(189 days)
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
The proposed Zenition 30 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).
The provided text describes the K232420 submission for the Philips Zenition 30, a mobile X-ray imaging system, and compares it to a predicate device, Zenition 70 (K212813). The submission argues for substantial equivalence based on non-clinical performance data and compliance with various standards and guidance documents. There is no multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance data mentioned, as the device is an imaging system and not an AI-powered diagnostic tool. The ground truth concept is not directly applicable in the context of validating an X-ray imaging system for substantial equivalence; rather, the focus is on meeting specified performance criteria and demonstrating that the new device operates similarly and as safely and effectively as its predicate.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and compliance with various international and FDA-recognized consensus standards and guidance documents. The reported device performance is demonstrated by the technical characteristics listed in the comparison tables and the declaration of compliance with these standards.
Table 1: Key Performance Characteristics and Comparison (Derived from Section 7, Table 2)
| Component/Feature | Acceptance Criteria (Implied from Predicate Zenition 70 and Standards) | Reported Zenition 30 Performance | Conclusion on Equivalence |
|---|---|---|---|
| X-ray Generator | - Peak output power: 15 kW (max) | - Peak output power: 4kW | - Subset of predicate's performance in terms of peak power, kV range, mA, and pulse rate. |
- Continuous X-ray mode at 30 fps is equivalent to 30pps pulsed mode of predicate.
- Clinically acceptable image quality for intended use.
- No impact on safety and effectiveness. Substantially Equivalent. |
| | - kV range: 40-120 kV | - kV Range: 40 to 110kV | |
| | - Mode of operation: Pulse (with 30 pps max) | - Pulse/ Continuous: Pulsed and Continuous (15 pps max pulsed) | |
| | - Maximum mA: 125 mA | - Maximum mA: 36mA | |
| X-ray Tube | - Rotating Anode (e.g., RTM 780 H) | - Fixed Anode (e.g., OX 125 -0612) | - Similar target angle leads to similar field of view. - 0.6 mm focal spot used for most applications, similar to predicate.
- No clinically significant difference in safety and clinical performance. Similar and substantially equivalent. |
| | - Focal spot: dual (0.3 & 0.6) | - Focal spot: dual (0.6 & 1.2) | |
| | - Target angle: 10° | - Target angle: 9° | |
| X-ray Housing Assembly | - Minimum limiting resolution: >= 2.2 lp/mm | - Minimum limiting resolution: >= 2.2 lp/mm | - Supports minimum limiting resolution of >=2.2 lp/mm. - Similar heat performance and safety mechanisms (thermal switch).
- Better inherent filtration.
- Complies with applicable X-ray safety standards (e.g., IEC 60601-1-3). Similar and substantially equivalent. |
| Flat Panel Detector | - Frame rate: 30fps | - Frame rate: 30fps | - Same design, scientific technology, and image acquisition workflow. - Similar physical size and zoom modes.
- Similar DQE (Zenition 30 slightly higher).
- Final system resolution >= 2.2 lp/mm due to similar anode angle and focal spot.
- No change in clinically relevant characteristics. Similar and substantially equivalent. |
| | - Detector size: approx. 207mm x 207mm | - Detector size: approx. 204mm x 204mm | |
| | - Pixel pitch: 154 μm | - Pixel pitch: 200 μm | |
| | - DQE: 77% | - DQE: 80% | |
| Imaging Processing Technology | Xres-3 (PC-based platform and algorithm) | Xres-3 (PC-based platform and algorithm) | Same. Substantially equivalent. |
| Anti Scatter Grid | Removable square grid, 70% transmission | Removable square grid, 70% transmission | Same technology. Similar and substantially equivalent. |
| Radiation Safety Features | Collimation, anti-scatter grid, fluoroscopy modes, pulsed fluoroscopy, recording/storing runs, last image hold, real-time dose monitoring. | Collimation, anti-scatter grid, fluoroscopy modes, pulsed fluoroscopy, recording/storing runs, last image hold, real-time dose monitoring. | Same features. Same and substantially equivalent. |
| Beam Limiting Device (Collimator) | Square (round in zooming/rotation) | Square (round in zooming/rotation) | Reuses predicate's collimator; minor modification for mounting. Performance and safety parameters remain the same. Similar and substantially equivalent. |
| C-arm Motions and Brakes | 4 axis movements (Angulation, Rotation, Longitudinal, Wigwag), 4 axis manual brakes. | 4 axis movements, 3 axis electromagnetic brakes, 1 axis manual brake. | Electromagenetic brakes improve workflow and ease of use. Usability studies and product safety assessment confirm no new risks. Similar and substantially equivalent. |
| Geometry | Hammerhead design, 206x82x162 cm, 332 Kg (FD12), 15.3" touch screen. | New design stand, 185x82x172 cm (without push bar/surgeon arm), 210x82x162 cm (with), 295 kg, 12.1" touch screen. | Improved maneuverability, lower operating forces, slimmer UI (12.1"). Improves workflow and ease of use. Similar and substantially equivalent. |
| System Architecture | PC Based Win 10 | PC Based Win 10 | Same. Same and substantially equivalent. |
| Ionizing Radiation | System uses X-ray for imaging | System uses X-ray for imaging | Same X-ray technology usage. Same and substantially equivalent. |
| Detector Laser Aiming Device | Specific model, Wavelength: 635 nm, Max output: 10mW, Beam divergence: 34 degrees. | Specific model, Wavelength: 635 nm, Max output: 10mW, Beam divergence: 34 degrees. | Same. Same and substantially equivalent. |
| Tube Laser Aiming Device | Specific model (4598 008 4322x) | Specific model (4598 008 4322x) | Same. Same and substantially equivalent. |
| DICOM Connectivity | Features for patient data export, unattended network transfer, local media export, multimodality viewer, improved transfer speed. | Same features for patient data export, unattended network transfer, local media export, multimodality viewer, improved transfer speed. | Same. Same and substantially equivalent. |
| Security Features | Local user account management, username/password combination, network time synchronization, audit trail, white listing, DIACAP hardening, disk encryption, FIPS 140-2. | Same features including local user account management, username/password combination, network time synchronization, audit trail, white listing, DIACAP hardening, disk encryption, FIPS 140-2. | Same. Same and substantially equivalent. |
| Room Interface | External x-ray and power indication interface. | External x-ray and power indication interface. | Same. Same and substantially equivalent. |
| Audible Signals | Speaker with volume control in the Stand. | Speaker with volume control in the Stand. | Same. Same and substantially equivalent. |
| Wired Footswitch and remote control unit | Same as predicate | Same as predicate | Same. Same and substantially equivalent. |
| Product Name | Zenition 70 | New Product name Zenition 30 | Labeling change only; no impact on system features, safety, and effectiveness. Substantially equivalent. |
Study Information
The document describes a non-clinical performance testing study to demonstrate compliance and substantial equivalence, rather than a clinical study focused on diagnostic accuracy or AI performance.
- Sample size used for the test set and the data provenance: Not applicable in the context of this submission, which relies on non-clinical testing and comparison to a predicate device's established performance parameters. The "test set" consisted of the physical device and its components undergoing engineering verification and validation tests. The provenance is internal to Philips Medical Systems Nederland B.V.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the performance of an X-ray imaging system is established through adherence to recognized international and FDA consensus standards (e.g., IEC 60601 series) and physical measurements, rather than expert consensus on medical images. The expertise would be in medical device engineering, physics, and regulatory affairs, not clinical interpretation of images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Device performance is evaluated against quantitative engineering specifications and standard requirements, which do not typically involve an adjudication process like those used for expert review of images.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done. This device is a new iteration of an X-ray imaging system, not an AI-assisted diagnostic tool or an image interpretation algorithm. The focus is on the fundamental performance and safety of the hardware and integrated software for image acquisition and display, not on assisting human readers with interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Zenition 30 is an X-ray imaging system, not an AI algorithm. Its performance is as a complete medical device intended for radiological guidance and visualization.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in this context, refers to the established technical specifications, safety standards (e.g., radiation dose, image resolution), and functional requirements for an X-ray imaging system. It is established through recognized international standards (e.g., IEC), FDA guidance documents, and the validated performance of the predicate device. For example, a "limiting resolution of >=2.2 lp/mm" is a measurable technical specification, not something derived from expert consensus on clinical images in this submission.
- The sample size for the training set: Not applicable. The Zenition 30 is a hardware system with integrated software, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/machine learning model. The validation and verification process involves testing the physical device and its components against predefined engineering requirements and regulatory standards.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.