(141 days)
No
The document describes standard CT technology and image processing, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is used for diagnostic imaging and screening for early detection of lung nodules, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These systems 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*."
No
The device description explicitly lists multiple hardware components (Gantry, Patient Support, Console, workstation hardware) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Philips CT Big Bore is a Computed Tomography X-Ray System. It produces images of the head and body using X-rays and computer reconstruction. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use is for diagnostic imaging and low dose CT lung cancer screening, which involves taking images of the patient's body directly, not analyzing samples taken from the body.
Therefore, based on the provided information, the Philips CT Big Bore is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Philips CT Big Bore 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 equipments and accessories. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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.
Product codes
JAK
Device Description
The Philips CT Big Bore is currently available in two system configurations, the Oncology configuration and the Radiology (Base) configuration.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips CT Big Bore 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 detector array, fixed to the Rotor frame - Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan
- Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated, powerful image reconstruction computer
In addition to the above components and the software operating them, each system includes workstation 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
Head and whole body
Indicated Patient Age Range
Patients of all ages.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing included basic CT performance tests on phantoms, safety tests and software tests for functional and non-functional attributes of the proposed Philips CT Big Bore system.
| CT Performance Metric | Values and ranges measured on phantoms |
|---|---|
| MTF | Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm |
| CTDIvol | Head: 10.61mGy/100mAs±25%; Body: 5.92mGy/100mAs±25% at 120kV |
| CT number accuracy | Water: 0±4HU |
| Noise | 0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UA filter |
| Slice Thickness | 0.5mm - 1.5mm at nominal 0.75mm; 1.0mm - 2.0mm at nominal 1.5mm |
The completed test protocols cover the main system level software and hardware requirements of the System Requirements Specification and the subsystem requirement specifications as well as the identified hazard mitigations from the Safety Risk Management Report. The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation.
The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report.
Conclusion: All verification tests were executed according to the System Verification Plan. There were no deviations to the System Verification Plan. All executed tests passed the specified requirements.
The completed test plan identified the tasks, deliverables, methodology, requirements and the resources for validation of the intended use and meets customer needs.
Summary of Clinical Testing:
The validation testing covered clinical validation, serviceability validation, manufacturing validation and validation by analysis. The clinical validation covered requirements related to clinical workflows and features. The serviceability validation covered requirements related to upgrade, installation, servicing and troubleshooting of the systems. The manufacturing validation covered requirements related to operations and manufacturing and the validation by analysis covered all other requirements that affect the end user that were not covered by the above testing.
Conclusion: The validation test plan was executed as planned and acceptance criteria met for each requirement. All defects were managed and closed. All validation tests of this Premarketing Notification [510(k)] submission demonstrates the safety and effectiveness of the Philips CT Big Bore in its performance as a CT system. The results of this validation testing are available in the Final Validation Report.
Sample clinical images were provided with this submission, which were reviewed and evaluated by radiologists. All images were evaluated to have good image quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K160743, K153444, K012238, K023785, K02005, K162025
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 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.
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November 9, 2017
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Philips Medical Systems (Cleveland) Inc. Michael Chilbert Regulatory Affairs Engineer 595 Miner Road Cleveland, Ohio 44143
Re: K171850
Trade/Device Name: Philips CT Big Bore Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 10, 2017 Received: October 12, 2017
Dear Mr. Michael Chilbert:
We have reviewed vour 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Robert Oaks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171850
Device Name Philips CT Big Bore
Indications for Use (Describe)
The Philips CT Big Bore 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 equipments and accessories. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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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Philips CT Big Bore 510(k) Submission
Section 5
510(k) Summary
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[As required by 21 CFR 807.92(c)] Applicant's Name: Philips Medical Systems (Cleveland), Inc. Address: 595 Miner Road Cleveland, OH 44143 USA Contact Person: Michael Chilbert, Ph.D., P.E. Title: Regulatory Affairs Engineer Address: 595 Miner Road Cleveland, OH 44143 USA Telephone number: +1 440 483-3284 Fax number: +1 440 483-4918 E-mail: michael.chilbert@philips.com 510(k) Summary Date of Preparation: 19-June-2017 Device Trade Name: Philips CT Big Bore Common or Usual Name: Computed Tomography X-ray system Classification Name: Computed Tomography X-ray system Regulation: 21 CFR 892.1750 Class: = Product Code: JAK Panel: Radiology Primary Predicate device K033357 - AcQSim Multislice CT Scanner Classification Name: Computed Tomography X-ray system Regulation: 21 CFR 892.1750 Class: = Product Code: JAK Panel: Radiology
510(k) Summary of Safety and Effectiveness
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Indications for Use
The Philips CT Big Bore 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. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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.
Intended Use:
The Philips CT Big Bore is a Computed Tomography X-Ray System intended to produce images of the head and body to be used for diagnostic imaging in radiology and in oncology as part of treatment preparation and radiation therapy planning. These systems are indicated for head and whole body X-ray Computed Tomography applications in patients of all ages and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
Device Description:
The Philips CT Big Bore is currently available in two system configurations, the Oncology configuration and the Radiology (Base) configuration.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips CT Big Bore 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 detector array, fixed to the Rotor frame
-
- Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan
-
- Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated, powerful image reconstruction computer
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In addition to the above components and the software operating them, each system includes workstation 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.
Substantial Equivalence:
Primary Predicate Device: AcQSim Multislice CT Scanner Manufacturer: Philips Medical Systems (Cleveland), Inc. Predicate Device k#: K033357
The design, intended use and technology provided with the proposed Philips CT Big Bore is identical to the predicate device, AcQSim Multislice CT Scanner, and therefore is considered substantially equivalent.
| Table 5-2: Substantial Equivalence Comparison
Comparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357)
| versus the proposed Philips CT Big Bore | |||
|---|---|---|---|
| AcQSim | |||
| Multislice CT | |||
| Scanner | Proposed | ||
| Philips CT | |||
| Big Bore | Comments | ||
| Design/Fundamental Scientific Technology | |||
| Application | Head/Body | Head/Body | Identical |
| Scan Regime | Continuous Rotation | Continuous | |
| Rotation | Identical | ||
| No. of Slices | Up to 40 | 16/32 | Both the predicate and proposed CT |
| systems currently use a 24 mm wide | |||
| detector providing 16 slices/channels. | |||
| The proposed Philips CT Big Bore can | |||
| increase the number of images to 32 | |||
| from the 16 channels of data using an | |||
| optional software algorithm called WARP | |||
| or DAS. This is available on Ingenuity | |||
| CT, K160743 | |||
| Scan Modes | Surview | ||
| Axial Scan | |||
| Helical Scan | Surview | ||
| Axial Scan | |||
| Helical Scan | Identical | ||
| Minimum Scan | |||
| Time | 0.42 sec for 360° | ||
| rotation | 0.42 sec for 360° | ||
| rotation | Identical | ||
| Image (Spatial) | |||
| Resolution | 15 lp/cm max. | 16 lp/cm (±2 lp/cm). | Identical |
| Image Noise, Body, | |||
| STD Res., 16.25 | |||
| mGy | 10.7 | 10.7 | Identical |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Identical |
| Display | 1024 x 1280 | 1024 x 1280 | Identical |
| Host Infrastructure | Windows XP | Windows 7 | Essentially the same, Windows based |
| computer running iPatient system | |||
| software, does not affect safety and | |||
| effectiveness | |||
| Table 5-2: Substantial Equivalence Comparison | |||
| Comparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357) | |||
| versus the proposed Philips CT Big Bore | |||
| AcQSim | |||
| Multislice CT | |||
| Scanner | Proposed | ||
| Philips CT | |||
| Big Bore | Comments | ||
| CIRS Infrastructure | PC/NT computer | ||
| based on Intel | |||
| processor & custom | |||
| Multiprocessor Array | Windows Vista & | ||
| custom | |||
| Multiprocessor | |||
| Array | Identical, Windows based computer | ||
| Communication | Compliance with | ||
| DICOM | Compliance with | ||
| DICOM | Identical | ||
| Dose Reporting | |||
| and Management | No | Compliance with | |
| MITA | MITA XR25 and XR29 compliance is | ||
| currently available on Philips CT Big | |||
| Bore systems and the predicate systems | |||
| with v3.6 software or higher, does not | |||
| affect safety and effectiveness | |||
| XR25 and XR29 | |||
| Generator and Tube | |||
| Power (kW Output) | 60 kW | 80 kW | |
| (Software limited to | |||
| 60kW) | Generator is FDA class I, 510(k) exempt, | ||
| no change in functionality, physically the | |||
| same. This change does not affect safety | |||
| and effectiveness. | |||
| mA Range | 30-500mA | 20-665mA | |
| (Software limited to | |||
| 500mA) | The impact of increasing the tube power | ||
| is an extended mA range, difference in | |||
| range does not affect safety and | |||
| effectiveness. | |||
| kV Settings | 80, 120, 140 | 80, 100, 120, 140 | Provides another setting that may be |
| useful in standard scanning, does not | |||
| affect safety and effectiveness | |||
| Focal Spot | Dynamic Focal Spot | Dynamic Focal | |
| Spot in X axis | Identical | ||
| Tube Type | MRC 800 | MRC Ice Tube | |
| (880) | Identical tube technology, the two tubes | ||
| share the same anode, cathode, bearing, | |||
| anode drive, and electrical interfaces, but | |||
| differ in housing, does not affect safety | |||
| and effectiveness | |||
| Detectors | |||
| Slice Thicknesses | 0.5, 0.625, 1.25, | ||
| 2.5mm and various | |||
| combinations up to | |||
| 4x10mm | Helical: 0.67mm – | ||
| 5mm | |||
| Axial: 0.625mm – | |||
| 12.5mm | Identical, slice thickness, does not affect | ||
| safety and effectiveness. | |||
| Table 5-2: Substantial Equivalence Comparison | |||
| Comparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357) | |||
| versus the proposed Philips CT Big Bore | |||
| AcQSim | |||
| Multislice CT | |||
| Scanner | Proposed | ||
| Philips CT | |||
| Big Bore | Comments | ||
| Type | 2.4 or 4 cm | ||
| NanoPanel detector | 2.4 cm NanoPanel | The detector for the Philips CT Big Bore | |
| is a revision of the detector that was | |||
| used in the predicate, both detectors | |||
| have the same design specifications but | |||
| the detector used in the Philips CT Big | |||
| Bore shows slightly better performance. | |||
| Marketing may use the "Elite" | |||
| nomenclature in the detector name. This | |||
| change does not affect safety and | |||
| effectiveness. | |||
| Scan Field of View | Up to 600 mm | Up to 600 mm | Identical |
| Detector Type | Single layer ceramic | ||
| scintillator plus | |||
| photodiode array | Single layer | ||
| ceramic scintillator | |||
| plus photodiode | |||
| array | Identical | ||
| Gantry | |||
| Gantry Tilt | $\pm 30^0$ | $\pm 30^0$ | Identical |
| Gantry Rotation | |||
| Speed | 143 RPM | 143 RPM | Identical |
| Bore Size | 850 mm | 850 mm | Identical |
| Clinical Features | |||
| Low dose CT lung | |||
| cancer screening | Yes | Yes | The proposed Philips CT Big Bore has |
| the same configuration with the Brilliance | |||
| Big Bore cited in K153444 and belongs | |||
| to the family of a series of CT devices | |||
| cleared in K153444. | |||
| Communication | |||
| between injector | |||
| and scanner | SAS (Spiral Auto | ||
| Start) | SAS and SyncRight | SyncRight is used in conjunction with the | |
| SAS to improve clinical workflow of | |||
| contrast enhanced scanning. | |||
| The functionality of the injector will not | |||
| be altered by SyncRight; only starting the | |||
| injector and, if necessary stopping of the | |||
| injector as well as entering injection | |||
| parameters is available from the scanner | |||
| console. | |||
| This modification does not affect the | |||
| safety or effectiveness of the device. | |||
| DoseRight / | |||
| Dose Management | |||
| (K012238) | Yes | Yes and iDose4 | DoseRight was cleared under K012238, |
| iDose is an extension of the existing | |||
| feature DoseRight, and both provide the | |||
| same basic function (low dose | |||
| scanning). This feature does not affect | |||
| the safety or effectiveness of the device. | |||
| Table 5-2: Substantial Equivalence Comparison | |||
| Comparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357) | |||
| versus the proposed Philips CT Big Bore | |||
| AcQSim | |||
| Multislice CT | |||
| Scanner | Proposed | ||
| Philips CT | |||
| Big Bore | Comments | ||
| Dose Modulation | |||
| (part of DoseRight, | |||
| above) | D-DOM and Z-DOM | D-DOM (Angular | |
| DOM) and Z-DOM | |||
| FDOM, 3D-DOM | Dose Modulation function modulates the | ||
| tube current based on patient body | |||
| symmetry change. FDOM incorporates | |||
| the features of Z-DOM and D-DOM and | |||
| does not introduce new hazards, but only | |||
| supports a mode which combines | |||
| angular and longitudinal modulation. This | |||
| feature does not affect the safety or | |||
| effectiveness of the device. | |||
| Cone Beam | |||
| Reconstruction | |||
| Algorithm - COBRA | Yes | Yes | Identical |
| Axial 2D | |||
| Reconstruction | Yes | Yes | Identical |
| Lung Nodule | |||
| Assessment | |||
| (K023785) | Yes | Yes | Identical |
| ECG Signal | |||
| Handling | Yes | Yes | Identical |
| Cardiac | |||
| Reconstruction | Yes | Yes | Identical |
| Bolus Tracking | |||
| (K02005) | Yes | Yes | Identical |
| Calcium Scoring | Yes | Yes | Identical |
| Heartbeat Calcium | |||
| Scoring (HBCS) | Yes | Yes | Identical |
| Virtual | |||
| Colonoscopy | Yes | Yes | Identical |
| Pediatric | |||
| Applications | |||
| Support | Yes | Yes | Identical |
| Remote | |||
| Workstation Option | Yes - MxView - | ||
| later renamed | |||
| Extended Brilliance | |||
| Workstation | Yes - IntelliSpace | ||
| Portal (K162025) | Change of name, no effect on the safety | ||
| or effectiveness of the device. | |||
| Volume Rendering | Yes | Yes | Identical |
| Liver Perfusion | Yes | Yes | Identical |
| Dental Planning | Yes | Yes | Identical |
| Functional CT | Yes | Yes | Identical |
| Stent Planning | Yes | Yes | Identical |
| Retrospective | |||
| Tagging | Yes | Yes | Identical |
| Prospective | |||
| Cardiac Gating | Yes | Yes | Identical |
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Summary of Non-Clinical Testing:
This 510(k) premarket notification contains technical documentation, which demonstrates that the proposed Philips CT Big Bore is substantially equivalent to the primary predicate device, AcQSim Multislice CT Scanner in terms of safety and effectiveness. Testing was performed on the proposed Philips CT Big Bore according to the following international and FDA recognized consensus standards and FDA regulations and guidance documents:
- IEC 60601-1:2006 Medical electrical equipment -- Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2:2007. Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-3 Ed 2.0:2008 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic Xray equipment
- . IEC 60601-1-6:2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment
- . IEC 62304:2006 First Edition Medical device software -- Software life cycle processes
- ISO 14971 Medical devices Application of risk management to medical devices (Ed. ● 2.0, 2007)
- 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).
- . Code of Federal Regulations Title 21, Subchapter J - Radiological Health
Bench testing included basic CT performance tests on phantoms, safety tests and software tests for functional and non-functional attributes of the proposed Philips CT Big Bore system.
| CT Performance Metric | Values and ranges measured on phantoms |
|---|---|
| MTF | Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm |
| CTDIvol | Head: 10.61mGy/100mAs±25%; Body: 5.92mGy/100mAs±25% at 120kV |
| CT number accuracy | Water: 0±4HU |
| Noise | 0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UA filter |
| Slice Thickness | 0.5mm - 1.5mm at nominal 0.75mm; 1.0mm - 2.0mm at nominal 1.5mm |
The completed test protocols cover the main system level software and hardware requirements of the System Requirements Specification and the subsystem requirement specifications as well as the identified hazard mitigations from the Safety Risk Management Report. The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation.
The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report.
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Conclusion: All verification tests were executed according to the System Verification Plan. There were no deviations to the System Verification Plan. All executed tests passed the specified requirements.
The completed test plan identified the tasks, deliverables, methodology, requirements and the resources for validation of the intended use and meets customer needs.
Summary of Clinical Testing:
The validation testing covered clinical validation, serviceability validation, manufacturing validation and validation by analysis. The clinical validation covered requirements related to clinical workflows and features. The serviceability validation covered requirements related to upgrade, installation, servicing and troubleshooting of the systems. The manufacturing validation covered requirements related to operations and manufacturing and the validation by analysis covered all other requirements that affect the end user that were not covered by the above testing.
Conclusion: The validation test plan was executed as planned and acceptance criteria met for each requirement. All defects were managed and closed. All validation tests of this Premarketing Notification [510(k)] submission demonstrates the safety and effectiveness of the Philips CT Big Bore in its performance as a CT system. The results of this validation testing are available in the Final Validation Report.
Sample clinical images were provided with this submission, which were reviewed and evaluated by radiologists. All images were evaluated to have good image quality.
The proposed Philips CT Big Bore has the same configuration as the Brilliance Big Bore cited in K153444, therefore the Philips CT Big Bore is cleared for low dose CT lung cancer screening.
The proposed Philips CT Big Bore can be used as defined in its clinical workflow and intended use.
Conclusion:
Philips believes that the proposed Philips CT Big Bore is substantially equivalent to the predicate device, AcQSim Multislice CT Scanner. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests and user validation have been performed to demonstrate that the proposed Philips CT Big Bore is as safe and effective as the predicate device, AcQSim Multislice CT Scanner, without raising any new safety and/or effectiveness concerns.