The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologists and radiographers 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 babies, 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 Vascular Thoracic Cardiac

Device Description

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures.

The device consists mainly of two parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, mains control unit, an user interface for image/patient handling and optionally an integrated workstation).

All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

AI/ML Overview

Here's an analysis of the provided text regarding the Veradius device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided 510(k) summary is for a new version of a mobile C-arm X-ray system, where the primary change is the Image Detection Subsystem (IDS), specifically replacing an Image Intensifier with a Flat Detector. The summary emphasizes substantial equivalence to a predicate device (Pulsera K061685). Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the new component (IDS) does not compromise image quality or safety and maintains the same intended use as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (substantial equivalence for a component change), the acceptance criteria are not explicitly stated in quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they relate to overall image quality and functional equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain or Improve Image Quality compared to predicate device. (This is the core functional acceptance criterion due to the change in the IDS from Image Intensifier to Flat Detector.)	"Based on comparison between images pairs taken during non-clinical performance tests with the Veradius and its predicate device, it can be concluded that the Image Quality is equal or even better." (Page 3, Section 8)The new IDS detects X-rays and converts them to digital images, applying calibration to obtain required data, functionally similar to the predicate's IDS. (Page 2, Section 5)
No new indications for use.	"The Veradius does not introduce any new indications for use..." (Page 2, Section 7)"Indications for Use are equal to Pulsera." (Page 3, Table 1, Row 9)The Indications for Use statement on Page 5 is identical to the general description of the predicate's use.
No new potential hazards or effects on safety.	"Nor does the use of the device result in any new potential hazard." (Page 2, Section 7)"The new technologic characteristic does not affect safety or introduce any new type of hazards." (Page 2, Section 7)"A product risk management is executed and all risks are reduced to an acceptable level by implementation and verification of appropriate measures." (Page 3, Section 9)The Level of Software concern is MODERATE (Page 3, Section 9).
Maintain substantial equivalence to predicate device.	"Philips Medical Systems Nederland BV considers the Veradius to be substantially equivalent with the predicate device." (Page 2, Section 7)"Results of the conducted tests conclude that the Veradius is substantial equivalent to its predicate device." (Page 3, Section 8)
Function as intended for specified applications.	The device is intended for "radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies," across various applications (Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac). (Page 2, Section 6 and Page 5, Indications for Use)Non-clinical and clinical tests were performed to "verify and validate the system functionality for the intended use." (Page 3, Section 8)

Study Details from the Provided Text:

This document is a premarket notification (510(k)), not a detailed study report. As such, it provides summary statements rather than in-depth methodological details of the studies.

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

Sample Size for Test Set: Not explicitly stated. The text mentions "comparison between images pairs taken during non-clinical performance tests." This implies a set of images was used, but the quantity is not provided.
Data Provenance: The study is described as "non-clinical performance tests." This suggests the data was likely generated in a controlled, engineering-focused environment within Philips Medical Systems Nederland B.V. (The Netherlands, where the manufacturer is located). Given it's a "non-clinical" test, it likely involved phantoms or standardized test objects, not patient data in the clinical sense of "retrospective or prospective."

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. This type of detail is usually found in a full study report, which is not this document. Since the evaluation was likely "non-clinical performance tests" focused on image quality comparison, it may not have required formal adjudication of clinical diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not explicitly mentioned or described. The performance evaluation focuses on "Image Quality is equal or even better" based on the "comparison between images pairs taken during non-clinical performance tests." This typically implies objective measurements or subjective comparison by engineers/specialists, not a formal MRMC study involving human readers diagnosing clinical cases with and without AI assistance (as this is an X-ray system, not an AI diagnostic tool in the modern sense).

6. If a Standalone Performance (Algorithm Only) Was Done

Standalone Performance: The description of "non-clinical performance tests" to evaluate "Image Quality" of the new "Image Detection Subsystem (IDS)" is essentially a standalone performance evaluation of the system's image acquisition and processing capabilities. The IDS itself is an algorithm-driven component (converting X-rays to digital images and applying calibration). However, it's not "algorithm only" in the sense of a pure AI diagnostic software; it's a core hardware/software component of the imaging chain.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Type of Ground Truth: Not explicitly stated. For "non-clinical performance tests" assessing "Image Quality," the ground truth likely involved:
- Objective image quality metrics: Such as spatial resolution, contrast-to-noise ratio, modulation transfer function (MTF), dose efficiency, etc., measured using phantoms.
- Reference images: Comparison against images produced by the predicate device under identical conditions, or against established standards for image quality.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable in the context of advanced AI models that require large training datasets. The "Veradius" is a C-arm X-ray system with a new detector, not an AI diagnostic algorithm that learns from vast image datasets to identify pathologies. The "IDS" performs image conversion and calibration, which are rule-based or empirically derived processes, not deep learning-based training.

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

Ground Truth for Training Set: Not applicable for the same reasons as #8. The "training" of such a system would involve engineering and calibration procedures during design and manufacturing, not data-driven machine learning.

Summary Takeaway:

This 510(k) emphasizes substantial equivalence for a physical device (mobile C-arm X-ray system) with a component change (detector type). The "studies" mentioned are "non-clinical performance tests" designed to show that the new detector either maintains or improves image quality and that the overall system remains as safe and effective as its predicate. It is not an AI diagnostic device, so many of the requested details concerning AI-specific study methodologies (MRMC, large training sets, expert consensus for ground truth) are not present in this type of submission.

Summary

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K09.05-590

510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

Page 1 of 3 November 10, 2008

510(k) Summary of Veradius device

MAR 1 6 2009

In accordance with the requirements of 21 CFR 807.92

1) Submitted by

Philips Medical Systems North America Company 22100 Bothell Everett Highway Bothell, WA 98021 Establishment Registration No. 1217116

Contact: Phone: Fax: Email: Date prepared: Lynn Harmer (425) 487-7312 (425) 487-8666 lynn.harmer@philips.com November 10, 2008

2) Manufacturer

Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration No. 3003768277

3) Device name and classification

Trade name: VERADIUS Classification name: System, x-ray, mobile and Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification panel: Radiology devices Regulatory status: Class II 21CFR 892.1720 Class II (IZL) and 21 CFR Device classification reg.nr: 892.1650 Class II (MQB)

4) Predicate device

Device name: K-Number: Trade name: Manufacturer:

Pulsera K061685 3D-RX Option for BV Pulsera, Release 2.2 Philips Medical Systems Nederland B.V.

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510(k) Premarket Notification. Veradius Philips Medical Systems Nederland B.V.

Page 2 of 3 November 10, 2008

5) Device description (summarized)

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures.

All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

6) Indications for Use

Applications:

Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

7) Technological characteristics and substantial equivalence

The Veradius does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems Nederland BV considers the Veradius to be substantially equivalent with the predicate device.

The Veradius is a mobile X-ray system consisting of components mention in Table 1 Device Comparison.

All units are the same as in the predicate device and known to FDA, except 4 and 5.

Image Detection Subsystem

The Image Detection Subsystem (IDS) is new. For the Veradius the IDS based on an Image Intensifier is replaced by an IDS with a Flat Detector. The IDS detect X-rays and convert them to digital images, and apply calibration to obtain the required data.

The function (intended use) of the Image Detection Subsystem is not different from its predicate device. Only the technologic characteristics are different.

The new IDS consist out of an anti scatter grid, a flat dynamic X-ray detector and a detector controller. The new technologic characteristic does not affect safety or introduce any new type of hazards.

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510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

Table 1 Device Comparison

		Pulsera		Veradius
		Manufacturer	Model	Manufacturer	Type
1	X-ray generator	Gilardoni	iXion HF Generator	Gilardoni	iXion HF Generator
2	X-ray tubehousingassembly	Gilardoni	iXion Monoblock withX-ray tube from PhilipsRO-0306	Gilardoni	iXion Monoblock withX-ray tube from PhilipsRO-0306
3	Beam LimitingDevice	PMS Ned. BV	X-ray beam collimatorBV300	PMS Ned. BV	X-ray beam collimatorBV300
4	Image DetectionSubsystem	PMS Ned. BV	IDS-7Circular grid.Detector is a 9" or 12"II with digital camera.Controller integrated incamera.	PMS Ned. BV	FDS S FL1.1Rectangular grid.Flat detector.Separate FDcontroller.
5	Detector laseraiming device	LAB Laser	Mounted with beltaround II	PMS Ned. BV	Integrated in FDcovers.
6	Laser AlignmentTool	PMS Ned. BV	Laser Alignment ToolBV300	PMS Ned. BV	Laser Alignment ToolBV300
7	Mobile C-armStand	PMS Ned. BV	C-arm Stand BVFamily R2	PMS Ned. BV	C-arm Stand BVFamily R2
8	Mobile ViewingStation	PMS Ned. BV	MVS BV Family R2	PMS Ned. BV	MVS BV Family R2
9	Indications forUse	PMS Ned. BV	Refer to 510(k)K061685	PMS Ned. BV	Indications for Use areequal to Pulsera. Referto chapter 6.

8) Non-Clinical and Clinical performance tests

Non-Clinical and clinical tests have been performed to verify and validate the system functionality for the intended use. Results of the conducted tests conclude that the Veradius is substantial equivalent to its predicate device.

Based on comparison between tmages pairs laken during non-clinical performance tests with the Veradius and its predicate device, it can be concluded that the Image Quality is equal or even better.

9) Safety information

The Level of Software concern is MODERATE as determined according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May/11/2005.

A product risk management is executed and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUL 30 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Philips Medical Systems, North America Company % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K090590 Trade/Device Name: Veradius Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: March 3. 2009 Received: March 4, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of March 16, 2009.

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 (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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

Page 1 of 1 November 10, 2008

Indications for Use

510(k) Number (if known):

Device Name: Veradius

Indications For Use:

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologist, radiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

Applications:

Orthopedic Neuro Abdominal Vascular

Thoracic

Cardiac

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

Section A6

Regulation Number and Section

§ 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.