(266 days)
The Incisive CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Incisive CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The proposed Philips Incisive CT is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV).
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Ingenuity CT (K160743, 08/08/2016).
The main system modules and functionalities are:
- Gantry. The Gantry consists of 4 main internal units:
a. Stator - a fixed mechanical frame that carries HW and SW
b. Rotor - A rotating circular stiff frame that is mounted in and supported by the stator.
c. X-Ray Tube (XRT) and Generator, - fixed to the Rotor frame
d. Data Measurement System (DMS) – a detectors array, fixed to the Rotor frame - Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan
- Console - Containing a Host computer and display that is the primary user interface.
In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Philips Incisive CT, a computed tomography x-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for an AI/CADe device.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving an AI device meets those criteria (especially points 3, 4, 5, 7, 8, 9) is largely missing from this specific document. The document describes a traditional CT scanner, not an AI feature or independent AI device.
However, I can extract the relevant information that is present and note the missing parts:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and imaging features. The "performance" is implicitly the device meeting, matching, or improving upon these characteristics without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Philips Incisive CT) | Conclusion (vs. Predicate Philips Ingenuity CT K160743) |
|---|---|---|
| Scan Characteristics: | ||
| No. of Slices: 64/128 | 64/128 | Identical. Substantially equivalent. |
| Scan Modes: Surview, Axial, Helical | Surview, Axial, Helical | Identical. Substantially equivalent. |
| Minimum Scan Time: 0.42 sec for 360° rotation (predicate) | 0.35 sec for 360° rotation | Faster. Safety and effectiveness not affected. Substantially equivalent. |
| Image (Spatial) Resolution: High: 16 lp/cm, Standard: 13 lp/cm | High: 16 lp/cm, Standard: 13 lp/cm | Identical. Substantially equivalent. |
| Image Noise: 0.27% at 120 kV, 250 mAs, 10 mm slice (predicate) | 0.27% at 120 kV, 230 mAs, 10 mm slice | Identical. Substantially equivalent. |
| Slice Thicknesses: Helical: 0.67-5mm, Axial: 0.625-12.5mm (predicate) | Helical: 0.67mm-5mm, Axial: 0.625mm-10.0mm | Essentially the same. Does not affect safety and effectiveness. Substantially equivalent. |
| Scan Field of View: Up to 500 mm | Up to 500 mm | Identical. Substantially equivalent. |
| Image Matrix: Up to 1024 * 1024 | Up to 1024 * 1024 | Identical. Substantially equivalent. |
| Display: 1024 * 1280 (predicate) | 1920 * 1080 | Higher resolution. Safety and effectiveness not affected. Substantially equivalent. |
| Host Infrastructure: Windows 7 (predicate) | Windows 10 | Same supplier, same technology, similar function. Substantially equivalent. |
| Communication: Compliance with DICOM | Compliance with DICOM | Identical. Substantially equivalent. |
| Dose Reporting & Management: Compliance with NEMA XR25 and XR29 (predicate) | Compliance with NEMA XR25, XR28 and XR29 | Compliance with more NEMA standards. Safety and effectiveness not affected. Substantially equivalent. |
| Imaging Features: (Compared to Secondary Predicate Philips Incisive CT K180015) | ||
| 2D Viewer, MPR, 3D (volume mode), Virtual Endoscopy, Filming, Image matrix (1024x1024), O-MAR, Dose Modulation, Scan Preparation, On line MPR, Control Panel (iStation), iBatch, Bolus Tracking, SAS, Worklist, MPPS, Reporting, CCT, Brain Perfusion, Dental, iDose4, Helical Retrospective Tagging, Axial Prospective Gating calcium scoring, Step & Shoot Cardiac, CCS (Cardiac calcium scoring), CTC, VA, LNA, CAA, CFA, DE (Spin/Spin scan mode) | Yes (Identical functionality) | Identical. Functionally equivalent. |
| Precise image reconstruction (AI-driven) | No | Different. Referred to K210760 for safety and effectiveness. |
| Precise Cardiac (AI-driven) | No | Different. Referred to K203020 for safety and effectiveness. |
| Precise Position (AI-driven workflow) | No | Different. Referred to K203514 for safety and effectiveness. |
| Direct results (workflow enhancement) | No | Different. Workflow update, no impact on safety and effectiveness. |
| Parallel workflow | No | Workflow update, no impact on safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document states: "The proposed Philips Incisive CT did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
This means there was no dedicated clinical test set in the traditional sense of patient data used for performance claims. The "testing" appears to be primarily engineering verification and validation against design specifications and industry standards, and comparison to the technical specifications of a predicate device. Therefore, no specific sample size, country of origin, or retrospective/prospective nature of a clinical test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there was no clinical study and no clinical test set for independent performance evaluation (rather, it was a substantial equivalence submission based on technical and functional comparison), this information is not applicable/provided. Ground truth establishment by experts for specific clinical findings is not described.
4. Adjudication method for the test set
Not applicable as no clinical test set and ground truth establishment by experts are described.
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. The submission is for a CT scanner itself, not an AI-assisted reading tool. While some newer "Precise" features mention deep learning (e.g., "Precise image reconstruction"), the document explicitly states these are "Different" and refers to other 510(k) clearances (K210760, K203020, K203514) for their safety and effectiveness. This document does not contain the MRMC study details for those specific AI features.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable for the CT scanner itself. For the "Precise" features that hint at AI, the performance data is referenced in other submissions, not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this submission's stated "verification/validation testing" which focuses on technical specifications and functional equivalence to predicates.
8. The sample size for the training set
Not applicable, as this document does not describe the development or training of an AI model.
9. How the ground truth for the training set was established
Not applicable, as this document does not describe the development or training of an AI model.
Summary of what the document does provide:
The document describes the Philips Incisive CT as a Computed Tomography X-Ray System. Its acceptance criteria and proving methodology revolve around demonstrating substantial equivalence to existing, legally marketed predicate CT devices (Philips Ingenuity CT K160743 and Philips Incisive CT K180015). This is achieved through:
- Comparison of technical specifications: Scan characteristics (slices, scan modes, scan time, resolution, noise, slice thickness, FOV, image matrix, display, infrastructure, communication, dose reporting).
- Comparison of imaging features/functionalities: A comprehensive list of features like 2D Viewer, MPR, 3D, O-MAR, Dose Modulation, Bolus Tracking, various analysis applications (Lung Nodule, Cardiac Artery, etc.), and others.
- Compliance with recognized consensus standards: A list of international and FDA-recognized standards (e.g., IEC 60601 series, IEC 62304, ISO 14971, NEMA XR standards) which the device is stated to comply with.
- Non-clinical design verification and validation testing: The document briefly states that "The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). ... Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation."
The core assertion for the Philips Incisive CT's acceptance is that its design, intended use, technology, and principal technological components are substantially equivalent to the predicate devices, and that the product's differences do not raise new questions of safety or effectiveness. For specific features that appear to involve AI (like "Precise image reconstruction"), the document explicitly points to other 510(k) submissions, indicating that their clinical performance and acceptance would be detailed there.
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April 27, 2022
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Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Regulatory Affairs Engineer No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA
Re: K212441
Trade/Device Name: Philips Incisive CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: March 16, 2022 Received: March 16, 2022
Dear Shiguang An:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Philips Incisive CT
Indications for Use (Describe)
The Incisive CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Incisive CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| Date Prepared: | July 30, 2021 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhongyuan Road, Suzhou Industrial Park,Suzhou Jiangsu, CHINA, 215024Establishment Registration Number: 3009529630 |
| Primary Contact Person: | Shiguang AnRegulatory Affairs EngineerPhone: +86-24-28206367E-mail: shiguang.an@philips.com |
| Secondary Contact Person | Erhong WangSenior Manager Regulatory AffairsPhone: +86-512-67336804E-mail: ErHong.WANG@philips.com |
| Device Name: | Philips Incisive CT |
| Classification: | Classification name: Computed tomography x-ray systemClassification Regulation: 21CFR 892.1750Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: JAK |
| Primary Predicate Device: | Trade name: Philips Ingenuity CTManufacturer: Philips Medical Systems (Cleveland), Inc.510(k) Clearance: K160743Classification Regulation: 21CFR 892.1750Classification name: Computed tomography x-ray systemClassification Panel: RadiologyDevice class: Class IIProduct Code: JAK |
| Secondary Predicate Device: | Trade name: Philips Incisive CTManufacturer: Philips Healthcare (Suzhou) Co., Ltd.510(k) Clearance: K180015Classification Regulation: 21CFR 892.1750Classification name: Computed tomography x-ray systemClassification Panel: RadiologyDevice class: Class IIProduct Code: JAK |
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| Device Description: | The proposed Philips Incisive CT is a whole-bodycomputed tomography (CT) X-Ray System featuring acontinuously rotating x-ray tube, detectors, and gantry withmulti-slice capability. The acquired x-ray transmission datais reconstructed by computer into cross-sectional images ofthe body taken at different angles and planes. This systemalso includes signal analysis and display equipment, patientand equipment supports, components, and accessories.The Philips Incisive CT has a 72cm bore and includes adetector array that provides 50cm scan field of view (FOV). | Traditional 510k |
|---|---|---|
| The main components (detection system, the reconstructionalgorithm, and the x-ray system) that are used in theproposed Philips Incisive CT have the same fundamentaldesign characteristics and are based on comparabletechnologies as the current market predicate PhilipsIngenuity CT (K160743, 08/08/2016). | ||
| The main system modules and functionalities are: | ||
| 1. Gantry. The Gantry consists of 4 main internal units: | ||
| a. Stator - a fixed mechanical frame that carries HWand SW | ||
| b. Rotor - A rotating circular stiff frame that ismounted in and supported by the stator. | ||
| c. X-Ray Tube (XRT) and Generator, - fixed to theRotor frame | ||
| d. Data Measurement System (DMS) – a detectorsarray, fixed to the Rotor frame | ||
| 2. Patient Support (Couch) - carries the patient in and outthrough the Gantry bore synchronized with the scan | ||
| 3. Console - Containing a Host computer and display that isthe primary user interface. | ||
| In addition to the above components and the softwareoperating them, each system includes hardware andsoftware for data acquisition, display, manipulation, storageand filming as well as post-processing into views other thanthe original axial images. Patient supports (positioning aids)are used to position the patient. | ||
| Traditional 510(k) | ||
| Indications for Use: | The Incisive CT is a Computed Tomography X-Ray Systemintended to produce images of the head and body bycomputer reconstruction of x-ray transmission data taken atdifferent angles and planes. These devices may includesignal analysis and display equipment, patient andequipment supports, components and accessories. TheIncisive CT is indicated for head, whole body, cardiac andvascular X-ray Computed Tomography applications inpatients of all ages. | |
| These scanners are intended to be used for diagnosticimaging and for low dose CT lung cancer screening for theearly detection of lung nodules that may represent cancer*.The screening must be performed within the establishedinclusion criteria of programs / protocols that have beenapproved and published by either a governmental body orprofessional medical society. | ||
| *Please refer to clinical literature, including the results of theNational Lung Screening Trial (N Engl J Med 2011;365:395-409) and subsequent literature, for furtherinformation. | ||
| FundamentalScientificTechnology: | The proposed Philips Incisive CT is advanced continuous-rotation computed tomography systems suitable for a widerange of computed tomographic (CT) applications. | |
| The proposed Philips Incisive CT is used clinically as adiagnostic patient imaging device that produces images thatcorrespond to tissue density. The quality of the imagesdepends on the level and amount of X-ray energy deliveredto the tissue. CT imaging displays both high-density tissue,such as bone, and soft tissue. | ||
| The principal technological components (rotating x-ray tube,detector and gantry) of the proposed Philips Incisive CTsubstantially equivalent to the currently marketed predicatedevice Philips Ingenuity CT (K160743, 08/08/2016) | ||
| Based on the information provided above, the proposedPhilips Incisive CT does not raise different questions ofsafety and effectiveness compare to the currently marketedpredicate device Philips Ingenuity CT (K160743,08/08/2016). | ||
| Summary of Non-Clinical Performance Data: | The proposed Philips Incisive CT comply with the following international and FDA-recognized consensus standards: | |
| • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R) 2012 (ConsolidatedText) Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And Essential Performance(IEC 60601-1:2005, MOD).FDA/CDRH recognition number 19-4 | ||
| • IEC 60601-1-2:2014, Medical electrical equipment - Part1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and testsFDA/CDRH recognition number 19-8 | ||
| • IEC 60601-1-3:2013 Medical electrical equipment -- Part1-3: General requirements for basic safety - Collateralstandard: Radiation protection in diagnostic X-rayequipmentFDA/CDRH recognition number 12-269 | ||
| • IEC 60601-1-6:2013 Medical electrical equipment -- Part1-6: General requirements for basic safety and essentialperformance – Collateral standard: UsabilityFDA/CDRH recognition number 5-89 | ||
| • IEC 60601-2-44:2016 Medical electrical equipment - Part2-44: Particular requirements for the safety and essentialperformance of X-ray equipment for computed tomographyFDA/CDRH recognition number 12-302 | ||
| • IEC 62304:2015 Medical device software -- Software lifecycle processesFDA/CDRH recognition number 13-79 | ||
| • IEC 62366-1:2015, Medical devices -- Part 1: Applicationof usability engineering to medical devicesFDA/CDRH recognition number 5-114 | ||
| • ISO14971 Medical devices - Application of riskmanagement to medical devices (Ed. 3.0, 2019)FDA/CDRH recognition number 5-125 | ||
| • NEMA XR 25-2010 Computed Tomography Dose CheckFDA/CDRH recognition number 12-225 |
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Traditional 510(k) • NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT FDA/CDRH recognition number 12-287 • NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management · Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005, document number 337). • Guidance for Industry and FDA Staff — Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014) • Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016) · Guidance for Industry and FDA Staff - Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016) The systems comply with industry guidance and performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively). The systems performed a comparison to the predicate using these technological characteristics and image quality metrics to establish that the subject device is substantially equivalent to the predicate for its intended use. The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). System verification activities demonstrate the system meet the established system design input requirements. System requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation.
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| The test results demonstrate that the proposed Philips Incisive CT meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable. | |
|---|---|
| Summary of Clinical Data: | The proposed Philips Incisive CT did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing. |
Substantial Equivalence
| Scan characteristics Comparison | |||
|---|---|---|---|
| Proposed PhilipsIncisive CT | Predicate DevicePhilips IngenuityCT(K160743) | Conclusion | |
| No. of Slices | 64/128 | 64/128 | Identical.Therefore, substantiallyequivalent. |
| Scan Modes | SurviewAxial ScanHelical Scan | SurviewAxial ScanHelical Scan | Identical.Therefore, substantiallyequivalent. |
| Minimum ScanTime | 0.35 sec for 360°rotation | 0.42 sec for 360° rotation | The proposed PhilipsIncisive CT rotationspeed faster thanIngenuity CT to meetthe wider heart rateapplication.Safety andeffectiveness are notaffected.Therefore,demonstratingsubstantialequivalence. |
| Image (Spatial)Resolution | High resolution mode:16 lp/cmStandard resolutionmode: 13 lp/cm | High resolution mode:16 lp/cmStandard resolution mode:13 lp/cm | Identical.Therefore, substantiallyequivalent. |
| Image Noise | 0.27% at 120 kV, 230 mAs, 10 mm slice thickness | 0.27% at 120 kV, 250 mAs, 10 mm slice thickness | Identical.Therefore, substantiallyequivalent. |
| SliceThicknesses | Helical: 0.67mm – 5mmAxial: 0.625mm – 10.0mm | Helical: 0.67mm – 5mmAxial: 0.625mm – 12.5mm | Essentially the same slice thickness, does not affect safety and effectiveness.Therefore, demonstrating substantial equivalence. |
| Scan Field of View | Up to 500 mm | Up to 500 mm | Identical.Therefore, substantiallyequivalent. |
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical.Therefore, substantiallyequivalent. |
| Display | 1920 * 1080 | 1024 * 1280 | The proposed Philips Incisive CT provide higher resolution than Ingenuity CT.Safety and effectiveness are not affected.Therefore, demonstrating substantial equivalence. |
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| HostInfrastructure | Windows 10 | Windows 7 | Same supplier, sametechnology and similarfunction.Therefore, substantiallyequivalent. |
|---|---|---|---|
| Communication | Compliance withDICOM | Compliance with DICOM | Identical.Therefore, substantiallyequivalent. |
| Dose ReportingandManagement | Compliance with NEMAXR25 , XR28 and XR29 | Compliance with NEMAXR25 and XR29 | Compliance with moreNEMA standard.Safety andeffectiveness are notaffected.Therefore,demonstratingsubstantialequivalence. |
| Imaging features Comparison | |||
|---|---|---|---|
| Incisive CTFeaturesName | Feature description | SecondaryPredicateDevice PhilipsIncisiveCT(K180015) | Conclusion(Function/ Userinterface/Workflow) |
| 2D Viewer | In 2D Viewer mode operator can revieworiginal axial images as acquired by thescanner. | Yes | Identical. |
| MPR | Use the MPR mode to view three-planeorthogonal images. In this mode, the threeshown planes can be easily correlated.Three orthogonal cutplanes are shown:• Axial Orientation• Coronal Orientation• Sagittal Orientation | Yes | Identical. |
| 3D(volumemode) | The volume mode is used to display CTscanner data in a full volume image. It | Yes | Identical. |
| provides basic tools for image editing andgeneration of cine movies. | |||
| VirtualEndoscopy(Endo) | The CT Endo viewer is a review functionthat allows you to perform a generalflythrough of any suitable anatomicalstructure that is filled with air or withcontrast material, including general vessels,cardiac vessels, the bronchus, and thecolon. | Yes | Identical. |
| Filming | The Filming application is used for viewing,rearranging, windowing and zoomingimages prior to sending them to be printed. | Yes | Identical. |
| Image matrix | 1024 * 1024 | Yes | Identical. |
| O-MAR | O-MAR stands for orthopedic metal artifactreduction. This post processing capabilityreduces metal induced artifacts and isdirected for large orthopedics metals thatcause photon starvation of the rays thatpass through the metal object. | Yes | Identical. |
| DoseModulation | Dose-Modulation is a scanner functionwhich modulates the tube current in twoways (angular and longitudinal modulation)simultaneously. | Yes | Identical. |
| ScanPreparation | iPlanning / Manual | Yes | Identical. |
| On line MPR | Use the on line MPR mode to view three-plane orthogonal images. In this mode, thethree shown planes can be easilycorrelated. | Yes | Identical. |
| ControlPanel | iStation (Touch Panel) | Yes | Identical. |
| iBatch | iBatch application enables the system toassist the user to identify the lumbar diskspace automatically and creating a batchbased on the protocol selected. | Yes | Identical. |
| BolusTracking | The Bolus tracking function maximizes theefficiency of CT scans that are enhancedthrough the use of a contrast agent. This isdone by preceding the Clinical scan withLocator and Tracker scans. | Yes | Identical. |
| SAS(SpiralAuto Start) | This feature enable the usage of the injectorscan trigger. | Yes | Identical. |
| Worklist | The Worklist displays patient informationprovided by the HIS/RIS. | Yes | Identical. |
| MPPS | If the patient is from the Worklist and theMPPS function is enabled, feedbackregarding the study status of the patient canbe sent to the hospital HIS/RIS. | Yes | Identical. |
| Reporting | Traditional 510(k) | ||
| Reporting | The Reporting package allows you to create customized reports using pre-formatted templates. A template is a specially designed formatting document that places the analytical information and images that you send from an application into an organized report which can be printed and saved. | Yes | Identical. |
| CCT(Continuous CT) | Continuous CT (CCT) is a scanning mode that allows the physician to perform extended, low-dose scans while performing a biopsy. The resulting images display on a remote monitor in the scan room, providing visual feedback during the biopsy. | Yes | Identical. |
| Brain Perfusion | Brain Perfusion is a blood flow imaging application that analyzes the uptake of injected contrast in order to determine perfusion-related information about one or more regions of interest. | Yes | Identical. |
| Dental (Dental planning) | Dental application uses to create true-size (life size) film images of the mandible and maxilla for assisting oral surgeons in planning implantation of prostheses. Using a special dental planning procedure, and the images will be created from this scan which can be input into the Dental planning application. | Yes | Identical. |
| iDose4 | iDose4 is an iterative reconstruction technique that improves image quality through artifact prevention and increased spatial resolution at low dose. | Yes | Identical. |
| Helical Retrospective Tagging | Helical retrospective cardiac scanning enables the system to acquire a volume of data while the patient's ECG is recorded. The acquired data is tagged and reconstructed retrospectively at any desired phase of the cardiac cycle. | Yes | Identical. |
| Axial Prospective Gating calcium scoring | Axial prospective gating uses an external ECG gating system to synchronize individual axial scans with the patient's heartbeat. The ECG-triggered scans significantly minimize heart-motion artifacts. | Yes | Identical. |
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Traditional 510(k) Step & Shoot Cardiac provides high quality Step & Yes Identical. CT images of the coronary arteries and Shoot heart anatomy at very low radiation dose levels. During Step & Shoot Cardiac, X-rays are generated only during the cardiac phase of interest. The Cardiac Calcium Scoring application is CCS(Cardia Yes ldentical. used to quantify the buildup of calcium c calcium plaque on the walls of the patient's coronary scoring) arteries and other relevant locations. The potential calcifications are highlighted by the application during launch. Precise image reconstruction is a recon Precise No Different: mode where the system uses a image safety and trained deep learning neural network to effectiveness generate noise reduction images refer to and improve low contrast detectability K210760 for with reduced dose compared with Precise Image standard FBP recon mode. Precise Cardiac is a reconstruction Different: Precise No technique with the potential to cardiac safety and provide compensation for cardiac effectiveness refer to motion. K203020 for Precise Cardiac Precise Position is a camera based Precise No Different: workflow designed to assist with position Safety and positioning the patient automatically effectiveness from console or OnPlan, it can: refer to • automatically select patient orientation. K203514 for • automatically set vertical centering & Precise Position positioning of the patient to the Surview start and end positions. • support editing Surview start & end range and scan direction. In Precise Intervention viewer there are Precise No Different: Precise several tools, they will help intervention intervention is a you to navigate the needle safely during function that the intervention. support user to view the distance, angle between the injector and the object, system validation report proved that
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| Directresults | Direct Result-With Direct Result the useris able to choose a desiredresult during scan planning phase and getthe result for diagnosis withoutfurther intervention. | No | Different: Directresult isworkflowenhancement tomake user directget derivedimage afteracquisition noimpact onsystem safetyand effectiveness | there is noimpact onsystem safetyand effectiveness |
|---|---|---|---|---|
| Parallelworkflow | Parallel workflowThe system support Parallel workflow usingDual monitor as below:- main monitor: Patients, scan, service, "showall" for scan planning, Help.- extend monitor: Completed, viewers, Analysis,recon, filming, report | No | The Parallelworkflow ofIncisive CT is theworkflowupdate, noimpact safetyandeffectiveness. |
| Supplementary Imaging features Comparison | |||
|---|---|---|---|
| Incisive CTFeaturesName | Feature description | SecondaryPredicateDevice PhilipsIncisiveCT(K180015) | Conclusion(Function/ Userinterface/Workflow) |
| CTC(CTColonoscopy) | CT Colonoscopy (CTC) application enablesfast and easy visualization of colon scans,using acquired CT images. | Yes | Identical. |
| VA(VesselAnalysis) | Vessel Analysis (VA) offers a set of tools forgeneral vascular analysis. With VA the usercan easily remove bone, and extractvessels. User also can performmeasurements such as intraluminaldiameter, cross-sectional lumen area,length. | Yes | Identical. |
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| LNA(LungNoduleAnalysis) | The Lung Nodule Analysis (LNA)application assists the radiologist with thedetection and quantification of pulmonarynodules and lesions. | Yes | Identical. |
|---|---|---|---|
| CAA(CardiacArteryAnalysis) | The Coronary Artery Analysis providesviewing and measuring tools that allow youto perform dimensional and quantitativemeasurements of the coronary arteries tohelp you identify and examine the patientstudy for stenosis. | Yes | Identical. |
| CFA(CardiacFunctionAnalysis) | Cardiac Function Analysis (CFA) applicationis used to assess the state of the leftventricle (LV) and to analyze functionalheart data. | Yes | Identical. |
| DE(DualEnergy) | Spin / Spin scan modeDual energy Viewer is an application forreview and analysis of CT dual-energyscans. User need to load CT dual-energyscan data which is two series with similarKV. It provides registration function and cangenerate different weighted KV images.User can use the tools to separatematerials. | Yes | Identical. |
| SubstantialEquivalenceConclusion: | The design, intended use, technology and principal technologicalcomponents (Tube, Generator, Detector) of the proposed PhilipsIncisive CT substantially equivalent to the currently marketed | |
|---|---|---|
| primary predicate device Philips Ingenuity CT (K160743,08/08/2016).Based on the information provided above, the | ||
| proposed Philips Incisive CT does not raise different questionsof safety and effectiveness compare to the currently marketedprimary predicate device Philips Ingenuity CT (K160743,08/08/2016). The proposed Philips Incisive CT is identical to theprimary predicate device Philips Ingenuity CT (K160743,08/08/2016), and therefore is considered substantially equivalent. | ||
| Additionally, substantial equivalence was demonstrated with non-clinical performance, V&V and consensus standards tests, whichcomplied with the requirements specified in the international andFDA-recognized consensus standards. | ||
| The results of these tests demonstrate that the proposed PhilipsIncisive CT meet the acceptance criteria and is adequate for itsintended use. |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.