(260 days)
Yes
The document explicitly mentions "Al algorithm" and "CNN architecture" in the description of the "Precise Position" feature, indicating the use of Artificial Intelligence, specifically a Convolutional Neural Network, which is a type of Machine Learning.
No
The device is described as a Computed Tomography X-Ray System intended for diagnostic imaging, which produces images for reconstruction of x-ray transmission data. It is used for diagnostic purposes and screening, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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." This directly indicates its use for diagnosis.
No
The device description explicitly details multiple hardware components including an X-Ray Tube, High voltage generator, Gantry, Patient Table, and Console, in addition to the software.
No, 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 for diagnosis, monitoring, or screening.
- Device Function: The CT 5300 is a Computed Tomography X-Ray System. It produces images of the internal structures of the body using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is for "producing images of the head and body" and "diagnostic imaging." This is consistent with an in vivo imaging device, not an in vitro diagnostic device.
The device is an imaging system used for diagnostic purposes by visualizing internal anatomy, which is distinct from the analysis of biological samples performed by IVDs.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The CT 5300 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 CT 5300 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 etther 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 proposed device is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
The CT 5300 has a 72 cm bore and includes a detector array that provides 50 cm scan field of view (FOV).
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed device have the same fundamental design characteristics and are based on comparable technologies as the current marketed predicate Philips Incisive CT K212441(April 27, 2022).
The key system modules and functionalities are:
- Gantry
The Gantry consists of 4 main internal units:
a. X-Ray Tube – produces X-rays necessary for scanning.
b. High voltage generator - produces high voltage power supply to X-ray tube, consists of system Interface Unit, Power Block Unit and Anode Drive Unit.
c. A-plane: adjusts the slice thickness during axial scan and monitor the changes of X-ray.
d. DMS (Data Management System) – absorbs X-ray radiation by detectors and converts it to digital readout. - Patient Table (Couch)
The Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. - Console
The console is used to operate the system and monitor the scan. The Operator console includes a computer, monitors and CTBOX. - CT on Trailer Kit
The CT 5300 installed and secured on a trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. Besides being installed in hospital, the CT may also be installed on trailer to be transported to designated locations for use within a professional healthcare environment.
The CT 5300 on Trailer Kit has the same fundamental design characteristics and technologies as the current marketed Philips Incisive CT on trailer (K211168 - November 22, 2021). The CT on Trailer configuration is identical to the K211168 trailer configuration. The CT system should only be used in designated locations for use with appropriate radiation controls and safety measures.
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.
Upgrades Kit is available to upgrade earlier Incisive CT installations to latest version.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
Head, whole body, cardiac, vascular, lung, spine
Indicated Patient Age Range
Patients of all ages. For Precise Position: patients aged 16 years and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Precise Image: All models were adequately trained.
Precise Position: The original model was trained using a broad dataset.
Description of the test set, sample size, data source, and annotation protocol
Precise Image: The comparative image quality assessment using phantoms demonstrated acceptable performance for the new models used in Precise Image. Additionally, a comparative image evaluation by two US Board Certified Radiologists of 126 image set pairs (including cases with pathology) comprising 31 unique patients representing the newly supported reconstructions.
Precise Position: Evaluation/assessment of the modified Precise Position algorithm, system level verification and validation activities have been properly carried out.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical verification and or validation tests have been performed with reqards to the intended use, the technical claims, the requirement specifications and the risk management results. Non- Clinical verification and or validation test results demonstrate that the proposed device:
. Complies with the aforementioned international standards, FDA-recognized consensus standards, Subchapter-J performance standards, NEMA industry standards and FDA guidance documents.
. Meets the acceptance criteria and is adequate for its intended use.
Precise Image (K210760) was modified for use in the CT 5300 system. With no changes to the algorithm architecture, new models were introduced to enable the reconstruction of a new organ type (cardiac), support more slice thickness and increment combinations, a new scan mode (high resolution head), and more clinical scenarios for body and head. All models were adequately trained and successfully compared using half-dose Precise Image reconstructions with full-dose iDose4 reconstructions. The comparative image quality assessment using phantoms demonstrated acceptable performance for the new models used in Precise Image. Additionally, a comparative image evaluation by two US Board Certified Radiologists of 126 image set pairs (including cases with pathology) comprising 31 unique patients representing the newly supported reconstructions. The comparative image assessment demonstrated that halfdose images processed by Precise Image in CT 5300. including both new and original existing models, are of equal or greater diagnostic quality compared to full dose images processed by iDose4. The comparative external image assessment confirms the validity of successful bench testing and clinical image quality evaluations, and when taken together, demonstrate Precise Image in CT 5300 to be as safe and effective as the predicate, and thus substantially equivalent to Precise Image (K210760) in predicate Incisive CT (K212441).
Precise Position (originally cleared in K203514) was modified for use in the CT 5300 with no change to the design of the AI algorithm, the body joints detection algorithm including CNN architecture, model parameters, inference pipeline, pre- and post-processing is same as what is used in the predicate Incisive CT. The original model was trained using a broad dataset and performance data using clinical images demonstrate the model can further support more exams (cardiac, spine, runoff). Evaluation/assessment of the modified Precise Position algorithm, system level verification and validation activities have been properly carried out to demonstrate it is as safe and effective as the predicate to process the newly integrated exams (cardiac, spine, runoff), hence the modified Precise Position in the CT 5300 is substantially equivalent to the predicate Incisive CT (K212441), which integrates Precise Position (originally cleared in K203514).
The proposed device did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing, bench testing, retrospective clinical data, and other evidence as outlined.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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May 3, 2024
Philips Healthcare (Suzhou) Co., Ltd. % An Shiguang Regulatory Affairs Manager No. 258, Zhongyuan Road, Suzhou Industrial Park SUZHOU JIANGSU, CHINA, 215024
Re: K232491
Trade/Device Name: CT 5300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 4, 2024 Received: April 4, 2024
Dear An Shiguang:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232491
Device Name CT 5300
Indications for Use (Describe)
The CT 5300 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 CT 5300 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 etther a governmental body or professional medical society.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| Date Prepared: | Mar 8, 2024 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| No. 258, Zhongyuan Road, Suzhou Industrial Park, | |
| Suzhou Jiangsu, CHINA, 215024 | |
| Establishment Registration Number: 3009529630 |
Additional Manufacturing Site:
Philips Medical Systems Technologies, LTD.
Advanced Technology Center MATAM, Building 34,
3100202 Haifa Israel.
Establishment Registration Number: 9617978 |
| Primary Contact
Person: | Shiguang An
Regulatory Affairs Engineer
Phone: +86-0-13940106467
E-mail: shiguang.an@philips.com |
| Secondary Contact
Person | Erhong Wang
Senior Manager Regulatory Affairs
Phone : +86-0-13021019589
E-mail : erhong.wang@philips.com |
| Device Name: | CT 5300 |
| Classification: | Classification name: Computed tomography x-ray
system
Classification Regulation: 21CFR 892.1750
Classification Panel: Radiology
Device Class: Class II
Primary Product Code: JAK |
| Primary Predicate
Device: | Trade name: Philips Incisive CT
Manufacturer: Philips Healthcare (Suzhou)
Co., Ltd.
510(k) Clearance: K212441
Classification Regulation: 21CFR 892.1750
Classification name: Computed tomography x-ray
system
Classification Panel: Radiology
Device class Class II
Product Code: JAK |
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| Device Description: | Traditional 510
The proposed device is a whole-body computed
tomography (CT) X-Ray System featuring a continuously
rotating x-ray tube, detectors, and gantry with multi-slice
capability. The acquired x-ray transmission data is
reconstructed by computer into cross-sectional images of
the body taken at different angles and planes. This system
also includes signal analysis and display equipment, patient
and equipment supports, components, and accessories.
The CT 5300 has a 72 cm bore and includes a detector
array that provides 50 cm scan field of view (FOV).
The main components (detection system, the reconstruction
algorithm, and the x-ray system) that are used in the
proposed device have the same fundamental design
characteristics and are based on comparable technologies
as the current marketed predicate Philips Incisive CT
K212441(April 27, 2022). |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The key system modules and functionalities are:
- Gantry
The Gantry consists of 4 main internal units: |
| | a. X-Ray Tube – produces X-rays necessary for
scanning.
b. High voltage generator - produces high voltage
power supply to X-ray tube, consists of system
Interface Unit, Power Block Unit and Anode Drive
Unit.
c. A-plane: adjusts the slice thickness during axial
scan and monitor the changes of X-ray. |
| | d. DMS (Data Management System) – absorbs X-ray
radiation by detectors and converts it to digital
readout. - Patient Table (Couch)
The Couch is used to position the patient. Carries the
patient in and out through the Gantry bore synchronized
with the scan. |
| | 3. Console
The console is used to operate the system and monitor
the scan. The Operator console includes a computer,
monitors and CTBOX. |
| | 4. CT on Trailer Kit
The CT 5300 installed and secured on a trailer requires
locking motion parts during trailer transportation and
unlocking motion parts before CT operations. Besides
being installed in hospital, the CT may also be installed on
trailer to be transported to designated locations for use
within a professional healthcare environment. |
| | The CT 5300 on Trailer Kit has the same fundamental design characteristics and technologies as the current marketed Philips Incisive CT on trailer (K211168 - November 22, 2021). The CT on Trailer configuration is identical to the K211168 trailer configuration. The CT system should only be used in designated locations for use with appropriate radiation controls and safety measures. |
| | 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. |
| | Upgrades Kit is available to upgrade earlier Incisive CT installations to latest version. |
| Indications for Use: | The CT 5300 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 CT 5300 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. |
| | Traditional 510(k |
| Fundamental
Scientific
Technology: | The proposed device is an advanced continuous rotation
computed tomography system suitable for a wide range of
computed tomographic (CT) applications.
The proposed device 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 device are
substantially equivalent to the currently marketed predicate
device Philips Incisive CT (K212441 (April 27, 2022).
Based on the information provided above, the proposed
device does not raise different questions of safety and
effectiveness compared to the currently marketed predicate
device Philips Incisive CT (K212441(April 27, 2022). |
| Summary of Non-Clinical Performance Data: | Traditional 510(k) |
| | The proposed device conforms to international standards,
FDA-recognized consensus standards, 21 CFR Subchapter-
J performance standards, NEMA industry standards, and
FDA guidance documents. |
| | • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated
Text) [Incl. AMD2:2021] Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) [Incl. AMD2:2021].
FDA/CDRH recognition number 19-46 |
| | • IEC 60601-1-2:2020 (Consolidated Text) 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 19-36 |
| | • IEC 60601-1-3:2021(Consolidated Text) Medical electrical
equipment -- Part 1-3: General requirements for basic safety
- Collateral standard: Radiation protection in diagnostic X-
ray equipment
FDA/CDRH recognition number 12-336 |
| | • IEC 60601-1-6:2020(Consolidated Text) Medical electrical
equipment -- Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability
FDA/CDRH recognition number 5-132 |
| | • IEC 60601-2-44:2016 Medical electrical equipment - Part
2-44: Particular requirements for the safety and essential
performance of X-ray equipment for computed tomography
FDA/CDRH recognition number 12-302 |
| | • IEC 62304:2015 (Consolidated Text) Medical device
software -- Software life cycle processes
FDA/CDRH recognition number 13-79 |
| | • IEC 62366-1:2020 Medical devices -- Part 1: Application of
usability engineering to medical devices
FDA/CDRH recognition number 5-129 |
| | • ISO14971:2019 Medical devices – Application of risk
management to medical devices
FDA/CDRH recognition number 5-125 |
| | |
| • ISO 10993-1:2018 Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk | |
| management process | |
| FDA/CDRH recognition number 2-258 | |
| · NEMA XR 25-2019 Computed Tomography Dose Check | |
| FDA/CDRH recognition number 12-325 | |
| • NEMA XR 26:2020 Access Controls for Computed | |
| Tomography: Identification, Interlocks, and Logs | |
| • NEMA XR 28-2018 Supplemental Requirements for User | |
| Information and System Function Related to Dose in CT
FDA/CDRH recognition number 12-330 | |
| • 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 Device Software | |
| functions | |
| (Issued June 14, 2023, document number GUI00000337). | |
| · Guidance for Industry and FDA Staff - Cybersecurity in | |
| Medical Devices: Quality System Considerations and | |
| Content of Premarket Submissions (issued September 27,
2023, document number GUI00001825) | |
| | |
| • 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 September 4, 2020, | |
| document number 1811-R1) | |
| • Guidance for Industry and Food and Drug Administration | |
| Staff - Electromagnetic Compatibility (EMC) of Medical | |
| Devices: (issued June 6, 2022, document number 1400057) | |
| · Performance standards for Computed Tomography (CT) | |
| Equipment and Laser products (21 CFR 1020.33 and 21 | |
| CFR 1040.10, respectively). | |
| | |
| | |
| | |
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Non-Clinical verification and or validation tests have been performed with reqards to the intended use, the technical claims, the requirement specifications and the risk management results. Non- Clinical verification and or validation test results demonstrate that the proposed device: . Complies with the aforementioned international standards, FDA-recognized consensus standards, Subchapter-J performance standards, NEMA industry standards and FDA guidance documents. . Meets the acceptance criteria and is adequate for its intended use. Precise Image (K210760) was modified for use in the CT 5300 system. With no changes to the algorithm architecture, new models were introduced to enable the reconstruction of a new organ type (cardiac), support more slice thickness and increment combinations, a new scan mode (high resolution head), and more clinical scenarios for body and head. All models were adequately trained and successfully compared using half-dose Precise Image reconstructions with full-dose iDose4 reconstructions. The comparative image quality assessment using phantoms demonstrated acceptable performance for the new models used in Precise lmage. Additionally, a comparative image evaluation by two US Board Certified Radiologists of 126 image set pairs (including cases with pathology) comprising 31 unique patients representing the newly supported reconstructions. The comparative image assessment demonstrated that halfdose images processed by Precise Image in CT 5300. including both new and original existing models, are of equal or greater diagnostic quality compared to full dose images processed by iDose4. The comparative external image assessment confirms the validity of successful bench testing and clinical image quality evaluations, and when taken together, demonstrate Precise Image in CT 5300 to be as safe and effective as the predicate, and thus substantially equivalent to Precise lmage (K210760) in predicate Incisive CT (K212441). Precise Position (originally cleared in K203514) was modified for use in the CT 5300 with no change to the
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| | design of the Al algorithm, the body joints detection
algorithm including CNN architecture, model parameters,
inference pipeline, pre- and post-processing is same as
what is used in the predicate Incisive CT. The original model
was trained using a broad dataset and performance data
using clinical images demonstrate the model can further
support more exams (cardiac, spine, runoff).
Evaluation/assessment of the modified Precise Position
algorithm, system level verification and validation activities
have been properly carried out to demonstrate it is as safe
and effective as the predicate to process the newly
integrated exams (cardiac, spine, runoff), hence the
modified Precise Position in the CT 5300 is substantially
equivalent to the predicate Incisive CT (K212441), which
integrates Precise Position (originally cleared in K203514).
Therefore, the proposed device is substantially equivalent to
the primary currently marketed and predicate device
Predicate Philips Incisive CT (K212441(April 27, 2022) in
terms of safety and effectiveness. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Clinical
Data: | The proposed device did not require clinical study since
substantial equivalence to the legally marketed predicate
device was proven with the verification/validation testing,
bench testing, retrospective clinical data, and other
evidence as outlined |
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Substantial Equivalence
Substantial equivalence is established through comparison of features and functions of the proposed CT 5300 device and predicate Philips Incisive CT (K212441).
| Scan Characteristics Comparison | |||
|---|---|---|---|
| Proposed CT 5300 | |||
| device | Predicate Philips | ||
| Incisive CT (K212441) | Conclusion | ||
| No. of Slices | 64/128 | 64/128 | Identical. |
| Therefore, substantially | |||
| equivalent. | |||
| Scan Modes | Surview | ||
| Axial Scan | |||
| Helical Scan | Surview | ||
| Axial Scan | |||
| Helical Scan | Identical. | ||
| Therefore, substantially | |||
| equivalent. | |||
| Minimum Scan Time | 0.35 sec for 360° rotation | 0.35 sec for 360° rotation | Identical. |
| Therefore, substantially | |||
| equivalent. | |||
| Image (Spatial) | |||
| Resolution | High resolution mode: 16 | ||
| lp/cm | |||
| Standard resolution | |||
| mode: 13 lp/cm | High resolution mode: 16 | ||
| lp/cm | |||
| Standard resolution | |||
| mode: 13 lp/cm | Identical. | ||
| Therefore, substantially | |||
| equivalent. | |||
| Image Noise | 0.27% at 120 kV, 230 | ||
| mAs, 10 mm slice | |||
| thickness | 0.27% at 120 kV, 230 | ||
| mAs, 10 mm slice | |||
| thickness | Identical. | ||
| Therefore, substantially | |||
| equivalent. | |||
| Slice | |||
| Thicknesses | Helical: 0.67mm – 5mm | ||
| Axial: 0.625 mm – | |||
| 10.0mm | Helical: 0.67mm – 5mm | ||
| Axial: 0.625 mm – | |||
| 10.0mm | Identical. | ||
| Therefore, substantially | |||
| equivalent. | |||
| Scan Field of | |||
| View | Up to 500 mm | Up to 500 mm | Identical. |
| Therefore, substantially | |||
| equivalent. | |||
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical. |
| Therefore, substantially | |||
| equivalent. | |||
| Display | 1920 * 1080 | 1920 * 1080 | Identical. |
| Traditional 510(k) | |||
| Host | |||
| Infrastructure | Windows 10 | Windows 10 | Therefore, substantially |
| equivalent. | |||
| Identical. | |||
| Therefore, substantially | |||
| equivalent. | |||
| Communication | Compliance with DICOM | Compliance with DICOM | Identical. |
| Therefore, substantially | |||
| equivalent. | |||
| Dose Reporting | |||
| and | |||
| Management | Compliance with NEMA | ||
| XR25, XR26, XR28 and | |||
| XR29 | Compliance with NEMA | ||
| XR25, XR28 and XR29 | Compliance with more | ||
| NEMA standard. | |||
| Safety and | |||
| effectiveness are not | |||
| affected. | |||
| Therefore, | |||
| demonstrating | |||
| substantial | |||
| equivalence. |
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Image /page/12/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 image space. The background is white.
| Software or Imaging Features Comparison | |||
|---|---|---|---|
| CT 5300 | |||
| Features | |||
| Name | Feature description | Same feature | |
| cleared in | |||
| Predicate | |||
| Philips | |||
| Incisive CT | |||
| (K212441) | Conclusion | ||
| (Function/ User | |||
| interface/ | |||
| Workflow) | |||
| 2D Viewer | In 2D Viewer mode operator can review | ||
| original axial images as acquired by the | |||
| scanner. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| MPR | Use the MPR mode to view three-plane | ||
| orthogonal images. In this mode, the three | |||
| shown planes can be easily correlated. | |||
| Three orthogonal cut planes are shown: | |||
| • Axial Orientation | |||
| · Coronal Orientation | |||
| · Sagittal Orientation | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| 3D (volume | |||
| mode) | The volume mode is used to display CT | ||
| scanner data in a full volume image. It | |||
| provides basic tools for image editing and | |||
| generation of cine movies. | Yes | Identical. |
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Image /page/13/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. The font is sans-serif and appears to be a standard typeface.
Traditional 510(k) Therefore, substantially equivalent. The CT Endo viewer is a review function Virtual Yes Identical. that allows you to perform a general Endoscopy Therefore. flythrough of any suitable anatomical (Endo) substantially structure that is filled with air or with equivalent. contrast material, including general vessels, cardiac vessels, the bronchus, and the colon. The Image Matrix parameter sets the lmage matrix Yes ldentical. number of pixels that the reconstructed Therefore, image will contain. Select 512, 768, or substantially 1024. equivalent. O-MAR stands for orthopedic metal artifact O-MAR Yes ldentical. reduction. This post processing capability Therefore, reduces metal induced artifacts and is substantially directed for large orthopedics metals that equivalent. cause photon starvation of the rays that pass through the metal object. DoseRight DoseRight Index (DRI) is according to the Yes Identical. Index current scan site and body size of the Therefore, patient, the mAs suitable for the patient is (DRI) substantially automatically recommended, so that the equivalent. image quality can meet the requirements of the diagnosis, and the radiation dose of the patient can be reduced as far as possible. DOM combines angular and longitudinal DOM Yes Identical. information to modulate dose in three Therefore. dimensions. Personalizes dose for each substantially patient by automatically suggesting tube equivalent. current settings according to the estimated patient diameter in the scan region. Anqular dose modulation varies the tube current during helical scans according to changes in patient shape (eccentricity) and tissue attenuation as the tube rotates. Precise Planning can automatically adjust Yes Precise ldentical. the scan range of subsequent Axial or Planning Therefore, Helical scan series, based on the Surview substantially Image. equivalent. Support the adjustment of sagittal / coronal Oblique Yes Revised feature, image construction in the planned scanning on the basis of the MPR phase, and finally obtain the adjusted tilted (It is called cleared "Insert multiplane image. MPR", added the "Insert MPR" in ability for users to On the basis of Insert MPR. surface predicate tilt the MPR reconstruction is carried out by interpolation imaqe. device) of axial image and corresponding tilted Safety and image is generated. effectiveness are not affected.
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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 the primary focus of the image and is set against a white background.
Traditional 510(k) Therefore, substantially equivalent. OnPlan OnPlan is a gantry operational touch panel Yes ldentical. located on both sides of the gantry. The Therefore. OnPlan qantry controls are used to activate substantially the laser marker, controls patient table equivalent. movements, display patient information and images, and conduct a new patient exam. Precise Precise Spine application enables the Yes ldentical. Spine system to assist the user to identify the Therefore. lumbar disk space automatically and create substantially equivalent. a batch based on the protocol selected. Precise Precise Brain application for a series of Yes ldentical. Brain brain tissue slices that are parallel or Therefore, vertical in the plane of the cranial CT scan. substantially equivalent. The Bolus tracking function maximizes the Bolus Yes Identical. efficiency of CT scans that are enhanced Therefore, Tracking through the use of a contrast agent. This is substantially done by preceding the Clinical scan with equivalent. Locator and Tracker scans. SAS (Spiral This feature enables the usage of the Yes Identical. injector scan trigger. Auto Start) Therefore, substantially equivalent. Filming The Filming application is used for viewing, Yes ldentical. rearranging, windowing and zooming Therefore, images prior to sending them to be printed. substantially equivalent. Worklist The Worklist displays patient information Yes Identical. Therefore, provided by the HIS/RIS. substantially equivalent. If the patient is from the Worklist and the MPPS Yes Identical. MPPS function is enabled, feedback Therefore, reqarding the study status of the patient can substantially be sent to the hospital HIS/RIS. equivalent. The Reporting package allows you to create Yes Reporting Identical. customized reports using pre-formatted Therefore, templates. substantially A template is a specially designed equivalent. formatting document that places the analytical information and images that you send from an application into an organized report which can be printed and saved. CCT Continuous CT (CCT) is a scanning mode Yes Identical. (Continuous that allows the physician to perform CT)
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Image /page/15/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.
| Traditional 510(k) | |||
|---|---|---|---|
| extended, low-dose scans while performing | |||
| a biopsy. | |||
| The resulting images are displayed on a | |||
| remote monitor in the scan room, providing | |||
| visual feedback during the biopsy. | Therefore, | ||
| substantially | |||
| equivalent. | |||
| Brain | |||
| Perfusion | Brain Perfusion is a blood flow imaging | ||
| application that analyzes the uptake of | |||
| injected contrast in order to determine | |||
| perfusion-related information about one or Yes Identical. | |||
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Dental | |||
| (Dental | |||
| planning) | Dental applications are used to create true- | ||
| size (life size) film images of the mandible | |||
| and maxilla for assisting oral surgeons in | |||
| planning implantation of prostheses. Using | |||
| a special dental planning procedure, the | |||
| images will be created from this scan which | |||
| can be input into the Dental planning | |||
| application. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| iDose4 | iDose4 is an iterative reconstruction | ||
| technique that improves image quality | |||
| through artifact prevention and increased | |||
| spatial resolution at low dose. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Helical | |||
| Retrospectiv | |||
| -e Tagging | Helical retrospective cardiac scanning | ||
| enables the system to acquire a volume of | |||
| data while the patient's ECG is recorded. | |||
| The acquired data is tagged and | |||
| reconstructed retrospectively at any desired | |||
| phase of the cardiac cycle. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Axial | |||
| Prospective | |||
| Gating | |||
| calcium | |||
| scoring | Axial prospective gating uses an external | ||
| ECG gating system to synchronize | |||
| individual axial scans with the patient's | |||
| heartbeat. The ECG-triggered scans | |||
| significantly minimize heart-motion artifacts. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Step & | |||
| Shoot | Step & Shoot Cardiac provides high quality | ||
| CT images of the coronary arteries and | |||
| heart anatomy at very low radiation dose | |||
| levels. During Step & Shoot Cardiac, X-rays | |||
| are generated only during the cardiac phase | |||
| of interest. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| CCS | |||
| (Cardiac | |||
| calcium | |||
| scoring) | The Cardiac Calcium Scoring application is | ||
| used to quantify the buildup of calcium | |||
| plaque on the walls of the patient's coronary | |||
| arteries and other relevant locations. The | |||
| potential calcifications are highlighted by the | |||
| application during launch. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Precise | |||
| image | Precise image reconstruction is a recon | ||
| mode where the system uses a trained | |||
| deep learning neural network to generate | |||
| noise reduction images compared with | |||
| standard FBP recon mode for adult | |||
| patients only. Precise Image has not been | Yes | Same AI/ML | |
| image recon | |||
| algorithm, | |||
| modified with new | |||
| models to enable | |||
| the reconstruction | |||
| Traditional 510(k) | |||
| validated for lung cancer screening | |||
| indications. | of a new organ | ||
| type (cardiac), | |||
| support more slice | |||
| thicknesses, a | |||
| new scan mode | |||
| (high resolution | |||
| head), and more | |||
| clinical scenarios | |||
| for body and | |||
| head. | |||
| No change to | |||
| algorithm | |||
| architecture | |||
| compared to | |||
| predicate device, | |||
| therefore, | |||
| substantially | |||
| equivalent. | |||
| Precise | |||
| cardiac | Precise Cardiac is a reconstruction | ||
| technique with the potential to | |||
| provide compensation for cardiac motion. | Yes | Identical. | |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| Precise | |||
| position | Precise Position is a camera-based | ||
| workflow designed to assist with positioning | |||
| the patients aged 16 years and older | |||
| automatically from console or OnPlan, it | |||
| can: | |||
| • automatically select patient orientation. | |||
| • automatically set vertical centering & | |||
| positioning of the patient to the Surview | |||
| start and end positions. | |||
| • support editing Surview start & end range | |||
| and scan direction. | Yes | Same AI/ML | |
| algorithm, | |||
| modified to | |||
| support more | |||
| exams (cardiac, | |||
| spine, runoff). | |||
| No change to | |||
| algorithm | |||
| architecture | |||
| compared to | |||
| predicate device, | |||
| therefore, | |||
| substantially | |||
| equivalent. | |||
| Precise | |||
| intervention | In Precise Intervention viewer there are | ||
| several tools, they will help you to navigate | |||
| the needle safely during the intervention. | Yes | Same | |
| interventional | |||
| feature as | |||
| predicate device. | |||
| To duplicate one | |||
| additional | |||
| Interventional | |||
| controls panel | |||
| from couch side to | |||
| a mobile cart for | |||
| convenience. | |||
| There is no | |||
| change to SW | |||
| algorithm |
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Image /page/16/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out.
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Image /page/17/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, providing a strong contrast that makes the word stand out.
Traditional 510(k) compared to predicate device. Therefore. substantially equivalent. Direct Direct Result-With Direct Result the user is Yes ldentical. results able to choose a desired result during scan Therefore, planning phase and get the result for substantially diagnosis without equivalent. further intervention. Yes Parallel The system support Parallel workflow using Identical. workflow Dual monitor as below: Therefore, - main monitor: Patients, scan, service, substantially "show all" for scan planning, Help. equivalent. - extend monitor: Completed, viewers, Analysis, recon, filming, report CT Colonoscopy (CTC) application enables СТС (СТ Yes Identical. fast and easy visualization of colon scans, Therefore, Colonoscopy) using acquired CT images. substantially equivalent. Vessel Analysis (VA) offers a set of tools for VA (Vessel Yes Identical. general vascular analysis. With VA the user Therefore, Analysis) can easily remove bone, and extract substantially vessels. Users also can perform equivalent. measurements such as intraluminal diameter, cross-sectional lumen area, length. The Lung Nodule Analysis (LNA) LNA (Lung Yes ldentical. application assists the radiologist with the Nodule Therefore, detection and quantification of pulmonary Analysis) substantially nodules and lesions. equivalent. The Coronary Artery Analysis provides CAA Yes ldentical. viewing and measuring tools that allow you (Cardiac Therefore. to perform dimensional and quantitative Arterv substantially measurements of the coronary arteries to Analysis) equivalent. help you identify and examine the patient study for stenosis. Cardiac Function Analysis (CFA) application CFA Yes ldentical. is used to assess the state of the left (Cardiac Therefore. ventricle (LV) and to analyze functional Function substantially heart data. Analysis) equivalent. Dual energy Viewer is an application for Dual Energy Yes Identical. review and analysis of CT dual-energy Therefore. scans. Users need to load CT dualsubstantially enerqy scan data which is two series equivalent. with similar KV. It provides registration function and can generate different
18
Image /page/18/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.
| | weighted KV images. Users can use the
tools to separate materials. | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Substantial
Equivalence
Conclusion: | The CT 5300 system design, intended use, technology and principal
technological components (Tube, Generator, Detector) of the proposed
device are substantially equivalent to the currently marketed predicate
device Philips Incisive CT (K212441 - April 27, 2021). Based on the
information provided above, the proposed device with modifications does
not raise new questions of safety and effectiveness compared to the
currently marketed predicate device Philips Incisive CT (K212441 - April
27, 2022). | | |