(77 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: 1. 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 2. Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan 3. 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 Philips Incisive CT scanner is compared to a predicate device, the Philips Ingenuity CT (K160743), for substantial equivalence. The provided document focuses on technical comparisons and non-clinical performance data rather than a clinical study with specific acceptance criteria that would typically be seen for a new AI-powered diagnostic device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative sense with pass/fail thresholds for clinical performance. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and imaging features. The core "acceptance criterion" is proving substantial equivalence to the predicate device, Philips Ingenuity CT (K160743).
| Category | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Philips Incisive CT) | Conclusion |
|---|---|---|---|
| Scan Characteristics | |||
| Number of Slices | 64/128 | 64/128 | Identical. Substantially equivalent. |
| Scan Modes | Surview, Axial Scan, Helical Scan | Surview, Axial Scan, Helical Scan | Identical. Substantially equivalent. |
| Minimum Scan Time | 0.42 sec for 360° rotation | 0.35 sec for 360° rotation | Faster rotation speed to meet wider heart rate application. Safety and effectiveness are not affected. Substantially equivalent. |
| Image (Spatial) Resolution | High resolution: 16 lp/cm, Standard resolution: 13 lp/cm | High resolution: 16 lp/cm, Standard resolution: 13 lp/cm | Identical. Substantially equivalent. |
| Image Noise | 0.27% at 120 kV, 250 mAs, 10 mm slice thickness | 0.27% at 120 kV, 230 mAs, 10 mm slice thickness | Identical (despite slightly different mAs, the noise level is the same). Substantially equivalent. |
| Slice Thicknesses | Helical: 0.67mm-5mm, Axial: 0.625mm-12.5mm | 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. |
| Imaging Features | (Function/User Interface/Workflow similar to Predicate) | ||
| 2D Viewer | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| MPR | Yes | Yes | User interface, algorithm principle, function, and workflow are similar/same. Substantially equivalent. |
| 3D (volume mode) | Yes | Yes | Volume rendering protocol, function, and workflow are similar/same. Substantially equivalent. |
| Virtual Endoscopy (Endo) | Yes | Yes | VE rendering protocol, function, and workflow are similar/same. Substantially equivalent. |
| Filming | Yes | Yes | Basic function (display, layout, editing, print management) similar/same. Substantially equivalent. |
| Image matrix | 1024 * 1024 | 1024 * 1024 | Both are 1024 * 1024. Substantially equivalent. |
| O-MAR | Yes | Yes | Algorithm Principle and workflow are same. Substantially equivalent. |
| Dose Modulation | Yes | Yes | Function and workflow are same. Substantially equivalent. |
| iPlanning | Manual | iPlanning (automated adjustment) | Workflow improvement for user assistance. Safety and effectiveness are not affected. Substantially equivalent. |
| On line MPR | Yes (with tilt and trim) | Yes (without trim and tilt) | Can generate sagittal and coronal results. Other functions and workflow are same. Substantially equivalent. |
| iBatch | Manual Batch | iBatch (automated identification) | Workflow feature to improve productivity. Safety and effectiveness are not affected. Substantially equivalent. |
| Bolus Tracking | Yes | Yes (Post Threshold Delay longer) | Function and workflow are same (despite longer Post Threshold Delay). Substantially equivalent. |
| SAS (Spiral Auto Start) | Yes | Yes (manual trigger only) | Other functions and workflow are same. Substantially equivalent. |
| Worklist | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| MPPS | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Reporting | Yes (including PDF) | Yes (no PDF support) | Format of exported report similar. Other functions and workflow are same. Substantially equivalent. |
| CCT (Continuous CT) | Yes (with Volume display) | Yes (no Volume display support) | Other functions and workflow are same. Substantially equivalent. |
| Brain Perfusion | Yes | Yes | User interface, principle, mechanism, and analysis parameters are similar/same. Substantially equivalent. |
| Dental (Dental planning) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| iDose4 | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Helical Retrospective Tagging | Yes | Yes | ECG viewer user interface, function, and workflow are similar/same. Substantially equivalent. |
| Axial Prospective Gating calcium scoring | Yes | Yes | ECG viewer user interface, function, and workflow are similar/same. Substantially equivalent. |
| Step & Shoot | Yes (with arrhythmia handling) | Yes (no arrhythmia handling) | Other functions and workflow are same. Substantially equivalent. The lack of arrhythmia handling is noted but not deemed to affect substantial equivalence. |
| CCS (Cardiac calcium scoring) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to Philips MX 16 SLICE K091195) | |||
| CTC (CT Colonoscopy) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| VA (Vessel Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| LNA (Lung Nodule Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to IntelliSpace Portal Platform K162025) | |||
| CAA (Cardiac Artery Analysis) | Yes | Yes | User interface, analysis of cardiac coronary artery, and workflow are similar/same. Substantially equivalent. |
| CFA (Cardiac Function Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to BRILLIANCE DUAL ENERGY OPTION K090462) | |||
| DE (Dual Energy) | Yes | Yes | User interface, function, Algorithm Principle, and workflow are similar/same. Substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document explicitly 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."
Therefore, there is no mention of a "test set" in the context of patient data, nor any information about data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical performance data, primarily engineering verification and validation testing, as well as comparisons to the predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no clinical study was performed and no patient-based "test set" was described, there were no experts used to establish ground truth in the traditional sense of clinical outcome assessment for the Incisive CT device. The ground truth for the technical comparisons was the established performance and specifications of the predicate device.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication of findings was 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. This is a CT scanner, not an AI-powered diagnostic software that assists human readers. The context is about the substantial equivalence of the imaging hardware and associated software functionalities.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of the CT scanner itself, a hardware device with integrated software, not a separate standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "study" (which was non-clinical verification/validation and substantial equivalence comparison) was the established technical specifications and performance characteristics of the predicate device (Philips Ingenuity CT, K160743) and compliance with various international and FDA-recognized consensus standards.
8. The sample size for the training set
Not applicable. This device is a CT scanner, not a machine learning model that requires a training set of data in the AI sense. Its underlying technology and algorithms are based on established CT principles, and its performance is verified through engineering tests.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and consists of a stylized emblem. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Regulatory Affairs Engineer No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA
March 20, 2018
Re: K180015
Trade/Device Name: Philips Incisive CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 27, 2017 Received: January 2, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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: | December 15, 2017 | |
|---|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |
| No. 258, Zhongyuan Road, Suzhou Industrial Park, | ||
| Suzhou Jiangsu, CHINA, 215024 | ||
| Establishment Registration Number: 3009529630 | ||
| Primary ContactPerson: | Shiguang AnRegulatory Affairs EngineerPhone: +86-24-28206367E-mail: shiguang.an@philips.com | |
| Secondary ContactPerson | Gordon ShuSenior Regulatory ManagerPhone: +86-512-67336804E-mail: Gordon.Shu@philips.com | |
| Device Name: | Philips Incisive CT | |
| Classification: | Classification name: | Computed tomography x-ray system |
| Classification Regulation: | 21CFR 892.1750 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | JAK | |
| Primary PredicateDevice: | Trade name: | Philips Ingenuity CT |
| Manufacturer: | Philips Medical Systems(Cleveland), Inc. | |
| 510(k) Clearance: | K160743 | |
| Classification Regulation: | 21CFR 892.1750 | |
| Classification name: | Computed tomography x-ray system | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | JAK | |
| Reference PredicateDevice: | Trade name: | Philips MX 16 SLICE |
| Manufacturer: | Philips Medical Systems(Cleveland), Inc. | |
| 510(k) Clearance: | K091195 | |
| Classification Regulation: | 21CFR 892.1750 | |
| Classification name: | Computed tomography x-ray system | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | JAK | |
| Reference Predicate | Trade name: | IntelliSpace Portal Platform |
| Device: | Manufacturer: | Philips Medical SystemsNederlands B.V. |
| 510(k) Clearance: | K162025 | |
| Classification Regulation: | 21CFR 892.2050 | |
| Classification name: | system, image processing,radiological | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | LLZ | |
| Reference PredicateDevice: | Trade name: | BRILLIANCE DUAL ENERGYOPTION |
| Manufacturer: | Philips Medical Systems(Cleveland), Inc. | |
| 510(k) Clearance: | K090462 | |
| Classification Regulation: | 21CFR 892.1750 | |
| Classification name: | Computed tomography x-raysystem | |
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | JAK |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT
Section 5-510(k) Summary Page 1 of 16
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| Device Description: | 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 reconstructionalgorithm, 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: | ||
| 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 is | ||
| mounted 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 out | ||
| through the Gantry bore synchronized with the scan | ||
| 3. 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. | ||
| Indications for Use: | Traditional 510 | |
| 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: | Traditional 510 |
| • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements 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 - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsFDA/CDRH recognition number 19-8 | ||
| • IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipmentFDA/CDRH recognition number 12-269 | ||
| • IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityFDA/CDRH recognition number 5-89 | ||
| • IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipmentFDA/CDRH recognition number 12-256 | ||
| • IEC 62304:2015 Medical device software -- Software life cycle processesFDA/CDRH recognition number 13-79 | ||
| • IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical DevicesFDA/CDRH recognition number 5-87 | ||
| • ISO14971 Medical devices - Application of risk management to medical devices (Ed. 2.0, 2007)FDA/CDRH recognition number 5-40 | ||
| • 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 UserInformation and System Function Related to Dose in CTFDA/CDRH recognition number 12-287 |
| • NEMA XR 29-2013 Standard Attributes on CT EquipmentRelated to Dose Optimization and Management |
| • Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Containedin Medical Devices(issued May 11, 2005, document number 337). |
| • Guidance for Industry and FDA Staff – Content ofPremarket Submissions for Management of Cybersecurity inMedical Devices (issued October 2, 2014) |
| • Guidance for Industry and FDA Staff – Use of InternationalStandard ISO 10993-1, "Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process" (issued June 16, 2016) |
| • Guidance for Industry and FDA Staff – Information toSupport a Claim of Electromagnetic Compatibility (EMC) ofElectrically-Powered Medical Devices (issued July 11, 2016) |
| The systems comply with industry guidance andperformance standards for Computed Tomography (CT)Equipment and Laser products (21 CFR 1020.33 and 21CFR 1040.10, respectively). |
| The systems performed a comparison to the predicate usingthese technological characteristics and image qualitymetrics to establish that the subject device is substantiallyequivalent to the predicate for its intended use, whichincludes low dose CT lung cancer screening among moregeneral diagnostic imaging indications. |
| The test results demonstrate that the proposed PhilipsIncisive CT meets the acceptance criteria and is adequatefor its intended use. Additionally, the risk managementactivities show that all risks are sufficiently mitigated, that nonew risks are introduced, and that the overall residual risksare acceptable. |
Philips Healthcare (Suzhou) Co., Ltd.
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| Summary of ClinicalData: | The proposed Philips Incisive CT did not require clinicalstudy since substantial equivalence to the legally marketedpredicate device was proven with the verification/validationtesting. |
|---|---|
| Clinical and phantom sample images were provided tosupport the ability of proposed Philips Incisive CT togenerate diagnostic quality images. |
Substantial Equivalence
| Scan Characteristics Comparison | |||
|---|---|---|---|
| Scancharacteristics | 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 meet thewider heart rateapplication.Safety and effectivenessare not affected.Therefore,demonstratingsubstantialequivalence. |
| Image (Spatial)Resolution | High resolution mode:16 lp/cmStandard resolution | High resolution mode:16lp/cmStandard resolution mode: | Identical.Therefore, substantiallyequivalent. |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT
Section 5-510(k) Summary
Page 7 of 16
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Philips Healthcare (Suzhou) Co., Ltd.
Traditional 510(k)
| mode: 13 lp/cm | 13 lp/cm | ||
|---|---|---|---|
| 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, substantially equivalent. |
| 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, substantially equivalent. |
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical.Therefore, substantially equivalent. |
| Imaging Features Comparison | |||
|---|---|---|---|
| ProposedPhilipsIncisive CTFeatures | Feature description | Predicate DevicePHILIPS IngenuityCT (K160743) | Conclusion(Function/ Userinterface/Workflow) |
| 2D Viewer | In 2D Viewer mode operator can revieworiginal axial images as acquired by thescanner. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| MPR | Use the MPR mode to view three-planeorthogonal images. In this mode, thethree shown planes can be easily | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| Traditional 510(k) | |||
| correlated. Three orthogonal cutplanes are shown:• Axial Orientation• Coronal Orientation• Sagittal Orientation | CT and IngenuityCT are similar.The AlgorithmPrinciple, functionand workflow aresame.Therefore,substantiallyequivalent. | ||
| 3D(volumemode) | The volume mode is used to display CTscanner data in a full volume image. Itprovides basic tools for image editingand generation of cine movies. | Yes | Volume renderingprotocol ofIncisive CT andIngenuity CT aresimilar. Thefunction andworkflow aresame.Therefore,substantiallyequivalent. |
| 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 generalvessels, cardiac vessels, the bronchus,and the colon. | Yes | VE renderingprotocol ofIncisive CT andIngenuity CT aresimilar. Thefunction andworkflow aresame.Therefore,substantiallyequivalent. |
| Filming | The Filming application is used forviewing, rearranging, windowing andzooming images prior to sending them tobe printed. | Yes | Filming's basicfunction likedisplay setting,layout tools, andimage editingtools, printmanagement ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| Image matrix | 1024 * 1024 | Yes | Both are 1024 *1024.Therefore,substantiallyequivalent. |
| Traditional 510(k) | |||
| O-MAR | O-MAR stands for orthopedic metalartifact reduction. This post processingcapability reduces metal induced artifactsand is directed for large orthopedicsmetals that cause photon starvation ofthe rays that pass through the metalobject. | Yes | The AlgorithmPrinciple andworkflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| DoseModulation | Dose-Modulation is a scanner functionwhich modulates the tube current in twoways (angular and longitudinalmodulation) simultaneously. | Yes | The function andworkflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| iPlanning | iPlanning can automatically adjust thescan range of subsequent Axial orHelical scan series, based on theSurview Image. It enables the system toautomatically recognize the Head, Lung,Lumbar Disc, Heart, Cervical Spine,Liver, Pelvis, Caput femoris. The Head,Cervical Spine and Lumbar Discrecognition are based on lateral Surview,the Heart recognition is based on dualSurview, and the Lung and the otherparts recognition is based on frontalSurview. | Manual | iPlanning is aworkflowimprovement toassist user toplace the planbox.Safety andeffectiveness arenot affected.Therefore,demonstratingSubstantialequivalence. |
| On line MPR | Use the on line MPR mode to view three-plane orthogonal images. In this mode,the three shown planes can be easilycorrelated. | Yes | Ingenuity CT cangenerate sagittaland coronalresults andsupport tilt andtrim. Incisive CTcan generatesagittal andcoronal resultswithout trim andtilt. The otherfunctions andworkflow aresame.Therefore,substantiallyequivalent. |
| iBatch | iBatch application enables the system toassist the user to identify the lumbar disk | Manual Batch | iBatch is aworkflow feature |
| Traditional 510(k) | |||
| space automatically and creating a batchbased on the protocol selected. | to improveproductivity withspine scan.Safety andeffectiveness arenot affected.Therefore,demonstratingsubstantialequivalence. | ||
| Bolus Tracking | The Bolus tracking function maximizesthe efficiency of CT scans that areenhanced through the use of a contrastagent. This is done by preceding theClinical scan with Locator and Trackerscans. | Yes | Post ThresholdDelay is longerthan IngenuityCT. The functionand workflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| SAS(Spiral AutoStart) | This feature enable the usage of theinjector scan trigger. | Yes | The Incisive CTcould only triggerinject manually inSAS. The otherfunctions andworkflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| Worklist | The Worklist displays patient informationprovided by the HIS/RIS. | Yes | The user interfaceappearance ofIncisive CT andIngenuity CT aresimilar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| MPPS | If the patient is from the Worklist and theMPPS function is enabled, feedbackregarding the study status of the patientcan be sent to the hospital HIS/RIS. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function and |
| Traditional 510(k) | |||
| workflow aresame.Therefore,substantiallyequivalent. | |||
| Reporting | The Reporting package allows you tocreate customized reports using pre-formatted templates.A template is a specially designedformatting document that places theanalytical information and images thatyou send from an application into anorganized report which can be printedand saved. | Yes | The format ofexported reportare similar,Incisive CT do notsupport PDFformat. The otherfunctions andworkflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| CCT(Continuous CT) | Continuous CT (CCT) is a scanningmode that allows the physician toperform extended, low-dose scans whileperforming a biopsy.The resulting images display on a remotemonitor in the scan room, providingvisual feedback during the biopsy. | Yes | Incisive CT doesnot supportVolume display.The otherfunctions andworkflow ofIncisive CT andIngenuity CT aresame.Therefore,substantiallyequivalent. |
| Brain Perfusion | Brain Perfusion is a blood flow imagingapplication that analyzes the uptake ofinjected contrast in order to determineperfusion-related information about oneor more regions of interest. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar,the principle andmechanism aresame.Both provide thesame brainperfusion analysisparameters.Therefore,substantiallyequivalent. |
| Dental (Dentalplanning) | Dental application uses to create true-size (life size) film images of themandible and maxilla for assisting oralsurgeons in planning implantation ofprostheses. Using a special dental | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar. |
| Traditional 510(k) | |||
| planning procedure, and the images willbe created from this scan which can beinput into the Dental planning application. | The function andworkflow aresame.Therefore,substantiallyequivalent. | ||
| iDose4 | iDose4 is an iterative reconstructiontechnique that improves image qualitythrough artifact prevention and increasedspatial resolution at low dose. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| HelicalRetrospectiveTagging | Helical retrospective cardiac scanningenables the system to acquire a volumeof data while the patient's ECG isrecorded. The acquired data is taggedand reconstructed retrospectively at anydesired phase of the cardiac cycle. | Yes | The ECG vieweruser interface ofIncisive CT andIngenuity CT aresimilar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| AxialProspectiveGatingcalcium scoring | Axial prospective gating uses an externalECG gating system to synchronizeindividual axial scans with the patient'sheartbeat. The ECG-triggered scanssignificantly minimize heart-motionartifacts. | Yes | The ECG vieweruser interface ofIncisive CT andIngenuity CT aresimilar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| Step & Shoot | Step & Shoot Cardiac provides highquality CT images of the coronaryarteries and heart anatomy at very lowradiation dose levels. During Step &Shoot Cardiac, X-rays are generatedonly during the cardiac phase of interest. | Yes | The ECG vieweruser interface ofIncisive CT andIngenuity CT aresimilar. IncisiveCT does notsupportarrhythmiahandling in Step& Shoot scanmode. |
| Traditional 510(k) | |||
| The function and workflow are same.Therefore, substantially equivalent. | |||
| CCS(Cardiac calcium scoring) | The Cardiac Calcium Scoring application is used to quantify the buildup of calcium plaque on the walls of the patient's coronary arteries and other relevant locations. The potential calcifications are highlighted by the application during launch. | Yes | The user interface layout of Incisive CT and Ingenuity CT are similar.The function and workflow are same.Therefore, substantially equivalent. |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT
Section 5-510(k) Summary
Page 8 of 16
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Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT
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Philips Healthcare (Suzhou) Co., Ltd.
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT
Section 5-510(k) Summary
Page 11 of 16
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Philips Healthcare (Suzhou) Co., Ltd. Traditional 510(k)
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd.
Section 5-510(k) Summary
Page 12 of 16
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Philips Healthcare (Suzhou) Co., Ltd. : = :
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT
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| Supplementary Imaging Features Comparison | |||
|---|---|---|---|
| ProposedIncisive CTFeatures | Feature description | ReferencePredicate DevicePHILIPS MX 16SLICE (K091195) | Conclusion(Function/ Userinterface/Workflow) |
| CTC(CTColonoscopy) | CT Colonoscopy (CTC) application enablesfast and easy visualization of colon scans,using acquired CT images. | Yes | The user interfaceof Incisive CT andIngenuity CT aresimilar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| VA(VesselAnalysis) | Vessel Analysis (VA) offers a set of tools forgeneral vascular analysis. With VA the usercan easily remove bone, and extract vessels.User also can perform measurements suchas intraluminal diameter, cross-sectionallumen area, length. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| Traditional 510(k)equivalent. | |||
| LNA(LungNoduleAnalysis) | The Lung Nodule Analysis (LNA) applicationassists the radiologist with the detection andquantification of pulmonary nodules andlesions. | Yes | The user interfaceof Incisive CT andIngenuity CT aresimilar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| ProposedIncisive CTFeatures | Feature description | ReferencePredicate DeviceIntelliSpacePortalPlatform(K162025) | Conclusion(Function/ Userinterface/Workflow) |
| CAA(CardiacArteryAnalysis) | The Coronary Artery Analysis providesviewing and measuring tools that allow you toperform dimensional and quantitativemeasurements of the coronary arteries tohelp you identify and examine the patientstudy for stenosis. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.Both provide ananalysis ofcardiac coronaryartery.The workflow aresame.Therefore,substantiallyequivalent. |
| CFA(CardiacFunctionAnalysis) | Cardiac Function Analysis (CFA) applicationis used to assess the state of the leftventricle (LV) and to analyze functional heartdata. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function andworkflow aresame.Therefore,substantiallyequivalent. |
| ProposedIncisive CTFeatures | Feature description | ReferencePredicate DeviceBRILLIANCEDUAL ENERGYOPTION(K090462) | Conclusion(Function/ Userinterface/Workflow) |
| 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 similar KV.It provides registration function and cangenerate different weighted KV images. Usercan use the tools to separate materials. | Yes | The user interfacelayout of IncisiveCT and IngenuityCT are similar.The function,AlgorithmPrinciple andworkflow aresame.Therefore,substantiallyequivalent. |
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| SubstantialEquivalenceConclusion: | The design, intended use, technology and principal technologicalcomponents (Tube, Generator, Detector) of the proposed PhilipsIncisive CT substantially equivalent to the currently marketedprimary predicate device Philips Ingenuity CT (K160743,08/08/2016).Based on the information provided above, theproposed 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 (verification and validation) 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. |
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§ 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.