Who is the manufacturer of Zenition 50?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for Zenition 50 (K183101).

What is the FDA product code for Zenition 50?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Zenition 50?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Zenition 50?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Indications for 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)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 31, 2018 Philips Medical Systems Nederland BV Sumit Kumar Regulatory Approbation Officer Veenpluis 4-6 BEST, NL 5684PC Re: K183101 Trade/Device Name: Zenition 50 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: November 1, 2018 Received: November 7, 2018 Dear Sumit Kumar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Hole 2. Nils for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | 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. | | ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." PSC {3}------------------------------------------------ ## 510(k) Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. Date Prepared: November 1, 2018 | Manufacturer: | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277 | | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Primary Contact Person: | Sumit Kumar Regulatory Approbation Officer Phone: +91 7028039288 E-mail: sumit.kumar_3@philips.com | | | Secondary Contact Person: | Sonavane, Neena Sandeep Regulatory Affairs Manager Phone: +91 8446020023 E-mail: neena.sonavane@philips.com | | | Device: | Trade Name: | Zenition 50 | | | Classification Name: | Image-intensified fluoroscopic x-ray system | | | Classification Regulation: | 21CFR §892.1650 | | | Classification Panel: | 90-Radiology | | | Device Class: | Class II | | | Primary Product Code: | OWB | | | Secondary Product Code: | JAA, OXO | | Primary Predicate 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 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. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: Orthopedic Neuro Abdominal Vascular Thoracic Cardiac | | | Fundamental Scientific Technology: | The proposed Zenition 50 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate BV Pulsera. The technology used in the development of the major components of the proposed Zenition 50, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is identical to the currently marketed and predicate BV Pulsera. See the below table for the comparison of the major components of the proposed Zenition 50 and the currently marketed and predicate BV Pulsera. | | | | The outcome of this comparison demonstrates that the minor differences in the technological | | {4}------------------------------------------------ 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 Pulsera versus the proposed Zenition 50 | | | | |------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Component /feature | Currently market BV Pulsera | Proposed Zenition 50 | Conclusion | | X-ray Generator | iXion HF Generator Model: 10359400 | iXion HF Generator Model: 10359400 | Identical. | | X-ray tube | Model: RTM 780 H (Type RO-0306) | Model : RTM 780 H (Type RO-0306) | Identical. | | X-ray housing assembly | iXion Monoblock IV with X-ray tube RO-0306 | iXion Monoblock V with X-ray tube RO-0306 | | | | | | Similar with minor change in monoblock design for providing more clearance to the floor. The monoblock design has been updated to reduce the height with 3.5cm, and thus improves clearance between the tank and the floor which resulting in more space to move. In addition, the filtration has been reduced to lower the amount of power necessary for the same dose. The updated monoblock is evaluated in risk management. The change does not introduce new risks. 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 safety and essential performance. Hence, this change does not impact the safety and effectiveness of the Device. Thus, demonstrating substantial equivalence. | | Image Intensifier 9" | 23HRC | 23HRC | Identical. | | Image Intensifier 12" | 31GG | 31GG | Identical | | II Laser alignment tool | Z-LAD 9 Inch Z-LAD 12 Inch | Z-LAD 9 Inch Z-LAD 12 Inch | Identical | | Beam Limiting Device | CoRa 9890 010 23201 | Collimator IITV 459801200241 | A new collimator has been designed such that it reuses the design of existing reference device Veradius Unity (K142708) FD15 (PX2630Sv) collimator with the only exception the square fixed diaphragm is removed to match the format for IITV9" and IITV12". There is no change in the functional specification compared to predicate device. All other parts of the collimator are identical. This change was shown to be compliant with the international and FDA recognized | | | | | | | Laser Alignment tool | Tube Laser Aiming Device | Tube Laser Aiming Device | essential performance. Hence, this does not impact safety or effectiveness of the device Thus, demonstrating substantially equivalent. | | | | | Changed to fit in new collimator. Functional specification are similar compared to predicate device. This tube laser unit is reused from the reference device Veradius Unity (K142708). Hence, this change do not impact the safety or effectiveness of the Device. Thus, demonstrating substantial equivalence | | Mobile C-arm Stand | BV Pulsera Stand | Pulsera R3.1 Stand | The mechanical interfaces have been updated for the updated monoblock and the stand touchscreen. These changes are assessed in risk management, and they did not introduce new risks. The changes was also shown to be compliant with the FDA recognized standard IEC60601-1 for basic safety and essential performance. Therefore, the change does not impact safety and effectiveness. Thus, demonstrating substantial equivalence. | | Mobile Viewing Station | MVS BV Family R2 | MVS BV Family R3 | The MVS has been changed to match the updated interfaces from the System architecture and room interface changes. These changes are assessed in risk management, and they did not introduce new risks. The changes was also shown to be compliant with the FDA recognized standard IEC60601-1 for basic safety and essential performance. Therefore, the change does not impact safety and effectiveness. Thus, demonstrating substantial equivalence | | System architecture | Current System architecture | Improved system architecture with PC platform • Solved obsolescence | These changes were assessed in risk management, and they did not introduce new risks. This change was shown to be compliant with the 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 Appendix A38 . This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence. | | ClearGuide and color coding | Not Present | Introduction of ClearGuide and color coding | These visual aids are ease-of-use improvements and improve communication in the OR between surgeon and operator. These features are reused from the reference device Veradius Unity (K142708). The changes do not introduce new risks or change any of the existing risks compared to the predicate device. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence. | | C-arm Stand user interface | C-arm Stand user interface based on hard keys and a small monochrome display | C-arm Stand touch screen user interface | The hard-key based interface on the predicate device has been replaced with a touch-screen based stand user interface This feature is reused from the reference device Veradius Unity (K142708). This change was shown to be compliant with the international and FDA recognized standards IEC60601-1, IEC60601- | | | | | 2-43 and IEC60601-2-54 for basic safety and essential performance, IEC60601-1-2 for Electromagnetic compatibility, IEC62366 for application of usability engineering. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial | | Manual Outline | Not Present | Manual outlining | equivalence With this so-called Manual Outline function, it is possible to draw lines and dots on an overlay of the clinical image with help of the finger, stylus pen or mouse. It is not related to diagnostics. This feature is reused from the reference device Veradius Unity (K142708). The changes do not introduce new risks or change any of the existing risks compared to the predicate device. | | | | | This change does not affect safety or effectiveness of the device. Thus, substantial demonstrating equivalence. | | Wireless footswitch | Not Present | Wireless footswitch | Next to the wired footswitch and optional wireless footswitch can be used with the system. This wireless footswitch is reused from reference device Veradius Unity (K142708). The change does not introduce new risks, but only minor update to existing risks compared to the predicate device. This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence. | | DICOM connectivity | Current DICOM connectivity | Improved DICOM connectivity workflow · Easier selection of patient data for export • Introduced unattended network transfer of export jobs • Integrated workflow for export to local | The improvements are ease-of-use improvements, fully compliant with the DICOM standard and do not impact clinical functionality. The changes are shown to be compliant with the international and FDA recognized standard IEC62366 for application of usability engineering. Therefore, this change does not impact safety or effectiveness of the | | | | media (USB and DICOM DVD) • Improved workflow for multimodality viewer functionality • Improved DICOM transfer speed | demonstrating device. Thus, substanti…

Zenition 50

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

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