Zenition 50

K183101 · Philips Medical Systems Nederland B.V. · OWB · Dec 31, 2018 · Radiology

Device Facts

• Record ID: K183101
• Device Name: Zenition 50
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: OWB · Radiology
• Decision Date: Dec 31, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Mobile diagnostic X-ray imaging and viewing system comprising C-arm stand and Mobile View Station (MVS). Inputs: X-ray radiation; outputs: fluoroscopic images for clinical visualization. Operated by trained healthcare professionals in OR or clinical settings. System architecture utilizes PC platform with migrated software-based image processing. Features include touch-screen interface, ClearGuide color coding, and manual outlining tools. Output aids surgeons in real-time guidance during interventional procedures. Benefits include improved workflow, enhanced security, and optimized X-ray tube heat management. Device provides visual feedback to clinicians to support surgical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including verification and validation against international consensus standards (IEC 60601-1, 60601-2-43, 60601-2-54, 62304, 62366) and FDA guidance documents.

Technological Characteristics

Mobile C-arm X-ray system. Components: iXion HF generator, RTM 780 H X-ray tube, iXion Monoblock V. Connectivity: wireless network, DICOM. Software: PC-based platform, migrated image processing. Standards: IEC 60601-1 (safety), IEC 60601-2-43/54 (X-ray performance), IEC 62366 (usability), IEC 62304 (software lifecycle). Cybersecurity: disk encryption, FIPS 140-2, audit trails, white listing.

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures (orthopedic, neuro, abdominal, vascular, thoracic, cardiac) in healthcare facilities. Patient population: all patients except neonates (birth to one month).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BV Pulsera (K010435)

Reference Devices

• Veradius Unity (K142708)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: | <ul><li>Orthopedic</li><li>Neuro</li><li>Abdominal</li><li>Vascular</li><li>Thoracic</li><li>Cardiac</li></ul> |
| Type of Use (Select one or both, as applicable) | |
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |

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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.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Primary<br>Contact<br>Person: | Sumit Kumar<br>Regulatory Approbation Officer<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary<br>Contact<br>Person: | Sonavane, Neena Sandeep<br>Regulatory Affairs Manager<br>Phone: [phone]<br>E-mail: [e-mail] | |
| 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 |
| Primary<br>Predicate<br>Device: | 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 |
| Reference<br>device: | 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.<br>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.<br>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.<br>Applications:<br>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, BV<br>Pulsera versus the proposed Zenition 50 | | | |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Component<br>/feature | Currently<br>market BV<br>Pulsera | Proposed Zenition 50 | Conclusion |
| X-ray<br>Generator | iXion HF<br>Generator<br>Model: 10359400 | iXion HF Generator<br>Model: 10359400 | Identical. |
| X-ray tube | Model: RTM 780<br>H (Type RO-0306) | Model : RTM 780 H<br>(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 in<br>monoblock design for providing<br>more clearance to the floor.<br>The monoblock design has been<br>updated to reduce the height with<br>3.5cm, and thus improves clearance<br>between the tank and the floor which<br>resulting in more space to move. In<br>addition, the filtration has been<br>reduced to lower the amount of<br>power necessary for the same dose.<br>The updated monoblock is evaluated<br>in risk management. The change<br>does not introduce new risks. This<br>change was shown to be compliant<br>with the international and FDA<br>recognized standards IEC60601-1,<br>IEC60601-2-43 and IEC60601-2-54<br>for basic safety and essential<br>performance. Hence, this change<br>does not impact the safety and<br>effectiveness of the Device. Thus,<br>demonstrating substantial<br>equivalence. |
| Image Intensifier 9" | 23HRC | 23HRC | Identical. |
| Image Intensifier 12" | 31GG | 31GG | Identical |
| II Laser alignment tool | Z-LAD 9 Inch<br>Z-LAD 12 Inch | Z-LAD 9 Inch<br>Z-LAD 12 Inch | Identical |
| Beam Limiting Device | CoRa<br>9890 010 23201 | Collimator IITV<br>459801200241 | A new collimator has been designed<br>such that it reuses the design of<br>existing reference device Veradius<br>Unity (K142708) FD15 (PX2630Sv)<br>collimator with the only exception<br>the square fixed diaphragm is<br>removed to match the format for<br>IITV9" and IITV12". There is no<br>change in the functional<br>specification compared to predicate<br>device. All other parts of the<br>collimator are identical.<br>This change was shown to be<br>compliant with the international and<br>FDA recognized |
| | | | |
| Laser<br>Alignment<br>tool | Tube Laser<br>Aiming Device | Tube Laser Aiming<br>Device | essential performance. Hence, this<br>does not impact safety or<br>effectiveness of the device Thus,<br>demonstrating substantially<br>equivalent. |
| | | | Changed to fit in new collimator.<br>Functional specification are similar<br>compared to predicate device. This<br>tube laser unit is reused from the<br>reference device Veradius Unity<br>(K142708).<br>Hence, this change do not impact<br>the safety or effectiveness of the<br>Device. Thus, demonstrating<br>substantial equivalence |
| Mobile C-arm<br>Stand | BV Pulsera Stand | Pulsera R3.1 Stand | The mechanical interfaces have<br>been updated for the updated<br>monoblock and the stand<br>touchscreen. These changes are<br>assessed in risk management, and<br>they did not introduce new risks.<br>The changes was also shown to be<br>compliant with the FDA recognized<br>standard IEC60601-1 for basic<br>safety and essential performance.<br>Therefore, the change does not<br>impact safety and effectiveness.<br>Thus, demonstrating substantial<br>equivalence. |
| Mobile<br>Viewing<br>Station | MVS BV Family<br>R2 | MVS BV Family R3 | The MVS has been changed to<br>match the updated interfaces from<br>the System architecture and room<br>interface changes. These changes<br>are assessed in risk management,<br>and they did not introduce new risks.<br>The changes was also shown to be<br>compliant with the FDA recognized<br>standard IEC60601-1 for basic<br>safety and essential performance.<br>Therefore, the change does not<br>impact safety and effectiveness.<br>Thus, demonstrating substantial<br>equivalence |
| System<br>architecture | Current System<br>architecture | Improved system<br>architecture with PC<br>platform<br>• Solved obsolescence | These changes were assessed in risk<br>management, and they did not<br>introduce new risks. This change<br>was shown to be compliant with the<br>international 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 <b>Appendix A38</b> .<br>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 <i>Veradius Unity</i> (K142708).<br>The changes do not introduce new risks or change any of the existing risks compared to the predicate device.<br>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 <i>Veradius Unity</i> (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 basic<br>safety and essential performance,<br>IEC60601-1-2 for Electromagnetic<br>compatibility,<br>IEC62366<br>for<br>application of usability engineering.<br>This change does not affect safety or<br>effectiveness of the device. Thus,<br>demonstrating<br>substantial |
| Manual<br>Outline | Not Present | Manual outlining | equivalence<br>With this so-called Manual Outline<br>function, it is possible to draw lines<br>and dots on an overlay of the clinical<br>image with help of the finger, stylus<br>pen or mouse. It is not related to<br>diagnostics. This feature is reused<br>from the reference device Veradius<br>Unity (K142708).<br>The changes do not introduce new<br>risks or change any of the existing<br>risks compared to the predicate<br>device. |
| | | | This change does not affect safety or<br>effectiveness of the device. Thus,<br>substantial<br>demonstrating<br>equivalence. |
| Wireless<br>footswitch | Not Present | Wireless footswitch | Next to the wired footswitch and<br>optional wireless footswitch can be<br>used with the system. This wireless<br>footswitch is reused from reference<br>device Veradius Unity (K142708).<br>The change does not introduce new<br>risks, but only minor update to<br>existing risks compared to the<br>predicate device.<br>This change does not affect safety or<br>effectiveness of the device. Thus,<br>demonstrating<br>substantial<br>equivalence. |
| DICOM<br>connectivity | Current DICOM<br>connectivity | Improved DICOM<br>connectivity workflow<br>· Easier selection of<br>patient data for<br>export<br>• Introduced<br>unattended network<br>transfer of export<br>jobs<br>• Integrated workflow<br>for export to local | The improvements are ease-of-use<br>improvements, fully compliant with<br>the DICOM standard and do not<br>impact clinical functionality. The<br>changes are shown to be compliant<br>with the international and FDA<br>recognized standard IEC62366 for<br>application of usability engineering.<br>Therefore, this change does not<br>impact safety or effectiveness of the |
| | | media (USB and<br>DICOM DVD)<br>• Improved workflow<br>for multimodality<br>viewer functionality<br>• Improved DICOM<br>transfer speed | demonstrating<br>device.<br>Thus,<br>substanti…