ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Device Description

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:

Footrest ●
Hand Grips 0

Radiation Protection Accessories

Flexible Radiation Protection Apron 0
Front Radiation Protection Apron ●
Additional Accessories (Optional)
Monitor Trolley ●
Monitor Ceiling Suspension
Parking Frame for Accessories ●
Shoulder Support ●
Side bar ●
Compression Belt ●
Adjustable Lateral Cassette Holder
Leg Supports
o Infusion Bottle Holder
Arm Support for Catheterization
Ankle Clamps
Overhead Hand Grip
Adult Headrest
Mattress
Rotatable Stool for Footrest
Pediatric Micturition Set
Stretch Grip for Wall Stand
Bar Code Scanner o
Patient Support ●
o Stitching Ruler

Accessories for the SkyPlate Detector (Optional)

Mobile Detector Holder ●
Detector Holder Patient Bed ●
Portable Panel Protector ●
Detector Handle ●
WPD Bags ●
o Grids for SkyPlate Detector large

The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:

Eleva Workspot and RF Viewer ●
UPS for Eleva Workspot (Optional) ●
Table ●
Indication Box ●
Foot Switch
Ceiling Suspension Motorized CSM3 (Optional) ●
Wall Stand (Vertical Stand VS2) (Optional)
SkyPlate / Portable Detector (Optional) 0

The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like Xray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

AI/ML Overview

The information provided is about a regulatory submission (510(k)) to the FDA for a medical device called ProxiDiagnost N90 / Precision CRF. This type of submission aims to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. Therefore, the "study" referred to is primarily focused on demonstrating this equivalence rather than a traditional clinical study proving novel efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the acceptance criteria in terms of compliance with various FDA-recognized standards and guidance documents, and the reported device performance is that it "Passes" these criteria. The safety and effectiveness of the device are deemed "Equivalent" to the predicate device.

Acceptance Criteria (What the device must meet)	Reported Device Performance (How the device performed)
Compliance with FDA-recognized consensus standards and guidance documents for medical electrical equipment, radiation protection, usability, software life cycle, risk management, and biological evaluation (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62304, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-2-28, IEC 6220-1-3).	The proposed device ProxiDiagnost N90 / Precision CRF complies with these standards. Test results demonstrate that the device conforms to its specifications and is safe and effective for its intended use.
Compliance with specific FDA guidance documents for Solid State X-Ray Imaging Devices (Sept 1, 2016).	The proposed device complies. "The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837)." "Image quality testing has been performed on the proposed device for the changes that are affecting the image quality."
Compliance with FDA guidance for Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).	The proposed device complies. "The software for the proposed device ProxiDiagnost N90 / Precision CRF has the same 'Level of concern (Moderate)' as that of the predicate device (K212837). The software verification testing has been conducted as per the level of concern."
Compliance with FDA guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (Nov 2017).	The proposed device complies. "The changes made to the proposed device do not affect the pediatric application. The indication for use of the proposed device is the same as the predicate device (K212837)."
Compliance with FDA guidance for Radio Frequency Wireless Technology in Medical Devices (Aug 14, 2013).	The proposed device complies. "All the radiofrequency components of the predicate device (K212837) and proposed device are the same except for the replacement of Bluetooth remote control in the predicate device by infrared remote control in the proposed device. The verification testing has been conducted for the safety and efficacy of the remote control."
Compliance with FDA guidance for Management of Cybersecurity in Medical Devices (Oct 2, 2014, and updated Sep 2023).	The proposed device complies. "A set of cybersecurity controls to assure proposed device's cybersecurity and maintain medical device functionality and safety are in place. Cybersecurity plan and risk document are prepared..." "Results demonstrate that the test complies with the Cybersecurity requirements."
Specific Verification Tests	Results
System Verification testing (System conforms to system requirements)	Pass. System verification test activities substantiate that the system conforms to the system requirements.
Software verification testing (Software conforms to requirements)	Pass. Software verification test activities substantiate that the software conforms to the requirements.
Risk control (System meets defined risk control measures)	Pass. System meets the defined risk control measures.
Cybersecurity testing	Pass. Results demonstrate that the test complies with the Cybersecurity requirements.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing and mentions "non-clinical performance test data" and "tests performed on the proposed ProxiDiagnost N90 / Precision CRF". This type of submission relies on engineering and design verification/validation, not patient data in the sense of a clinical trial. Therefore, there is no information on a "test set" sample size in terms of patient data or data provenance (country of origin, retrospective/prospective). The testing was conducted on manufactured devices and their components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Again, for this type of non-clinical submission, there is no mention of experts establishing a "ground truth" for a test set in the clinical image interpretation sense. The "ground truth" for non-clinical performance refers to the device's adherence to engineering specifications and regulatory standards, which are verified through various tests and reports.

4. Adjudication Method:

Given that this is not a study involving human reader interpretation of images for diagnosis, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "There is no clinical data submitted in this 510(k) premarket notification." The purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical performance and a comparison of technological characteristics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Based on the information, this is an X-ray system, not an AI algorithm for image interpretation. The "Eleva software" is described as used by an operator to "preset examination data and to generate, process and handle digital x-ray images." While software verification testing was done, it pertains to the functionality of the system's control and image processing, not a standalone diagnostic algorithm. Therefore, a standalone AI algorithm study was not performed.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" is effectively the engineering specifications and the requirements outlined in the FDA-recognized consensus standards and guidance documents. For example, the "System Verification testing" aims to confirm that the "system conforms to the system requirements," which serve as the ground truth for that specific test.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI diagnostic algorithm, there is no "training set" in the context of machine learning. The device is a traditional X-ray imaging system with integrated software for image acquisition and processing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as point 8.

Summary

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January 11, 2024

Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, Hamburg 22335 GERMANY

Re: K233945

Trade/Device Name: ProxiDiagnost N90 / Precision CRF (706110, 706400) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: December 14, 2023 Received: December 14, 2023

Dear Ming Xiao:

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)

K233945

Device Name

ProxiDiagnost N90 / Precision CRF (706110, 706400)

Indications for Use (Describe)

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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510(k) Summary of Safety and Effectiveness

K233945

This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR క్తి807.92.

Preparation Date:	December 14th., 2023
510(k) Owner:	Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 Hamburg, GERMANYEstablishment registration number: 3003768251
Primary Contact:	Ming XiaoRegulatory Affairs Manager Diagnostic X-Ray (DXR)Phone: +49(40) 34971-2306E-mail: ming.xiao@philips.com
Secondary Contact:	Shalin DaveHead of Regulatory Affairs Diagnostic X-Ray (DXR)Phone: +31(6) 42532604E-mail: shalin.dave@philips.com
Proposed Device
Device Name	ProxiDiagnost N90 / Precision CRF (706110, 706400)
Legal Manufacturer	Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 Hamburg, GERMANY
Classification Name:	Image-intensified Fluoroscopic X-ray System
Classification Regulation:	21 CFR Part 892.1650
Classification Panel:	90 - Radiology
Device Class:	Class II
Classification Product Code:	JAA
Subsequent Product Code:	KPR
Predicate Device
Device Name	ProxiDiagnost N90 (K212837, September 21, 2021)
Legal Manufacturer	Philips Medical Systems DMC GmbHRöntgenstrasse 2422335 Hamburg, GERMANY
Classification Name:	Image-intensified Fluoroscopic X-ray System
Classification Regulation:	21 CFR Part 892.1650
Classification Panel:	90 – Radiology
Device Class:	Class II
Classification Product Code:	JAA
Subsequent Product Code:	KPR

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Device Description

The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:

Footrest ●
Hand Grips 0

Radiation Protection Accessories

Flexible Radiation Protection Apron 0

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Front Radiation Protection Apron ●
Additional Accessories (Optional)
Monitor Trolley ●
Monitor Ceiling Suspension
Parking Frame for Accessories ●
Shoulder Support ●
Side bar ●
Compression Belt ●
Adjustable Lateral Cassette Holder
Leg Supports
o Infusion Bottle Holder
Arm Support for Catheterization
Ankle Clamps
Overhead Hand Grip
Adult Headrest
Mattress
Rotatable Stool for Footrest
Pediatric Micturition Set
Stretch Grip for Wall Stand
Bar Code Scanner o
Patient Support ●
o Stitching Ruler

Accessories for the SkyPlate Detector (Optional)

Mobile Detector Holder ●
Detector Holder Patient Bed ●
Portable Panel Protector ●
Detector Handle ●
WPD Bags ●
o Grids for SkyPlate Detector large

The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:

Eleva Workspot and RF Viewer ●
UPS for Eleva Workspot (Optional) ●
Table ●
Indication Box ●
Foot Switch
Ceiling Suspension Motorized CSM3 (Optional) ●
Wall Stand (Vertical Stand VS2) (Optional)
SkyPlate / Portable Detector (Optional) 0

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image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

Indication for Use:

Comparison to Predicate Device / Design Changes Summary:

The proposed ProxiDiagnost N90 / Precision CRF uses the same workflow as the predicate device ProxiDiangost N90 (K212837) with only the following modifications. Differences on the proposed device with respect to the predicate device ProxiDiagnost N90 (K212837) are as follows:

1. Change #1: Modifications to System Software Baseline upgrade releases for ProxiDiagnost N90
- Release Version R1.1.0 was internally released only, never released a) for production, based on predicate device ProxiDiagnost N90 (K212837)
- b) Release Version R1.1.1 was released based on design changes on Software updates
- c) Release Version R1.1.2 was aborted
- Release Version R1.1.3 is for proposed device ProxiDiagnost N90 d) per current submission