(28 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or performance metrics indicative of AI/ML.
No.
The device is described as a "mobile, diagnostic X-ray imaging and viewing system" used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." Its purpose is imaging and guidance, not direct treatment of a disease or condition.
Yes
The "Intended Use / Indications for Use" section states the device is used for “radiological guidance and visualization during diagnostic, interventional and surgical procedures.” Additionally, the "Device Description" explicitly calls it a "mobile, diagnostic X-ray imaging and viewing system."
No
The device description explicitly states that the system comprises two main components: the C-arm stand and a mobile view station, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Zenition 70 is described as a "mobile, diagnostic X-ray imaging and viewing system." Its intended use is for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." This involves imaging the inside of the body using X-rays, not analyzing samples taken from the body.
- Input Modality: The input modality is X-ray, which is an imaging technique, not a method for analyzing biological specimens.
The device is clearly an imaging device used for visualizing internal structures during medical procedures.
N/A
Intended Use / Indications for Use
The proposed Zenition 70 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of 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, OXO, JAA
Device Description
The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises two main components: The C-arm stand and a mobile view station
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 / health care facilities both inside and outside the operating room, sterile as well as non-sterile environment
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 70 and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents:
- ES60601-1:2005/(R)2012 and A1:2012 (Edition 3.1); Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition Number: 19-4)
- IEC 60601-1-2 (Edition 4.0 2014-02); Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests (Recognition Number: 19-8)
- IEC 60601-1-3 (Edition 2.1 2013-04); Medical Electrical Equipment -Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment (Recognition Number: 12-269)
- IEC 60601-1-6 (Edition 3.1 2013-10); Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (Recognition Number: 5-89)
- IEC 60601-2-43 (Edition 2.1 2017-05); Medical Electrical Equipment -Part 2-43: Particular Requirements For The Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures (Recognition Number: 12-308)
- IEC 60601-2-54 (Edition 1.2 2018-06); Medical Electrical Equipment -Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy (Recognition Number: 12-317)
- IEC 60601-2-28 (Edition 2.0 2010-03); Medical Electrical Equipment -Part 2-28: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Tube Assemblies For Medical Diagnosis (Recognition Number: 12-204)
- IEC 62304 (Edition 1.1 2015-06); Medical device software - Software life cycle processes (Recognition Number: 13-79)
- IEC 62366-1 (Edition 1.0 2015-02); Medical devices – Part 1: Application of usability engineering to medical devices (Recognition Number: 5-114)
- ISO 14971 (Edition 2.0 2007-03); Medical Devices Application Of Risk Management To Medical Devices (Recognition Number: 5-40)
- ISO 15223-1 (Edition 3.0 2016-11); Medical devices Symbols to be used with medical device labels, labelling and information to be supplied (Recognition Number: 5-117)
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff (Issue date: 9/1/2016)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Issue date: 11/28/2017)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff (Issue date: 5/11/2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Issue date: 10/02/2014).
Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results. All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed Zenition 70: Complies with the above-mentioned international and FDA-recognized consensus standards and FDA guidance documents, and Meets the acceptance criteria and is adequate for its intended use. Therefore, the proposed Zenition 70 is substantially equivalent to the currently marketed Zenition 70 in terms of safety and effectiveness.
The proposed Zenition 70 did not require clinical study since substantial equivalence to the currently marketed and predicate device Zenition 70 was demonstrated with the following attributes: Indications for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness.
Furthermore, the optional FD17 detector (Pixium3030S) utilizes the same design, technology and Image acquisition workflow compared to the previously FD12 (Pixium 2121CV/S) and FD15 (Pixium 2630SV) detectors used in the marketed and predicate device Zenition 70 (K183040, December 6, 2018). 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"; issued on September 1, 2016.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
October 1, 2021
Philips Medical Systems Nederland BV % Swapnil Sharadkumar Jain, Ph.D. Regulatory Affairs Specialist Veenpluis 4-6 Best, 5684PC THE NETHERLANDS
Re: K212813
Trade/Device Name: Zenition 70 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: August 27, 2021 Received: September 3, 2021
Dear Dr. Jain:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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
1
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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212813
Device Name Zenition 70
Indications for Use (Describe)
The proposed Zenition 70 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures.
Applications:
- · Orthopedic
- Neuro
- Abdominal
- Vascular
- · Thoracic
- Cardiac
| 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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K212813 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | August 27, 2021 |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland BV |
| Veenpluis 4-6, 5684 PC Best, | |
| The Netherlands | |
| Establishment Registration Number: 3003768277 | |
| Primary Contact | |
| Person: | Swapnil Sharadkumar Jain |
| Regulatory Affairs Specialist | |
| Phone: +91-8788984943 | |
| E-mail: swapnil.jain@philips.com | |
| Secondary Contact | |
| Person: | Neena Sonavane |
| Senior RA Manager, Q&R R&C Affairs - IGT | |
| Phone: +91-8446020023 | |
| E-mail: neena.sonavane@philips.com | |
| Device: | Trade Name: Zenition 70 |
| Classification Name: Image intensified fluoroscopic x-ray system | |
| Classification Regulation: 21CFR §892.1650 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: OWB, OXO, JAA | |
| Predicate Device: | Trade Name: Zenition 70 |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K183040 (December 6, 2018) | |
| Classification Name: Image intensified fluoroscopic x-ray system | |
| Classification Regulation: 21CFR §892.1650 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: OWB, OXO, JAA | |
| Reference Device: | Trade Name: Digiscan FDX |
| Manufacturer: Allengers Medical Systems Limited | |
| 510(k) Clearance: K200218 (July 13, 2020) | |
| Classification Name: Image intensified fluoroscopic x-ray system | |
| Classification Regulation: 21CFR §892.1650 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: OWB, OXO, JAA | |
| Device description: | The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing |
| system. It is designed for medical use in healthcare facilities where X-ray imaging | |
| is needed. The system comprises two main components: The C-arm stand and a | |
| mobile view station | |
| Indications for Use: | The proposed Zenition 70 is intended to be used and operated by: adequately |
| trained, qualified and authorized health care professionals who have full | |
| understanding of 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) |
4
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
The proposed Zenition 70 has identical indications to the currently marketed and predicate device Zenition 70. Based on the information provided above, the proposed Zenition 70 is considered substantially equivalent to the currently marketed and predicate device Zenition 70 (K183040, December 6, 2018) in terms of Indications for Use.
Technological The proposed Zenition 70 employs the same basic construction and fundamental characteristics: scientific technology as the currently marketed and predicate Zenition 70.
The difference between the proposed Zenition 70 and the predicate device Zenition 70 (K183040, December 6, 2018) is summarized as follows:
The Philips Medical Systems Nederland BV, Zenition 70 (K183040, December 6, 2018) device currently incorporates FD12 (Pixium 2121CV/S) and FD15 (Pixium 2630Sv) solid-state flat-panel detectors (FPD). This submission adds an additional option of a slightly larger FD17 (Pixium3030S) solid-state flat-panel detector and its associated Beam limiting device FD17 and Grid FD17. The newly introduced FD17 (Pixium3030S) detector has the same design, technology and image acquisition workflow compared to the previously cleared FD12 (Pixium 2121CV/S) and FD15 (Pixium 2630Sv) detectors used in the marketed predicate device Zenition 70 (K183040, December 6, 2018), except for difference in the dimensions. FD17 (Pixium3030S) detector is also manufactured by the same manufacturer of the already cleared FD12 (Pixium 2121CV/S) and FD15 (Pixium 2630Sv) detectors (Thales from France) used in the predicate device.
The differences between the proposed Zenition 70 and the predicate device Zenition 70 (K183040, December 6, 2018) do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the proposed Zenition 70 is considered substantially equivalent to the
5
currently marketed predicate Zenition 70 in terms of fundamental scientific technology.
See Table 5-1 below comparing the proposed Zenition 70 and the predicate device Zenition 70 (K183040, December 6, 2018). The outcome of this comparison demonstrates that the differences in the technological characteristics do not affect the safety or effectiveness of the proposed Zenition 70 when compared to the currently marketed and predicate Zenition 70 (K183040, December 6, 2018).
The newly introduced FD17 (Pixium3030S) detector of the proposed Zenition 70 is identical to the detector used in the currently marketed and reference device, Digiscan FDX (K200218, July 13, 2020) manufactured by Allengers Medical Systems Limited. Therefore, both the FD17 (Pixium3030S) detector of the proposed Zenition 70 and the currently marketed and reference device, Digiscan FDX employ identical fundamental scientific technology.
| Table 5-1. Technological characteristics comparison of the proposed Zenition 70 and the | |
|---|---|
| predicate device Zenition 70 (K183040, December 6, 2018) |
| Component
/feature | Currently marketed
and predicate device
Zenition 70
(K183040, December
6, 2018) | Proposed
Zenition 70 | Comparison |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-ray
Generator | iXion HF Generator
Model: 10359400 | iXion HF Generator
Model: 10359400 | No difference; thus, demonstrating SE. |
| X-ray tube | Model: RTM 780 H
(Type RO-0306) | Model: RTM 780 H (Type RO-0306) | No difference; thus, demonstrating SE. |
| X-ray tube
housing
assembly | iXion Monoblock V
with X-ray tube RO-0306 | iXion Monoblock V with X-ray tube RO-0306 | No difference; thus, demonstrating SE. |
| Detectors
(Image
detection
subsystem) | FD15 Flat detector
(Pixium 2630Sv) | FD15 Flat
detector
(Pixium 2630Sv) | No difference; thus, demonstrating SE. |
| | FD12 Flat detector
(Pixium 2121CV/S) | FD12 Flat
detector (Pixium
2121CV/S) | No difference; thus, demonstrating SE. |
| | N/A | FD17 Flat
detector (Pixium
3030S) | The optional FD17 (PX3030S) detector is
based on the same design, scientific
technology, and image acquisition
workflow as the FD15 (PX2630Sv) and
FD12 (PX2121CV/S) detectors used in
the predicate device. The FD17
(PX3030S) is different compared to the
FD15 (PX2630Sv) and FD12
(PX2121CV/S) detectors in dimensions |
| Component
/feature | Currently marketed
and predicate device
Zenition 70
(K183040, December
6, 2018) | Proposed
Zenition 70 | Comparison |
| | | | and pixel size. There is no change in
clinically relevant characteristics of the
detector that relate to the acquisition to X-
ray images and X-ray dose sensitivity.
The image quality performance of the
FD17 (PX3030S) and FD15 (PX2630Sv)
and FD12 (PX2121CV/S) detector is
compared and found to be equal. The
change does not introduce new risks, and
it 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.
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". The
optional FD17 (Pixium3030S) detector is
already used in the currently marketed and
reference device, Digiscan FDX
(K200218, July 13, 2020).
Hence, this change does not impact the
safety or effectiveness of the device. Thus,
demonstrating substantial equivalence. |
| Detachable
grids | Grid FD15 | Grid FD15 | No difference; thus,
demonstrating SE. |
| | Grid FD12 | Grid FD12 | No difference; thus,
demonstrating SE. |
| | N/A | Grid FD17 | The FD17 (PX3030S) detector
introduction includes the introduction of a
removable anti- scatter grid. The FD17
(PX3030S) detector grid has exactly same
design and technology compared to FD15
(PX2630Sv) and FD12 (PX2121CV/S)
grid used in currently marketed predicate
device, except for the difference in
dimensions. Addition of new grid for
FD17 (PX3030S) introduction
has no impact on clinical
workflow. This change does not affect |
| Component
/feature | Currently marketed
and predicate device
Zenition 70
(K183040, December
6, 2018) | Proposed
Zenition 70 | Comparison |
| | | | demonstrating substantial equivalence. |
| Collimator
(Beam limiting
device) | Beam limiting device
FD15- PX2630Sv | Beam limiting
device
FD15-
PX2630Sv | No difference; thus,
demonstrating SE. |
| | Beam limiting device
FD12- PX2121CV/S | Beam limiting
device
FD12 -
PX2121CV/
S | No difference; thus,
demonstrating SE. |
| | N/A | Beam limiting
device
FD17-
Pixium3030
S | A new collimator for the FD17 -
Pixium3030S has been designed such that
it reuses the design of the existing
predicate device, FD15 (PX2630Sv) and
FD12 (PX2121S) collimator with the
only exception the square fixed
diaphragm that has a larger window to
match the larger detector format of the
FD17 - Pixium3030S. All other parts of
the collimator are identical. Addition of
new collimator for FD17 (PX3030S)
introduction has no impact on clinical
workflow. Hence, this does not impact
safety or effectiveness of the
device.
Thus, demonstrating substantial
equivalence. |
| Detector laser
aiming device | Integrated in FD covers
(Model: FP-L-635-10-
34-Philips-V2-C2) | Integrated in
FD covers
(Model: FP-
L-635-10-
34-Philips-
V2-C2) | No difference; thus,
demonstrating SE. |
| Mobile
C- arm Stand | Veradius R3.1
Stand with FD | Veradius R3.1
Stand with FD | No difference; thus,
demonstrating SE. |
| Mobile
Viewing Station | MVS BV Family R3 | MVS BV Family
R3 | No difference; thus,
demonstrating SE. |
| DICOM
connectivity | DICOM
compatible | DICOM
compatible | No difference; thus,
demonstrating SE. |
| Component
/feature | Currently marketed
and predicate device
Zenition 70
(K183040, December
6, 2018) | Proposed
Zenition 70 | Comparison |
| Operating
System | Windows 7 embedded | Windows 10
embedded | No change in software architecture as this
is migration in same family of operating
system. There are no changes in the
Windows 10 operating system that
influences the architecture of the
application. Hence the overall
architecture has remained the same
during the process of migration.
Introduction of operating system
Windows 10 embedded does not impact
clinical image quality. Therefore, there is
no impact on the safety and effectiveness
of the device; thus, demonstrating SE. |
| Touch screen
monitor (TSM) | Touch screen monitor
(TSM) option not
available | Touch
screen
monitor
(TSM)
option
available | The TSM replicates the same information
as on the C-arm stand touchscreen
enabling table side control of the C-arm
stand functions. This is additional user
interface on table side with no change in
control mechanism, operating principle, or
energy type. Therefore, there is no impact
on the safety and effectiveness of the
device; thus, demonstrating SE. |
| iApp
(Interventional
applications)
software
interface | iApp software interface
option not available | iApp
software
interface
option
available | iApp is an optional feature that enables the
proposed Zenition 70 to work with
compatible third-party software medical
devices/iApps. The third-party software
application(s) will only do post processing
functions, without impacting Zenition 70
operation workflow or intended use. This
change in software only introduces non-
therapeutic and non-diagnostic feature.
Therefore, there is no impact on the safety
and effectiveness of the device; thus,
demonstrating SE. |
6
7
8
9
Non-clinical performance testing has been performed on the proposed Zenition Summary of Non-Clinical Performance 70 and demonstrates compliance with the following International and FDA-Data: recognized consensus standards and FDA guidance documents:
- . ES60601-1:2005/(R)2012 and A1:2012 (Edition 3.1); Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Recognition Number: 19-4)
- . IEC 60601-1-2 (Edition 4.0 2014-02); Medical Electrical Equipment -Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests (Recognition Number: 19-8)
- . IEC 60601-1-3 (Edition 2.1 2013-04); Medical Electrical Equipment -Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment (Recognition Number: 12-269)
- IEC 60601-1-6 (Edition 3.1 2013-10); Medical Electrical Equipment -● Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (Recognition Number: 5-89)
- IEC 60601-2-43 (Edition 2.1 2017-05); Medical Electrical Equipment -Part 2-43: Particular Requirements For The Safety And Essential Performance Of X-Ray Equipment For Interventional Procedures (Recognition Number: 12-308)
- IEC 60601-2-54 (Edition 1.2 2018-06); Medical Electrical Equipment -Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy (Recognition Number: 12-317)
- . IEC 60601-2-28 (Edition 2.0 2010-03); Medical Electrical Equipment -Part 2-28: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Tube Assemblies For Medical Diagnosis (Recognition Number: 12-204)
- . IEC 62304 (Edition 1.1 2015-06); Medical device software - Software life cycle processes (Recognition Number: 13-79)
- IEC 62366-1 (Edition 1.0 2015-02); Medical devices – Part 1: Application of usability engineering to medical devices (Recognition Number: 5-114)
- ISO 14971 (Edition 2.0 2007-03); Medical Devices Application Of ● Risk Management To Medical Devices (Recognition Number: 5-40)
- ISO 15223-1 (Edition 3.0 2016-11); Medical devices Symbols to be ● used with medical device labels, labelling and information to be supplied (Recognition Number: 5-117)
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff (Issue date: 9/1/2016)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Issue date: 11/28/2017)
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- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff (Issue date: 5/11/2005) ● Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Issue date: 10/02/2014) Non-clinical verification and validation tests have been performed with regards to the intended use, the technical claims, requirement specifications, and the risk management results. All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed Zenition 70: ● Complies with the above-mentioned international and FDA-recognized consensus standards and FDA guidance documents, and Meets the acceptance criteria and is adequate for its intended use. ● Therefore, the proposed Zenition 70 is substantially equivalent to the currently marketed Zenition 70 in terms of safety and effectiveness. Summary of Clinical The proposed Zenition 70 did not require clinical study since substantial Performance Data: equivalence to the currently marketed and predicate device Zenition 70 was demonstrated with the following attributes: . Indications for use; ● Technological characteristics; Non-clinical performance testing; and ●
- . Safety and effectiveness.
Furthermore, the optional FD17 detector (Pixium3030S) utilizes the same design, technology and Image acquisition workflow compared to the previously FD12 (Pixium 2121CV/S) and FD15 (Pixium 2630SV) detectors used in the marketed and predicate device Zenition 70 (K183040, December 6, 2018). 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"; issued on September 1, 2016. The optional FD17 (Pixium3030S) detector is already used in the currently marketed and reference device, Digiscan FDX (K200218, July 13, 2020).