Philips Incisive CT on Trailer

K211168 · Philips Healthcare (Suzhou) Co., Ltd. · JAK · Nov 22, 2021 · Radiology

Device Facts

• Record ID: K211168
• Device Name: Philips Incisive CT on Trailer
• Applicant: Philips Healthcare (Suzhou) Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Nov 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Incisive CT 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 Incisive CT 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. Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.

Device Story

Incisive CT on Trailer is a whole-body CT system featuring a continuously rotating X-ray tube, detector array, and gantry; reconstructs X-ray transmission data into cross-sectional images. System includes signal analysis, display equipment, and patient support. Designed for hospital use or installation on a trailer for transport to designated locations. Trailer kit includes locking mechanisms to secure gantry and couch during transit; unlocked for operation. Operated by clinicians for diagnostic imaging and lung cancer screening. Output consists of reconstructed images for clinical review, aiding in diagnosis and decision-making. Benefits include diagnostic imaging capabilities in mobile/transportable settings.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing and compliance with consensus standards, including vibration testing to simulate 10-year lifetime transport.

Technological Characteristics

Continuous rotation CT system; 72cm bore; 50cm scan FOV. Components: Gantry (stator, rotor, X-ray tube, generator, DMS), patient couch, console. Connectivity: Networked. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-44, IEC 62304, IEC 62366, NEMA XR 25/28/29, MIL-STD-810F (vibration).

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT imaging in patients of all ages, including low-dose CT 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 (K180015)

Submission Summary (Full Text)

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November 22, 2021

Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Regulatory Affairs Engineer No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA

## Re: K211168

Trade/Device Name: Philips Incisive CT on Trailer Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 19, 2021 Received: October 19, 2021

## Dear Shiguang An:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K21168

Device Name Philips Incisive CT on Trailer

#### Indications for Use (Describe)

The Incisive CT 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 Incisive CT 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.

Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.

*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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary or Statement

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date Prepared: | March 30, 2021 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024<br>Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA<br>Establishment Registration Number: 3009529630 |
| Contact Person: | Shiguang An<br>Advanced Regulatory Engineer<br>Phone cell: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Name: | Philips Incisive CT on Trailer |
| Classification: | Classification Name: Computed tomography x-ray system<br>Classification Regulation: 21CFR §892.1750<br>Classification Panel: Radiology<br>Device Class: Class II<br>Primary product code: JAK |
| Predicate Device: | Trade Name: Philips Incisive CT<br>Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.<br>510(k) Clearance: K180015-March 20, 2018<br>Classification Regulation: 21 CFR, Part 892.1750<br>Classification Name: Computed tomography x-ray system<br>Classification Panel: Radiology<br>Device Class: Class II<br>Product Code: JAK |

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| Device description: | The proposed Philips Incisive CT on Trailer is a whole-<br>body computed tomography (CT) X-Ray System featuring a<br>continuously rotating x-ray tube, detectors, and gantry with<br>multi-slice capability. The acquired x-ray transmission data<br>is 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 support, components, and accessories.<br>The Philips Incisive CT has a 72cm bore and includes a<br>detector array that provides 50cm scan field of view (FOV). |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Besides installed in hospital, Philips Incisive CT can also<br>be installed on trailer and be transported to designated<br>locations. |
| | The main components (detection system, the reconstruction<br>algorithm, and the x-ray system) that are used in the<br>proposed Philips Incisive CT on trailer are identical to the<br>currently marketed and predicate Philips Incisive CT<br>(K180015, 20/March/2018). |
| | The components of the proposed Philips Incisive CT on<br>trailer include the following: |
| | 1. Gantry. The Gantry consists of 4 main internal units:<br>a. Stator – a fixed mechanical frame that carries HW and SW<br>b. Rotor – A rotating circular stiff frame that is mounted in<br>and supported by the stator<br>c. X-Ray Tube (XRT) and Generator, - fixed to the Rotor<br>frame |
| | d. Data Measurement System (DMS) - a detectors array,<br>fixed to the Rotor frame<br>2. Patient Support (Couch) - carries the patient in and out<br>through the Gantry bore synchronized with the scan.<br>3. Console - Containing a Host computer and display that is<br>the primary user interface. |
| | 4. CT on Trailer Kit - Modified Incisive CT installed and<br>secured on trailer requires locking motion parts during<br>trailer transportation and unlocking motion parts before<br>CT operations. |
| | In addition to the above components and the software<br>operating them, each system includes hardware and software<br>for data acquisition, display, manipulation, storage and |

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| | Traditional 510(k) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use: | filming as well as post-processing into views other than the<br>original axial images. Patient supports (positioning aids) are<br>used to position the patient. |
| | The Incisive CT is a Computed Tomography X-Ray System<br>intended to produce images of the head and body by<br>computer reconstruction of x-ray transmission data taken at<br>different angles and planes. These devices may include<br>signal analysis and display equipment, patient and equipment<br>supports, components and accessories. The Incisive CT is<br>indicated for head, whole body, cardiac and vascular X-ray<br>Computed Tomography applications in patients of all ages. |
| | These scanners are intended to be used for diagnostic<br>imaging and for low dose CT lung cancer screening for the<br>early detection of lung nodules that may represent cancer*.<br>The screening must be performed within the established<br>inclusion criteria of programs / protocols that have been<br>approved and published by either a governmental body or<br>professional medical society. |
| | Besides installed in hospital, the proposed Philips Incisive<br>CT may also be installed on trailer and be transported to<br>designated locations for use. And Incisive CT installed on<br>trailer has the same intended use as installed in hospital. |
| | *Please refer to clinical literature, including the results of the<br>National Lung Screening Trial (N Engl J Med 2011;365:395-<br>409) and subsequent literature, for further information. |
| Fundamental scientific<br>technology: | The proposed Philips Incisive CT on Trailer is advanced<br>continuous rotation computed tomography systems suitable<br>for a wide range of computed tomographic (CT)<br>applications. |
| | The proposed Philips Incisive CT on Trailer can be<br>transported by the trailer to designated locations and is used<br>clinically as a diagnostic patient imaging device that<br>produces images that correspond to tissue density. The<br>quality of the images depends on the level and amount of X-<br>ray energy delivered to the tissue. CT imaging displays both<br>high-density tissue, such as bone, and soft tissue. |
| | The principal technological components (rotating x-ray tube,<br>detector, gantry, patient support and console) of the proposed<br>Philips Incisive CT are identical to the currently marketed |
| | Traditional 510(k) |
| | predicate device Philips Incisive CT (K180015, 20/March/2018). |
| | In addition, the Proposed <b>Philips Incisive CT on Trailer</b> provides CT on trailer kit which is used to install and secure Philips Incisive CT (K180015, 20/March/2018) on a trailer. |
| | Based on the information provided above, the proposed <b>Philips Incisive CT on Trailer</b> does not raise different questions of safety and effectiveness compare to the currently marketed predicate device Philips Incisive CT (K180015, 20/March/2018). |
| Summary of Non-Clinical<br>Performance data: | The currently marketed <b>Philips Incisive CT</b> (K180015) complies with the following international and FDA Recognized Consensus standards:<br>• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).<br>FDA/CDRH recognition number 19-4<br>• IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests<br>FDA/CDRH recognition number 19-8<br>• IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment<br>FDA/CDRH recognition number 12-269<br>• IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability<br>FDA/CDRH recognition number 5-89<br>• IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment<br>FDA/CDRH recognition number 12-256<br>• IEC 62304:2015 Medical device software -- Software life cycle processes<br>FDA/CDRH recognition number 13-79<br>• IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical Devices |
| • ISO14971 Medical devices – Application of risk<br>management to medical devices (Ed. 2.0, 2007)<br>FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2010 Computed Tomography Dose Check<br>FDA/CDRH recognition number 12-225 | |
| • NEMA XR 28-2013 Supplemental Requirements for User<br>Information and System Function Related to Dose in CT<br>FDA/CDRH recognition number 12-287 | |
| • NEMA XR 29-2013 Standard Attributes on CT Equipment<br>Related to Dose Optimization and Management | |
| • Guidance for Industry and FDA Staff – Guidance for the<br>Content of Premarket Submissions for Software Contained<br>in Medical Devices (issued May 11, 2005, document number<br>337). | |
| • Guidance for Industry and FDA Staff – Content of<br>Premarket Submissions for Management of Cybersecurity in<br>Medical Devices (issued October 2, 2014) | |
| • Guidance for Industry and FDA Staff – Use of<br>International Standard ISO 10993-1, "Biological evaluation<br>of medical devices – Part 1: Evaluation and testing within a<br>risk management process" (issued June 16, 2016) | |
| • Guidance for Industry and FDA Staff – Information to<br>Support a Claim of Electromagnetic Compatibility (EMC) of<br>Electrically-Powered Medical Devices (issued July 11, 2016) | |
| Additionally, the Philips Incisive CT complies with<br>performance standards for Computed Tomography (CT)<br>Equipment and Laser products (21 CFR 1020.33 and 21 CFR<br>1040.10, respectively). | |
| The proposed Philips Incisive CT on Trailer is identical to<br>the currently marketed and predicate Philips Incisive CT<br>(K180015) with regards to intended use, design and<br>fundamental scientific technology except for trailer kit that is<br>utilized to securely mount the CT system on the trailer. The<br>trailer kit consists of locking mechanism that lock the gantry<br>and couch parts of the CT System to the trailer. | |
| With regards to transportation testing the proposed Philips<br>Incisive CT on Trailer complies with Department of<br>Defense Test Method Standard for Environmental<br>Engineering Considerations and Laboratory Tests (MIL-<br>STD-810F). Method 514.5: Composite wheeled vehicle | |
| | Traditional 510(k) |
| | vibration exposures, as described in the main body, Annex<br>A, Annex B and Annex C of this method.<br>Philips Incisive CT on Trailer has passed the vibration test<br>of 300 hours to simulate a 10 years or 120,690 kM lifetime<br>with QA test including MeanCT, Uniformity, Noise, Spatial<br>Resolution, Slice Thickness, Linearity and Low Contrast<br>Resolution.<br>The QA test process and acceptance criteria are same as the<br>predicate device, this can demonstrate the Philips Incisive |
| | CT on Trailer performs as well as the predicate device. |
| Summary of Clinical<br>Data: | Clinical data is not warranted to demonstrate safety and<br>effectiveness of the proposed Philips Incisive CT on<br>Trailer since its design, intended use and fundamental<br>scientific technology is identical to the currently marketed<br>and predicate Philips Incisive CT (K180015,<br>20/March/2018). |
| Substantial Equivalence<br>Conclusion: | The design, intended use, fundamental scientific technology<br>and principal technological components (Tube, Generator,<br>Detector, gantry, patient support and console) of the<br>proposed Philips Incisive CT on Trailer are identical to the<br>currently marketed predicate Philips Incisive CT (K180015,<br>20/March/2018) except for the addition of a trailer Kit to<br>secure the CT System in a trailer. |
| | Based on the information provided above, the proposed<br>Philips Incisive CT on Trailer does not raise different<br>questions of safety and effectiveness as compared to the<br>currently marketed predicate Philips Incisive CT (K180015,<br>20/March/2018). The proposed Philips Incisive CT on<br>Trailer is therefore substantially equivalent to the currently<br>marketed and predicate Philips Incisive CT (K180015,<br>20/March/2018). |

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