(28 days)
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
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.
The provided text is a 510(k) summary for the Philips Zenition 70, a fluoroscopic X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (previous Zenition 70 model K183040) and a reference device (Digiscan FDX K200218) by adding a new flat panel detector (FD17) and some software/UI updates.
The document states that no clinical studies were required as substantial equivalence was demonstrated through non-clinical performance testing and similarity in indications for use and technological characteristics. Therefore, the device's acceptance criteria are primarily met through compliance with recognized standards and verification of technical performance, rather than a clinical study involving human readers or a set of clinical cases with ground truth.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of specific clinical acceptance criteria and corresponding performance metrics from a study involving clinical cases. Instead, the acceptance criteria are largely defined by adherence to a comprehensive list of international and FDA-recognized consensus standards and FDA guidance documents. The "reported device performance" is the statement that the device complies with these standards.
| Acceptance Criteria Category | Specific Criteria (as derived from the text) | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance | Compliance with ES60601-1:2005/(R)2012 and A1:2012 | Complies |
| Electromagnetic Disturbances | Compliance with IEC 60601-1-2 (Edition 4.0 2014-02) | Complies |
| Radiation Protection (Diagnostic X-Ray) | Compliance with IEC 60601-1-3 (Edition 2.1 2013-04) | Complies |
| Usability | Compliance with IEC 60601-1-6 (Edition 3.1 2013-10) and IEC 62366-1 (Edition 1.0 2015-02) | Complies |
| Safety & Performance (Interventional X-Ray) | Compliance with IEC 60601-2-43 (Edition 2.1 2017-05) | Complies |
| Safety & Performance (Radiography and Radioscopy) | Compliance with IEC 60601-2-54 (Edition 1.2 2018-06) | Complies |
| X-Ray Tube Assemblies | Compliance with IEC 60601-2-28 (Edition 2.0 2010-03) | Complies |
| Software Life Cycle Processes | Compliance with IEC 62304 (Edition 1.1 2015-06) | Complies |
| Risk Management | Compliance with ISO 14971 (Edition 2.0 2007-03) | Complies |
| Medical Device Symbols | Compliance with ISO 15223-1 (Edition 3.0 2016-11) | Complies |
| Solid State X-ray Imaging Devices | Adherence to "FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" | Assessed and Verified |
| Pediatric Information | Adherence to "Pediatric Information for X-ray Imaging Device Premarket Notifications" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Software in Medical Devices (Content of Submissions) | Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Cybersecurity Management | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | (Not explicitly stated as "complies" but is a guidance document followed) |
| Image Quality Performance | Image quality performance of FD17 (PX3030S) compared to FD15 (PX2630Sv) and FD12 (PX2121CV/S) detectors. | Found to be equal. |
| Safety and Effectiveness | No new questions regarding safety or effectiveness raised by differences. | Demonstrated for substantial equivalence. |
| Intended Use & Technical Claims | Non-clinical V&V tests performed with regards to intended use, technical claims, requirement specifications, and risk management results. | All tests used to support substantial equivalence and demonstrate the device meets acceptance criteria and is adequate for intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "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."
Therefore, there was no test set of clinical cases that a sample size would apply to. The testing involved non-clinical performance evaluations against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set requiring expert ground truth was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for an X-ray imaging system, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable, as this is an imaging system, not a standalone algorithm. Its performance is evaluated through technical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission comes from the established and recognized international and FDA standards for medical electrical equipment and X-ray imaging devices. The performance of the new FD17 detector was compared to the predicate detectors, where "image quality performance...is compared and found to be equal." This comparison is technical/physical, not clinical.
8. The sample size for the training set
Not applicable, as this is an X-ray system. The "training" for such a device involves engineering, design, and manufacturing processes compliant with quality systems, not machine learning training on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning for this device.
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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
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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 BVVeenpluis 4-6, 5684 PC Best,The NetherlandsEstablishment Registration Number: 3003768277 |
| Primary ContactPerson: | Swapnil Sharadkumar JainRegulatory Affairs SpecialistPhone: +91-8788984943E-mail: swapnil.jain@philips.com |
| Secondary ContactPerson: | Neena SonavaneSenior RA Manager, Q&R R&C Affairs - IGTPhone: +91-8446020023E-mail: neena.sonavane@philips.com |
| Device: | Trade Name: Zenition 70Classification Name: Image intensified fluoroscopic x-ray systemClassification Regulation: 21CFR §892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: OWB, OXO, JAA |
| Predicate Device: | Trade Name: Zenition 70Manufacturer: Philips Medical Systems Nederland B.V.510(k) Clearance: K183040 (December 6, 2018)Classification Name: Image intensified fluoroscopic x-ray systemClassification Regulation: 21CFR §892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: OWB, OXO, JAA |
| Reference Device: | Trade Name: Digiscan FDXManufacturer: Allengers Medical Systems Limited510(k) Clearance: K200218 (July 13, 2020)Classification Name: Image intensified fluoroscopic x-ray systemClassification Regulation: 21CFR §892.1650Classification Panel: RadiologyDevice Class: Class IIProduct Code: OWB, OXO, JAA |
| Device description: | The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewingsystem. It is designed for medical use in healthcare facilities where X-ray imagingis needed. The system comprises two main components: The C-arm stand and amobile view station |
| Indications for Use: | The proposed Zenition 70 is intended to be used and operated by: adequatelytrained, qualified and authorized health care professionals who have fullunderstanding of the safety information and emergency procedures as well as thecapabilities 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) |
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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
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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 marketedand predicate deviceZenition 70(K183040, December6, 2018) | ProposedZenition 70 | Comparison |
|---|---|---|---|
| X-rayGenerator | iXion HF GeneratorModel: 10359400 | iXion HF GeneratorModel: 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 tubehousingassembly | iXion Monoblock Vwith X-ray tube RO-0306 | iXion Monoblock V with X-ray tube RO-0306 | No difference; thus, demonstrating SE. |
| Detectors(Imagedetectionsubsystem) | FD15 Flat detector(Pixium 2630Sv) | FD15 Flatdetector(Pixium 2630Sv) | No difference; thus, demonstrating SE. |
| FD12 Flat detector(Pixium 2121CV/S) | FD12 Flatdetector (Pixium2121CV/S) | No difference; thus, demonstrating SE. | |
| N/A | FD17 Flatdetector (Pixium3030S) | The optional FD17 (PX3030S) detector isbased on the same design, scientifictechnology, and image acquisitionworkflow as the FD15 (PX2630Sv) andFD12 (PX2121CV/S) detectors used inthe predicate device. The FD17(PX3030S) is different compared to theFD15 (PX2630Sv) and FD12(PX2121CV/S) detectors in dimensions | |
| Component/feature | Currently marketedand predicate deviceZenition 70(K183040, December6, 2018) | ProposedZenition 70 | Comparison |
| and pixel size. There is no change inclinically relevant characteristics of thedetector that relate to the acquisition to X-ray images and X-ray dose sensitivity.The image quality performance of theFD17 (PX3030S) and FD15 (PX2630Sv)and FD12 (PX2121CV/S) detector iscompared and found to be equal. Thechange does not introduce new risks, andit was shown to be compliant with theinternational and FDA recognizedstandards IEC60601-1, IEC60601-2-43and IEC60601-2-54 for basic safety andessential performance.All technical detector characteristics thatpotentially have an influence on imagequality are assessed and verified accordingto "FDA Guidance for Industry and Foodand Drug Administration Staff: Guidancefor the Submission of 510(k)'s for SolidState X-ray Imaging Devices". Theoptional FD17 (Pixium3030S) detector isalready used in the currently marketed andreference device, Digiscan FDX(K200218, July 13, 2020).Hence, this change does not impact thesafety or effectiveness of the device. Thus,demonstrating substantial equivalence. | |||
| Detachablegrids | 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) detectorintroduction includes the introduction of aremovable anti- scatter grid. The FD17(PX3030S) detector grid has exactly samedesign and technology compared to FD15(PX2630Sv) and FD12 (PX2121CV/S)grid used in currently marketed predicatedevice, except for the difference indimensions. Addition of new grid forFD17 (PX3030S) introductionhas no impact on clinicalworkflow. This change does not affect | |
| Component/feature | Currently marketedand predicate deviceZenition 70(K183040, December6, 2018) | ProposedZenition 70 | Comparison |
| demonstrating substantial equivalence. | |||
| Collimator(Beam limitingdevice) | Beam limiting deviceFD15- PX2630Sv | Beam limitingdeviceFD15-PX2630Sv | No difference; thus,demonstrating SE. |
| Beam limiting deviceFD12- PX2121CV/S | Beam limitingdeviceFD12 -PX2121CV/S | No difference; thus,demonstrating SE. | |
| N/A | Beam limitingdeviceFD17-Pixium3030S | A new collimator for the FD17 -Pixium3030S has been designed such thatit reuses the design of the existingpredicate device, FD15 (PX2630Sv) andFD12 (PX2121S) collimator with theonly exception the square fixeddiaphragm that has a larger window tomatch the larger detector format of theFD17 - Pixium3030S. All other parts ofthe collimator are identical. Addition ofnew collimator for FD17 (PX3030S)introduction has no impact on clinicalworkflow. Hence, this does not impactsafety or effectiveness of thedevice.Thus, demonstrating substantialequivalence. | |
| Detector laseraiming device | Integrated in FD covers(Model: FP-L-635-10-34-Philips-V2-C2) | Integrated inFD covers(Model: FP-L-635-10-34-Philips-V2-C2) | No difference; thus,demonstrating SE. |
| MobileC- arm Stand | Veradius R3.1Stand with FD | Veradius R3.1Stand with FD | No difference; thus,demonstrating SE. |
| MobileViewing Station | MVS BV Family R3 | MVS BV FamilyR3 | No difference; thus,demonstrating SE. |
| DICOMconnectivity | DICOMcompatible | DICOMcompatible | No difference; thus,demonstrating SE. |
| Component/feature | Currently marketedand predicate deviceZenition 70(K183040, December6, 2018) | ProposedZenition 70 | Comparison |
| OperatingSystem | Windows 7 embedded | Windows 10embedded | No change in software architecture as thisis migration in same family of operatingsystem. There are no changes in theWindows 10 operating system thatinfluences the architecture of theapplication. Hence the overallarchitecture has remained the sameduring the process of migration.Introduction of operating systemWindows 10 embedded does not impactclinical image quality. Therefore, there isno impact on the safety and effectivenessof the device; thus, demonstrating SE. |
| Touch screenmonitor (TSM) | Touch screen monitor(TSM) option notavailable | Touchscreenmonitor(TSM)optionavailable | The TSM replicates the same informationas on the C-arm stand touchscreenenabling table side control of the C-armstand functions. This is additional userinterface on table side with no change incontrol mechanism, operating principle, orenergy type. Therefore, there is no impacton the safety and effectiveness of thedevice; thus, demonstrating SE. |
| iApp(Interventionalapplications)softwareinterface | iApp software interfaceoption not available | iAppsoftwareinterfaceoptionavailable | iApp is an optional feature that enables theproposed Zenition 70 to work withcompatible third-party software medicaldevices/iApps. The third-party softwareapplication(s) will only do post processingfunctions, without impacting Zenition 70operation workflow or intended use. Thischange in software only introduces non-therapeutic and non-diagnostic feature.Therefore, there is no impact on the safetyand effectiveness of the device; thus,demonstrating SE. |
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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).
§ 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.