(91 days)
No
The summary describes a standard CT scanner with image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Batch image processing (iBatch)" feature is a common image processing technique and does not necessarily indicate AI/ML.
No
The device is described as a diagnostic patient imaging device that produces images for interpretation by a trained physician to yield diagnostic information, not to provide therapy.
Yes
The "Intended Use / Indications for Use" states that the Access CT scanner system takes X-ray transmission data which is "reconstructed by computer into cross-sectional images". The "Device Description" states that the system "is used clinically as a diagnostic patient imaging device that produces images that correspond to tissue density" and that "When interpreted by a trained physician, CT images yield useful diagnostic information." This clearly indicates it is used for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a Gantry (with stator, rotor, X-ray tube, generator, and data measurement system), a Patient Support (Couch), and a Console with a Host computer and display. It also mentions hardware for data acquisition, display, manipulation, storage, and filming. This clearly indicates it is a hardware-based medical device with accompanying software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Access CT scanner system is an imaging device that uses X-rays to create cross-sectional images of the inside of the body. It directly interacts with the patient and does not analyze specimens taken from the body.
- Intended Use: The intended use is for diagnostic patient imaging by producing images that correspond to tissue density. This is a direct imaging function, not an in vitro analysis.
- Device Description: The description details the hardware components involved in generating and detecting X-rays and processing the resulting data into images. There is no mention of handling or analyzing biological specimens.
Therefore, the Access CT scanner system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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:
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
Whole Body (except cardiac), head
Indicated Patient Age Range
The system is suitable for all patients.
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)
The proposed Access CT complies with the following international and FDA-recognized consensus standards:
AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD). FDA/CDRH recognition number 19-4
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA/CDRH recognition number 19-8
IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment FDA/CDRH recognition number 12-269
IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability FDA/CDRH recognition number 5-89
IEC 60601-2-44:2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography FDA/CDRH recognition number 12-302
IEC 62304:2006 Medical device software -- Software life cycle processes FDA/CDRH recognition number 13-32
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices FDA/CDRH recognition number 5-114
ISO14971 Medical devices – Application of risk management to medical devices (Ed. 2.0, 2007) FDA/CDRH recognition number 5-40
NEMA XR 25-2011 Computed Tomography Dose Check FDA/CDRH recognition number 12-225
NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT FDA/CDRH recognition number 12-287
NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management
Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005, document number 337).
Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014)
Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016)
Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016)
The systems comply with industry guidance and performance standards for Computed Tomography (CT) Equipment and Laser products (21 CFR 1020.33 and 21 CFR 1040.10, respectively).
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.
Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Access CT Systems. Validation testing included clinical workflow validation, service validation, and manufacturing validation.
Conclusion: Traceability from requirements to test plans to test results confirmed, for both design verification and design validation, that design requirements were met. The Access CT System meets system design requirements and user needs and intended use.
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.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
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.
3
Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and the overall impression is clean and modern.
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, 215024 | |
| Establishment Registration Number: 3009529630 | |
| Primary Contact | |
| Person: | Ray Sun |
| Regulatory Affair Engineer | |
| Phone: +86-13109886838 | |
| E-mail: wei.ws.sun@philips.com | |
| Secondary Contact | |
| Person | Shiguang An |
| Regulatory Affair Engineer | |
| Phone: +86-13940106467 | |
| E-mail: shiguang.an@philips.com | |
| Device Name: | Access CT |
| Classification: | Classification name: Computed tomography x-ray system |
| Classification Regulation: 21CFR 892.1750 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: JAK | |
| Predicate Device: | Trade name: PHILIPS MX 16 SLICE |
| Manufacturer: Philips Medical Systems (Cleveland), Inc. | |
| 510(k) Clearance: K091195 | |
| Classification Regulation: 21CFR 892.1750 | |
| Classification name: Computed tomography x-ray system | |
| Classification Panel: Radiology | |
| Device class: Class II | |
| Product Code: JAK | |
| Reference Device: | Trade name: Philips Ingenuity CT |
| Manufacturer: Philips Medical Systems (Cleveland), Inc. | |
| 510(k) Clearance: K160743 | |
| Classification Regulation: 21CFR 892.1750 | |
| Classification name: Computed tomography x-ray system | |
| Classification Panel: Radiology | |
| Device class: Class II | |
| Product Code: JAK | |
| Reference 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:
- 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. |
| Indications for Use: | 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 multi-slice capability up to 6/16 slices
simultaneously. The acquired X-RAY transmission data is
reconstructed by computer into cross-sectional images of the
body from the same axial plane taken at different angles. The
system is suitable for all patients. |
| Fundamental
Scientific
Technology: | The proposed Access CT is an advanced continuous-
rotation computed tomography systems suitable for a wide
range of computed tomographic (CT) applications.
The proposed Access CT 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.
The principal technological components (rotating x-ray tube,
detector and gantry) of the proposed Access CT is
substantially equivalent to the currently marketed predicate
Philips MX 16 SLICE (K091195, 05/27/2009).
Based on the information provided above, the proposed
Access CT does not raise different questions of safety and
effectiveness compare to the currently marketed predicate
Philips MX 16 SLICE (K091195, 05/27/2009). |
| Summary of Non-
Clinical Performance
Data: | The proposed Access CT complies with the following
international and FDA-recognized consensus standards:
• AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012,
C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated
Text) Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential Performance
(IEC 60601-1:2005, MOD).
FDA/CDRH recognition number 19-4
• IEC 60601-1-2:2014, Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
FDA/CDRH recognition number 19-8
• IEC 60601-1-3:2013 Medical electrical equipment -- Part
1-3: General requirements for basic safety - Collateral |
| standard: Radiation protection in diagnostic X-ray
equipment
FDA/CDRH recognition number 12-269 | |
| • IEC 60601-1-6:2013 Medical electrical equipment -- Part
1-6: General requirements for basic safety and essential
performance – Collateral standard: Usability
FDA/CDRH recognition number 5-89 | |
| • IEC 60601-2-44:2016 Medical electrical equipment - Part
2-44: Particular requirements for the basic safety and
essential performance of x-ray equipment for computed
tomography
FDA/CDRH recognition number 12-302 | |
| • IEC 62304:2006 Medical device software -- Software life
cycle processes
FDA/CDRH recognition number 13-32 | |
| • IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
FDA/CDRH recognition number 5-114 | |
| • ISO14971 Medical devices – Application of risk
management to medical devices (Ed. 2.0, 2007)
FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2011 Computed Tomography Dose Check
FDA/CDRH recognition number 12-225 | |
| • NEMA XR 28-2013 Supplemental Requirements for User
Information and System Function Related to Dose in CT
FDA/CDRH recognition number 12-287 | |
| • NEMA XR 29-2013 Standard Attributes on CT Equipment
Related to Dose Optimization and Management | |
| • Guidance for Industry and FDA Staff – Guidance for the
Content of Premarket Submissions for Software Contained
in Medical Devices (issued May 11, 2005, document
number 337). | |
| • Guidance for Industry and FDA Staff – Content of
Premarket Submissions for Management of Cybersecurity in
Medical Devices (issued October 2, 2014) | |
| • Guidance for Industry and FDA Staff – Use of International | |
| | |
| | Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016)
• Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of |
| | Electrically-Powered Medical Devices (issued July 11, 2016)
The systems comply with industry guidance and
performance standards for Computed Tomography (CT)
Equipment and Laser products (21 CFR 1020.33 and 21 |
| | CFR 1040.10, respectively).
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. |
| | Design validation of user needs and intended use was
conducted via simulated use testing with production
equivalent Access CT Systems. Validation testing included
clinical workflow validation, service validation, and
manufacturing validation. |
| | Conclusion: Traceability from requirements to test plans to
test results confirmed, for both design verification and
design validation, that design requirements were met. The
Access CT System meets system design requirements and
user needs and intended use. |
| Summary of Clinical
Data: | 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. |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT
4
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface.
5
Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The overall impression is clean and modern.
6
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and appears to be a standard typeface. The background is plain white, which makes the blue letters stand out.
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The background is white, which makes the blue letters stand out.
8
Image /page/8/Picture/0 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 presented in a straightforward, clean design, emphasizing the brand name.
Substantial Equivalence
| Table 5-1 Design/fundamental scientific technologies Comparison | |||
|---|---|---|---|
| Proposed | |||
| Access CT | Predicate | ||
| Device Philips | |||
| MX 16- | |||
| slice(K091195) | Conclusion | ||
| Application | Head/Body | Head/Body | Identical |
| Substantially Equivalent | |||
| Scan Regime | Continuous | ||
| Rotation | Continuous | ||
| Rotation | Identical | ||
| Substantially Equivalent | |||
| No. of Slices | 6/16 | 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 | 0.75 sec for 360° | ||
| rotation | 0.5 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 : | |||
| $15\pm10%$ | |||
| lp/cm@0% | High resolution | ||
| mode : 15 lp/cm | Identical | ||
| Substantially Equivalent | |||
| Image Noise | ≤0.35% | ≤0.35% | Identical |
| Substantially Equivalent | |||
| Image Matrix | 512x512. | 512x512. | Identical |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Access CT
9
Image /page/9/Picture/0 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.
| Display | 768x768,
1024x1024 | 768x768,
1024x1024 | Substantially Equivalent |
|-------------------------------------|---------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1024 * 1280 | 1024 * 1280 | Identical
Substantially Equivalent |
| Host
Infrastructure | Windows 7 | Windows XP | Changing the Windows
platform from Windows XP
to Windows 7 does not
affect the safety or
effectiveness of the device.
Therefore demonstrating
substantial equivalence. |
| Communicatio
n | Compliance with
DICOM | Compliance with
DICOM | Identical
Substantially Equivalent |
| Dose
Reporting and
Management | Compliance with
NEMA
XR25, XR28 and
XR29 | none | Subject device compliant
with NEMA standards.
There is no impact on
safety or effectiveness. |
| Generator and Tube | | | |
| Power (kW
Output) | 28 kW | 50 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 | 10mA-233mA | 30mA-420mA | 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 | 70kV, 80kV,
100kV, 120kV,
140kV | 90KV, 120KV
and 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. |
10
Image /page/10/Picture/0 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.
| | | | affect safety or
effectiveness.
Therefore, demonstrating
substantial equivalence. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tube Type | CTR1735 | CTR 2150
CEPN | Identical tube technology,
and same tube supplier,
does not affect safety or
effectiveness.
Therefore, demonstrating
substantial equivalence. |
| Detectors | | | |
| Type | NanoPanel Elite | NanoPanel Elite | Identical
Substantially Equivalent |
| Scan Field of
View(SFOV) | 450 mm | 500 mm | The difference of SFOV
impact on the scan field,
does not affect safety or
effectiveness.
Therefore, substantially
equivalent |
| Detector Type | Single layer
ceramic
scintillator plus a
photodiode | Single layer
ceramic
scintillator plus a
photodiode | Identical
Substantially equivalent |
| Material | GOS solid | GOS solid | Identical
Substantially equivalent |
| Gantry | | | |
| Tilt capability | There is no
physical tilt on
gantry. If the
tilted images are
requested by
user, the digital
tilt based images
are created. | $\pm$ 30° | Both are available for axial
scans.
The difference does not
affect safety or
effectiveness.
Therefore, substantially
equivalent. |
| Gantry
Rotation
Speed | 80 RPM | 120 RPM | Identical transmission
design with lower rotation
speed
Safety and effectiveness
are not affected.
Therefore, substantially
equivalent. |
11
Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface.
| Bore Size | 650mm | 700mm | Bore Size decreasing does
not affect safety or
effectiveness.
Therefore, substantially
equivalent. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Couch | | | |
| Maximum
scannable
range | Fixed height
couch:
≤ 1200mm (with
general head
holder or foot
extension)
Vertical
moveable couch:
≤1380mm(with
general head
holder or foot
extension) | 1,500 mm | 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 | Fixed height
couch: 815mm
vertical
movement
couch: 480mm | 579mm | The difference of table
height does not affect safety
or effectiveness.
Therefore, substantially
equivalent. |
| Maximum load
capacity | Fixed height
couch: 150kg
vertical
movement
couch: 200kg | 200kg | Both are compliant with
IEC60601 series standards.
The difference does not
affect safety or
effectiveness.
Therefore, substantially
equivalent. |
| Clinical Features | | | |
| 2D Viewer | Yes | Yes | Identical
Substantially equivalent |
| MPR | Yes | Yes | Identical
Substantially equivalent |
| 3D | Yes | Yes | Identical
Substantially equivalent |
12
Image /page/12/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 white, providing a strong contrast to the blue text.
| VE(Virtual
Endoscopy) | Yes | Yes | Identical
Substantially equivalent |
|---------------------------|-----------|-----------|---------------------------------------|
| Filming | Yes | Yes | Identical
Substantially equivalent |
| MAR | Yes | Yes | Identical
Substantially equivalent |
| Dose
Modulation | ACS,DOM | ACS,DOM | Identical
Substantially equivalent |
| MPR | InsertMPR | InsertMPR | Identical
Substantially equivalent |
| Bolus Tracking | Yes | Yes | Identical
Substantially equivalent |
| SAS(Spiral
Auto Start) | Yes | Yes | Identical
Substantially equivalent |
| Worklist | Yes | Yes | Identical
Substantially equivalent |
| MPPS | Yes | Yes | Identical
Substantially equivalent |
| Reporting | Yes | Yes | Identical
Substantially equivalent |
| CCT(Continuo
us CT) | Yes | Yes | Identical
Substantially equivalent |
| Brain Perfusion | Yes | Yes | Identical
Substantially equivalent |
| Dental | Yes | Yes | Identical
Substantially equivalent |
| VA(Vessel
Analysis) | Yes | Yes | Identical
Substantially equivalent |
13
Image /page/13/Picture/0 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.
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.
| | Proposed
Access CT | Reference Device
Philips Ingenuity
CT(K160743) | Conclusion |
|-----------------------------------------------------------------|-----------------------|------------------------------------------------------|------------|
| Table 5-2 Design/fundamental scientific technologies Comparison | | | |
| | | | |
| Clinical Features | | | |
| Iterative recon | iDose4 | iDose4 | Identical |
| CTC(CT
Colonoscopy) | Yes | Yes | Identical |
| LNA(Lung Nodule
Analysis) | 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 | |||
|---|---|---|---|
| Proposed | |||
| Access CT | Reference Device | ||
| Philips Incisive | |||
| CT(K180015) | Conclusion | ||
| Clinical Features | |||
| iPlanning | Yes | Yes | Identical |
| Batch image | |||
| processing (iBatch) | Yes | Yes | Identical |
14
Image /page/14/Picture/0 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 plain white.
| Substantial
Equivalence
Conclusion: | The design, intended use, technology and principal technological
components (Tube, Generator, Detector) of the proposed Access
CT are substantially equivalent to the predicate PHILIPS MX 16
SLICE (K091195 -05/27/2009). Based on the information
provided above, the proposed Access CT does not raise different
questions of safety or effectiveness compared to the predicate
PHILIPS MX 16 SLICE (K091195 - 05/27/2009).
Therefore the proposed Access CT is considered substantially
equivalent to the predicate PHILIPS MX 16 SLICE (K091195 -
05/27/2009). |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additionally, substantial equivalence was demonstrated with non-
clinical performance (verification and validation) tests, which
complied with the requirements specified in the international and
FDA-recognized consensus standards.
The results of these tests demonstrate that the proposed Access
CT meet the acceptance criteria and is adequate for its intended |
| | use. |