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 is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures.

Applications:

Orthopedic .
· Neuro
· Abdominal
. Vascular
· Thoracic
· Cardiac

Device Description

The proposed Zenition 70 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 two main components: the C-arm stand and a mobile view station

AI/ML Overview

The provided text describes the regulatory clearance for the Philips Zenition 70, an image-intensified fluoroscopic x-ray system, based on substantial equivalence to a predicate device (Veradius Unity).

Here's an analysis of the acceptance criteria and supporting study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific quantitative acceptance criteria for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy for a diagnostic task). Instead, the acceptance criteria are framed in terms of compliance with recognized standards and guidance documents. The "reported device performance" is primarily that it meets these standards and is comparable to the predicate device.

Acceptance Criteria (General)	Reported Device Performance
Compliance with International and FDA-recognized consensus standards and FDA guidance documents.	The Zenition 70 demonstrates compliance with a comprehensive list of standards including IEC 62304, ISO 14971, IEC 60601 series (2-43, 2-54, 2-28, 1, 1-2, 1-3, 1-6), IEC 62366, and several FDA guidance documents (e.g., Solid State X-ray Imaging Devices, Software in Medical Devices, Human Factors, Cybersecurity, Radiofrequency Wireless Technology).
Adequate for its intended use.	Non-clinical validation testing covered intended use, commercial claims, service needs, user needs, effectiveness of safety measures, instructions for use, and usability testing. The device "meets the acceptance criteria and is adequate for its intended use."
No new questions regarding safety or effectiveness compared to the predicate device.	Risk management activities show all risks are sufficiently mitigated, and residual risks are acceptable. Differences do not raise new safety or effectiveness concerns.
Substantial equivalence to the predicate device (Veradius Unity) in terms of:	Demonstrated substantial equivalence based on:
a. Indication for use	Identical indications for use.
b. Technological characteristics	Employs the same basic construction and fundamental scientific technology (X-ray generator, X-ray tube, image detection, beam-limiting device) as the predicate. Modifications (e.g., improved architecture, optional detector, DICOM connectivity, security features) do not alter fundamental technology.
c. Non-clinical performance testing	Demonstrated robust non-clinical performance testing against recognized standards as listed above. The optional 12-inch detector's technical characteristics were assessed and verified according to FDA guidance for Solid State X-ray Imaging Devices.
d. Safety and effectiveness	Demonstrated through compliance with standards and non-clinical testing; no new safety/effectiveness concerns.

2. Sample size used for the test set and the data provenance:

Test Set (Non-clinical Performance Data): The document refers to "Non-clinical performance testing" and "Non-clinical validation testing." It states that these tests demonstrate compliance with standards and that the device meets acceptance criteria.
- Sample Size: The document does not specify a sample size for the non-clinical tests. This type of testing typically involves engineering and bench testing, not patient-based data, so a "sample size" in the clinical sense is not applicable.
- Data Provenance: The data comes from internal non-clinical verification and validation testing conducted by the manufacturer, Philips Medical Systems Nederland B.V. The nature of the studies implies prospective testing against engineering specifications and regulatory standards. No patient data or country of origin for such data is mentioned as this device clearance did not involve clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document explicitly states: "The Zenition 70 did not require clinical study since substantial equivalence... was demonstrated." Therefore, there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests would be the design specifications and the requirements of the standards themselves, assessed by engineers and regulatory experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable for the same reason as point 3. There was no clinical test set requiring image interpretation or expert adjudication.

5. 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:

This is not applicable. The device is an image-intensified fluoroscopic x-ray system, which is a hardware device for imaging. It is not an AI-driven diagnostic assistance tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance. The clearance is based on substantial equivalence to another fluoroscopy system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. As mentioned above, the Zenition 70 is a medical imaging hardware system, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance and validation tests, the "ground truth" was derived from:

Engineering specifications and design requirements of the device.
Requirements stipulated by the international and FDA-recognized consensus standards (e.g., IEC 60601 series for electrical safety, radiation protection; ISO 14971 for risk management; IEC 62304 for software lifecycle processes).
FDA guidance documents relevant to X-ray imaging devices.

8. The sample size for the training set:

This is not applicable. The Zenition 70 is a hardware imaging device, not a machine learning or AI model that requires a "training set." The development process would involve traditional engineering design, manufacturing, and testing.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8.

Summary

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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.

Philips Medical Systems Nederland BV Sumit Kumar Regulatory Approbation Officer Veenpluis 4-6 Best. 5684PC THE NETHERLANDS

December 6, 2018

Re: K183040

Trade/Device Name: Zenition 70 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: October 29, 2018 Received: November 1, 2018

Dear Sumit Kumar:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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

(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement 4

The Indication for Use Statement is included in the next pages.

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)K183040

Device Name Zenition 70

Indications for Use (Describe)

Applications:

Orthopedic .
· Neuro
· Abdominal
. Vascular
· Thoracic
· Cardiac

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17) Publishing Services (301) 443-6740 Section 4 - Indication for Use Statement

Page 1 of 1 EF Confidential

PSC

Page 2 of 2

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5 510 (k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	October 29, 2018
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
PrimaryContact Person:	Sumit KumarRegulatory Approbation OfficerPhone: +91 7028039288E-mail: sumit.kumar_3@philips.com
SecondaryContact Person:	Sonavane, Neena SandeepRegulatory Affairs ManagerPhone: +91 8446020023E-mail: neena.sonavane@philips.com
Device:	Trade Name:	Zenition 70
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21CFR §892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Primary Product Code:Secondary Product Code:	OWBOXO, JAA
PrimaryPredicateDevice:	Trade Name:	Veradius Unity
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K142708
	Classification Name:	Image-intensified fluoroscopic x-ray system
	Classification Regulation:	21CFR §892.1650
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	OWB; OXO; JAA
Devicedescription:	The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. Itis designed for medical use in healthcare facilities where X-ray imaging is needed. Thesystem comprises two main components: the C-arm stand and a mobile view station
Indications forUse:	The proposed Zenition 70 is intended to be used and operated by: adequately trained,qualified and authorized health care professionals who have full understanding of thesafety information and emergency procedures as well as the capabilities and functions ofthe device.The device is used for radiological guidance and visualization during diagnostic,interventional and surgical procedures on all patients, except neonates (birth to onemonth), within the limits of the device. The device is to be used in health care facilitiesboth inside and outside the operating room, sterile as well as non-sterile environment ina variety of procedures.Applications:• Orthopedic• Neuro• Abdominal• Vascular• Thoracic• Cardiac
	The proposed Philips Zenition 70 has identical indications to the currently marketed andpredicate device Veradius Unity
Technologicalcharacteristics:	The proposed Zenition 70 employs the same basic construction and fundamentalscientific technology as the currently marketed and predicate Veradius Unity. Thetechnology used in the development of the major components of the proposed Zenition70, which includes X-ray generator, X-ray tube, X-ray tube housing assembly, Imagedetection system and beam-limiting device is identical to the currently marketed andpredicate Veradius Unity. Modifications implemented in the proposed Zenition 70include
	• Improved system architecture with PC platform.• Monoblock reduced height and reduced filtration• Introduction of an optional 12"( PX2121S) Flat Detector• Live DVD recording option no longer supported• System service functions• Introduction of metal exclusion• Improved DICOM connectivity workflow• Introduction of the security features• Improved User Interfaces• Improved tube heat management• Analogue video out no longer supported• Room interface• Audible signals

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management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable .The differences between the Zenition 70 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the Zenition 70 is considered substantially equivalent to the currently marketed predicate Veradius Unity in terms of fundamental scientific technology.

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Non-clinical performance testing has been performed on the Zenition 70, and it Summary of Non-Clinical demonstrates compliance with the following International and FDA-recognized Performance consensus standards and FDA guidance documents. Data:

IEC 62304 Medical device software Software life cycle processes (Edition 1.1, ● 2015). FDA/CDRH recognition number 13-79.
ISO 14971 Medical devices Application of risk management to medical ● devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.1, 2017). FDA/CDRH recognition number 12-308.
IEC 60601-2-54, Medical Electrical Equipment- Part 2-54: Particular ● Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
. IEC 60601-2-28-Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 2.0 2010) FDA/CDRH recognition number 12-204.
IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.1). FDA/CDRH recognition number 19-4.
IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements ● for Basic Safety and Essential Performance. - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements ● for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
IEC 62366 IEC Application of Usability Engineering to Medical Devices . (Edition 1.0 2015). FDA/CDRH recognition number 5-114
FDA Guidance for Industry and Food and Drug Administration Staff: Guidance ● for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (document number 644)
Pediatric information for x-ray imaging device premarket notifications (document number 1771)
Guidance for Industry and FDA Staff Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
. Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices(document number (1757)
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and FDA Staff (document number 1825).

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. Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff (document number 1618).
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service needs, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users.

Non-clinical verification and validation test results demonstrate that the Zenition 70:

Complies with the aforementioned international and FDA recognized consensus ● standards and FDA guidance documents.
Meets the acceptance criteria and is adequate for its intended use. .

Summary ofClinicalPerformanceData:	The Zenition 70 did not require clinical study since substantial equivalence to theprimary currently marketed and predicate device Veradius Unity was demonstrated withthe following attributes:• Indication for use;• Technological characteristics;• Non-clinical performance testing; and• Safety and effectiveness.
	Furthermore, the optional 12-inch detector in Zenition 70 also has same design,technology and Image acquisition workflow compared to the previously cleared detectorused in the marketed predicate device Veradius Unity, except difference in the dimensionand pixel size. All technical detector characteristics that potentially have an influence onimage quality are assessed and verified according to FDA Guidance for Industry andFood and Drug Administration Staff: Guidance for the Submission of 510(k)'s for SolidState X-ray Imaging Devices. So Nonclinical information used to support the substantialequivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-rayImaging Devices.
SubstantialEquivalenceConclusion:	The Zenition 70 is substantially equivalent to the currently marketed predicate deviceVeradius Unity K142708 in terms of indications for use, fundamental scientifictechnology and safety and effectiveness.Additionally, substantial equivalence was demonstrated by non-clinical performancetests provided in this 510(k) premarket notification. These tests demonstrate thatZenition 70 complies with the requirements specified in the international and FDA-recognized consensus standards and guidance, and is as safe and effective as its predicatedevice without raising any new safety and/or effectiveness concerns.

Summary ofClinicalPerformanceData:

The Zenition 70 did not require clinical study since substantial equivalence to theprimary currently marketed and predicate device Veradius Unity was demonstrated withthe following attributes:• Indication for use;• Technological characteristics;• Non-clinical performance testing; and• Safety and effectiveness.

Furthermore, the optional 12-inch detector in Zenition 70 also has same design,technology and Image acquisition workflow compared to the previously cleared detectorused in the marketed predicate device Veradius Unity, except difference in the dimensionand pixel size. All technical detector characteristics that potentially have an influence onimage quality are assessed and verified according to FDA Guidance for Industry andFood and Drug Administration Staff: Guidance for the Submission of 510(k)'s for SolidState X-ray Imaging Devices. So Nonclinical information used to support the substantialequivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-rayImaging Devices.

SubstantialEquivalenceConclusion:

The Zenition 70 is substantially equivalent to the currently marketed predicate deviceVeradius Unity K142708 in terms of indications for use, fundamental scientifictechnology and safety and effectiveness.Additionally, substantial equivalence was demonstrated by non-clinical performancetests provided in this 510(k) premarket notification. These tests demonstrate thatZenition 70 complies with the requirements specified in the international and FDA-recognized consensus standards and guidance, and is as safe and effective as its predicatedevice without raising any new safety and/or effectiveness concerns.

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.