Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard X-ray imaging and image processing without mentioning AI/ML capabilities.

Therapeutic

No
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures, not for direct therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the device is used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." Additionally, the "Device Description" explicitly refers to the Zenition 50 as a "mobile, diagnostic X-ray imaging and viewing system."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system comprises two main hardware components: the C-arm stand and a Mobile View Station (MVS). While it mentions migrating image processing to software, the overall device is a hardware system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Zenition 50 device is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states the device is for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." This involves imaging the inside of the body using X-rays, which is an in vivo (within the living body) process, not in vitro (outside the living body, typically involving samples like blood or tissue).
Device Description: The description confirms it's a "mobile, diagnostic X-ray imaging and viewing system." X-ray imaging is a form of medical imaging, not an IVD process.
Input Imaging Modality: The input modality is X-ray, which is used for imaging the body directly.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

Therefore, the Zenition 50 is a medical imaging device, specifically a mobile C-arm X-ray system, and does not fall under the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Zenition 50 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. 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

Product codes (comma separated list FDA assigned to the subject device)

OWB, JAA, OXO

Device Description

The proposed Zenition 50 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)

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

all patients, except neonates (birth to one month)

Intended User / Care Setting

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 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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Zenition 50 did not require clinical study since substantial equivalence to the primary currently marketed and predicate device BV Pulsera was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K010435

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K142708

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains 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.

December 31, 2018

Philips Medical Systems Nederland BV Sumit Kumar Regulatory Approbation Officer Veenpluis 4-6 BEST, NL 5684PC

Re: K183101

Trade/Device Name: Zenition 50 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: November 1, 2018 Received: November 7, 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

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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 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,

Hole 2. Nils

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
	See PRA Statement below.
510(k) Number (if known)	K183101
Device Name	Zenition 50
Indications for Use (Describe)	The Zenition 50 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. 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:	OrthopedicNeuroAbdominalVascularThoracicCardiac
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC

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510(k) Summary

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

Date Prepared: November 1, 2018

| Manufacturer: | Philips Veenpluis 4-6
5684 PC Best
The Netherlands
Establishment Registration Number: 3003768277 |------------------------------------|------------------ | Primary
Contact
Person: | Sumit Kumar
Regulatory Approbation Officer
Phone: +91 7028039288
E-mail: Contact
Person: | Sonavane, Neena Sandeep
Regulatory Affairs Manager
Phone: +91 8446020023
E-mail: Predicate
Device: | Trade Name: | | Manufacturer: | | 510(k) Clearance: | | Classification Name: | | Classification Regulation: | | Classification Panel: | | Device Class: | | Product Code: | Reference
device: | Trade Name: | | Manufacturer | | 510(k) Clearance: | | Classification Name: | | Classification Regulation: | | Classification Panel: | | Device Class: | | Product Code: | Device description: | The proposed | Indications for Use: | The proposed The device is used for radiological guidance and The device is to be used in health care facilities Applications:
Orthopedic Neuro Abdominal Vascular Thoracic Cardiac | | Fundamental Scientific Technology: | The proposed | | The outcome Medical Systems Nederland B.V.
| |
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">sumit.kumar_3@philips.com | |
target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">neena.sonavane@philips.com | |
| Zenition 50 |
| Image-intensified fluoroscopic x-ray system |
| 21CFR §892.1650 |
| 90-Radiology |
| Class II |
| OWB |
| JAA, OXO |
| BV Pulsera |
| Philips Medical Systems Nederland B.V. |
| K010435 |
| Image-intensified fluoroscopic x-ray system |
| 21CFR §892.1650 |
| 90-Radiology |
| Class II |
| OWB; JAA; OXO |
| Veradius Unity |
| Philips Medical Systems Nederland B.V |
| K142708 |
| Image-intensified fluoroscopic x-ray system |
| 21CFR §892.1650 |
| 90-Radiology |
| Class II |
| OWB; JAA; OXO |
Zenition 50 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) | |
Zenition 50 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.
visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
|
Zenition 50 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate BV Pulsera. The technology used in the development of the major components of the proposed Zenition 50, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is identical to the currently marketed and predicate BV Pulsera. See the below table for the comparison of the major components of the proposed Zenition 50 and the currently marketed and predicate BV Pulsera. | |
of this comparison demonstrates that the minor differences in the technological | |

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characteristics do not affect the safety or effectiveness of the Zenition 50 when compared to the currently marketed and predicate BV Pulsera.

| Technological characteristics comparison of the currently marketed predicate device, BV

Pulsera versus the proposed Zenition 50
Component
/feature	Currently
market BV
Pulsera	Proposed Zenition 50	Conclusion
X-ray
Generator	iXion HF
Generator
Model: 10359400	iXion HF Generator
Model: 10359400	Identical.
X-ray tube	Model: RTM 780
H (Type RO-0306)	Model : RTM 780 H
(Type RO-0306)	Identical.
X-ray housing assembly	iXion Monoblock IV with X-ray tube RO-0306	iXion Monoblock V with X-ray tube RO-0306
			Similar with minor change in
monoblock design for providing
more clearance to the floor.
The monoblock design has been
updated to reduce the height with
3.5cm, and thus improves clearance
between the tank and the floor which
resulting in more space to move. In
addition, the filtration has been
reduced to lower the amount of
power necessary for the same dose.
The updated monoblock is evaluated
in risk management. The change
does not introduce new risks. This
change was shown to be compliant
with the international and FDA
recognized standards IEC60601-1,
IEC60601-2-43 and IEC60601-2-54
for basic safety and essential
performance. Hence, this change
does not impact the safety and
effectiveness of the Device. Thus,
demonstrating substantial
equivalence.
Image Intensifier 9"	23HRC	23HRC	Identical.
Image Intensifier 12"	31GG	31GG	Identical
II Laser alignment tool	Z-LAD 9 Inch
Z-LAD 12 Inch	Z-LAD 9 Inch
Z-LAD 12 Inch	Identical
Beam Limiting Device	CoRa
9890 010 23201	Collimator IITV
459801200241	A new collimator has been designed
such that it reuses the design of
existing reference device Veradius
Unity (K142708) FD15 (PX2630Sv)
collimator with the only exception
the square fixed diaphragm is
removed to match the format for
IITV9" and IITV12". There is no
change in the functional
specification compared to predicate
device. All other parts of the
collimator are identical.
This change was shown to be
compliant with the international and
FDA recognized

Laser
Alignment
tool	Tube Laser
Aiming Device	Tube Laser Aiming
Device	essential performance. Hence, this
does not impact safety or
effectiveness of the device Thus,
demonstrating substantially
equivalent.
			Changed to fit in new collimator.
Functional specification are similar
compared to predicate device. This
tube laser unit is reused from the
reference device Veradius Unity
(K142708).
Hence, this change do not impact
the safety or effectiveness of the
Device. Thus, demonstrating
substantial equivalence
Mobile C-arm
Stand	BV Pulsera Stand	Pulsera R3.1 Stand	The mechanical interfaces have
been updated for the updated
monoblock and the stand
touchscreen. These changes are
assessed in risk management, and
they did not introduce new risks.
The changes was also shown to be
compliant with the FDA recognized
standard IEC60601-1 for basic
safety and essential performance.
Therefore, the change does not
impact safety and effectiveness.
Thus, demonstrating substantial
equivalence.
Mobile
Viewing
Station	MVS BV Family
R2	MVS BV Family R3	The MVS has been changed to
match the updated interfaces from
the System architecture and room
interface changes. These changes
are assessed in risk management,
and they did not introduce new risks.
The changes was also shown to be
compliant with the FDA recognized
standard IEC60601-1 for basic
safety and essential performance.
Therefore, the change does not
impact safety and effectiveness.
Thus, demonstrating substantial
equivalence
System
architecture	Current System
architecture	Improved system
architecture with PC
platform
• Solved obsolescence	These changes were assessed in risk
management, and they did not
introduce new risks. This change
was shown to be compliant with the
international and FDA recognized

		hardware and software by moving to state of the art computing hardware and corresponding interconnects. Migrated system software to the new computing hardware Migrated image processing from hardware to software implementation Integrated internal distributed components related to power functions into the mains control unit to simplify the design Integrated wireless network connection design to simplify configuration and setting to work by service engineers	standards IEC60601-1, IEC60601-2-43 and IEC60601-2-54 for basic safety and essential performance, IEC60601-1-2 for Electromagnetic compatibility, IEC62366 for application of usability engineering and the FDA Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21 CFR 1020.30 / 1020.32). Image processing performance is compared by means of an image quality performance comparison with the predicate device and found equal or improved, see Appendix A38 .
This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.
ClearGuide and color coding	Not Present	Introduction of ClearGuide and color coding	These visual aids are ease-of-use improvements and improve communication in the OR between surgeon and operator. These features are reused from the reference device Veradius Unity (K142708).
The changes do not introduce new risks or change any of the existing risks compared to the predicate device.
This change does not affect safety or effectiveness of the device. Thus, demonstrating substantial equivalence.
C-arm Stand user interface	C-arm Stand user interface based on hard keys and a small monochrome display	C-arm Stand touch screen user interface	The hard-key based interface on the predicate device has been replaced with a touch-screen based stand user interface This feature is reused from the reference device Veradius Unity (K142708). This change was shown to be compliant with the international and FDA recognized standards IEC60601-1, IEC60601-
			2-43 and IEC60601-2-54 for basic
safety and essential performance,
IEC60601-1-2 for Electromagnetic
compatibility,
IEC62366
for
application of usability engineering.
This change does not affect safety or
effectiveness of the device. Thus,
demonstrating
substantial
Manual
Outline	Not Present	Manual outlining	equivalence
With this so-called Manual Outline
function, it is possible to draw lines
and dots on an overlay of the clinical
image with help of the finger, stylus
pen or mouse. It is not related to
diagnostics. This feature is reused
from the reference device Veradius
Unity (K142708).
The changes do not introduce new
risks or change any of the existing
risks compared to the predicate
device.
			This change does not affect safety or
effectiveness of the device. Thus,
substantial
demonstrating
equivalence.
Wireless
footswitch	Not Present	Wireless footswitch	Next to the wired footswitch and
optional wireless footswitch can be
used with the system. This wireless
footswitch is reused from reference
device Veradius Unity (K142708).
The change does not introduce new
risks, but only minor update to
existing risks compared to the
predicate device.
This change does not affect safety or
effectiveness of the device. Thus,
demonstrating
substantial
equivalence.
DICOM
connectivity	Current DICOM
connectivity	Improved DICOM
connectivity workflow
· Easier selection of
patient data for
export
• Introduced
unattended network
transfer of export
jobs
• Integrated workflow
for export to local	The improvements are ease-of-use
improvements, fully compliant with
the DICOM standard and do not
impact clinical functionality. The
changes are shown to be compliant
with the international and FDA
recognized standard IEC62366 for
application of usability engineering.
Therefore, this change does not
impact safety or effectiveness of the
		media (USB and
DICOM DVD)
• Improved workflow
for multimodality
viewer functionality
• Improved DICOM
transfer speed	demonstrating
device.
Thus,
substantially equivalent
X-ray tube
heat
management	Current X-ray
tube heat
management	• Improved
presentation to the
user of tube and oil
heating information
· Reduced · ·
energy
waste in non-x-ray
(pump, stator)	These
improvements
allow
minimizing
wasted
energy by updating the control
functions for the oil pump and stator
control and improve feedback to the
user on tube and oil heat status. The
changes have been evaluated in risk
management, and they do not lead to
new risks. The changes are shown to
be compliant with the international
and FDA recognized standard
IEC62366 for application of
usability engineering. This change
impact
clinical
does
not
functionality.
Therefore, this change does not
			impact safety or effectiveness of the
device.
Thus, demonstrating
substantial equivalence.
User Interface
Mobile
viewing
station	Current User
Interface Mobile
viewing station	New identity look for
MVS-UI. The
Graphical User
Interface look and feel
of the mobile viewing
station is changed to
the Philips New
Experience Identity
look and feel.	These features are to improve the
look and feel of the device and does
not impact clinical functionality.
The changes have been evaluated in
risk management, and they do not
lead to new risks. The changes are
shown to be compliant with the
international and FDA recognized
standard IEC62366 for application
of usability engineering.
Therefore, this change does not
			impact safety or effectiveness of the
Thus. demonstrating
device.
substantially equivalent.
Wired
Footswitch
and remote
control unit	Current Wired
Footswitch and
remote control
unit	The current wired
remote
footswitch, footswitch,
unit
control
are
replaced with a new
wired footswitch and
remote control
new	The current wired footswitch and
remote control unit are replaced
with a new wired footswitch and
new remote control with identical
functionality. This change does not
impact clinical functionality. These
features are to improve the look and
		with identical
functionality	feel of the device and does not
impact clinical functionality. The
changes have been evaluated in risk
management, and they do not lead to
new risks. The changes are shown to
be compliant with the international
and FDA recognized standard IEC
62366 for application of usability
engineering. Therefore, this change
does not impact safety or
effectiveness of the device. Thus,
demonstrating
substantial
equivalence.
RAD
(radiography)	RAD support
(Optional)	RAD not supported	The removal of RAD (radiography)
is evaluated in risk management The
change does not introduce new risks
Therefore; this change does not
impact safety or effectiveness of the
device. Thus, demonstrating
substantial equivalence.
Live DVD
Recording	Live DVD
recording support
(Optional)	Live DVD recording
option not supported	The removal of Live DVD recording
is evaluated in risk management The
change does not introduce new risks
Therefore; this change does not
impact safety or effectiveness of the
device. Thus, demonstrating
substantial equivalence.
Security
features	Current Security
features	Introduction of the
security features
• Local user account
management
o Function improved
to enable a
username/passwor
d combination.
• Network time
synchronization
o Different
implementation only
• Audit trail
• White listing
• DIACAP hardening
• Disk encryption
• FIPS 140-2	These features are to improve
security of the device and do not
impact clinical functionality.
Therefore, this change does not
impact safety or effectiveness of the
device.
Thus, demonstrating substantial
equivalence.
Introduction of
metal
exclusion	Not present	Metal exclusion added	The feature is to minimize the
impact of added metal in the X-ray
image by excluding metal (black

			exclusion) from the automatic
exposure control. It has the same
design as the currently available
BodySmart (white exclusion)
function of the predicate device.
This change was shown to be
			compliant with the international and
FDA recognized standards
IEC60601-2-43 and IEC60601-2-54
for basic safety and essential
performance. Thus, demonstrating
substantial equivalence
System service
functions	Current System
service functions	• BV-scope field
service infrastructure
is replaced by Philips
Support Connect field
service infrastructure.
• Introduction of PSC
implies also that the
Service UI is located
on the target machine
itself, and thus
enabling access to
field service
functionality via the
MVS-UI.
• Using CAT tool to
view logging.
• All field service
procedures are
migrated to the PSC
based field service
infrastructure	The change is only impacting the
service interface and has no clinical
impact. Therefore this change does
not impact safety or effectiveness of
the device
Thus, demonstrating substantial
equivalence
Room
Interface	Not Present	External x-ray and
power indication
interface	This feature is to optionally allow
connecting an external x-ray and
power lamp to the system and does
not impact clinical functionality.
Therefore, this change does not
impact safety or effectiveness of the
device.
Thus, demonstrating
substantial
equivalence.
Audible
signals	Audible signals
with fixed volume	Speaker with volume
control added in the
Stand	This feature is to allow control of the
volume produced by the system for
audible signals. This change does
not impact clinical functionality.
Therefore, this change does not
Analogue video out	original	Analogue video out no longer supported	The analog video-out was used to connect external monitors. This is an outdated video interface and has been removed. This change does not impact clinical functionality. Therefore, this change does not impact safety or effectiveness of the device. Thus, demonstrating substantial equivalence.
			impact safety or effectiveness of the device.
Thus, demonstrating substantial equivalence.

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Non-clinical performance testing has been performed on the proposed Zenition 50 and demonstrates Summary of Non-Clinical compliance with the following International and FDA-recognized consensus standards and FDA Performance 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
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Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, 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 50 :

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.

14

| Summary of
Clinical
Performance
Data: | The Zenition 50 did not require clinical study since substantial equivalence to the primary currently
marketed and predicate device BV Pulsera was demonstrated with the following attributes: |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness. |
| Substantial
Equivalence
Conclusion: | The Zenition 50 is substantial equivalent to the currently marketed predicate device BV Pulsera K010435 in terms of indications for use, fundamental scientific technology and safety and effectiveness.
Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that Zenition 50 complies with the requirements specified in the international and FDA-recognized consensus standards and guidance, and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. |