CT 5300

K232491 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · May 3, 2024 · Radiology

Device Facts

• Record ID: K232491
• Device Name: CT 5300
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: May 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended 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.

Device Story

CT 5300 is a whole-body CT system with a continuously rotating X-ray tube, detector array, and gantry. It acquires X-ray transmission data at various angles/planes, reconstructed by computer into cross-sectional images. Used in hospitals or mobile trailer configurations by clinicians for diagnostic imaging and lung cancer screening. Includes signal analysis, display equipment, and patient support. Features include AI-based image reconstruction (Precise Image) and patient positioning (Precise Position). Output consists of 2D/3D images and quantitative data for clinical decision-making, aiding in diagnosis, biopsy guidance, and surgical planning. Benefits include improved image quality, reduced radiation dose, and automated workflow assistance.

Clinical Evidence

No prospective clinical study required. Evidence includes bench testing, phantom image quality assessments, and retrospective clinical data. Comparative evaluation by two US Board Certified Radiologists of 126 image set pairs (31 patients) demonstrated that half-dose images processed by Precise Image in CT 5300 are of equal or greater diagnostic quality compared to full-dose images processed by iDose4. System-level verification and validation activities confirmed performance against consensus standards.

Technological Characteristics

Continuous rotation CT system; 72 cm bore; 50 cm scan FOV; 64/128 slice capability. Components: X-ray tube, high-voltage generator, detector array, patient couch. Connectivity: DICOM compliant. Software: Windows 10 host. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, NEMA XR-25/26/28/29. AI/ML: Deep learning neural network for image reconstruction and CNN-based patient positioning.

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT applications in patients of all ages, including low-dose lung cancer screening for early detection of lung nodules.

Regulatory Classification

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.

Predicate Devices

• Philips Incisive CT (K212441)

Reference Devices

• Precise Image (K210760)
• Precise Position (K203514)
• Philips Incisive CT on trailer (K211168)

Submission Summary (Full 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 ([e-mail]) or phone [phone] 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)

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> 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.<br>No. 258, Zhongyuan Road, Suzhou Industrial Park,<br>Suzhou Jiangsu, CHINA, 215024<br>Establishment Registration Number: 3009529630<br><br>Additional Manufacturing Site:<br>Philips Medical Systems Technologies, LTD.<br>Advanced Technology Center MATAM, Building 34,<br>3100202 Haifa Israel.<br>Establishment Registration Number: 9617978 |
| Primary Contact<br>Person: | Shiguang An<br>Regulatory Affairs Engineer<br>Phone: [phone]<br>E-mail: [e-mail] |
| Secondary Contact<br>Person | Erhong Wang<br>Senior Manager Regulatory Affairs<br>Phone : [phone]<br>E-mail : [e-mail] |
| Device Name: | CT 5300 |
| Classification: | Classification name: Computed tomography x-ray<br>system<br>Classification Regulation: 21CFR 892.1750<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary Product Code: JAK |
| Primary Predicate<br>Device: | Trade name: Philips Incisive CT<br>Manufacturer: Philips Healthcare (Suzhou)<br>Co., Ltd.<br>510(k) Clearance: K212441<br>Classification Regulation: 21CFR 892.1750<br>Classification name: Computed tomography x-ray<br>system<br>Classification Panel: Radiology<br>Device class Class II<br>Product Code: JAK |

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| Device Description: | Traditional 510<br>The proposed device is a whole-body computed<br>tomography (CT) X-Ray System featuring a continuously<br>rotating x-ray tube, detectors, and gantry with multi-slice<br>capability. The acquired x-ray transmission data is<br>reconstructed by computer into cross-sectional images of<br>the body taken at different angles and planes. This system<br>also includes signal analysis and display equipment, patient<br>and equipment supports, components, and accessories.<br>The CT 5300 has a 72 cm bore and includes a detector<br>array that provides 50 cm scan field of view (FOV).<br>The main components (detection system, the reconstruction<br>algorithm, and the x-ray system) that are used in the<br>proposed device have the same fundamental design<br>characteristics and are based on comparable technologies<br>as the current marketed predicate Philips Incisive CT<br>K212441(April 27, 2022). |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The key system modules and functionalities are:<br>1. Gantry<br>The Gantry consists of 4 main internal units: |
| | a. X-Ray Tube – produces X-rays necessary for<br>scanning.<br>b. High voltage generator - produces high voltage<br>power supply to X-ray tube, consists of system<br>Interface Unit, Power Block Unit and Anode Drive<br>Unit.<br>c. A-plane: adjusts the slice thickness during axial<br>scan and monitor the changes of X-ray. |
| | d. DMS (Data Management System) – absorbs X-ray<br>radiation by detectors and converts it to digital<br>readout.<br>2. Patient Table (Couch)<br>The Couch is used to position the patient. Carries the<br>patient in and out through the Gantry bore synchronized<br>with the scan. |
| | 3. Console<br>The console is used to operate the system and monitor<br>the scan. The Operator console includes a computer,<br>monitors and CTBOX. |
| | 4. CT on Trailer Kit<br>The CT 5300 installed and secured on a trailer requires<br>locking motion parts during trailer transportation and<br>unlocking motion parts before CT operations. Besides<br>being installed in hospital, the CT may also be installed on<br>trailer to be transported to designated locations for use<br>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<br>Scientific<br>Technology: | The proposed device is an advanced continuous rotation<br>computed tomography system suitable for a wide range of<br>computed tomographic (CT) applications.<br>The proposed device is used clinically as a diagnostic<br>patient imaging device that produces images that<br>correspond to tissue density. The quality of the images<br>depends on the level and amount of X-ray energy delivered<br>to the tissue. CT imaging displays both high-density tissue,<br>such as bone, and soft tissue.<br>The principal technological components (rotating x-ray tube,<br>detector and gantry) of the proposed device are<br>substantially equivalent to the currently marketed predicate<br>device Philips Incisive CT (K212441 (April 27, 2022).<br>Based on the information provided above, the proposed<br>device does not raise different questions of safety and<br>effectiveness compared to the currently marketed predicate<br>device Philips Incisive CT (K212441(April 27, 2022). |
| Summary of Non-Clinical Performance Data: | Traditional 510(k) |
| | The proposed device conforms to international standards,<br>FDA-recognized consensus standards, 21 CFR Subchapter-<br>J performance standards, NEMA industry standards, and<br>FDA guidance documents. |
| | • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated<br>Text) [Incl. AMD2:2021] Medical Electrical Equipment - Part<br>1: General Requirements for Basic Safety and Essential<br>Performance (IEC 60601-1:2005, MOD) [Incl. AMD2:2021].<br>FDA/CDRH recognition number 19-46 |
| | • IEC 60601-1-2:2020 (Consolidated Text) Medical<br>electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral<br>Standard: Electromagnetic disturbances – Requirements<br>and tests<br>FDA/CDRH recognition number 19-36 |
| | • IEC 60601-1-3:2021(Consolidated Text) Medical electrical<br>equipment -- Part 1-3: General requirements for basic safety<br>- Collateral standard: Radiation protection in diagnostic X-<br>ray equipment<br>FDA/CDRH recognition number 12-336 |
| | • IEC 60601-1-6:2020(Consolidated Text) Medical electrical<br>equipment -- Part 1-6: General requirements for basic safety<br>and essential performance – Collateral standard: Usability<br>FDA/CDRH recognition number 5-132 |
| | • IEC 60601-2-44:2016 Medical electrical equipment - Part<br>2-44: Particular requirements for the safety and essential<br>performance of X-ray equipment for computed tomography<br>FDA/CDRH recognition number 12-302 |
| | • IEC 62304:2015 (Consolidated Text) Medical device<br>software -- Software life cycle processes<br>FDA/CDRH recognition number 13-79 |
| | • IEC 62366-1:2020 Medical devices -- Part 1: Application of<br>usability engineering to medical devices<br>FDA/CDRH recognition number 5-129 |
| | • ISO14971:2019 Medical devices – Application of risk<br>management to medical devices<br>FDA/CDRH recognition number 5-125 |
| | |
| • ISO 10993-1:2018 Biological evaluation of medical<br>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<br>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<br>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,<br>2023, document number GUI00001825) | |
| | |
| • Guidance for Industry and FDA Staff – Use of International | |
| Standard ISO 10993-1, "Biological evaluation of medical<br>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<br>algorithm including CNN architecture, model parameters,<br>inference pipeline, pre- and post-processing is same as<br>what is used in the predicate Incisive CT. The original model<br>was trained using a broad dataset and performance data<br>using clinical images demonstrate the model can further<br>support more exams (cardiac, spine, runoff).<br>Evaluation/assessment of the modified Precise Position<br>algorithm, system level verification and validation activities<br>have been properly carried out to demonstrate it is as safe<br>and effective as the predicate to process the newly<br>integrated exams (cardiac, spine, runoff), hence the<br>modified Precise Position in the CT 5300 is substantially<br>equivalent to the predicate Incisive CT (K212441), which<br>integrates Precise Position (originally cleared in K203514).<br><br>Therefore, the proposed device is substantially equivalent to<br>the primary currently marketed and predicate device<br>Predicate Philips Incisive CT (K212441(April 27, 2022) in<br>terms of safety and effectiveness. |
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| Summary of Clinical<br>Data: | The proposed device did not require clinical study since<br>substantial equivalence to the legally marketed pre…