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K Number
K240224
Device Name
Zenition 90
Manufacturer
Philips Medical Systems Nederlands B.V.
Date Cleared
2024-05-22

(117 days)

Product Code
OWBJAAOXO
Regulation Number
892.1650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside 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 proposed Zenition 90 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).
More Information

K212813

Not Found

No
The summary does not mention AI, ML, or any related terms, and the description of performance studies focuses on compliance with standards and validation testing, not AI/ML model performance metrics.

No
The device is described as a "mobile, diagnostic X-ray imaging and viewing system" used for "radiological guidance and visualization" during procedures. Its purpose is to provide images for diagnosis and real-time guidance, not to directly treat a condition.

Yes

The device description explicitly states, "The proposed Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system."

No

The device description clearly states it is a "mobile, diagnostic X-ray imaging and viewing system" comprising a "C-arm stand and a Mobile View Station (MVS)," indicating it includes significant hardware components beyond just software.

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

Here's why:

  • Intended Use: The intended use is for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." This describes a device used on the patient's body to produce images, not a device used to examine specimens from the body (like blood, urine, or tissue) in a laboratory setting.
  • Device Description: The device is a "mobile, diagnostic X-ray imaging and viewing system." This is a medical imaging device, not a diagnostic test performed on biological samples.
  • Input Imaging Modality: The input is "X-ray," which is a form of radiation used for imaging the internal structures of the body. IVDs typically analyze biological or chemical properties of specimens.
  • Anatomical Site: While not explicitly stated, the listed applications (Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac) clearly indicate the device is used to image various parts of the human body.
  • Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.

In summary, the device described is a medical imaging system used for visualizing internal structures of the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside 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 90 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

Intended User / Care Setting

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)

Non-clinical performance testing has been performed on the proposed Zenition 90 and it demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

  • IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.2 2020-08). FDA/CDRH recognition number 19-49.
  • ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text) FDA/CDRH recognition number 19-4
  • o IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.2, 2019). FDA/CDRH recognition number 12-329.
  • 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 1.2 2018). FDA/CDRH recognition number 12-317.
  • IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safetv and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.1 2020). FDA/CDRH recognition number 19-36.
  • . 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 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 3.0, corrected version, 2019). FDA/CDRH recognition number 5-125.
  • . IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.1 2020-06 CONSOLIDATED VERSION). FDA/CDRH recognition number 5-129
  • Pediatric information for x-ray imaging device premarket notifications, Nov 28, 2017 (document number 1771)
  • o Content of Premarket Submissions for Device Software Functions, June 14, 2023 (document number GUI00000337)
  • Applying Human Factors and Usability Engineering to Medical Devices, Feb 03, 2016 ● (document number (1757)
  • Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 27, 2023 (document number GUI00001825)
  • Radio frequency wireless technology in medical devices- Guidance for Industry and Food and ● Drug Administration Staff, Aug 14, 2013 (document number 1618).
  • Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for ● Industry and Food and Drug Administration Staff, Sep 01, 2016 (document number 644)

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. The Subject device Zenition 90 meets the acceptance criteria and is adequate for its intended use.

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.

K212813

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.

Not Found

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

§ 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.

0

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.

May 22, 2024

Philips Medical Systems Nederlands B.V. % Rahul Kumar Sinha Regulatory Approbation Officer Veenpluis 6 Best. NB 5684 PC NETHERLANDS

Re: K240224

Trade/Device Name: Zenition 90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: January 25, 2024 Received: April 22, 2024

Dear Rahul Kumar Sinha:

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).

1

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)

K240224

Device Name

Zenition 90

Indications for Use (Describe)

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications:

  • · Orthopedic
  • · Neuro
  • Abdominal
  • · Vascular
  • · Thoracic
  • · Cardiac

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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3

PHILIPS - IGT Systems 510(k) Number: K240224

510 (k) Summary

The 510(k) Summary is given in the below pages.

4

510(k) Summary

K240224

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

Date PreparedJanuary 25, 2024
Manufacturer:Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 PC Best
The Netherlands
Establishment Registration Number: 3003768277
Primary
Contact
Person:Rahul Kumar Sinha
Regulatory Approbation Officer
Phone: +91 9940259360
E-mail: rahulkumar.sinha@philips.com
Secondary
Contact
Person:Neena Sonavane
Regulatory Affairs Leader
Phone: +91-8446020023
E-mail: neena.sonavane@philips.com
Device:Trade Name:Zenition 90
Classification Name:Image-intensified fluoroscopic x-ray system
Classification Regulation:21CFR §892.1650
Classification Panel:90-Radiology
Device Class:Class II
Primary Product Code:OWB
Secondary Product Code:JAA, OXO
Primary
Predicate
Device:Trade Name:Zenition 70
Manufacturer:Philips Medical Systems Nederland B.V.
510(k) Clearance:K212813
Classification Name:Image-intensified fluoroscopic x-ray system
Classification Regulation:21CFR §892.1650
Classification Panel:90-Radiology
Device Class:Class II
Product Code:OWB; JAA; OXO

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Device The proposed Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for description: medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a Mobile View Station (MVS).

The proposed Zenition 90 is used for radiological guidance and visualization during diagnostic, Indications for interventional and surgical procedures on all patients. The device is to be used in health care facilities Use: 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

The proposed Zenition 90 demonstrates substantial equivalence with predicate Zenition 70 in terms of intended use. and do not raise questions of safety and effectiveness.

| Table 1. Indications for use comparison of the proposed Zenition 90 versus the currently

marketed and predicate device, Zenition 70
Predicate Device Zenition 70Proposed Zenition 90Conclusion
Indications for Use
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. 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 | The device is used for
radiological guidance and
visualization during diagnostic,
interventional and surgical
procedures on all patients. The
device is to be used in health care
facilities both inside and outside
the operating room, sterile as well
as non-sterile environment in a
variety of procedures.

Applications:
● Orthopedic
● Neuro
● Abdominal
● Vascular
● Thoracic
● Cardiac | Substantially Equivalent
SE analysis:
Same

The proposed Zenition 90 is
used for all patients including
neonates (birth to one month).
The safety and effectiveness is
in line with FDA guidance
"Pediatric information for x-
ray imaging device premarket
notifications"

Therefore, proposed Zenition
90 demonstrates substantial
equivalence with predicate
Zenition 70 in terms of
intended use and is safe and
effective. |

6

• Vascular
• Thoracic
• Cardiac

Fundamental Scientific Technology:

The proposed Zenition 90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Zenition 70. The technology used in the development of the major components of the proposed Zenition 90, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is similar to the currently marketed and predicate Zenition 70.

Table 2 shows that the proposed Zenition 90 is considered substantially equivalent to the currently marketed predicate, Zenition 70 in terms of major components and technological characteristics.

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| Component
/feature | Currently market
Zenition 70 | Proposed Zenition
90 | Conclusion |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C-arm
motions and
brakes | Manual | Motorized | The c-arm movements are motorized in
Zenition 90 as against manual in Zenition 70.
The Zenition 70 system provide manual brake
levers to release and lock the brakes while
Zenition 90 system uses electromagnetic
brakes to release or lock the c-arm axis to
simplify the workflow.
Motorized movement and the electromagnetic
brakes are an added advantage in Zenition 90
compared to the equivalent devices Zenition
70.

Zenition 90 introduces motorized movement in
3 axis (angulation, rotation, and longitudinal)
that are manual in Zenition 70.

Conclusion:
Similar and substantially equivalent |
| X-ray
Generator | -Peak output power:
15 kW | -Peak output power:
15kW/25kW | The kV range of proposed Zenition 90 is the
same as compared to the predicate Zenition 70.

The maximum mA of the Zenition 90 (15kW)
is the same compared to the Zenition 70.

While in Zenition 90 we also have a 25kW
version, where higher mA is possible.

Make of Generators are different in both the
devices however, the technology, energy
source and output are similar.

This change does not impact the safety and
effectiveness of the device. Thus,
demonstrating substantial equivalence.

Conclusion:
Similar and substantially equivalent |
| X-ray tube | -Rotating Anode
(Model: RTM 780
H (Type RO-0306) | - Rotating Anode
(Model: RTM 780 H
(Type RO-0306) | The design and characteristics of X-ray tube of
subject device Zenition 90 and the predicate
device Zenition 70 are the same and from same
supplier.

Conclusion:
Same and substantially equivalent |
| | -Focal spot: dual
(0.3 & 0.6)
-Target angle: 10° | Focal spot: dual (0.3
& 0.6)
Target angle: 10° | |
| | -Anode heat
content: 225kJ | Anode heat content:
225kJ | |
| | -Maximum anode
cooling rate: 550W | Maximum anode
cooling rate: 550W | |
| | -Nominal anode
input power: 15kW | -Nominal anode input
power: 15kW | |
| | | -Nominal anode input
power: 25kW | |
| Monoblock | | | The Monoblock is the combination of x-ray
tube, transformer, cooling oil and oil pump. |
| Oil
circulation | Active oil
circulation with AC
Pump | Active oil circulation
with DC Pump | The proposed device Zenition 90 has similar
heat performance compared to the predicate |
| Monoblock
heat content | Monoblock heat
content: 1350kJ | Monoblock heat
content: 1350kJ | device Zenition 70. There are no technological
significant difference in the safety and clinical
performance of the devices. |
| Safety
mechanisms | Safety mechanisms:
Thermal Switch | Safety mechanisms:
Thermal Switch | Proposed device Zenition 90 uses DC oil pump
while the predicate Zenition 70 uses AC oil |
| Inherent
filtration | filtration | filtration | pump. DC Pump in Zenition 90 helps for better
Oil circulation with lower power consumption
which results in lower energy losses. |
| Fluoro time | fluoro time: 296W
for 60mins | fluoro time: 296W
for 60mins | Both the devices Zenition 70 and Zenition 90
use the same safety mechanism of thermal
switch to address undesirable overheating
scenarios. |
| | | | Conclusion:
Same and substantially equivalent |
| Flat Panel
Detector /
Image
Intensifier | | | The subject device Zenition 90 uses the same
flat panel detector which has been previously
cleared in predicate device Zenition 70
(K212813) and sourced from the same
supplier. |
| - Frame rate | Frame rate: 30fps | Frame rate: 30fps | |
| - Zoom
modes | Zoom modes:
Overview mode + 2
zoom modes | Zoom modes:
Overview mode + 2
zoom modes | |
| - Detector
size ( x/y) | -Detector size (x/y):
207mm x 207mm
(square) | Detector size (x/y):
207mm x 207mm
(square) | |
| | - Detector size (x/y):
301mm x 301mm
(square) | Detector size (x/y):
301mm x 301mm
(square) | |
| - Pixel pitch

  • Image
    matrix | pixel pitch: 154 $\mu$ m
    Image matrix:
    1344x1344
    DQE: 77% | pixel pitch: 154 $\mu$ m
    Image matrix:
    1344x1344
    DQE: 77% | |
    | - "Detector
    quantum
    efficiency
    (DQE) | Pixel pitch: 154 $\mu$ m | Pixel pitch: 154 $\mu$ m | |
    | | Image matrix:
    1000x1000
    DQE: 77% | Image matrix:
    1000x1000
    DQE: 77% | Conclusion:
    Same and substantially equivalent |
    | Imaging
    Processing | Xres-3 | Xres-3 | The predicate device Zenition 70 and the
    proposed device Zenition 90 both use the same |
    | | | | Conclusion: |
    | | | | Same and substantially equivalent |
    | Anti Scatter
    Grid | Removable grid
    (square) | Removable grid
    (square) | The proposed Zenition 90 has same as of
    predicate Zenition 70 |
    | | Transmission: 70% | Transmission: 70% | Conclusion:
    Same and substantially equivalent |
    | Radiation
    safety
    features | Collimation | Collimation | Both the proposed device Zenition 90 and the
    predicate device Zenition 70 share the same
    radiation safety features. |
    | | Anti-scatter grid | Anti-scatter grid | |
    | | Fluoroscopy modes | Fluoroscopy modes | |
    | | Pulsed fluoroscopy | Pulsed fluoroscopy | |
    | | Recording and
    storing fluoroscopic
    runs | Recording and
    storing fluoroscopic
    runs | |
    | | Last image hold | Last image hold | Conclusion:
    Same and substantially equivalent |
    | | Real-time dose
    monitoring | Real-time dose
    monitoring | |
    | Beam
    Limiting
    Device
    (Collimator) | Square (but round in
    zooming and
    rotation) | Square (but round in
    zooming and
    rotation) | The proposed Zenition 90 system uses the same
    collimator as is in predicate device Zenition 70.
    Conclusion:
    Same and substantially equivalent |
    | Geometry | Hammerhead design
    Length : 206 x 82 x
    162 cm | New design stand
    Size: 206 x 82 x 162
    cm | The proposed Zenition 90 new stand design
    comes with lower C-arm operating forces,
    provision to mount additional User Interface
    monitor. This helps in maneuverability and
    ease of use. |
    | | Weight: 332 Kg | Weight:
    400 kg (Motorized)
    375 Kg (Non-
    motorized) | The Proposed Zenition 90 stand brings higher
    weight (400 kg) due to motorization in
    comparison with Zenition 70 (Conclusion:
    Similar and substantially equivalent. |
    | Injector
    interface | Manual Injection
    possible. User can
    manually add X-ray
    delay from an
    injector device | Integrated injector
    interface where user
    can add needed X-ray
    delay based on
    Injection volume.
    Manual Injection is
    also possible. | Manual Injector is always possible in both the
    systems the proposed Zenition 90 as well as the
    equivalent device Zenition 70. In addition to
    manual injector, Zenition 90 has provision to
    connect an external injector, so the user can add
    X-ray start delay time based on injection
    volume. Hence, clinically, no change is
    introduced in the workflow by using integrated
    Injector interface.

Thus, there is no significant difference in the
safety and effectiveness of the devices

Conclusion:
Similar and substantially equivalent. |

8

9

10

11

Based on the information provided above, the Zenition 90 is considered substantially equivalent to the currently marketed predicate Zenition 70 in terms of fundamental scientific technology.

Summary of Non-Clinical Performance Data:

Non-clinical performance testing has been performed on the proposed Zenition 90 and it demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

  • IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.2 2020-08). FDA/CDRH recognition number 19-49.
  • ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 ● (Consolidated Text) FDA/CDRH recognition number 19-4
  • o IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.2, 2019). FDA/CDRH recognition number 12-329.
  • 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 1.2 2018). FDA/CDRH recognition number 12-317.
  • IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safetv and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.1 2020). FDA/CDRH recognition number 19-36.
  • . 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 62304 Medical device software Software life cycle processes (Edition 1.1, 2015). ● FDA/CDRH recognition number 13-79.

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  • . ISO 14971 Medical devices - Application of risk management to medical devices (Edition 3.0, corrected version, 2019). FDA/CDRH recognition number 5-125.
  • . IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.1 2020-06 CONSOLIDATED VERSION). FDA/CDRH recognition number 5-129
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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. The Subject device Zenition 90 meets the acceptance criteria and is adequate for its intended use.

Substantial The Zenition 90 is substantial equivalent to the currently marketed predicate device Zenition 70 Equivalence (K212813), in terms of indications for use, fundamental scientific technology, safety and effectiveness. Conclusion: