Who is the manufacturer of Zenition 90?

Philips Medical Systems Nederlands B.V. filed the 510(k) submission for Zenition 90 (K240224).

What is the FDA product code for Zenition 90?

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 90?

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

Who can help prepare an FDA 510(k) submission like Zenition 90?

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 90

K240224 · Philips Medical Systems Nederlands B.V. · OWB · May 22, 2024 · Radiology

Device Facts

Record ID	K240224
Device Name	Zenition 90
Applicant	Philips Medical Systems Nederlands B.V.
Product Code	OWB · Radiology
Decision Date	May 22, 2024
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended 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 and outside 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 a C-arm stand and Mobile View Station (MVS). Inputs: X-ray radiation transmitted through patient anatomy. Transformation: X-ray generator and tube assembly produce X-rays; flat panel detector captures images; system processes images using Xres-3 software. Outputs: Real-time fluoroscopic images displayed on MVS for clinician viewing. Used in OR and clinical settings by trained healthcare professionals. Features motorized 3-axis C-arm movement, electromagnetic brakes, and integrated injector interface for X-ray delay. Includes Automatic Vascular Outlining (AVO) for ease of use. Output assists clinicians in real-time guidance during interventional/surgical procedures, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, 60601-2-43, 60601-2-54, 60601-1-2, 60601-1-3, 60601-1-6, IEC 62304, ISO 14971, and IEC 62366-1. Validation testing confirmed intended use, commercial claims, safety measures, and usability with representative users.

Technological Characteristics

Mobile C-arm X-ray system. Rotating anode X-ray tube (RTM 780 H, RO-0306), dual focal spot (0.3/0.6), 10° target angle. 15kW/25kW generator. Flat panel detector (207mm x 207mm or 301mm x 301mm, 154μm pixel pitch, 77% DQE). Motorized 3-axis movement, electromagnetic brakes. Connectivity: DICOM. Software: PC-based, Windows 10. Sterilization: N/A (device is mobile imaging equipment).

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures for all patients, including neonates, in healthcare facilities (OR and non-OR settings). Applications include orthopedic, neuro, abdominal, vascular, thoracic, and cardiac procedures.

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)

Related Devices

K183101 — Zenition 50 · Philips Medical Systems Nederland B.V. · Dec 31, 2018
K232420 — Zenition 30 · Philips Medical Systems Nederland B.V. · Feb 16, 2024
K153232 — Cios Select · Siemens Medical Solutions USA, Inc. · Feb 10, 2016
K073346 — ZIEHM VISION 2 · Ziehm Imaging, Inc. · Mar 21, 2008
K231700 — Ziehm Vision FD · Ziehm Imaging GmbH · Dec 15, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 22, 2024 Philips Medical Systems Nederlands B.V. % Rahul Kumar Sinha Regulatory Approbation Officer Veenpluis 6 Best. NB 5684 PC NETHERLANDS Re: K240224 Trade/Device Name: Zenition 90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: January 25, 2024 Received: April 22, 2024 Dear Rahul Kumar Sinha: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use Submission Number (if known) #### K240224 Device Name Zenition 90 #### Indications for Use (Describe) The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: - · Orthopedic - · Neuro - Abdominal - · Vascular - · Thoracic - · Cardiac Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # PHILIPS - IGT Systems 510(k) Number: K240224 ## 510 (k) Summary The 510(k) Summary is given in the below pages. {4}------------------------------------------------ ### 510(k) Summary K240224 This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared | January 25, 2024 | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V. | | | | Veenpluis 6 | | | | 5684 PC Best | | | | The Netherlands | | | | Establishment Registration Number: 3003768277 | | | Primary Contact Person: | Rahul Kumar Sinha Regulatory Approbation Officer Phone: +91 9940259360 E-mail: rahulkumar.sinha@philips.com | | | Secondary Contact Person: | Neena Sonavane Regulatory Affairs Leader Phone: +91-8446020023 E-mail: neena.sonavane@philips.com | | | Device: | Trade Name: | Zenition 90 | | | Classification Name: | Image-intensified fluoroscopic x-ray system | | | Classification Regulation: | 21CFR §892.1650 | | | Classification Panel: | 90-Radiology | | | Device Class: | Class II | | | Primary Product Code: | OWB | | | Secondary Product Code: | JAA, OXO | | 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}------------------------------------------------ Device The proposed Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for description: medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station (MVS). The proposed Zenition 90 is used for radiological guidance and visualization during diagnostic, Indications for interventional and surgical procedures on all patients. The device is to be used in health care facilities Use: both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: - Orthopedic - . Neuro - Abdominal ● - Vascular ● - Thoracic - . Cardiac The proposed Zenition 90 demonstrates substantial equivalence with predicate Zenition 70 in terms of intended use. and do not raise questions of safety and effectiveness. | Table 1. Indications for use comparison of the proposed Zenition 90 versus the currently marketed and predicate device, Zenition 70 | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device Zenition 70 | Proposed Zenition 90 | 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 environment in a variety of procedures. Applications: ● Orthopedic ● Neuro ● Abdominal | 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 The proposed Zenition 90 is used for all patients including neonates (birth to one month). The safety and effectiveness is in line with FDA guidance "Pediatric information for x- ray imaging device premarket notifications" Therefore, proposed Zenition 90 demonstrates substantial equivalence with predicate Zenition 70 in terms of intended use and is safe and effective. | {6}------------------------------------------------ | • Vascular | | | |------------|--|--| | • Thoracic | | | | • Cardiac | | | Fundamental Scientific Technology: The proposed Zenition 90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Zenition 70. The technology used in the development of the major components of the proposed Zenition 90, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is similar to the currently marketed and predicate Zenition 70. Table 2 shows that the proposed Zenition 90 is considered substantially equivalent to the currently marketed predicate, Zenition 70 in terms of major components and technological characteristics. {7}------------------------------------------------ | Component /feature | Currently market Zenition 70 | Proposed Zenition 90 | Conclusion | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | C-arm motions and brakes | Manual | Motorized | The c-arm movements are motorized in Zenition 90 as against manual in Zenition 70. The Zenition 70 system provide manual brake levers to release and lock the brakes while Zenition 90 system uses electromagnetic brakes to release or lock the c-arm axis to simplify the workflow. Motorized movement and the electromagnetic brakes are an added advantage in Zenition 90 compared to the equivalent devices Zenition 70. Zenition 90 introduces motorized movement in 3 axis (angulation, rotation, and longitudinal) that are manual in Zenition 70. Conclusion: Similar and substantially equivalent | | X-ray Generator | -Peak output power: 15 kW | -Peak output power: 15kW/25kW | The kV range of proposed Zenition 90 is the same as compared to the predicate Zenition 70. The maximum mA of the Zenition 90 (15kW) is the same compared to the Zenition 70. While in Zenition 90 we also have a 25kW version, where higher mA is possible. Make of Generators are different in both the devices however, the technology, energy source and output are similar. This change does not impact the safety and effectiveness of the device. Thus, demonstrating substantial equivalence. Conclusion: Similar and substantially equivalent | | X-ray tube | -Rotating Anode (Model: RTM 780 H (Type RO-0306) | - Rotating Anode (Model: RTM 780 H (Type RO-0306) | The design and characteristics of X-ray tube of subject device Zenition 90 and the predicate device Zenition 70 are the same and from same supplier. Conclusion: Same and substantially equivalent | | | -Focal spot: dual (0.3 & 0.6) -Target angle: 10° | Focal spot: dual (0.3 & 0.6) Target angle: 10° | | | | -Anode heat content: 225kJ | Anode heat content: 225kJ | | | | -Maximum anode cooling rate: 550W | Maximum anode cooling rate: 550W | | | | -Nominal anode input power: 15kW | -Nominal anode input power: 15kW | | | | | -Nominal anode input power: 25kW | | | Monoblock | | | The Monoblock is the combination of x-ray tube, transformer, cooling oil and oil pump. | | Oil circulation | Active oil circulation with AC Pump | Active oil circulation with DC Pump | The proposed device Zenition 90 has similar heat performance compared to the predicate | | Monoblock heat content | Monoblock heat content: 1350kJ | Monoblock heat content: 1350kJ | device Zenition 70. There are no technological significant difference in the safety and clinical performance of the devices. | | Safety mechanisms | Safety mechanisms: Thermal Switch | Safety mechanisms: Thermal Switch | Proposed device Zenition 90 uses DC oil pump while the predicate Zenition 70 uses AC oil | | Inherent filtration | filtration | filtration | pump. DC Pump in Zenition 90 helps for better Oil circulation with lower power consumption which results in lower energy losses. | | Fluoro time | fluoro time: 296W for 60mins | fluoro time: 296W for 60mins | Both the devices Zenition 70 and Zenition 90 use the same safety mechanism of thermal switch to address undesirable overheating scenarios. | | | | | Conclusion: Same and substantially equivalent | | Flat Panel Detector / Image Intensifier | | | The subject device Zenition 90 uses the same flat panel detector which has been previously cleared in predicate device Zenition 70 (K212813) and sourced from the same supplier. | | - Frame rate | Frame rate: 30fps | Frame rate: 30fps | | | - Zoom modes | Zoom modes: Overview mode + 2 zoom modes | Zoom modes: Overview mode + 2 zoom modes | | | - Detector size ( x/y) | -Detector size (x/y): 207mm x 207mm (square) | Detector size (x/y): 207mm x 207mm (square) | | | | - Detector size (x/y): 301mm x 301mm (square) | Detector size (x/y): 301mm x 301mm (square) | | | - Pixel pitch - Image matrix | pixel pitch: 154 $\mu$ m Image matrix: 1344x1344 DQE: 77% | pixel pitch: 154 $\mu$ m Image matrix: 1344x1344 DQE: 77% | | | - "Detector quantum efficiency (DQE) | Pixel pitch: 154 $\mu$ m | Pixel pitch: 154 $\mu$ m | | | | Image matrix: 1000x1000 DQE: 77% | Image matrix: 1000x1000 DQE: 77% | Conclusion: Same and substantially equivalent | | Imaging Processing | Xres-3 | Xres-3 | The predicate device Zenition 70 and the proposed device Zenition 90 both use the same | | | | | Conclusion: | | | | | Same and substantially equivalent | | Anti Scatter Grid | Removable grid (square) | Removable grid (square) | The proposed Zenition 90 has same as of predicate Zenition 70 | | | Transmission: 70% | Transmission: 70% | Conclusion: Same and substantially equivalent | | Radiation safety features | Collimation | Collimation…

Zenition 90

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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