(91 days)
The Access CT scanner system can be used as a Whole Body (except cardiac) Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice capability up to 6/16 slices simultaneously. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the same axial plane taken at different angles. The system is suitable for all patients.
The proposed Access CT is currently available in two system configurations, 6 slices and 16 slices.
The Access CT system is used clinically as a diagnostic patient imaging device that produces images that correspond to tissue density. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images yield useful diagnostic information. The system is intended for use in the head and whole body.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Access CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria:
This document is a 510(k) Premarket Notification for the Philips Access CT system. It does not present a clinical study for proving the device meets specific acceptance criteria in the context of diagnostic accuracy or AI performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technical specifications, performance standards, and non-clinical testing.
The "acceptance criteria" here relate to engineering and performance specifications for a CT scanner, rather than diagnostic performance of an AI algorithm. The "study" described is primarily non-clinical verification and validation testing, ensuring the device meets its design requirements and complies with relevant safety and performance standards.
Therefore, many of the requested points regarding AI performance, human-in-the-loop studies, ground truth establishment for AI, and expert adjudication are not applicable to this document as it describes a non-AI medical device (a CT scanner).
Acceptance Criteria and Device Performance (as presented in the document)
The document outlines acceptance criteria as technical specifications that the device must meet to be considered substantially equivalent to predicate devices. The "reported device performance" are the actual specifications of the Access CT that are compared against these criteria and the predicate device's specifications.
1. Table of Acceptance Criteria and Reported Device Performance
The closest representation of "acceptance criteria" and "reported device performance" in this document is found in the "Table 5-1 Design/fundamental scientific technologies Comparison" on page 8. The "Acceptance Criteria" are implicitly the values or characteristics of the "Predicate Device Philips MX 16-slice (K091195)", and the "Reported Device Performance" are the values for the "Proposed Access CT".
| Characteristic | Acceptance Criteria (Predicate: Philips MX 16-slice K091195) | Reported Device Performance (Proposed: Access CT) | Conclusion (Meeting Criteria) |
|---|---|---|---|
| Application | Head/Body | Head/Body | Identical / Substantially Equivalent |
| Scan Regime | Continuous Rotation | Continuous Rotation | Identical / Substantially Equivalent |
| No. of Slices | 16 | 6/16 | Access CT 6 and Access CT 16 use the same Detector and other hardware configuration, by software control, 6 slices is implemented by combining different detecting units to achieve different slice thickness configuration. This does not affect the safety or effectiveness. Therefore, demonstrating substantial equivalence. |
| Scan Modes | Surview, Axial Scan, Helical Scan | Surview, Axial Scan, Helical Scan | Identical / Substantially Equivalent |
| Minimum Scan Time | 0.5 sec for 360° rotation | 0.75 sec for 360° rotation | Increasing the Minimum scan time from 0.5 to 0.75 sec on the proposed Access CT does not affect the safety or effectiveness. Therefore, demonstrating substantial equivalence. |
| Image (Spatial) Resolution | High resolution mode: 15 lp/cm | High resolution mode: 15 ± 10% lp/cm @ 0% | Identical / Substantially Equivalent |
| Image Noise | ≤0.35% | ≤0.35% | Identical / Substantially Equivalent |
| Image Matrix | 512x512. | 512x512. | Identical |
| Display | 768x768, 1024x1024, 1024x1280 | 768x768, 1024x1024, 1024x1280 | Substantially Equivalent (for all three resolutions, listed together) |
| Host Infrastructure | Windows XP | Windows 7 | Changing the Windows platform from Windows XP to Windows 7 does not affect the safety or effectiveness of the device. Therefore demonstrating substantial equivalence. |
| Communication | Compliance with DICOM | Compliance with DICOM | Identical / Substantially Equivalent |
| Dose Reporting and Management | None (for predicate) | Compliance with NEMA XR25, XR28 and XR29 | Subject device compliant with NEMA standards. There is no impact on safety or effectiveness. |
| Generator and Tube Power (kW Output) | 50 kW | 28 kW | The difference of power output from 50 KW to 28KW does not have an impact on the functionality / performance and/or safety or effectiveness of the device. Therefore, demonstrating substantial equivalence. |
| mA Range | 30mA-420mA | 10mA-233mA | The impact of decreasing the tube power is an extended lower limit of mA range and decreased upper limit of mA range, difference in range does not affect safety or effectiveness. Therefore, demonstrating substantial equivalence. |
| kV Settings | 90kV, 120kV, 140kV | 70kV, 80kV, 100kV, 120kV, 140kV | The impact of decreasing the tube power is an extended kV range, difference in range does not affect safety or effectiveness. Therefore, demonstrating substantial equivalence. |
| Tube Type | CTR 2150 CEPN | CTR1735 | Identical tube technology, and same tube supplier, does not affect safety or effectiveness. Therefore, demonstrating substantial equivalence. |
| Detector Type | NanoPanel Elite | NanoPanel Elite | Identical / Substantially Equivalent |
| Scan Field of View (SFOV) | 500 mm | 450 mm | The difference of SFOV impact on the scan field, does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Detector Type (Detail) | Single layer ceramic scintillator plus a photodiode | Single layer ceramic scintillator plus a photodiode | Identical / Substantially Equivalent |
| Detector Material | GOS solid | GOS solid | Identical / Substantially Equivalent |
| Gantry Tilt capability | ± 30° | No physical tilt (digital tilt for images) | Both are available for axial scans. The difference does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Gantry Rotation Speed | 120 RPM | 80 RPM | Identical transmission design with lower rotation speed. Safety and effectiveness are not affected. Therefore, substantially equivalent. |
| Bore Size | 700mm | 650mm | Bore Size decreasing does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Maximum Scannable Range | 1,500 mm | Fixed height couch: ≤ 1200mm; Vertical moveable couch: ≤1380mm | Maximum scannable range decreasing does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Z-position Accuracy | +/- 0.25 mm | +/- 0.25 mm | Identical / Substantially Equivalent |
| Lowest Table Height | 579mm | Fixed height couch: 815mm; Vertical movement couch: 480mm | The difference of table height does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Maximum Load Capacity | 200kg | Fixed height couch: 150kg; Vertical movement couch: 200kg | Both are compliant with IEC60601 series standards. The difference does not affect safety or effectiveness. Therefore, substantially equivalent. |
| Clinical Features (e.g., 2D Viewer, MPR, 3D, VE, Filming, MAR, Dose Modulation, Bolus Tracking, Worklist, MPPS, Reporting, CCT, Brain Perfusion, Dental, VA) | Yes (for all listed) | Yes (for all listed) | Identical / Substantially Equivalent (for each feature) |
The document also compares against two other reference devices (Philips Ingenuity CT and Philips Incisive CT) for specific "clinical features" (Iterative recon, CTC, LNA, iPlanning, Batch image processing (iBatch)), concluding they are "Identical".
Study Details (as presented in the document, primarily non-clinical)
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Description: The document refers to "Design Verification planning and testing" and "Design validation of user needs and intended use" with "simulated use testing with production equivalent Access CT Systems."
- Sample Size: The document does not specify a sample size in terms of patient data or scanned images for non-clinical verification. It focuses on testing the system's compliance with engineering requirements and standards.
- Data Provenance: The testing was conducted internally by Philips Healthcare (Suzhou) Co., Ltd. in China ("Philips Healthcare (Suzhou) Co., Ltd., No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024"). The data stems from design verification and validation activities rather than a clinical study. The type of data is technical performance measurements, rather than patient scans with clinical findings. The document states: "The proposed Access CT System did not require any external clinical site testing."
- Retrospective or Prospective: Not applicable in the context of clinical data. The verification and validation testing would have been "prospective" in the sense that it was planned and executed for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable: This is a submission for a CT scanner itself, not an AI algorithm that requires expert ground truth for diagnostic accuracy. The "ground truth" for the device's performance is adherence to technical specifications and safety standards, as measured by engineering tests.
4. Adjudication Method for the Test Set
- Not Applicable: There is no clinical test set requiring adjudication in this document. Adjudication methods are relevant for clinical studies where multiple human readers interpret medical images or data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No: The document explicitly states: "The proposed Access CT System did not require any external clinical site testing. Clinical evaluation of workflow was conducted via simulated use testing and is accounted for in the Summary of Non-Clinical Testing section of the summary."
- This also means there is no effect size given for human readers improving with AI vs. without AI assistance, as AI assistance is not the subject of this 510(k).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a CT scanner, not a standalone algorithm.
7. The Type of Ground Truth Used
- For the technical and safety performance of the CT scanner, the "ground truth" is established by international and FDA-recognized consensus standards (listed in the "Summary of Non-Clinical Performance Data" section on pages 4-5) and system design requirements. The device's performance is measured against these established standards and requirements. Examples of standards cited include AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, IEC 62304, IEC 62366-1, ISO14971, NEMA XR 25-2011, NEMA XR 28-2013, and NEMA XR 29-2013.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/machine learning device submission. There is no "training set" in the context of model development.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI model, this question is not relevant to the content of the document.
In summary, the provided document details the 510(k) submission for a CT scanner, demonstrating its substantial equivalence to previously cleared predicate devices through comparisons of technical specifications and compliance with established safety and performance standards via non-clinical verification and validation. It is not an application for an AI-powered diagnostic device, and thus, many of the questions related to AI study design, clinical efficacy, and human reader performance are not addressed.
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Philips Healthcare (Suzhou) Co., Ltd. Ray Sun Regulatory Affairs Engineer No.258, ZhongYuan Road, Suzhou Industrial Park SUZHOU, 215024 CHINA
Re: K191136
Trade/Device Name: Access CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: May 5, 2019 Received: May 7, 2019
Dear Ray Sun:
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/cfpmp/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.
July 29, 2019
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,
For
Thalia 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Access CT
Indications for Use (Describe)
The Access CT scanner system can be used as a Whole Body (except cardiac) Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice capability up to 6/16 slices simultaneously. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the same axial plane taken at different angles. The system is suitable for all patients.
| 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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Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT
CONFIDENTIAL Section 4-Indications For Use Statement page 2 of 2
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| Date Prepared: | March 5 2019 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhongyuan Road, Suzhou Industrial Park,Suzhou Jiangsu, CHINA, 215024Establishment Registration Number: 3009529630 |
| Primary ContactPerson: | Ray SunRegulatory Affair EngineerPhone: +86-13109886838E-mail: wei.ws.sun@philips.com |
| Secondary ContactPerson | Shiguang AnRegulatory Affair EngineerPhone: +86-13940106467E-mail: shiguang.an@philips.com |
| Device Name: | Access CT |
| Classification: | Classification name: Computed tomography x-ray systemClassification Regulation: 21CFR 892.1750Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: JAK |
| Predicate Device: | Trade name: PHILIPS MX 16 SLICEManufacturer: Philips Medical Systems (Cleveland), Inc.510(k) Clearance: K091195Classification Regulation: 21CFR 892.1750Classification name: Computed tomography x-ray systemClassification Panel: RadiologyDevice class: Class IIProduct Code: JAK |
| Reference 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 |
| Reference Device: | Philips Incisive CT |
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| 510(k) Clearance: | K180015 |
| Classification Regulation: | 21CFR 892.1750 |
| Classification name: | Computed tomography x-ray system |
| Classification Panel: | Radiology |
| Device class | Class II |
| Product Code: | JAK |
| Device Description: | The proposed Access CT is currently available in two system configurations, 6 slices and 16 slices.The Access CT system is used clinically as a diagnostic patient imaging device that produces images that correspond to tissue density. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images yield useful diagnostic information. The system is intended for use in the head and whole body.The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Access CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.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. |
| Indications for Use: | The Access CT Scanner System can be used as a wholebody (except cardiac) computed tomography X-ray systemfeaturing a continuously rotating X-ray tube and detectorarray with multi-slice capability up to 6/16 slicessimultaneously. The acquired X-RAY transmission data isreconstructed by computer into cross-sectional images of thebody from the same axial plane taken at different angles. Thesystem is suitable for all patients. |
| FundamentalScientificTechnology: | The proposed Access CT is an advanced continuous-rotation computed tomography systems suitable for a widerange of computed tomographic (CT) applications.The proposed Access CT is used clinically as a diagnosticpatient 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 Access CT issubstantially equivalent to the currently marketed predicatePhilips MX 16 SLICE (K091195, 05/27/2009).Based on the information provided above, the proposedAccess CT does not raise different questions of safety andeffectiveness compare to the currently marketed predicatePhilips MX 16 SLICE (K091195, 05/27/2009). |
| Summary of Non-Clinical PerformanceData: | The proposed Access CT complies with the followinginternational 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 - Collateral |
| standard: 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 basic safety andessential performance of x-ray equipment for computedtomographyFDA/CDRH recognition number 12-302 | |
| • IEC 62304:2006 Medical device software -- Software lifecycle processesFDA/CDRH recognition number 13-32 | |
| • IEC 62366-1:2015 Medical devices - Part 1: Application ofusability engineering to medical devicesFDA/CDRH recognition number 5-114 | |
| • ISO14971 Medical devices – Application of riskmanagement to medical devices (Ed. 2.0, 2007)FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2011 Computed Tomography Dose CheckFDA/CDRH recognition number 12-225 | |
| • 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, documentnumber 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 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 andperformance standards for Computed Tomography (CT)Equipment and Laser products (21 CFR 1020.33 and 21 | |
| CFR 1040.10, respectively).Design Verification planning and testing was conducted atthe sub-system and at the system level. The sub-systems | |
| are tested against the Sub-System RequirementSpecifications (SSRSs) and the system level verification isconducted against the System Requirement Specification(SRS). System and sub-system verification activitiesdemonstrate the system or sub-systems meet theestablished system and sub-system level design inputrequirements. System and sub-system level requirementsmay be verified by manual test, automated test,inspection/analysis, or any combination of the three. Designverification also includes Image Quality verification and riskanalysis risk mitigation testing. | |
| Design validation of user needs and intended use wasconducted via simulated use testing with productionequivalent Access CT Systems. Validation testing includedclinical workflow validation, service validation, andmanufacturing validation. | |
| Conclusion: Traceability from requirements to test plans totest results confirmed, for both design verification anddesign validation, that design requirements were met. TheAccess CT System meets system design requirements anduser needs and intended use. | |
| Summary of ClinicalData: | The proposed Access CT System did not require anyexternal clinical site testing. Clinical evaluation of workflowwas conducted via simulated use testing and isaccounted for in the Summary of Non-Clinical Testingsection of the summary. |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT
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Substantial Equivalence
| Table 5-1 Design/fundamental scientific technologies Comparison | |||
|---|---|---|---|
| ProposedAccess CT | PredicateDevice PhilipsMX 16-slice(K091195) | Conclusion | |
| Application | Head/Body | Head/Body | IdenticalSubstantially Equivalent |
| Scan Regime | ContinuousRotation | ContinuousRotation | IdenticalSubstantially Equivalent |
| No. of Slices | 6/16 | 16 | Access CT 6 and AccessCT 16 use the sameDetector and otherhardware configuration, bysoftware control, 6 slices isimplemented by combiningdifferent detecting units toachieve different slicethickness configuration.This does not affect thesafety or effectiveness.Therefore, demonstratingsubstantial equivalence. |
| Scan Modes | SurviewAxial ScanHelical Scan | SurviewAxial ScanHelical Scan | IdenticalSubstantially Equivalent |
| Minimum ScanTime | 0.75 sec for 360°rotation | 0.5 sec for 360°rotation | Increasing the Minimumscan time from 0.5 to 0.75sec on the proposedAccess CT does not affectthe safety or effectiveness.Therefore, demonstratingsubstantial equivalence. |
| Image (Spatial)Resolution | High resolutionmode :$15\pm10%$lp/cm@0% | High resolutionmode : 15 lp/cm | IdenticalSubstantially Equivalent |
| Image Noise | ≤0.35% | ≤0.35% | IdenticalSubstantially Equivalent |
| Image Matrix | 512x512. | 512x512. | Identical |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT
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| Display | 768x768,1024x1024 | 768x768,1024x1024 | Substantially Equivalent |
|---|---|---|---|
| 1024 * 1280 | 1024 * 1280 | IdenticalSubstantially Equivalent | |
| HostInfrastructure | Windows 7 | Windows XP | Changing the Windowsplatform from Windows XPto Windows 7 does notaffect the safety oreffectiveness of the device.Therefore demonstratingsubstantial equivalence. |
| Communication | Compliance withDICOM | Compliance withDICOM | IdenticalSubstantially Equivalent |
| DoseReporting andManagement | Compliance withNEMAXR25, XR28 andXR29 | none | Subject device compliantwith NEMA standards.There is no impact onsafety or effectiveness. |
| Generator and Tube | |||
| Power (kWOutput) | 28 kW | 50 kW | The difference of poweroutput from 50 KW to 28KWdoes not have an impact onthe functionality /performance and/or safetyor effectiveness of thedevice.Therefore, demonstratingsubstantial equivalence. |
| mA Range | 10mA-233mA | 30mA-420mA | The impact of decreasingthe tube power is anextended lower limit of mArange and decreased upperlimit of mA range, differencein range does not affectsafety or effectiveness.Therefore, demonstratingsubstantial equivalence. |
| kV Settings | 70kV, 80kV,100kV, 120kV,140kV | 90KV, 120KVand 140KV | The impact of decreasingthe tube power is anextended kV range, difference in range does not affect safety or effectiveness. Therefore, demonstrating substantial equivalence. |
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| affect safety oreffectiveness.Therefore, demonstratingsubstantial equivalence. | |||
|---|---|---|---|
| Tube Type | CTR1735 | CTR 2150CEPN | Identical tube technology,and same tube supplier,does not affect safety oreffectiveness.Therefore, demonstratingsubstantial equivalence. |
| Detectors | |||
| Type | NanoPanel Elite | NanoPanel Elite | IdenticalSubstantially Equivalent |
| Scan Field ofView(SFOV) | 450 mm | 500 mm | The difference of SFOVimpact on the scan field,does not affect safety oreffectiveness.Therefore, substantiallyequivalent |
| Detector Type | Single layerceramicscintillator plus aphotodiode | Single layerceramicscintillator plus aphotodiode | IdenticalSubstantially equivalent |
| Material | GOS solid | GOS solid | IdenticalSubstantially equivalent |
| Gantry | |||
| Tilt capability | There is nophysical tilt ongantry. If thetilted images arerequested byuser, the digitaltilt based imagesare created. | $\pm$ 30° | Both are available for axialscans.The difference does notaffect safety oreffectiveness.Therefore, substantiallyequivalent. |
| GantryRotationSpeed | 80 RPM | 120 RPM | Identical transmissiondesign with lower rotationspeedSafety and effectivenessare not affected.Therefore, substantiallyequivalent. |
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| Bore Size | 650mm | 700mm | Bore Size decreasing doesnot affect safety oreffectiveness.Therefore, substantiallyequivalent. |
|---|---|---|---|
| Couch | |||
| Maximumscannablerange | Fixed heightcouch:≤ 1200mm (withgeneral headholder or footextension)Verticalmoveable couch:≤1380mm(withgeneral headholder or footextension) | 1,500 mm | Maximum scannable rangedecreasing does not affectsafety or effectiveness.Therefore, substantiallyequivalent. |
| Z-positionaccuracy | +/- 0.25 mm | +/- 0.25 mm | IdenticalSubstantially equivalent |
| Lowest tableheight | Fixed heightcouch: 815mmverticalmovementcouch: 480mm | 579mm | The difference of tableheight does not affect safetyor effectiveness.Therefore, substantiallyequivalent. |
| Maximum loadcapacity | Fixed heightcouch: 150kgverticalmovementcouch: 200kg | 200kg | Both are compliant withIEC60601 series standards.The difference does notaffect safety oreffectiveness.Therefore, substantiallyequivalent. |
| Clinical Features | |||
| 2D Viewer | Yes | Yes | IdenticalSubstantially equivalent |
| MPR | Yes | Yes | IdenticalSubstantially equivalent |
| 3D | Yes | Yes | IdenticalSubstantially equivalent |
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| VE(VirtualEndoscopy) | Yes | Yes | IdenticalSubstantially equivalent |
|---|---|---|---|
| Filming | Yes | Yes | IdenticalSubstantially equivalent |
| MAR | Yes | Yes | IdenticalSubstantially equivalent |
| DoseModulation | ACS,DOM | ACS,DOM | IdenticalSubstantially equivalent |
| MPR | InsertMPR | InsertMPR | IdenticalSubstantially equivalent |
| Bolus Tracking | Yes | Yes | IdenticalSubstantially equivalent |
| SAS(SpiralAuto Start) | Yes | Yes | IdenticalSubstantially equivalent |
| Worklist | Yes | Yes | IdenticalSubstantially equivalent |
| MPPS | Yes | Yes | IdenticalSubstantially equivalent |
| Reporting | Yes | Yes | IdenticalSubstantially equivalent |
| CCT(Continuous CT) | Yes | Yes | IdenticalSubstantially equivalent |
| Brain Perfusion | Yes | Yes | IdenticalSubstantially equivalent |
| Dental | Yes | Yes | IdenticalSubstantially equivalent |
| VA(VesselAnalysis) | Yes | Yes | IdenticalSubstantially equivalent |
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Table 5-2 shows that the proposed Access CT is considered substantially equivalent to the predicate Philips Ingenuity CT for the Iterative recon function, in terms of design/fundamental scientific technology.
| ProposedAccess CT | Reference DevicePhilips IngenuityCT(K160743) | Conclusion | |
|---|---|---|---|
| Table 5-2 Design/fundamental scientific technologies Comparison | |||
| Clinical Features | |||
| Iterative recon | iDose4 | iDose4 | Identical |
| CTC(CTColonoscopy) | Yes | Yes | Identical |
| LNA(Lung NoduleAnalysis) | Yes | Yes | Identical |
Table 5-3 shows that the proposed Access CT is considered substantially equivalent to the predicate Philips Incisive CT for the Clinical Features, in terms of design/fundamental scientific technology.
| Table 5-3 Design/fundamental scientific technologies Comparison | |||
|---|---|---|---|
| ProposedAccess CT | Reference DevicePhilips IncisiveCT(K180015) | Conclusion | |
| Clinical Features | |||
| iPlanning | Yes | Yes | Identical |
| Batch imageprocessing (iBatch) | Yes | Yes | Identical |
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| SubstantialEquivalenceConclusion: | The design, intended use, technology and principal technologicalcomponents (Tube, Generator, Detector) of the proposed AccessCT are substantially equivalent to the predicate PHILIPS MX 16SLICE (K091195 -05/27/2009). Based on the informationprovided above, the proposed Access CT does not raise differentquestions of safety or effectiveness compared to the predicatePHILIPS MX 16 SLICE (K091195 - 05/27/2009).Therefore the proposed Access CT is considered substantiallyequivalent to the predicate PHILIPS MX 16 SLICE (K091195 -05/27/2009). |
|---|---|
| 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 AccessCT meet the acceptance criteria and is adequate for its intended | |
| 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.