(189 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe training or test sets typically associated with AI/ML development. The focus is on standard image processing (Xres-3) and comparison to a predicate device based on technical characteristics and non-clinical testing.
No
The device is described as an X-ray imaging and viewing system used for "radiological guidance and visualization" during procedures, indicating a diagnostic rather than therapeutic purpose.
Yes.
The device description explicitly states, "The proposed Zenition 30 is a mobile, diagnostic X-ray imaging and viewing system."
No
The device description explicitly states it comprises a C-arm stand and a Mobile View Station (MVS), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients." This involves imaging the inside of the body using X-rays.
- Device Description: The device is described as a "mobile, diagnostic X-ray imaging and viewing system." This is consistent with an imaging device used on patients.
- Input Imaging Modality: The input modality is "X-ray," which is used for imaging the body, not for testing samples outside the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a medical imaging system used in vivo (on a living organism), not in vitro (in glass or outside the body).
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 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 30 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
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The proposed Zenition 30 is equipped with dedicated pediatric mode and capable of automatic dose control based on the subject size.
Intended User / Care Setting
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 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 30 and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents. 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 demonstrate that the Zenition 30: 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.
The 11-inch detector in Zenition 30 has similar design, technology and Image acquisition workflow compared to the previously cleared detector used in the marketed predicate device Zenition 70. All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to 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. So, no clinical information was used to support the substantial equivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.
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.
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
February 16, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Medical Systems Nederland B.V. Gyanendra Mani Tripathi Regulatory Approbation Officer Veenpluis 6 5684 PC Best The Netherlands
Re: K232420
Trade/Device Name: Zenition 30 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: August 4, 2023 Received: August 11, 2023
Dear Gyanendra Mani Tripathi:
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,
Gabriela M. Rodal -S
Digitally signed by Gabriela M. Rodal -S for
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
Enclosure
2
Indications for Use
510(k) Number (if known) K232420
Device Name
Zenition 30
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 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K232420
510 (k) Summary
The 510(k) Summary is given in the below pages.
4
510(k) Summary
K232420
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Date Prepared: August 25, 2023
Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277
Primary Gyanendra Mani Tripathi Contact Regulatory Approbation Officer Person: Phone: +91 9873846827 E-mail: gyanendramani.tripathi@philips.com
| Secondary | Sumit Kumar |
|---|---|
| Contact | Manager Regulatory Affairs |
| Person: | Phone: +91 7028039288 |
| E-mail: sumit.kumar_3@philips.com |
| Device: | Trade Name: | Zenition 30 |
|---|---|---|
| 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 |
5
The proposed Zenition 30 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for Device 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).
Indications for The device is used for radiological guidance and visualization during diagnostic, interventional and Use: 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
The proposed Philips Zenition 30 has same indications to the currently marketed and predicate device Zenition 70 (K212813, Oct 1, 2021).
Table 1 shows that the proposed Zenition 30 is substantially equivalent to the currently marketed and predicate device, Zenition 70, in terms of indications for use.
| Table 1 Indications for use comparison of the proposed Zenition 30 versus the currently
| marketed and predicate device, Zenition 70 | ||
|---|---|---|
| Predicate Device Zenition 70 | ||
| (K212813) | Proposed Zenition 30 | |
| (K232420) | Conclusion | |
| 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 | 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
Both the proposed
Zenition 30 and currently
marketed predicate device
Zenition 70 are intended
for radiological guidance
and visualization during
diagnostic, interventional
and surgical procedures.
The clinical application
areas for both predicate
Zenition 70 and the subject
device Zenition 30 are the
same.
The proposed Zenition 30
is equipped with dedicated |
6
| environment in a variety of
procedures. | pediatric mode and capable
of automatic dose control
based on the subject size. |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applications:
• Orthopedic
• Neuro
• Abdominal
• Vascular
• Thoracic
• Cardiac | The moment user selects
the pediatric mode for
acquisition, a popup
message will appear on the
screen to remove the grid
from the flat detector to
optimize the dose. The
Grid is placed in such a
way that it can be easily
removed without use of
tools. |
| | Zenition 30 has been
validated on different types
of phantom representing
the pediatric and adult
population. |
| | Therefore, Zenition 30
demonstrates substantial
equivalence with predicate
Zenition 70 in terms of
intended use. and do not
raise questions of safety
and effectiveness. |
Fundamental The proposed Zenition 30 employs the same basic construction and fundamental scientific technology Scientific as the currently marketed and predicate Zenition 70. The technology used in the development of the Technology: major components of the proposed Zenition 30, which includes X-ray generator, X-ray tube housing assembly, and Image detection system is similar to the currently marketed and predicate Zenition 70. Modifications implemented in the proposed Zenition 30 include:
- State of the art flat panel detector px2020S ●
- . New Scalable X-segment (Supports 2.1kW and 4.0kW modes)
- Introduction of the compact stand assembly
- Introducing Electro Magnetic Brakes
- Table Side UI
- Introduction of the light weight C-arc ●
- SCU changes ●
- Modification of Brake between wheels
- Introduction of general purpose I/O board(GPIO) ●
The risks associated with these changes were assessed and found to be acceptable. The minor differences between the Zenition 30 and the predicate device Zenition 70 do not raise any new questions regarding safety or effectiveness. The Zenition 30 is considered substantially equivalent to the currently marketed predicate Zenition 70 (K212813, Oct 1, 2021) in terms of fundamental scientific technology.
7
Table 2 shows that the proposed Zenition 30 is considered substantially equivalent to the currently marketed predicate, Zenition 70 in terms of major components and technological characteristics.
| Table 2 Technological characteristics comparison of the currently marketed predicate device, Zenition 70 versus the proposed Zenition 30 | Conclusion | ||
|---|---|---|---|
| Component /feature | Predicate Device Zenition 70 (K212813) | Proposed Zenition 30 (K232420) | |
| X-ray Generator | -Peak output power: 15 kW | -Peak output power: 4kW | The X-ray generator characteristics of proposed Zenition 30 is subset of predicate Zenition 70 in terms of peak output power, kV range, mode of operation, maximum mA and pulse rate. |
The maximum pulse rates supported by predicate Zenition 70 and proposed Zenition 30 are different, however, the Zenition 30 system provides a continuous x-ray mode that works at 30 fps, this is treated as equivalent to the 30pps pulsed mode of Zenition 70.
The X-ray power levels of the Zenition 70 and Zenition 30 are different. However, the image quality of Zenition 30 for the proposed intended use is clinically acceptable.
This change does not impact the safety and effectiveness of the device. Thus, demonstrating substantial equivalence. |
| | -kV range: 40-120 kV | -kV Range: 40 to 110kV | |
| | -Mode of operation: Pulse | -Pulse/ Continuous: Pulsed and Continuous. | |
| | -Maximum mA: 125 mA | -Maximum mA: 36mA | |
| | -Pulse Rate : 30 pps (max) | -Pulse rate: 15 pps (max) | |
| | -iXion HF Generator | -HF Generator | |
| | -Model : 10359400 | -Model : IRI.37.216.001 (HF1 4.0 kW ESU) | |
| | | | |
| | | | Conclusion: |
| | | | Similar and substantially equivalent |
| X-ray tube | -Rotating Anode (Model: RTM 780 H (Type RO-0306) | -Fixed Anode (model: OX 125 -0612) | The target angle affects the focal spot size and field of view. As target angle of proposed Zenition 30 and predicate Zenition-70 are similar, the field of view is also similar.
Focal spot size is contributing to resolution of the image. The predicate Zenition 70 uses the 0.6 focal spot for all application modes, and in proposed Zenition 30, 0.6 mm focal spot is used for all the applications except for single shot at 1.2 mm focal spot for the max power demonstration. |
| | -Focal spot: dual (0.3 & 0.6) | -Focal spot: dual (0.6 & 1.2) | |
| | -Target angle: 10° | -Target angle: 9° | |
| | -Anode heat content: 225kJ
-Maximum anode cooling rate: 550W
-Nominal anode input power: 15kW | -Anode heat content: 57kJ
-Maximum anode cooling rate: 600W
-Nominal anode input power: 4kW | |
| X-ray
housing
assembly | iXion 5 Monoblock,
model identification:
10454900 | I-40S, 3.5RF, model
identification:
101.01.179.001 | As both systems support a minimum
limiting resolution of > =2.2 lp/mm
in all detector modes, this
demonstrates a similarity in the
resolutions delivered to support the
intended use. |
| | -Active oil circulation
-Monoblock heat
content: 1350kJ
-Safety mechanisms:
Thermal Switch
-filtration: 1mm
Al+0.1mmCu
-fluoro time: 296W for
60mins | -Active oil circulation
-Monoblock heat
content: 1056kJ
-Safety mechanisms:
Thermal Switch
-filtration:
3.8mmAl+0.1mmCu
-fluoro time: 300W @
50mins, 600W @
20mins | There is no clinically significant
difference in the safety and clinical
performance of Zenition 30 as
compared to predicate Zenition 70. |
| | | | Both the devices comply to
applicable x-ray safety standards
(e.g., IEC 60601-1-3, 2.1edition). |
| | | | Conclusion:
Similar and substantially equivalent,
technological characteristics of the
devices do not raise questions of
safety and effectiveness |
| | | | The monoblock is the combination of
x-ray tube, transformer and cooling
oil. |
| | | | Having active oil circulation within
the monoblock helps in heat
dissipation and more available x-ray
time. The proposed device Zenition
30 has similar heat performance
compared to the predicate device
Zenition 70. There are no
technological significant difference in
the safety and clinical performance of
the devices. |
| | | | Both the devices Zenition 70 and
Zenition 30 use the same safety
mechanism of thermal switch to
address undesirable overheating
scenarios. |
| | | | Cu and Al filtration are meant to
remove the low energy x-ray part of
the spectrum that is not contributing to
the imaging. The inherent filtration is
better in Zenition 30 compared to the
predecessor device Zenition 70. |
| | | | Conclusion: |
| | | | Similar and substantially equivalent |
| | | | The proposed device Zenition 30 is
having similar heat performance as
compared to the predicate Zenition
70. Both the devices share the same
safety mechanism of thermal switch to |
| | | | |
| | | | address undesirable overheating
scenarios. Additionally, the inherent
filtration is better in Zenition 30
compared to the predecessor device
Zenition 70. |
| | | | Hence, we can conclude that both the
devices share the same technological
characteristics with no significant
difference in the safety and
effectiveness of the devices. |
| Flat Panel
Detector | Model: 45980120023x | Model: PIXIUM 2020S-
p | Both Zenition 30 and the predicate
device Zenition 70 systems use a Flat
Panel (FP) digital image detector
technology. |
| | -Frame rate: 30fps
-Zoom modes: Overview
mode + 2 zoom modes | -Frame rate: 30fps
-Zoom modes: Overview
mode + 2 zoom modes | |
| | -Detector size (x/y):
207mm x 207mm
(square) | -Detector size (x/y):
204mm x 204mm
(square) | The detector used in proposed device
Zenition 30 is based on the same
design, scientific technology and
image acquisition workflow as the
Flat Panel digital image detector used
in the predicate Zenition 70. The
frame rates of both detectors are also
the same. |
| | -pixel pitch: 154 μm
-Image matrix:
1344x1344 | -pixel pitch: 200 μm
-Image matrix:
1024x1024 | |
| | -DQE: 77% | -DQE: 80% | The physical size of the detectors are
not significantly different (207 x 207
mm2 versus 204 x 204 mm2) for the
predicate device Zenition 70 and the
proposed device Zenition 30.
Additionally, the number of zoom
modes are also identical for both the
devices. |
| | | | The pixel pitch of the Zenition 30 is
200 μm, which is similar to the pixel
pitch of the predicate Zenition 70
(154 μm). However, the final
resolution seen at the system level is
result of multiple factors. At
Zenition 30, Zenition 70 system
level, both systems demonstrate a
limiting resolution > 2.2 lp/mm in all
detector modes due to similar anode
angle and focal spot used for the
majority of the applications. |
| | | | DQE (detective quantum efficiency)
is a measure for the x-ray dose
sensitivity of the detector and defines
the image quality generated from the
detector. |
| | | | The DQE is similar for both the
detectors used in predicate Zenition |
| Imaging
Processing
technology | Xres-3 | Xres-3 | 30 with the sensitivity of the
Zenition 30 being slightly higher.
Better sensitivity of detector used in
Zenition 30 will have an advantage
over the predicate Zenition 70 in
terms of image quality with same or
lower X-Ray Dose.
There is no change in clinically
relevant characteristics of the
detector used in both the devices that
relate to the acquisition to X-ray
images and X-ray dose sensitivity.
Conclusion:
Similar and substantially equivalent
We can conclude that both the
devices share the same technological
characteristics with no significant
difference in the safety and
effectiveness of the devices
The predicate device Zenition 70 and
the proposed device Zenition 30 both
are using the same PC-based platform
and algorithm.
Conclusion:
Same and substantially equivalent |
| Anti Scatter
Grid | Removable grid (square)
Transmission: 70% | Removable grid (square)
Transmission: 70% | The proposed Zenition 30 has a
square removable grid, the same as of
predicate Zenition 70. The grids are
made using the same technology.
Conclusion:
Similar and substantially equivalent |
| Radiation
safety
features | Collimation
Anti-scatter grid
Fluoroscopy modes
Pulsed fluoroscopy
Recording and storing
fluoroscopic runs
Last image hold
Real-time dose
monitoring | Collimation
Anti-scatter grid
Fluoroscopy modes
Pulsed fluoroscopy
Recording and storing
fluoroscopic runs
Last image hold
Real-time dose
monitoring | The mobile x-ray c-arms have a range
of features (like collimation, anti-
scatter grid, different fluoroscopy
modes, last image hold and real time
dose monitoring) that enable the
management of dose. The available
features are the same on both the
systems.
Both the proposed device Zenition 30
and the predicate device Zenition 70
shares the same radiation safety
features.
Conclusion:
Same and substantially equivalent |
| Beam
Limiting
Device
(Collimator) | Square (but round in
zooming and rotation) | Square (but round in
zooming and rotation) | The proposed Zenition 30 system
introduces a collimator that is reusing
the collimator used in predicate device
Zenition 70. One modification is
made by extending the lead ring to the
bottom of collimator. This is done in
order to account for the minor
differences in the mounting
arrangement of the collimator and
monoblock mounting surface. |
| | | | In all other aspects the collimator of
predicate Zenition 70 and proposed
Zenition 30 remain the same in
performance and safety parameters.
Thus, demonstrating substantial
equivalence. |
| | | | Conclusion: |
| | | | Similar and substantially equivalent |
| C-arm
motions and
brakes | 4 axis movements
4 axis manual brakes | 4 axis movements
3 axis electromagnetic
brakes, 1 axis manual
brake | The number of axis in which the c-
arm movements are possible
(Angulation, Rotation, Longitudinal,
Wigwag) is the same for both the
systems under comparison.
The predicate Zenition 70 provide
manual brake levers to release and
lock the brakes. However, the
proposed Zenition 30 system uses
electromagnetic brakes to release or
lock the c-arm axis to simplify the
workflow and reduce manual efforts.
The electromagnetic brakes used in
proposed Zenition 30 will be an |
| | | | added advantage when compared
with the equivalent device Zenition
70.
The differences in the technology
used to operate the brakes does not |
| | | | introduce any new risk as conformed
by the usability studies and the
product safety assessment carried
out. |
| | | | Conclusion:
Similar and substantially equivalent |
| | | | Both proposed Zenition 30 and the
predicate Zenition 70 has the same
axis of movements and share the same
technological characteristics with no
significant difference in the safety and
effectiveness of the devices |
| | | | |
| Geometry | Hammerhead design
Size : 206 x 82 x 162 cm
Weight: 332 Kg (FD12)
Stand-U/I: 15.3" touch
screen display | New design stand
Size: 185 x 82 x 172 cm
(without push bar and
surgeon arm)
210 x 82 x 162 cm (with
push bar and surgeon
arm)
Weight : 295 kg
Stand-U/I: 12.1" touch
screen display | In the proposed Zenition 30, the new
stand design comes with lower C-arm
operating forces, provision to mount
foot switch, hand switch and other
options. The design also brings in the
slimmer version of the stand UI
display (12.1") compared to the
predicate device Zenition 70.
These features will improve the
workflow and help ease of use of
proposed Zenition 30 as compared to
predicate Zenition 70
The new stand that is used in the
proposed Zenition 30 helps improve
the maneuverability and ease of use
while keeping the essence of the
stand same.
Conclusion:
Similar and substantially equivalent |
| System
architecture | PC Based Win 10 | PC Based Win 10 | Conclusion:
Same and substantially equivalent |
| Ionizing
radiation | System uses X-ray for
imaging | System uses X-ray for
imaging | Same X-ray technology usage
Conclusion:
Same and substantially equivalent |
| Detector
Laser aiming
device | Integrated in FD covers
(Model: FP-L-635-10-
34-Philips-V2-C2)
Wavelength: 635 nm (±5
nm)
Maximum output: 10
mW (±1 mW)
Beam divergence: 34
degrees | Integrated in FD covers
(Model: FP-L-635-10-
34-Philips-V2-C2)
Wavelength: 635 nm (±5
nm)
Maximum output: 10
mW (±1 mW)
Beam divergence: 34
degrees | Conclusion:
Same and substantially equivalent |
| Laser
Alignment
tool | Tube Laser Aiming
Device (Model: 4598
008 4322x) | Tube Laser Aiming
Device (Model: 4598
008 4322x) | Conclusion:
Same and substantially equivalent |
| DICOM
connectivity | DICOM connectivity
workflow
-Easier selection of
patient data for export
-Introduced unattended
network transfer of
export jobs | DICOM connectivity
workflow
-Easier selection of
patient data for export
-Introduced unattended
network transfer of
export jobs | Conclusion:
Same and substantially equivalent |
| | | | |
| | -Integrated workflow for
export to local media
(USB and DICOM
DVD)
-Improved workflow for
multimodality viewer
functionality
-Improved DICOM
transfer speed | -Integrated workflow for
export to local media
(USB and DICOM
DVD)
-Improved workflow for
multimodality viewer
functionality
-Improved DICOM
transfer speed | |
| Security
features | -Local user account
management | -Local user account
management | Conclusion:
Same and substantially equivalent. |
| | -Function improved to
enable a
username/password
combination.
-Network time
synchronization | -Function improved to
enable a
username/password
combination.
-Network time
synchronization | |
| | -Different
implementation only | -Different
implementation only | |
| | -Audit trail
-White listing | -Audit trail
-White listing | |
| | -DIACAP hardening | -DIACAP hardening | |
| | -Disk encryption
-FIPS 140-2 | -Disk encryption
-FIPS 140-2 | |
| Room
Interface | External x-ray and
power indication
interface | External x-ray and
power indication
interface | Conclusion:
Same and substantially equivalent. |
| Audible
signals | Speaker with volume
control added in the
Stand | Speaker with volume
control added in the
Stand | Conclusion:
Same and substantially equivalent. |
| Wired
Footswitch
and remote
control unit | Same | Same | Conclusion:
Same and substantially equivalent. |
| Product
Name | Zenition 70 | New Product name
Zenition 30 | Labeling change that has no impact on system features, safety and effectiveness. Thus, demonstrating substantial equivalence. |
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9
10
11
12
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Summary of Non-clinical performance testing has been performed on the proposed Zenition 30 and demonstrates 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, 2019). FDA/CDRH recognition number 5-125.
- 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, 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 4.1 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 62366-1 IEC Application of Usability Engineering to Medical Devices (Edition 1.1 2020). FDA/CDRH recognition number 5-129
- ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied (Edition 4.0 2021). FDA/CDRH recognition number: 5-134.
- ISO 20417 Medical devices Information to be supplied by the manufacturer (First edition ● 2021-04 Corrected version 2021-12). FDA/CDRH recognition number 5-135
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issue date: ● 01-Sep-2016)
- . Pediatric Information for X-ray Imaging Device Premarket Notifications (Issue Date: 28-Nov-2017)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (11-May-2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (02-Oct-2014)
- Guidance for Industry and FDA Staff Applying Human Factors and Usability Engineering ● to Medical Devices(document number (03-Feb-2016)
- . Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff (14-Aug-2013)
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 demonstrate that the Zenition 30:
15
| 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. | |
|---|---|
| Therefore, the Zenition 30 is substantially equivalent to the currently marketed and predicate Zenition 70 (K212813, Oct 1, 2021) in terms of safety and effectiveness. | |
| Summary of | |
| Clinical | |
| Performance | |
| Data: | The 11-inch detector in Zenition 30 has similar design, technology and Image acquisition workflow compared to the previously cleared detector used in the marketed predicate device Zenition 70. All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to 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. So, no clinical information was used to support the substantial equivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. |
| Substantial | |
| Equivalence | |
| Conclusion: | The Zenition 30 is substantial equivalent to the currently marketed predicate device Zenition 70 (K212813, Oct 1, 2021) in terms of indications for use, fundamental scientific technology and safety and effectiveness. |
Additionally, substantial equivalence was demonstrated by non-clinical performance tests. These tests demonstrate that Zenition 30 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. |