(178 days)
Not Found
No
The document describes standard CT technology and image reconstruction algorithms, with no mention of AI or ML.
No.
The document states that the device is "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," which falls under diagnostic rather than therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These scanners are intended to be used for diagnostic imaging".
No
The device description clearly outlines multiple hardware components including a gantry, X-ray tube, generator, data measurement system, patient table, console (containing a host computer and reconstruction computer), and monitors. While it includes software for image reconstruction and analysis, it is an integral part of a larger hardware system.
Based on the provided information, the Philips iCT CT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Philips iCT CT System is an X-ray system that produces images of the head and body by computer reconstruction of X-ray transmission data. It directly interacts with the patient's body using radiation, rather than analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "diagnostic imaging" and "low dose CT lung cancer screening" by producing images of the patient's internal structures. This is a form of in vivo imaging, not in vitro analysis.
Therefore, the Philips iCT CT System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Philips iCT CT System 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. The iCT 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.
Product codes
JAK
Device Description
The Philips iCT is currently available in two system configurations, iCT and iCT SP. Identical to the predicate, the Philips iCT CT System produces cross-sectional images of the body head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips iCT 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 has an aperture of 700mm and consists of the following internal units:
- a. Stator a fixed mechanical frame that carries hardware and software.
- 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. The generator has a power rating of 100kW with optional 120kW.
- d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation).
-
- Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports:
- a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
- b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg)
- c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
-
- 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.
-
- Monitors
-
- Software features to view and analyze images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
head and 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)
Summary of Non-Clinical Testing:
Design Verification planning and testing was conducted at the sub-system and at the system level. The sub-systems are tested against the Sub-System Requirement Specifications (SSRSs) and the system level verification is conducted against the System Requirement Specification (SRS). System and sub-system verification activities demonstrate the system or sub-systems meet the established system and sub-system level design input requirements. System and sub-system level requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
Testing was performed on the proposed Philips iCT CT System according to the following international and FDA recognized consensus standards and FDA quidance documents:
- IEC 60601-1:2005+A1:2012 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 X-ray 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 44: Particular requirements for the safety of X-ray equipment
- IEC 62304:2006 First edition medical device software - Software life cycle processes
- . IEC 62366:2014 ED1.1 Medical devices -- Part 1: Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices Application of risk management to medical . devices
Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Philips iCT CT Systems. Validation testing included clinical workflow validation, service validation, and manufacturing validation.
Conclusion: Traceability from requirements to test results confirmed, for both design verification and design validation, that design requirements were met. The Philips iCT CT System meets system design requirements and user needs and intended use.
Summary of Clinical Testing:
The proposed Philips iCT 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060937 – Philips Brilliance Volume
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Philips Medical Systems (Cleveland), Inc. % Ms. Christine Anderson Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143
Re: K162838
Trade/Device Name: Philips iCT CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2017 Received: March 9, 2017
Dear Ms. Anderson:
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 (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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known) K162838
Device Name Philips iCT CT System
Indications for Use (Describe)
The Philips iCT CT System 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. The iCT 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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3
Philips Medical Systems (Cleveland) Inc.
Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
510(k) Summary of Safety and Effectiveness [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: | Christine Anderson |
| Title: | Regulatory Affairs Specialist |
| Address: | 595 Miner Road |
| Cleveland, OH 44143 USA | |
| Telephone number: | +1 440 483-7732 |
| Fax number: | +1 440 483-4918 |
| E-mail: | Christine.anderson@philips.com |
| 510(k) Summary Date | |
| of Preparation: | 07-Mar-2017 |
| Device Trade Name: | Philips iCT CT System |
| Common or Usual | |
| Name: | Computed Tomography X-Ray System |
| Classification | |
| Name: | Computed Tomography X-Ray System |
| Regulation: | 21 CFR 892.1750 |
| Class: | II |
| Product Code: | JAK |
| Panel: | Radiology |
| Predicate Device: | K060937 – Philips Brilliance Volume |
4
Philips Medical Systems (Cleveland) Inc.
Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
Indications for Use:
The Philips iCT CT System 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 iCT 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.
Device Description:
The Philips iCT is currently available in two system configurations, iCT and iCT SP. Identical to the predicate, the Philips iCT CT System produces cross-sectional images of the body head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips iCT 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 has an aperture of 700mm and consists of the following internal units:
- a. Stator a fixed mechanical frame that carries hardware and software.
- 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. The generator has a power rating of 100kW with optional 120kW.
- d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation).
5
Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
-
- Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports:
- a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
- b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg)
- c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
-
- 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.
-
- Monitors
-
- Software features to view and analyze images.
Substantial Equivalence:
Philips is citing substantial equivalence of the Philips iCT CT System to the Philips Brilliance Volume. The regulatory citations for the Brilliance Volume are listed below: Predicate Device: Brilliance Volume Predicate 510(k): K060937 Regulation: 21 CFR 892.1750 Class: II Product Code: JAK Panel: Radiology Manufacturer: Philips Medical Systems (Cleveland), Inc.
The design, intended use and technology provided with the proposed Philips iCT CT System is equivalent to the currently marketed predicate.
| Characteristics –
Components/specifications | Predicate: Brilliance
Volume
(K060937) | Proposed: Philips
iCT | Comments |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The "Brilliance
Volume" is a
Computed
Tomography X-Ray
System intended to
produce cross-
sectional images of
the body by computer
reconstruction of x-ray
transmission data
taken at different | The iCT 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 | Indications for Use
updated for
proposed iCT to
add reference to
patients of all ages
and low dose CT
lung cancer
screening
(K153444). The
predicate CT was
also indicated for |
| Characteristics –
Components/specifications | Predicate: Brilliance
Volume
(K060937) | Proposed: Philips
iCT | Comments |
| | angles and planes.
This device may
include signal analysis
and display
equipment, patient,
and equipment
supports, components
and accessories. | include signal analysis
and display equipment,
patient and equipment
supports, components
and accessories. The
iCT is indicated for
head, whole body,
cardiac and vascular
X-ray Computed
Tomography
applications in patients
of all ages. | patient of all ages,
but it was not
specifically stated
in the indications. |
| | | 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. | |
| Design/Fundamental Scientific Technology | | | |
| Application | Head/Body | Head/Body | No change |
| Scan regime | Continuous Rotation | Continuous Rotation | No change |
| Scan Modes | Surview | Surview | No change |
| | Spiral (helical)
Axial | Helical
Axial | |
| Gantry | | | |
| Gantry Aperture (Bore) size | 700 mm | 700 mm | No change |
| Characteristics –
Components/specifications | Predicate: Brilliance
Volume
(K060937) | Proposed: Philips
iCT | Comments |
| Gantry tilt | ±30° | 0° | The iCT Gantry
does not have the
tilt feature. This
change does not
affect safety or
effectiveness. |
| Focus-isocenter distance | 570 mm | 570 mm | No change |
| Focus-detector distance | 1040mm | 1040mm | No change |
| Rotation times | 0.3, 0.33, 0.375, 0.4,
0.5, 0.75, 1.0, 1.5
seconds for full 360°
scans; 0.2 for partial
angle 240°
scans.(Optional - 0.27
seconds for full 360°
scans; 0.18 seconds
for partial angle 240°
scans) | 0.3, 0.33, 0.375, 0.4,
0.5, 0.75, 1.0, 1.5
seconds for full 360°
scans; 0.2 for partial
angle 240°
scans.(Optional - 0.27
seconds for full 360°
scans; 0.18 seconds
for partial angle 240°
scans) | No change |
| | Patient Support/Couch/Table | | |
| Patient Supports | Standard
Bariatric | Standard
Bariatric
Extended (aka Long) | The predicate
device released
with two table
options. The long,
or extended, table
was added to the
CT System. The
extended table
allows for run off
studies and does
not affect safety or
effectiveness. |
| Patient table scan range | 1600 mm | Standard: 1750 mm
Bariatric: 1750 mm
Long: 2100 mm | The scannable
range increased
for the standard
and bariatric
patient supports. It
does not affect
safety or
effectiveness. |
| Table Z-position accuracy | +/- 0.25 mm | Standard: +/- 0.25 mm
Bariatric: +/- 0.25 mm
Long: +/- 0.25 mm | No change |
| Table longitudinal speed | 0.5 – 143 mm/sec | Standard: 0.5 - 185
mm/sec
Bariatric: 0.5 - 185
mm/sec
Long: 0.5 – 185
mm/sec | Slight increase in
longitudinal speed.
lt does not affect
safety or
effectiveness |
| Characteristics –
Components/specifications | Predicate: Brilliance
Volume
(K060937) | Proposed: Philips
ICT | Comments |
| Table maximum load capacity | Standard: 450 lbs.
(204kg)
Bariatric: 650 lbs.
(405kg) | Standard: 450 lbs.
(204kg)
Bariatric: 650 lbs.
(405kg)
Long: 450 lbs. (204kg) | No change |
| Generator power rating | 100kW (120kW
optional) | 100kW (120kW
optional) | No change |
| kVp settings | 80, 100, 120, 140 | 80, 100, 120, 140 | No change |
| mA range (step size) | 10-830 (1mA steps),
optional 10-1,000) | 10-830 (1mA steps),
optional 10-1,000) | No change |
| Focal spot size | small 0.6 x 0.7; large
1.1 x 1.2 | small 0.6 x 0.7; large
1.1 x 1.2 | No change |
| Anode effective heat capacity | 30 MHU | 30 MHU | No change |
| X-Ray tube, max. applied
power | Dynamic Focal Spot in
X and Z (2), up to
120kW, (8) | Dynamic Focal Spot in
X and Z (2), up to
120kW, (8) | No change |
| X-Ray power supply | High-Frequency
up to 120 kW, 10-1000
mA, 80-140 kV | High-Frequency
up to 120 kW, 10-1000
mA, 80-140 kV | No change |
| Detectors | NanoPanel: Ceramic
scintillator+
Photodiode 86016
elements - up to 128
slices simultaneously | iCT - same, but now
with 256 slices
iCT SP - 43008
photodiode elements
for 128 slices | The material is the
same as the
predicate. |
| Slices | Brilliance Volume: 128 | iCT configuration: 256
iCT SP configuration:
128 | Slice increase is
possible with the
capability of the x-
ray tube function. |
| Coverage | Brilliance Volume: 8
cm | iCT configuration: 8 cm
iCT SP configuration: 4
cm | The iCT SP
configuration has a
4 cm detector. It
does not affect
safety or
effectiveness as
compared to the
predicate. |
| Collimations available | 128 x 0.625 mm
64 x 0.625 mm
32 x 1.25 mm
16 x 2.5 mm
2 x 0.5 mm | iCT configuration:
128 x 0.625 mm
112 x 0.625 mm
96 x 0.625 mm
64 x 0.625 mm
32 x 0.625 mm
20 x 0.625 mm
16 x 0.625 mm
8 x 0.625 mm
4 x 0.625 mm
2 x 0.625 mm | The collimations
identified for the
proposed iCT and
iCT SP are
clarifications of the
available
collimations and
needed by the
user. |
| Characteristics -
Components/specifications | Predicate: Brilliance
Volume
(K060937) | Proposed: Philips
iCT | Comments |
| | | 64 x 1.25 mm
32 x 1.25 mm
iCT SP configuration:
64 x 0.625 mm
32 x 0.625 mm
20 x 0.625 mm
16 x 0.625 mm
8 x 0.625 mm
4 x 0.625 mm
2 x 0.625 mm
64 x 1.25 mm
32 x 1.25 mm | |
| Slice Thickness | Helical mode 0.67 –
7.5 mm
Axial mode 0.5 – 12
mm
Axial or helical? 0.5,
0.625, 1.25, 2.5mm
and various
combinations up to
4x10mm | Helical mode 0.67mm
– 10 mm
Axial mode 0.625 mm
– 10 mm | The slice
thicknesses
provided are
clarifications of the
original
specifications. |
| Scan field | 500 mm maximum | 50 -500 mm
continuous
25 - 250mm ultra-high
resolution (UHR) | These are the
same. The ultra-
high resolution was
not identified in the
predicate 510(k) |
| Console computer (Common Host) and Common Image Reconstruction System (CIRS) | | | |
| Computer and CIRS
(Common Image
Reconstruction System) | PC/XP computer
based on Intel
processors and
custom Multiprocessor
Array | Windows 7 based on
Intel processors and
customer
Multiprocessor Array. | The change to a
Windows 7 based
operating system
does not affect
safety or
effectiveness. |
| Image matrix | 5122, 7682, 10242 | 5122, 7682, 10242 | No change |
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Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
7
Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is blue. The background is white, providing a clear contrast that makes the brand name easily visible.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out.
9
Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
Summary of Non-Clinical Testing:
Design Verification planning and testing was conducted at the sub-system and at the system level. The sub-systems are tested against the Sub-System Requirement Specifications (SSRSs) and the system level verification is conducted against the System Requirement Specification (SRS). System and sub-system verification activities demonstrate the system or sub-systems meet the established system and sub-system level design input requirements. System and sub-system level requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
10
Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
Testing was performed on the proposed Philips iCT CT System according to the following international and FDA recognized consensus standards and FDA quidance documents:
- IEC 60601-1:2005+A1:2012 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 X-ray 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 44: Particular requirements for the safety of X-ray equipment
- IEC 62304:2006 First edition medical device software - Software life cycle processes
- . IEC 62366:2014 ED1.1 Medical devices -- Part 1: Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices Application of risk management to medical . devices
Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Philips iCT CT Systems. Validation testing included clinical workflow validation, service validation, and manufacturing validation.
Conclusion: Traceability from requirements to test results confirmed, for both design verification and design validation, that design requirements were met. The Philips iCT CT System meets system design requirements and user needs and intended use.
Summary of Clinical Testing:
The proposed Philips iCT 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.
Conclusion:
It is the conclusion of Philips that the proposed Philips iCT CT System is substantially equivalent to the predicate, Brilliance Volume. There are no significant differences that raise new issues of safety or effectiveness. The proposed Philips iCT CT and the
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predicate produce images of the head and body by computer reconstruction of x-ray transmission data. As provided in the table above, design and fundamental technology, and subsystems such as the patient supports, generator, x-ray tube and detector of the proposed iCT CT System are either identical to the predicate or have minor changes that do not affect safety and effectiveness. Verification and validation testing, risk management activities and conformance to international standards demonstrate the safety and effectiveness of the proposed Philips iCT CT System. The comparison of the proposed Philips iCT CT System in regards to design and technology as well as successful completion of verification, validation and risk management activities demonstrate that the proposed Philips iCT CT System is as safe and effective as the predicate device.