Who is the manufacturer of Zenition 30?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for Zenition 30 (K232420).

What is the FDA product code for Zenition 30?

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 30?

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

Who can help prepare an FDA 510(k) submission like Zenition 30?

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 30

K232420 · Philips Medical Systems Nederland B.V. · OWB · Feb 16, 2024 · Radiology

Device Facts

Record ID	K232420
Device Name	Zenition 30
Applicant	Philips Medical Systems Nederland B.V.
Product Code	OWB · Radiology
Decision Date	Feb 16, 2024
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1650
Device Class	Class 2

Indications for Use

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

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. Used in OR and clinical settings by trained healthcare professionals. System transforms X-ray signals via flat panel detector and PC-based processing (Xres-3 algorithm) into visual images for real-time guidance. Provides radiological visualization to assist clinicians during interventional/surgical procedures; enables dose management via collimation, anti-scatter grid, and real-time monitoring. Benefits include improved maneuverability, reduced manual effort via electromagnetic brakes, and optimized dose control for pediatric patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including verification of technical characteristics (DQE, resolution, dose management) per FDA guidance for solid-state X-ray imaging devices and compliance with consensus standards (IEC 60601 series, ISO 14971).

Technological Characteristics

Mobile C-arm X-ray system. Components: HF generator (4kW), fixed anode X-ray tube, PIXIUM 2020S-p flat panel detector, electromagnetic brakes. Connectivity: DICOM. Software: PC-based (Windows 10). Safety: Thermal switches, collimation, anti-scatter grid. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-43, 60601-2-54, IEC 62304, ISO 14971.

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients (orthopedic, neuro, abdominal, vascular, thoracic, cardiac).

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

Zenition 70 (K212813)

Submission Summary (Full Text)

{0}------------------------------------------------ February 16, 2024 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ### 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 complete 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." {3}------------------------------------------------ # K232420 # 510 (k) Summary The 510(k) Summary is given in the below pages. {4}------------------------------------------------ ## 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 7028039288 E-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 | | Primary Predicate Device: | 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 | {5}------------------------------------------------ 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 currently marketed and predicate device, Zenition 70 | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device Zenition 70 (K212813) | Proposed Zenition 30 (K232420) | Conclusion | | Indications for Use | | | | The Zenition 70 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 | The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: ● Orthopedic ● Neuro ● Abdominal ● Vascular ● Thoracic ● Cardiac | Substantially Equivalent SE analysis: Same Both the proposed Zenition 30 and currently marketed predicate device Zenition 70 are intended for radiological guidance and visualization during diagnostic, interventional and surgical procedures. The clinical application areas for both predicate Zenition 70 and the subject device Zenition 30 are the same. The proposed Zenition 30 is equipped with dedicated | {6}------------------------------------------------ | environment in a variety of procedures. | pediatric mode and capable of automatic dose control based on the subject size. | |--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applications: • Orthopedic • Neuro • Abdominal • Vascular • Thoracic • Cardiac | The moment user selects the pediatric mode for acquisition, a popup message will appear on the screen to remove the grid from the flat detector to optimize the dose. The Grid is placed in such a way that it can be easily removed without use of tools. | | | Zenition 30 has been validated on different types of phantom representing the pediatric and adult population. | | | Therefore, Zenition 30 demonstrates substantial equivalence with predicate Zenition 70 in terms of intended use. and do not raise questions of safety and 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. {7}------------------------------------------------ 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-ray housing assembly | iXion 5 Monoblock, model identification: 10454900 | I-40S, 3.5RF, model identification: 101.01.179.001 | As both systems support a minimum limiting resolution of > =2.2 lp/mm in all detector modes, this demonstrates a similarity in the resolutions delivered to support the intended use. | | | -Active oil circulation -Monoblock heat content: 1350kJ -Safety mechanisms: Thermal Switch -filtration: 1mm Al+0.1mmCu -fluoro time: 296W for 60mins | -Active oil circulation -Monoblock heat content: 1056kJ -Safety mechanisms: Thermal Switch -filtration: 3.8mmAl+0.1mmCu -fluoro time: 300W @ 50mins, 600W @ 20mins | There is no clinically significant difference in the safety and clinical performance of Zenition 30 as compared to predicate Zenition 70. | | | | | Both the devices comply to applicable x-ray safety standards (e.g., IEC 60601-1-3, 2.1edition). | | | | | Conclusion: Similar and substantially equivalent, technological characteristics of the devices do not raise questions of safety and effectiveness | | | | | The monoblock is the combination of x-ray tube, transformer and cooling oil. | | | | | Having active oil circulation within the monoblock helps in heat dissipation and more available x-ray time. The proposed device Zenition 30 has similar heat performance compared to the predicate device Zenition 70. There are no technological significant difference in the safety and clinical performance of the devices. | | | | | Both the devices Zenition 70 and Zenition 30 use the same safety mechanism of thermal switch to address undesirable overheating scenarios. | | | | | Cu and Al filtration are meant to remove the low energy x-ray part of the spectrum that is not contributing to the imaging. The inherent filtration is better in Zenition 30 compared to the predecessor device Zenition 70. | | | | | Conclusion: | | | | | Similar and substantially equivalent | | | | | The proposed device Zenition 30 is having similar heat performance as compared to the predicate Zenition 70. Both the devices share the same safety mechanism of thermal switch to | | | | | | | | | | address undesirable overheating scenarios. Additionally, the inherent filtration is better in Zenition 30 compared to the predecessor device Zenition 70. | | | | | Hence, we can conclude that both the devices share the same technological characteristics with no significant difference in the safety and effectiveness of the devices. | | Flat Panel Detector | Model: 45980120023x | Model: PIXIUM 2020S- p | Both Zenition 30 and the predicate device Zenition 70 systems use a Flat Panel (FP) digital image detector technology. | | | -Frame rate: 30fps -Zoom modes: Overview mode + 2 zoom modes | -Frame rate: 30fps -Zoom modes: Overview mode + 2 zoom modes | | | | -Detector size (x/y): 207mm x 207mm (square) | -Detector size (x/y): 204mm x 204mm (square) | The detector used in proposed device Zenition 30 is based on the same design, scientific technology and image acquisition workflow as the Flat Panel digital image detector used in the predicate Zenition 70. The frame rates of both detectors are also the 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 are not significantly different (207 x 207 mm2 versus 204 x 204 mm2) for the predicate device Zenition 70 and the proposed device Zenition 30. Additionally, the number of zoom modes are also identical for both the devices. | | | | | The pixel pitch of the Zenition 30 is 200 μm, which is similar to the pixel pitch of the predicate Zenition 70 (154 μm). However, the final resolution seen at the system level is result of multiple factors. At Zenition 30, Zenition 70 system level, both systems demonstrate a limiting resolution > 2.2 lp/mm in all detector modes due to similar anode angle and focal spot used for the majority of the applications. | | | | | DQE (detective quantum efficiency) is a measure for the x-ray dose sensitivity of the detector and defines the image quality generated from the detector. | | | | | The DQE is similar for both the detectors used in predicate Zenition | | Imaging Processing technology | Xres-3 | Xres-3 | 30 with the sensitivity of the Zenition 30 being slightly higher. Better sensitivity of detector used in Zenition 30 will have an advantage over the predicate Zenition 70 in terms of image quality with same or lower X-Ray Dose. There is no change in clinically relevant characteristics of the detector used in both the devices that relate to the acquisition to X-ray images and X-ray dose sensitivity. Conclusion: Similar and substantially equivalent We can conclude that both the devices share the same technological characteristics with no significant difference in the safety and effectiveness of the devices The predicate device Zenition 70 and the proposed device Zenition 30 both are using the same PC-based platform and algorithm. Conclusion: Same and substantially equivalent | | Anti Scatter Grid | Removable grid (square) Transmission: 70% | Removable grid (square) Transmission: 70% | The proposed Zenition 30 has a square removable grid, the same as of<b…

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