(217 days)
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.
The proposed Philips Incisive CT on Trailer 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 support, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV).
Besides installed in hospital, Philips Incisive CT can also be installed on trailer and be transported to designated locations.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT on trailer are identical to the currently marketed and predicate Philips Incisive CT (K180015, 20/March/2018).
The components of the proposed Philips Incisive CT on trailer include the following:
- Gantry. The Gantry consists of 4 main internal units:
a. Stator – a fixed mechanical frame that carries HW and SW
b. Rotor – A rotating circular stiff frame that is mounted in and supported by the stator
c. X-Ray Tube (XRT) and Generator, - fixed to the Rotor frame
d. Data Measurement System (DMS) - a detectors array, fixed to the Rotor frame - Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan.
- Console - Containing a Host computer and display that is the primary user interface.
- CT on Trailer Kit - Modified Incisive CT installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations.
In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.
The provided document is a 510(k) premarket notification for the Philips Incisive CT on Trailer. It seeks to demonstrate substantial equivalence to a predicate device, the Philips Incisive CT (K180015). This type of submission focuses on showing that the new device is as safe and effective as a legally marketed predicate device, rather than on providing extensive clinical performance data for an AI algorithm.
Therefore, the document does not contain the detailed information necessary to answer all parts of your request, especially those pertaining to AI/algorithm-specific studies. The device described is a CT scanner, not an AI algorithm for image analysis.
However, I can extract the relevant information regarding the device's performance criteria based on the context provided for a traditional 510(k) submission for an imaging device.
Here's an analysis based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document details that the "Philips Incisive CT on Trailer" is essentially the predicate "Philips Incisive CT" (K180015) installed on a trailer. The justification for substantial equivalence relies heavily on the fact that the core CT system (detection system, reconstruction algorithm, x-ray system) is identical to the predicate.
The primary performance evaluation mentioned, specifically for the "on Trailer" aspect, relates to robustness and image quality after transportation.
| Acceptance Criteria (for Incisive CT on Trailer vs. Predicate) | Reported Device Performance |
|---|---|
| Mechanical/Transport Robustness: Withstand vibration exposure simulating 10 years or 120,690 km lifetime. (MIL-STD-810F, Method 514.5: Composite wheeled vehicle vibration exposures) | The Philips Incisive CT on Trailer has passed the vibration test of 300 hours to simulate a 10 years or 120,690 kM lifetime. |
| Image Quality Performance QA Test: Maintain image quality performance identical to the predicate device after transportation (MeanCT, Uniformity, Noise, Spatial Resolution, Slice Thickness, Linearity, and Low Contrast Resolution). | QA test (including MeanCT, Uniformity, Noise, Spatial Resolution, Slice Thickness, Linearity and Low Contrast Resolution) was conducted. The QA test process and acceptance criteria are same as the predicate device, which is stated to "demonstrate the Philips Incisive CT on Trailer performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of patient cases. The "test set" in this context refers to the physical device undergoing vibration and QA tests. The tests were performed on "the proposed Philips Incisive CT on Trailer." This likely refers to one or more physical units of the device.
- Data Provenance: The testing was conducted by Philips Healthcare (Suzhou) Co., Ltd. within their development/validation process in China. The data is prospective in the sense that it's generated from testing the new "on Trailer" configuration.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable in the context of this 510(k) submission. This filing is for a physical CT device (mobile CT scanner) and its ability to maintain performance after transport, not for an AI algorithm that generates a "ground truth" often established by expert readers. The "ground truth" here is the physical performance of the CT scanner measured by established imaging quality metrics.
4. Adjudication Method for the Test Set
- Not applicable for this type of device submission. Adjudication generally refers to expert consensus in interpreting medical images or data. The performance of the CT scanner is measured objectively (e.g., noise levels, spatial resolution) against pre-defined engineering and image quality specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, an MRMC study was not done. This type of study is relevant for AI algorithms intended to assist human readers in diagnostic tasks. The device in focus is the CT scanner itself, not an AI software for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone AI algorithm performance study was not done. This 510(k) is for the CT imaging system, not an AI diagnostic algorithm.
7. The Type of Ground Truth Used
- For the physical performance of the CT scanner (MeanCT, Uniformity, Noise, Spatial Resolution, Slice Thickness, Linearity, Low Contrast Resolution), the "ground truth" is established by engineering specifications and phantoms/test objects yielding objective physical measurements, rather than clinical outcomes or expert consensus on patient images. The claim is that these measurements are "same as the predicate device," implying the predicate's performance serves as the benchmark.
8. The Sample Size for the Training Set
- Not applicable. This document is for a CT scanner hardware device (with integrated software for image acquisition and reconstruction), not a machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINAEstablishment Registration Number: 3009529630 |
| Contact Person: | Shiguang AnAdvanced Regulatory EngineerPhone cell: +86-139-40106467Fax: +86-512-68018677E-mail: shiguang.an@philips.com |
| Device Name: | Philips Incisive CT on Trailer |
| Classification: | Classification Name: Computed tomography x-ray systemClassification Regulation: 21CFR §892.1750Classification Panel: RadiologyDevice Class: Class IIPrimary product code: JAK |
| Predicate Device: | Trade Name: Philips Incisive CTManufacturer: Philips Healthcare (Suzhou) Co., Ltd.510(k) Clearance: K180015-March 20, 2018Classification Regulation: 21 CFR, Part 892.1750Classification Name: Computed tomography x-ray systemClassification Panel: RadiologyDevice Class: Class IIProduct Code: JAK |
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Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
| Device description: | The proposed Philips Incisive CT on Trailer is a whole-body computed tomography (CT) X-Ray System featuring acontinuously rotating x-ray tube, detectors, and gantry withmulti-slice capability. The acquired x-ray transmission datais reconstructed by computer into cross-sectional images ofthe body taken at different angles and planes. This systemalso includes signal analysis and display equipment, patientand equipment support, components, and accessories.The Philips Incisive CT has a 72cm bore and includes adetector array that provides 50cm scan field of view (FOV). |
|---|---|
| Besides installed in hospital, Philips Incisive CT can alsobe installed on trailer and be transported to designatedlocations. | |
| The main components (detection system, the reconstructionalgorithm, and the x-ray system) that are used in theproposed Philips Incisive CT on trailer are identical to thecurrently marketed and predicate Philips Incisive CT(K180015, 20/March/2018). | |
| The components of the proposed Philips Incisive CT ontrailer include the following: | |
| 1. Gantry. The Gantry consists of 4 main internal units:a. Stator – a fixed mechanical frame that carries HW and SWb. Rotor – A rotating circular stiff frame that is mounted inand supported by the statorc. X-Ray Tube (XRT) and Generator, - fixed to the Rotorframe | |
| d. Data Measurement System (DMS) - a detectors array,fixed to the Rotor frame2. Patient Support (Couch) - carries the patient in and outthrough the Gantry bore synchronized with the scan.3. Console - Containing a Host computer and display that isthe primary user interface. | |
| 4. CT on Trailer Kit - Modified Incisive CT installed andsecured on trailer requires locking motion parts duringtrailer transportation and unlocking motion parts beforeCT operations. | |
| In addition to the above components and the softwareoperating them, each system includes hardware and softwarefor 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 theoriginal axial images. Patient supports (positioning aids) areused to position the patient. |
| The Incisive CT is a Computed Tomography X-Ray Systemintended to produce images of the head and body bycomputer reconstruction of x-ray transmission data taken atdifferent angles and planes. These devices may includesignal analysis and display equipment, patient and equipmentsupports, components and accessories. The Incisive CT isindicated for head, whole body, cardiac and vascular X-rayComputed Tomography applications in patients of all ages. | |
| These scanners are intended to be used for diagnosticimaging and for low dose CT lung cancer screening for theearly detection of lung nodules that may represent cancer*.The screening must be performed within the establishedinclusion criteria of programs / protocols that have beenapproved and published by either a governmental body orprofessional medical society. | |
| Besides installed in hospital, the proposed Philips IncisiveCT may also be installed on trailer and be transported todesignated locations for use. And Incisive CT installed ontrailer has the same intended use as installed in hospital. | |
| *Please refer to clinical literature, including the results of theNational Lung Screening Trial (N Engl J Med 2011;365:395-409) and subsequent literature, for further information. | |
| Fundamental scientifictechnology: | The proposed Philips Incisive CT on Trailer is advancedcontinuous rotation computed tomography systems suitablefor a wide range of computed tomographic (CT)applications. |
| The proposed Philips Incisive CT on Trailer can betransported by the trailer to designated locations and is usedclinically as a diagnostic patient imaging device thatproduces images that correspond to tissue density. Thequality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays bothhigh-density tissue, such as bone, and soft tissue. | |
| The principal technological components (rotating x-ray tube,detector, gantry, patient support and console) of the proposedPhilips Incisive CT are identical to the currently marketed | |
| Traditional 510(k) | |
| predicate device Philips Incisive CT (K180015, 20/March/2018). | |
| In addition, the Proposed Philips Incisive CT on Trailer 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 Philips Incisive CT on Trailer 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-ClinicalPerformance data: | The currently marketed Philips Incisive CT (K180015) complies with the following international and FDA Recognized Consensus standards:• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).FDA/CDRH recognition number 19-4• IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsFDA/CDRH recognition number 19-8• IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipmentFDA/CDRH recognition number 12-269• IEC 60601-1-6:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityFDA/CDRH recognition number 5-89• IEC 60601-2-44:2012 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipmentFDA/CDRH recognition number 12-256• IEC 62304:2015 Medical device software -- Software life cycle processesFDA/CDRH recognition number 13-79• IEC 62366:2014 Medical Device-Application of Usability Engineering of Medical Devices |
| • ISO14971 Medical devices – Application of riskmanagement to medical devices (Ed. 2.0, 2007)FDA/CDRH recognition number 5-40 | |
| • NEMA XR 25-2010 Computed Tomography Dose CheckFDA/CDRH recognition number 12-225 | |
| • NEMA XR 28-2013 Supplemental Requirements for UserInformation and System Function Related to Dose in CTFDA/CDRH recognition number 12-287 | |
| • NEMA XR 29-2013 Standard Attributes on CT EquipmentRelated to Dose Optimization and Management | |
| • Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Containedin Medical Devices (issued May 11, 2005, document number337). | |
| • Guidance for Industry and FDA Staff – Content ofPremarket Submissions for Management of Cybersecurity inMedical Devices (issued October 2, 2014) | |
| • Guidance for Industry and FDA Staff – Use ofInternational Standard ISO 10993-1, "Biological evaluationof medical devices – Part 1: Evaluation and testing within arisk management process" (issued June 16, 2016) | |
| • Guidance for Industry and FDA Staff – Information toSupport a Claim of Electromagnetic Compatibility (EMC) ofElectrically-Powered Medical Devices (issued July 11, 2016) | |
| Additionally, the Philips Incisive CT complies withperformance standards for Computed Tomography (CT)Equipment and Laser products (21 CFR 1020.33 and 21 CFR1040.10, respectively). | |
| The proposed Philips Incisive CT on Trailer is identical tothe currently marketed and predicate Philips Incisive CT(K180015) with regards to intended use, design andfundamental scientific technology except for trailer kit that isutilized to securely mount the CT system on the trailer. Thetrailer kit consists of locking mechanism that lock the gantryand couch parts of the CT System to the trailer. | |
| With regards to transportation testing the proposed PhilipsIncisive CT on Trailer complies with Department ofDefense Test Method Standard for EnvironmentalEngineering Considerations and Laboratory Tests (MIL-STD-810F). Method 514.5: Composite wheeled vehicle | |
| Traditional 510(k) | |
| vibration exposures, as described in the main body, AnnexA, Annex B and Annex C of this method.Philips Incisive CT on Trailer has passed the vibration testof 300 hours to simulate a 10 years or 120,690 kM lifetimewith QA test including MeanCT, Uniformity, Noise, SpatialResolution, Slice Thickness, Linearity and Low ContrastResolution.The QA test process and acceptance criteria are same as thepredicate device, this can demonstrate the Philips Incisive | |
| CT on Trailer performs as well as the predicate device. | |
| Summary of ClinicalData: | Clinical data is not warranted to demonstrate safety andeffectiveness of the proposed Philips Incisive CT onTrailer since its design, intended use and fundamentalscientific technology is identical to the currently marketedand predicate Philips Incisive CT (K180015,20/March/2018). |
| Substantial EquivalenceConclusion: | The design, intended use, fundamental scientific technologyand principal technological components (Tube, Generator,Detector, gantry, patient support and console) of theproposed Philips Incisive CT on Trailer are identical to thecurrently marketed predicate Philips Incisive CT (K180015,20/March/2018) except for the addition of a trailer Kit tosecure the CT System in a trailer. |
| Based on the information provided above, the proposedPhilips Incisive CT on Trailer does not raise differentquestions of safety and effectiveness as compared to thecurrently marketed predicate Philips Incisive CT (K180015,20/March/2018). The proposed Philips Incisive CT onTrailer is therefore substantially equivalent to the currentlymarketed and predicate Philips Incisive CT (K180015,20/March/2018). |
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§ 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.