(260 days)
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.
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.
The provided document is a 510(k) Premarket Notification from Philips Healthcare (Suzhou) Co., Ltd. for their CT 5300 Computed Tomography X-Ray System. The purpose of this document is to demonstrate "Substantial Equivalence" to a legally marketed predicate device (Philips Incisive CT, K212441) and thus does not include acceptance criteria or detailed study results for standalone AI/ML device performance.
Instead, the document focuses on showing that the new CT 5300 system (which incorporates an updated version of the "Precise Image" and "Precise Position" algorithms) is as safe and effective as the predicate device.
However, based on the limited information provided regarding the "Precise Image" algorithm update, I can attempt to extract the relevant details and structure them according to your request, while highlighting what information is not present.
Please note: This document's primary goal is to establish substantial equivalence of the entire CT system, not to provide a detailed clinical validation study for a new AI/ML algorithm that is the subject of separate regulatory submissions (like a De Novo or full PMA). The "Precise Image" and "Precise Position" modifications are treated as part of the overall system's equivalence demonstration.
Device: CT 5300 (incorporating updated Precise Image and Precise Position algorithms)
Study Proving Device Meets Acceptance Criteria (as described for the specific algorithms):
The document states: "Non-Clinical verification and or validation tests have been performed... Non-Clinical verification and or validation test results demonstrate that the proposed device... Meets the acceptance criteria and is adequate for its intended use."
Specifically for "Precise Image": "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 half-dose 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)."
For "Precise Position": "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)."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from description) | Reported Device Performance (Precise Image) | Reported Device Performance (Precise Position) |
|---|---|---|
| Half-dose Precise Image reconstructions are of acceptable performance compared to full-dose iDose4 reconstructions (phantom study). | "acceptable performance" demonstrated for new models used in Precise Image. | N/A (Focus on clinical image and extended support) |
| Half-dose Precise Image reconstructions are of equal or greater diagnostic quality compared to full-dose iDose4 reconstructions (clinical image evaluation). | "equal or greater diagnostic quality" compared to full dose images processed by iDose4. | N/A (Focus on clinical image and extended support) |
| Supports new organ type (cardiac), more slice thickness/increment combinations, new scan mode (high resolution head), and more clinical scenarios for body and head. | Successfully enables these capabilities with maintained image quality. | N/A (Focus on clinical image and extended support) |
| Original AI algorithm design, CNN architecture, model parameters, inference pipeline, pre- and post-processing remain unchanged. | Confirmed: "no change to the design of the AI algorithm...is same as what is used in the predicate Incisive CT." | |
| Model can further support new exams (cardiac, spine, runoff). | "performance data using clinical images demonstrate the model can further support more exams (cardiac, spine, runoff)." |
2. Sample Size Used for the Test Set and Data Provenance
-
Precise Image:
- Clinical Image Evaluation: 126 image set pairs "comprising 31 unique patients".
- Data Provenance: Not explicitly stated, but "two US Board Certified Radiologists" implies the data used for the reading study was likely relevant to US clinical practice. It is mentioned as "retrospective clinical data" in the "Summary of Clinical Data" section (Page 10), but further details on geographical origin or specific institutions are not provided. The study is described as a "comparative image evaluation," which is by nature retrospective.
- Phantom Study: Not specified (number of phantoms/scans).
-
Precise Position:
- Clinical Images: "performance data using clinical images" was used, but the specific sample size of images/patients for this evaluation is not provided.
- Data Provenance: Not explicitly stated, but the "original model was trained using a broad dataset," suggesting varied provenance. The evaluation here uses "clinical images" and is implicitly retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
-
Precise Image:
- Number of Experts: Two (2)
- Qualifications: "US Board Certified Radiologists"
- Experience: Not specified (e.g., number of years of experience).
-
Precise Position: Not explicitly stated for performance evaluation, but the "original model was trained using a broad dataset" which often implies some form of expert annotation or clinical data used as ground truth during training. For the evaluation of its extended support, it's mentioned that the model was tested with "performance data using clinical images," but details on expert review for this test set are not provided.
4. Adjudication Method for the Test Set
-
Precise Image: The document describes a "comparative image evaluation by two US Board Certified Radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, or consensus reading). It's possible they read independently and their findings were compared, or they may have reached a consensus without formal arbitration by a third party.
-
Precise Position: No details on expert review or adjudication method for the specified performance evaluation are provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, a traditional MRMC comparative effectiveness study was not performed as described for human readers with/without AI assistance, in the sense of measuring diagnostic accuracy improvement.
- Instead, for "Precise Image," a comparative image quality assessment was performed between two different reconstruction methods: "half-dose Precise Image reconstructions" (new algorithm) vs. "full-dose iDose4 reconstructions" (predicate algorithm). The goal was to show non-inferiority or superiority of the image quality from the new algorithm at a reduced dose, rather than measuring reader performance improvement with AI assistance.
- The effect size related to reader performance is not applicable in this context as the study was about image quality comparison, not AI-assisted human reading. The conclusion was that the image quality was "equal or greater," which implicitly means readers can perform at least as well with the new images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, for "Precise Image," a standalone image quality assessment was performed using phantoms. This is described as "The comparative image quality assessment using phantoms demonstrated acceptable performance for the new models used in Precise Image." This evaluates the algorithm's output (image quality) independent of human interpretation of complex clinical cases.
- For "Precise Position," it is a "body joints detection algorithm." While it's part of a workflow to assist patient positioning, a standalone performance metric (e.g., accuracy of joint detection) is not explicitly provided in this document, only that the "original model was trained using a broad dataset" and "performance data using clinical images demonstrate the model can further support more exams."
7. The Type of Ground Truth Used
-
Precise Image:
- Phantom Study: Ground truth would be based on the known characteristics of the phantom and imaging parameters, allowing for objective image quality metrics (e.g., spatial resolution, noise, contrast).
- Clinical Image Evaluation: The ground truth for comparative diagnostic quality seems to be based on the "full-dose iDose4 reconstructions" themselves and inclusion of "cases with pathology." This implies that the full-dose images (processed by the predicate's iDose4 algorithm) were considered the reference truth against which the new algorithm's images were judged for diagnostic quality. The mention of "cases with pathology" likely means these cases had confirmed diagnoses, which serve as the ultimate ground truth for comparison.
-
Precise Position: The ground truth for the training set would likely be human-annotated or verified positions of body joints on CT images. For the evaluation, it's implied that the "clinical images" and the intended "support more exams" served as the basis for performance verification.
8. The Sample Size for the Training Set
- Precise Image: The document states "All models were adequately trained." However, the specific sample size (number of images/patients) used for training the "new models" for Precise Image is not provided.
- Precise Position: The document states "The original model was trained using a broad dataset." The specific sample size (number of images/patients) used for training is not provided.
9. How the Ground Truth for the Training Set was Established
- Precise Image: The document states "All models were adequately trained." For deep learning image reconstruction like Precise Image, training typically involves paired low-dose and standard-dose (or high-quality) images, where the standard-dose images serve as the ground truth reference for the algorithm to learn how to enhance low-dose images. This is inferred but not explicitly stated in the provided text.
- Precise Position: The document states "The original model was trained using a broad dataset." For a "body joints detection algorithm," ground truth for training would typically be established by expert (e.g., radiologist or trained annotator) manual annotation of anatomical landmarks or joint locations on a large dataset of CT images. This is inferred but not explicitly stated in the provided text.
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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, 215024Establishment Registration Number: 3009529630Additional Manufacturing Site:Philips Medical Systems Technologies, LTD.Advanced Technology Center MATAM, Building 34,3100202 Haifa Israel.Establishment Registration Number: 9617978 |
| Primary ContactPerson: | Shiguang AnRegulatory Affairs EngineerPhone: +86-0-13940106467E-mail: shiguang.an@philips.com |
| Secondary ContactPerson | Erhong WangSenior Manager Regulatory AffairsPhone : +86-0-13021019589E-mail : erhong.wang@philips.com |
| Device Name: | CT 5300 |
| Classification: | Classification name: Computed tomography x-raysystemClassification Regulation: 21CFR 892.1750Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: JAK |
| Primary PredicateDevice: | Trade name: Philips Incisive CTManufacturer: Philips Healthcare (Suzhou)Co., Ltd.510(k) Clearance: K212441Classification Regulation: 21CFR 892.1750Classification name: Computed tomography x-raysystemClassification Panel: RadiologyDevice class Class IIProduct Code: JAK |
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| Device Description: | Traditional 510The proposed device is a whole-body computedtomography (CT) X-Ray System featuring a continuouslyrotating x-ray tube, detectors, and gantry with multi-slicecapability. The acquired x-ray transmission data isreconstructed by computer into cross-sectional images ofthe body taken at different angles and planes. This systemalso includes signal analysis and display equipment, patientand equipment supports, components, and accessories.The CT 5300 has a 72 cm bore and includes a detectorarray that provides 50 cm scan field of view (FOV).The main components (detection system, the reconstructionalgorithm, and the x-ray system) that are used in theproposed device have the same fundamental designcharacteristics and are based on comparable technologiesas the current marketed predicate Philips Incisive CTK212441(April 27, 2022). |
|---|---|
| The key system modules and functionalities are:1. GantryThe Gantry consists of 4 main internal units: | |
| a. X-Ray Tube – produces X-rays necessary forscanning.b. High voltage generator - produces high voltagepower supply to X-ray tube, consists of systemInterface Unit, Power Block Unit and Anode DriveUnit.c. A-plane: adjusts the slice thickness during axialscan and monitor the changes of X-ray. | |
| d. DMS (Data Management System) – absorbs X-rayradiation by detectors and converts it to digitalreadout.2. Patient Table (Couch)The Couch is used to position the patient. Carries thepatient in and out through the Gantry bore synchronizedwith the scan. | |
| 3. ConsoleThe console is used to operate the system and monitorthe scan. The Operator console includes a computer,monitors and CTBOX. | |
| 4. CT on Trailer KitThe CT 5300 installed and secured on a trailer requireslocking motion parts during trailer transportation andunlocking motion parts before CT operations. Besidesbeing installed in hospital, the CT may also be installed ontrailer to be transported to designated locations for usewithin 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 | |
| FundamentalScientificTechnology: | The proposed device is an advanced continuous rotationcomputed tomography system suitable for a wide range ofcomputed tomographic (CT) applications.The proposed device is used clinically as a diagnosticpatient imaging device that produces images thatcorrespond to tissue density. The quality of the imagesdepends on the level and amount of X-ray energy deliveredto the tissue. CT imaging displays both high-density tissue,such as bone, and soft tissue.The principal technological components (rotating x-ray tube,detector and gantry) of the proposed device aresubstantially equivalent to the currently marketed predicatedevice Philips Incisive CT (K212441 (April 27, 2022).Based on the information provided above, the proposeddevice does not raise different questions of safety andeffectiveness compared to the currently marketed predicatedevice 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, andFDA guidance documents. | |
| • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R) 2012 (ConsolidatedText) [Incl. AMD2:2021] Medical Electrical Equipment - Part1: General Requirements for Basic Safety and EssentialPerformance (IEC 60601-1:2005, MOD) [Incl. AMD2:2021].FDA/CDRH recognition number 19-46 | |
| • IEC 60601-1-2:2020 (Consolidated Text) Medicalelectrical equipment - Part 1-2: General requirements forbasic safety and essential performance - CollateralStandard: Electromagnetic disturbances – Requirementsand testsFDA/CDRH recognition number 19-36 | |
| • IEC 60601-1-3:2021(Consolidated Text) Medical electricalequipment -- Part 1-3: General requirements for basic safety- Collateral standard: Radiation protection in diagnostic X-ray equipmentFDA/CDRH recognition number 12-336 | |
| • IEC 60601-1-6:2020(Consolidated Text) Medical electricalequipment -- Part 1-6: General requirements for basic safetyand essential performance – Collateral standard: UsabilityFDA/CDRH recognition number 5-132 | |
| • IEC 60601-2-44:2016 Medical electrical equipment - Part2-44: Particular requirements for the safety and essentialperformance of X-ray equipment for computed tomographyFDA/CDRH recognition number 12-302 | |
| • IEC 62304:2015 (Consolidated Text) Medical devicesoftware -- Software life cycle processesFDA/CDRH recognition number 13-79 | |
| • IEC 62366-1:2020 Medical devices -- Part 1: Application ofusability engineering to medical devicesFDA/CDRH recognition number 5-129 | |
| • ISO14971:2019 Medical devices – Application of riskmanagement to medical devicesFDA/CDRH recognition number 5-125 | |
| • ISO 10993-1:2018 Biological evaluation of medicaldevices - 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 CTFDA/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 theContent 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 medicaldevices - 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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Image /page/10/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 custom typeface associated with the Philips brand.
| design of the Al algorithm, the body joints detectionalgorithm including CNN architecture, model parameters,inference pipeline, pre- and post-processing is same aswhat is used in the predicate Incisive CT. The original modelwas trained using a broad dataset and performance datausing clinical images demonstrate the model can furthersupport more exams (cardiac, spine, runoff).Evaluation/assessment of the modified Precise Positionalgorithm, system level verification and validation activitieshave been properly carried out to demonstrate it is as safeand effective as the predicate to process the newlyintegrated exams (cardiac, spine, runoff), hence themodified Precise Position in the CT 5300 is substantiallyequivalent to the predicate Incisive CT (K212441), whichintegrates Precise Position (originally cleared in K203514).Therefore, the proposed device is substantially equivalent tothe primary currently marketed and predicate devicePredicate Philips Incisive CT (K212441(April 27, 2022) interms of safety and effectiveness. | |
|---|---|
| Summary of ClinicalData: | The proposed device did not require clinical study sincesubstantial equivalence to the legally marketed predicatedevice was proven with the verification/validation testing,bench testing, retrospective clinical data, and otherevidence 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 5300device | Predicate PhilipsIncisive CT (K212441) | Conclusion | |
| No. of Slices | 64/128 | 64/128 | Identical.Therefore, substantiallyequivalent. |
| Scan Modes | SurviewAxial ScanHelical Scan | SurviewAxial ScanHelical Scan | Identical.Therefore, substantiallyequivalent. |
| Minimum Scan Time | 0.35 sec for 360° rotation | 0.35 sec for 360° rotation | Identical.Therefore, substantiallyequivalent. |
| Image (Spatial)Resolution | High resolution mode: 16lp/cmStandard resolutionmode: 13 lp/cm | High resolution mode: 16lp/cmStandard resolutionmode: 13 lp/cm | Identical.Therefore, substantiallyequivalent. |
| Image Noise | 0.27% at 120 kV, 230mAs, 10 mm slicethickness | 0.27% at 120 kV, 230mAs, 10 mm slicethickness | Identical.Therefore, substantiallyequivalent. |
| SliceThicknesses | Helical: 0.67mm – 5mmAxial: 0.625 mm –10.0mm | Helical: 0.67mm – 5mmAxial: 0.625 mm –10.0mm | Identical.Therefore, substantiallyequivalent. |
| Scan Field ofView | Up to 500 mm | Up to 500 mm | Identical.Therefore, substantiallyequivalent. |
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical.Therefore, substantiallyequivalent. |
| Display | 1920 * 1080 | 1920 * 1080 | Identical. |
| Traditional 510(k) | |||
| HostInfrastructure | Windows 10 | Windows 10 | Therefore, substantiallyequivalent.Identical.Therefore, substantiallyequivalent. |
| Communication | Compliance with DICOM | Compliance with DICOM | Identical.Therefore, substantiallyequivalent. |
| Dose ReportingandManagement | Compliance with NEMAXR25, XR26, XR28 andXR29 | Compliance with NEMAXR25, XR28 and XR29 | Compliance with moreNEMA standard.Safety andeffectiveness are notaffected.Therefore,demonstratingsubstantialequivalence. |
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| Software or Imaging Features Comparison | |||
|---|---|---|---|
| CT 5300FeaturesName | Feature description | Same featurecleared inPredicatePhilipsIncisive CT(K212441) | Conclusion(Function/ Userinterface/Workflow) |
| 2D Viewer | In 2D Viewer mode operator can revieworiginal axial images as acquired by thescanner. | Yes | Identical.Therefore,substantiallyequivalent. |
| MPR | Use the MPR mode to view three-planeorthogonal images. In this mode, the threeshown planes can be easily correlated.Three orthogonal cut planes are shown:• Axial Orientation· Coronal Orientation· Sagittal Orientation | Yes | Identical.Therefore,substantiallyequivalent. |
| 3D (volumemode) | The volume mode is used to display CTscanner data in a full volume image. Itprovides basic tools for image editing andgeneration of cine movies. | Yes | Identical. |
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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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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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| Traditional 510(k) | |||
|---|---|---|---|
| extended, low-dose scans while performinga biopsy.The resulting images are displayed on aremote monitor in the scan room, providingvisual feedback during the biopsy. | Therefore,substantiallyequivalent. | ||
| BrainPerfusion | Brain Perfusion is a blood flow imagingapplication that analyzes the uptake ofinjected contrast in order to determineperfusion-related information about one or Yes Identical.Therefore,substantiallyequivalent. | ||
| Dental(Dentalplanning) | Dental applications are used to create true-size (life size) film images of the mandibleand maxilla for assisting oral surgeons inplanning implantation of prostheses. Usinga special dental planning procedure, theimages will be created from this scan whichcan be input into the Dental planningapplication. | Yes | Identical.Therefore,substantiallyequivalent. |
| iDose4 | iDose4 is an iterative reconstructiontechnique that improves image qualitythrough artifact prevention and increasedspatial resolution at low dose. | Yes | Identical.Therefore,substantiallyequivalent. |
| HelicalRetrospectiv-e Tagging | Helical retrospective cardiac scanningenables the system to acquire a volume ofdata while the patient's ECG is recorded.The acquired data is tagged andreconstructed retrospectively at any desiredphase of the cardiac cycle. | Yes | Identical.Therefore,substantiallyequivalent. |
| AxialProspectiveGatingcalciumscoring | Axial prospective gating uses an externalECG gating system to synchronizeindividual axial scans with the patient'sheartbeat. The ECG-triggered scanssignificantly minimize heart-motion artifacts. | Yes | Identical.Therefore,substantiallyequivalent. |
| Step &Shoot | Step & Shoot Cardiac provides high qualityCT images of the coronary arteries andheart anatomy at very low radiation doselevels. During Step & Shoot Cardiac, X-raysare generated only during the cardiac phaseof interest. | Yes | Identical.Therefore,substantiallyequivalent. |
| CCS(Cardiaccalciumscoring) | The Cardiac Calcium Scoring application isused to quantify the buildup of calciumplaque on the walls of the patient's coronaryarteries and other relevant locations. Thepotential calcifications are highlighted by theapplication during launch. | Yes | Identical.Therefore,substantiallyequivalent. |
| Preciseimage | Precise image reconstruction is a reconmode where the system uses a traineddeep learning neural network to generatenoise reduction images compared withstandard FBP recon mode for adultpatients only. Precise Image has not been | Yes | Same AI/MLimage reconalgorithm,modified with newmodels to enablethe reconstruction |
| Traditional 510(k) | |||
| validated for lung cancer screeningindications. | of a new organtype (cardiac),support more slicethicknesses, anew scan mode(high resolutionhead), and moreclinical scenariosfor body andhead.No change toalgorithmarchitecturecompared topredicate device,therefore,substantiallyequivalent. | ||
| Precisecardiac | Precise Cardiac is a reconstructiontechnique with the potential toprovide compensation for cardiac motion. | Yes | Identical.Therefore,substantiallyequivalent. |
| Preciseposition | Precise Position is a camera-basedworkflow designed to assist with positioningthe patients aged 16 years and olderautomatically from console or OnPlan, itcan:• automatically select patient orientation.• automatically set vertical centering &positioning of the patient to the Surviewstart and end positions.• support editing Surview start & end rangeand scan direction. | Yes | Same AI/MLalgorithm,modified tosupport moreexams (cardiac,spine, runoff).No change toalgorithmarchitecturecompared topredicate device,therefore,substantiallyequivalent. |
| Preciseintervention | In Precise Intervention viewer there areseveral tools, they will help you to navigatethe needle safely during the intervention. | Yes | Sameinterventionalfeature aspredicate device.To duplicate oneadditionalInterventionalcontrols panelfrom couch side toa mobile cart forconvenience.There is nochange to SWalgorithm |
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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
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| weighted KV images. Users can use thetools to separate materials. | |||
|---|---|---|---|
| SubstantialEquivalenceConclusion: | The CT 5300 system design, intended use, technology and principaltechnological components (Tube, Generator, Detector) of the proposeddevice are substantially equivalent to the currently marketed predicatedevice Philips Incisive CT (K212441 - April 27, 2021). Based on theinformation provided above, the proposed device with modifications doesnot raise new questions of safety and effectiveness compared to thecurrently marketed predicate device Philips Incisive CT (K212441 - April27, 2022). |
§ 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.