Zenition 90
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 |
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 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)
Submission Summary (Full Text)
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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).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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### 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)
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# PHILIPS - IGT Systems 510(k) Number: K240224
## 510 (k) Summary
The 510(k) Summary is given in the below pages.
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### 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<br>Contact<br>Person: | Rahul Kumar Sinha<br>Regulatory Approbation Officer<br>Phone: +91 9940259360<br>E-mail: rahulkumar.sinha@philips.com | |
| Secondary<br>Contact<br>Person: | Neena Sonavane<br>Regulatory Affairs Leader<br>Phone: +91-8446020023<br>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<br>Predicate<br>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 |
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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<br>marketed and predicate device, Zenition 70 | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device Zenition 70 | Proposed Zenition 90 | Conclusion |
| | Indications for Use | |
| The Zenition 70 device is<br>intended to be used and<br>operated by: adequately<br>trained, qualified and<br>authorized health care<br>professionals who have full<br>understanding of the safety<br>information and emergency<br>procedures as well as the<br>capabilities and functions of the<br>device.<br><br>The device is used for<br>radiological guidance and<br>visualization during diagnostic,<br>interventional and surgical<br>procedures on all patients,<br>except neonates (birth to one<br>month), within the limits of the<br>device. The device is to be used<br>in health care facilities both<br>inside and outside the operating<br>room, sterile as well as non-<br>sterile environment in a variety<br>of procedures.<br><br>Applications:<br>● Orthopedic<br>● Neuro<br>● Abdominal | The device is used for<br>radiological guidance and<br>visualization during diagnostic,<br>interventional and surgical<br>procedures on all patients. The<br>device is to be used in health care<br>facilities both inside and outside<br>the operating room, sterile as well<br>as non-sterile environment in a<br>variety of procedures.<br><br>Applications:<br>● Orthopedic<br>● Neuro<br>● Abdominal<br>● Vascular<br>● Thoracic<br>● Cardiac | Substantially Equivalent<br>SE analysis:<br>Same<br><br>The proposed Zenition 90 is<br>used for all patients including<br>neonates (birth to one month).<br>The safety and effectiveness is<br>in line with FDA guidance<br>"Pediatric information for x-<br>ray imaging device premarket<br>notifications"<br><br>Therefore, proposed Zenition<br>90 demonstrates substantial<br>equivalence with predicate<br>Zenition 70 in terms of<br>intended use and is safe and<br>effective. |
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| • 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.
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| Component<br>/feature | Currently market<br>Zenition 70 | Proposed Zenition<br>90 | Conclusion |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C-arm<br>motions and<br>brakes | Manual | Motorized | The c-arm movements are motorized in<br>Zenition 90 as against manual in Zenition 70.<br>The Zenition 70 system provide manual brake<br>levers to release and lock the brakes while<br>Zenition 90 system uses electromagnetic<br>brakes to release or lock the c-arm axis to<br>simplify the workflow.<br>Motorized movement and the electromagnetic<br>brakes are an added advantage in Zenition 90<br>compared to the equivalent devices Zenition<br>70.<br><br>Zenition 90 introduces motorized movement in<br>3 axis (angulation, rotation, and longitudinal)<br>that are manual in Zenition 70.<br><br>Conclusion:<br>Similar and substantially equivalent |
| X-ray<br>Generator | -Peak output power:<br>15 kW | -Peak output power:<br>15kW/25kW | The kV range of proposed Zenition 90 is the<br>same as compared to the predicate Zenition 70.<br><br>The maximum mA of the Zenition 90 (15kW)<br>is the same compared to the Zenition 70.<br><br>While in Zenition 90 we also have a 25kW<br>version, where higher mA is possible.<br><br>Make of Generators are different in both the<br>devices however, the technology, energy<br>source and output are similar.<br><br>This change does not impact the safety and<br>effectiveness of the device. Thus,<br>demonstrating substantial equivalence.<br><br>Conclusion:<br>Similar and substantially equivalent |
| X-ray tube | -Rotating Anode<br>(Model: RTM 780<br>H (Type RO-0306) | - Rotating Anode<br>(Model: RTM 780 H<br>(Type RO-0306) | The design and characteristics of X-ray tube of<br>subject device Zenition 90 and the predicate<br>device Zenition 70 are the same and from same<br>supplier.<br><br>Conclusion:<br>Same and substantially equivalent |
| | -Focal spot: dual<br>(0.3 & 0.6)<br>-Target angle: 10° | Focal spot: dual (0.3<br>& 0.6)<br>Target angle: 10° | |
| | -Anode heat<br>content: 225kJ | Anode heat content:<br>225kJ | |
| | -Maximum anode<br>cooling rate: 550W | Maximum anode<br>cooling rate: 550W | |
| | -Nominal anode<br>input power: 15kW | -Nominal anode input<br>power: 15kW | |
| | | -Nominal anode input<br>power: 25kW | |
| Monoblock | | | The Monoblock is the combination of x-ray<br>tube, transformer, cooling oil and oil pump. |
| Oil<br>circulation | Active oil<br>circulation with AC<br>Pump | Active oil circulation<br>with DC Pump | The proposed device Zenition 90 has similar<br>heat performance compared to the predicate |
| Monoblock<br>heat content | Monoblock heat<br>content: 1350kJ | Monoblock heat<br>content: 1350kJ | device Zenition 70. There are no technological<br>significant difference in the safety and clinical<br>performance of the devices. |
| Safety<br>mechanisms | Safety mechanisms:<br>Thermal Switch | Safety mechanisms:<br>Thermal Switch | Proposed device Zenition 90 uses DC oil pump<br>while the predicate Zenition 70 uses AC oil |
| Inherent<br>filtration | filtration | filtration | pump. DC Pump in Zenition 90 helps for better<br>Oil circulation with lower power consumption<br>which results in lower energy losses. |
| Fluoro time | fluoro time: 296W<br>for 60mins | fluoro time: 296W<br>for 60mins | Both the devices Zenition 70 and Zenition 90<br>use the same safety mechanism of thermal<br>switch to address undesirable overheating<br>scenarios. |
| | | | Conclusion:<br>Same and substantially equivalent |
| Flat Panel<br>Detector /<br>Image<br>Intensifier | | | The subject device Zenition 90 uses the same<br>flat panel detector which has been previously<br>cleared in predicate device Zenition 70<br>(K212813) and sourced from the same<br>supplier. |
| - Frame rate | Frame rate: 30fps | Frame rate: 30fps | |
| - Zoom<br>modes | Zoom modes:<br>Overview mode + 2<br>zoom modes | Zoom modes:<br>Overview mode + 2<br>zoom modes | |
| - Detector<br>size ( x/y) | -Detector size (x/y):<br>207mm x 207mm<br>(square) | Detector size (x/y):<br>207mm x 207mm<br>(square) | |
| | - Detector size (x/y):<br>301mm x 301mm<br>(square) | Detector size (x/y):<br>301mm x 301mm<br>(square) | |
| - Pixel pitch<br>- Image<br>matrix | pixel pitch: 154 $\mu$ m<br>Image matrix:<br>1344x1344<br>DQE: 77% | pixel pitch: 154 $\mu$ m<br>Image matrix:<br>1344x1344<br>DQE: 77% | |
| - "Detector<br>quantum<br>efficiency<br>(DQE) | Pixel pitch: 154 $\mu$ m | Pixel pitch: 154 $\mu$ m | |
| | Image matrix:<br>1000x1000<br>DQE: 77% | Image matrix:<br>1000x1000<br>DQE: 77% | Conclusion:<br>Same and substantially equivalent |
| Imaging<br>Processing | Xres-3 | Xres-3 | The predicate device Zenition 70 and the<br>proposed device Zenition 90 both use the same |
| | | | Conclusion: |
| | | | Same and substantially equivalent |
| Anti Scatter<br>Grid | Removable grid<br>(square) | Removable grid<br>(square) | The proposed Zenition 90 has same as of<br>predicate Zenition 70 |
| | Transmission: 70% | Transmission: 70% | Conclusion:<br>Same and substantially equivalent |
| Radiation<br>safety<br>features | Collimation | Collimation…
