6 & 1.2) | ||
| -Target angle: 10° | -Target angle: 9° | ||
| -Anode heat content: 225kJ-Maximum anode cooling rate: 550W-Nominal anode input power: 15kW | -Anode heat content: 57kJ-Maximum anode cooling rate: 600W-Nominal anode input power: 4kW | ||
| X-rayhousingassembly | iXion 5 Monoblock,model identification:10454900 | I-40S, 3.5RF, modelidentification:101.01.179.001 | As both systems support a minimumlimiting resolution of > =2.2 lp/mmin all detector modes, thisdemonstrates a similarity in theresolutions delivered to support theintended use. |
| -Active oil circulation-Monoblock heatcontent: 1350kJ-Safety mechanisms:Thermal Switch-filtration: 1mmAl+0.1mmCu-fluoro time: 296W for60mins | -Active oil circulation-Monoblock heatcontent: 1056kJ-Safety mechanisms:Thermal Switch-filtration:3.8mmAl+0.1mmCu-fluoro time: 300W @50mins, 600W @20mins | There is no clinically significantdifference in the safety and clinicalperformance of Zenition 30 ascompared to predicate Zenition 70. | |
| Both the devices comply toapplicable x-ray safety standards(e.g., IEC 60601-1-3, 2.1edition). | |||
| Conclusion:Similar and substantially equivalent,technological characteristics of thedevices do not raise questions ofsafety and effectiveness | |||
| The monoblock is the combination ofx-ray tube, transformer and coolingoil. | |||
| Having active oil circulation withinthe monoblock helps in heatdissipation and more available x-raytime. The proposed device Zenition30 has similar heat performancecompared to the predicate deviceZenition 70. There are notechnological significant difference inthe safety and clinical performance ofthe devices. | |||
| Both the devices Zenition 70 andZenition 30 use the same safetymechanism of thermal switch toaddress undesirable overheatingscenarios. | |||
| Cu and Al filtration are meant toremove the low energy x-ray part ofthe spectrum that is not contributing tothe imaging. The inherent filtration isbetter in Zenition 30 compared to thepredecessor device Zenition 70. | |||
| Conclusion: | |||
| Similar and substantially equivalent | |||
| The proposed device Zenition 30 ishaving similar heat performance ascompared to the predicate Zenition70. Both the devices share the samesafety mechanism of thermal switch to | |||
| address undesirable overheatingscenarios. Additionally, the inherentfiltration is better in Zenition 30compared to the predecessor deviceZenition 70. | |||
| Hence, we can conclude that both thedevices share the same technologicalcharacteristics with no significantdifference in the safety andeffectiveness of the devices. | |||
| Flat PanelDetector | Model: 45980120023x | Model: PIXIUM 2020S-p | Both Zenition 30 and the predicatedevice Zenition 70 systems use a FlatPanel (FP) digital image detectortechnology. |
| -Frame rate: 30fps-Zoom modes: Overviewmode + 2 zoom modes | -Frame rate: 30fps-Zoom modes: Overviewmode + 2 zoom modes | ||
| -Detector size (x/y):207mm x 207mm(square) | -Detector size (x/y):204mm x 204mm(square) | The detector used in proposed deviceZenition 30 is based on the samedesign, scientific technology andimage acquisition workflow as theFlat Panel digital image detector usedin the predicate Zenition 70. Theframe rates of both detectors are alsothe same. | |
| -pixel pitch: 154 μm-Image matrix:1344x1344 | -pixel pitch: 200 μm-Image matrix:1024x1024 | ||
| -DQE: 77% | -DQE: 80% | The physical size of the detectors arenot significantly different (207 x 207mm2 versus 204 x 204 mm2) for thepredicate device Zenition 70 and theproposed device Zenition 30.Additionally, the number of zoommodes are also identical for both thedevices. | |
| The pixel pitch of the Zenition 30 is200 μm, which is similar to the pixelpitch of the predicate Zenition 70(154 μm). However, the finalresolution seen at the system level isresult of multiple factors. AtZenition 30, Zenition 70 systemlevel, both systems demonstrate alimiting resolution > 2.2 lp/mm in alldetector modes due to similar anodeangle and focal spot used for themajority of the applications. | |||
| DQE (detective quantum efficiency)is a measure for the x-ray dosesensitivity of the detector and definesthe image quality generated from thedetector. | |||
| The DQE is similar for both thedetectors used in predicate Zenition | |||
| ImagingProcessingtechnology | Xres-3 | Xres-3 | 30 with the sensitivity of theZenition 30 being slightly higher.Better sensitivity of detector used inZenition 30 will have an advantageover the predicate Zenition 70 interms of image quality with same orlower X-Ray Dose.There is no change in clinicallyrelevant characteristics of thedetector used in both the devices thatrelate to the acquisition to X-rayimages and X-ray dose sensitivity.Conclusion:Similar and substantially equivalentWe can conclude that both thedevices share the same technologicalcharacteristics with no significantdifference in the safety andeffectiveness of the devicesThe predicate device Zenition 70 andthe proposed device Zenition 30 bothare using the same PC-based platformand algorithm.Conclusion:Same and substantially equivalent |
| Anti ScatterGrid | Removable grid (square)Transmission: 70% | Removable grid (square)Transmission: 70% | The proposed Zenition 30 has asquare removable grid, the same as ofpredicate Zenition 70. The grids aremade using the same technology.Conclusion:Similar and substantially equivalent |
| Radiationsafetyfeatures | CollimationAnti-scatter gridFluoroscopy modesPulsed fluoroscopyRecording and storingfluoroscopic runsLast image holdReal-time dosemonitoring | CollimationAnti-scatter gridFluoroscopy modesPulsed fluoroscopyRecording and storingfluoroscopic runsLast image holdReal-time dosemonitoring | The mobile x-ray c-arms have a rangeof features (like collimation, anti-scatter grid, different fluoroscopymodes, last image hold and real timedose monitoring) that enable themanagement of dose. The availablefeatures are the same on both thesystems.Both the proposed device Zenition 30and the predicate device Zenition 70shares the same radiation safetyfeatures.Conclusion:Same and substantially equivalent |
| BeamLimitingDevice(Collimator) | Square (but round inzooming and rotation) | Square (but round inzooming and rotation) | The proposed Zenition 30 systemintroduces a collimator that is reusingthe collimator used in predicate deviceZenition 70. One modification ismade by extending the lead ring to thebottom of collimator. This is done inorder to account for the minordifferences in the mountingarrangement of the collimator andmonoblock mounting surface. |
| In all other aspects the collimator ofpredicate Zenition 70 and proposedZenition 30 remain the same inperformance and safety parameters.Thus, demonstrating substantialequivalence. | |||
| Conclusion: | |||
| Similar and substantially equivalent | |||
| C-armmotions andbrakes | 4 axis movements4 axis manual brakes | 4 axis movements3 axis electromagneticbrakes, 1 axis manualbrake | The number of axis in which the c-arm movements are possible(Angulation, Rotation, Longitudinal,Wigwag) is the same for both thesystems under comparison.The predicate Zenition 70 providemanual brake levers to release andlock the brakes. However, theproposed Zenition 30 system useselectromagnetic brakes to release orlock the c-arm axis to simplify theworkflow and reduce manual efforts.The electromagnetic brakes used inproposed Zenition 30 will be an |
| added advantage when comparedwith the equivalent device Zenition70.The differences in the technologyused to operate the brakes does not | |||
| introduce any new risk as conformedby the usability studies and theproduct safety assessment carriedout. | |||
| Conclusion:Similar and substantially equivalent | |||
| Both proposed Zenition 30 and thepredicate Zenition 70 has the sameaxis of movements and share the sametechnological characteristics with nosignificant difference in the safety andeffectiveness of the devices | |||
| Geometry | Hammerhead designSize : 206 x 82 x 162 cmWeight: 332 Kg (FD12)Stand-U/I: 15.3" touchscreen display | New design standSize: 185 x 82 x 172 cm(without push bar andsurgeon arm)210 x 82 x 162 cm (withpush bar and surgeonarm)Weight : 295 kgStand-U/I: 12.1" touchscreen display | In the proposed Zenition 30, the newstand design comes with lower C-armoperating forces, provision to mountfoot switch, hand switch and otheroptions. The design also brings in theslimmer version of the stand UIdisplay (12.1") compared to thepredicate device Zenition 70.These features will improve theworkflow and help ease of use ofproposed Zenition 30 as compared topredicate Zenition 70The new stand that is used in theproposed Zenition 30 helps improvethe maneuverability and ease of usewhile keeping the essence of thestand same.Conclusion:Similar and substantially equivalent |
| Systemarchitecture | PC Based Win 10 | PC Based Win 10 | Conclusion:Same and substantially equivalent |
| Ionizingradiation | System uses X-ray forimaging | System uses X-ray forimaging | Same X-ray technology usageConclusion:Same and substantially equivalent |
| DetectorLaser aimingdevice | Integrated in FD covers(Model: FP-L-635-10-34-Philips-V2-C2)Wavelength: 635 nm (±5nm)Maximum output: 10mW (±1 mW)Beam divergence: 34degrees | Integrated in FD covers(Model: FP-L-635-10-34-Philips-V2-C2)Wavelength: 635 nm (±5nm)Maximum output: 10mW (±1 mW)Beam divergence: 34degrees | Conclusion:Same and substantially equivalent |
| LaserAlignmenttool | Tube Laser AimingDevice (Model: 4598008 4322x) | Tube Laser AimingDevice (Model: 4598008 4322x) | Conclusion:Same and substantially equivalent |
| DICOMconnectivity | DICOM connectivityworkflow-Easier selection ofpatient data for export-Introduced unattendednetwork transfer ofexport jobs | DICOM connectivityworkflow-Easier selection ofpatient data for export-Introduced unattendednetwork transfer ofexport jobs | Conclusion:Same and substantially equivalent |
| -Integrated workflow forexport to local media(USB and DICOMDVD)-Improved workflow formultimodality viewerfunctionality-Improved DICOMtransfer speed | -Integrated workflow forexport to local media(USB and DICOMDVD)-Improved workflow formultimodality viewerfunctionality-Improved DICOMtransfer speed | ||
| Securityfeatures | -Local user accountmanagement | -Local user accountmanagement | Conclusion:Same and substantially equivalent. |
| -Function improved toenable ausername/passwordcombination.-Network timesynchronization | -Function improved toenable ausername/passwordcombination.-Network timesynchronization | ||
| -Differentimplementation only | -Differentimplementation only | ||
| -Audit trail-White listing | -Audit trail-White listing | ||
| -DIACAP hardening | -DIACAP hardening | ||
| -Disk encryption-FIPS 140-2 | -Disk encryption-FIPS 140-2 | ||
| RoomInterface | External x-ray andpower indicationinterface | External x-ray andpower indicationinterface | Conclusion:Same and substantially equivalent. |
| Audiblesignals | Speaker with volumecontrol added in theStand | Speaker with volumecontrol added in theStand | Conclusion:Same and substantially equivalent. |
| WiredFootswitchand remotecontrol unit | Same | Same | Conclusion:Same and substantially equivalent. |
| ProductName | Zenition 70 | New Product nameZenition 30 | Labeling change that has no impact on system features, safety and effectiveness. Thus, demonstrating substantial equivalence. |
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Summary of Non-clinical performance testing has been performed on the proposed Zenition 30 and demonstrates 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, 2019). FDA/CDRH recognition number 5-125.
- 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.
- 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 1.2 2018). FDA/CDRH recognition number 12-317.
- 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 4.1 2020). FDA/CDRH recognition number 19-36.
- 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 62366-1 IEC Application of Usability Engineering to Medical Devices (Edition 1.1 2020). FDA/CDRH recognition number 5-129
- ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied (Edition 4.0 2021). FDA/CDRH recognition number: 5-134.
- ISO 20417 Medical devices Information to be supplied by the manufacturer (First edition ● 2021-04 Corrected version 2021-12). FDA/CDRH recognition number 5-135
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issue date: ● 01-Sep-2016)
- . Pediatric Information for X-ray Imaging Device Premarket Notifications (Issue Date: 28-Nov-2017)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (11-May-2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (02-Oct-2014)
- Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering ● to Medical Devices(document number (03-Feb-2016)
- . Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff (14-Aug-2013)
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 demonstrate that the Zenition 30:
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| 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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| Therefore, the Zenition 30 is substantially equivalent to the currently marketed and predicate Zenition 70 (K212813, Oct 1, 2021) in terms of safety and effectiveness. | |
| Summary ofClinicalPerformanceData: | The 11-inch detector in Zenition 30 has similar design, technology and Image acquisition workflow compared to the previously cleared detector used in the marketed predicate device Zenition 70. All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. So, no clinical information was used to support the substantial equivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. |
| SubstantialEquivalenceConclusion: | The Zenition 30 is substantial equivalent to the currently marketed predicate device Zenition 70 (K212813, Oct 1, 2021) in terms of indications for use, fundamental scientific technology and safety and effectiveness.Additionally, substantial equivalence was demonstrated by non-clinical performance tests. These tests demonstrate that Zenition 30 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.