(55 days)
The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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.
The proposed Philips CT 3500 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 analvsis and display equipment, patient and equipment supports, components, and accessories. The Philips CT 3500 has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, the proposed Philips CT 3500 may also be installed on trailer and be transported to designed locations for use. And Philips CT 3500 installed on trailer has the same intended use as installed in hospital. The key components that are used in the proposed Philips CT 3500 have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT (K212441 - April 27, 2022). CT on Trailer Kit that is used in the proposed Philips CT 3500 to install and secure the CT system on trailers have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT on trailer (K211168 - November 22, 2021). Trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. The key system modules and functionalities are: 1. Gantry. The Gantry consists of 4 main internal units: a) X-Ray Tube – produce X-ray necessary for scanning. b) High voltage generator - produce high voltage power supply to X-ray tube. consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c) A-plane: adjust the slice thickness during axial scan and monitors the changes of X-ray d) DMS (Data Measurement System) – absorb X-ray radiation by detectors and convert it to digital readout. 2. Patient Table (Couch) Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. 3. Console It is used to operate the system and monitor the scan. The Operator console includes computer, monitor and CTBOX. 4. CT on Trailer Kit Philips CT 3500 installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. CT on Trailer Kit is used to install and secure the CT system on trailers, trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. 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.
It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for the Philips CT 3500. This type of document declares a device substantially equivalent to a predicate device, based on non-clinical performance data (e.g., adherence to standards, design verification and validation), rather than a clinical study with specific acceptance criteria related to AI performance, human reader improvement, or detailed ground truth establishment for a test set.
The document does not describe an AI/algorithm-driven device requiring a study with acceptance criteria of the type typically seen for CADe/CADx devices (e.g., sensitivity, specificity, FROC analysis, MRMC studies). Instead, it's for a Computed Tomography X-Ray System (a hardware device), where "acceptance criteria" are related to its physical performance, safety, and adherence to established regulatory standards, demonstrating substantial equivalence to a previously cleared CT system.
Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for AI ground truth, MRMC study effect size) is not present in the provided text because it's not relevant to this type of device clearance.
However, I can extract the information that is relevant to the device clearance as described in the document, framed in the context of "acceptance criteria" through compliance with standards and a comparison with a predicate device.
Here's an interpretation based on the provided document:
Device: Philips CT 3500 (Computed Tomography X-Ray System)
Purpose of the Study (for 510(k) Clearance): To demonstrate substantial equivalence of the Philips CT 3500 to a legally marketed predicate device (Philips Incisive CT - K212441, K211168) through non-clinical performance data (design verification, design validation, and adherence to consensus standards).
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document primarily relies on demonstrating equivalence to predicate devices and compliance with recognized standards. There isn't a direct table of "acceptance criteria" and "reported performance" as one might see for AI algorithm metrics. Instead, the acceptance is based on meeting the criteria set by these standards and showing comparable characteristics to the predicate device.
| Acceptance Criteria Category (based on regulatory standards/predicate comparison) | Reported Device Performance (or comparison result) |
|---|---|
| Electrical Safety | Complies with 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). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.0 2014-02. |
| Radiation Protection | Complies with IEC 60601-1-3 Edition 2.1 2013-04. Also complies with 21 CFR 1020.33 for CT Equipment and 21 CFR 1040.10 for Laser products. |
| Usability | Complies with IEC 60601-1-6 Edition 3.2 2020-07 and IEC 62366-1 Edition 1.1 2020-06. |
| Software Life Cycle Processes | Complies with IEC 62304 Edition 1.1 2015-06. |
| Risk Management | Complies with ISO 14971 Third Edition 2019-12. All risks are sufficiently mitigated, no new risks introduced, overall residual risks acceptable. |
| Biological Evaluation (if applicable to patient contact parts) | Complies with ISO 10993-1 Fifth edition 2018-08. |
| CT Dose Reporting & Management | Complies with NEMA XR 25 -2019, NEMA XR 26-2020, NEMA XR 28-2013, and NEMA XR 29-2013. Note: Philips CT 3500 complies with more NEMA standards than its predicate, which is deemed not to affect safety and effectiveness. |
| Design Verification (vs. System Requirements) | Passed. System meets established system design input requirements. |
| Design Validation (vs. Intended Use/Commercial Claims) | Passed. Covered intended use, commercial claims, and workflow validation. |
| Installed Environment | Identical to predicate (In hospital, on trailer). |
| CT on Trailer | Functionally identical to predicate for securing the CT system on trailers. Gantry has no tilt function (differs from predicate, but all motion parts fixable, safety and effectiveness not affected). |
| Number of Slices | 32/64. (Predicate: 64/128). "The Philips CT 3500 uses the same DMS (20mm) as the Philips Incisive CT to support 64 slices." Deemed substantially equivalent. |
| Scan Modes | Identical to predicate (Surview, Axial Scan, Helical Scan). |
| Minimum Scan Time | 0.5 sec for 360° rotation. (Predicate: 0.35 sec for 360° rotation). "The proposed Philips CT 3500 rotation speed lower than Philips Incisive CT. Safety and effectiveness are not affected." |
| Image (Spatial) Resolution | Identical to predicate (High resolution mode: 16 lp/cm, Standard resolution mode: 13 lp/cm). |
| Image Noise | Identical to predicate (≤0.18% at 120kV, CTDIcenter (head) ≤ 33mGy, 10mm image thickness, iDose4). |
| Slice Thicknesses | Identical to predicate (Helical: 0.67mm - 5mm; Axial: 0.625mm – 10.0mm). |
| Scan Field of View | Identical to predicate (Up to 500 mm). |
| Image Matrix | Identical to predicate (Up to 1024 * 1024). |
| Display | Identical to predicate (1920 * 1080). |
| Host Infrastructure | Identical to predicate (Windows 10). |
| Communication | Identical to predicate (Compliance with DICOM). |
| Imaging Features (e.g., 2D Viewer, MPR, 3D, Virtual Endoscope, O-MAR, DoseRight Index, 3D-DOM, Bolus Tracking, Filming, Worklist, MPPS, Reporting, CCT, Brain Perfusion, Dental planning, Axial Gating, Parallel workflow, Precise image, Precise position, Direct results, CT Colonoscopy, Vessel Analysis, Lung Nodule Analysis, Dual Energy, Precise intervention, iDose4, Cardiac calcium scoring, Adaptive Filtering, Precise Brain) | All listed features are either identical ("Yes" indicates presence and equivalence to predicate) or have minor name changes/added capabilities (e.g., Precise Planning vs. iPlanning, Oblique MPR adding tilt capability, OnPlan vs. iStation, Precise Spine vs. iBatch) that are deemed not to affect safety and effectiveness, thus demonstrating substantial equivalence. |
Study Information (Based on 510(k) Non-Clinical Data Submission):
- Sample size used for the test set and the data provenance: Not applicable in the context of a "test set" for an AI algorithm. The validation was a non-clinical evaluation comparing the device to a predicate and established standards. The data provenance would be internal performance testing data and compliance documentation. The document doesn't specify a "test set" size or data origin in the sense of clinical images for an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established in this type of 510(k) for a CT system itself, as it is a hardware device. The "ground truth" for the clearance is compliance with engineering specifications, safety standards, and performance benchmarks compared to an existing device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done, as this is a CT scanner, not an AI-assisted diagnostic software. The document explicitly states: "The proposed Philips CT 3500 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging system, not an AI algorithm.
- The type of ground truth used: The "ground truth" for this clearance is defined by:
- Consensus Standards: Compliance with dozens of established national and international standards for medical electrical equipment, radiation protection, software, risk management, etc. (e.g., IEC 60601 series, ISO 14971, NEMA XR series).
- Predicate Device Performance: Direct comparison of fundamental design characteristics, key components, features, and technical specifications with the legally marketed Philips Incisive CT (K212441, K211168).
- Internal Verification and Validation: System verification against system requirement specifications (SRS) and validation testing covering intended use and commercial claims, including workflow validation.
- The sample size for the training set: Not applicable. This is not an AI algorithm clearance.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm clearance.
In summary, the provided document details a 510(k) clearance for a CT imaging system, which is a hardware device. The "study" proving it meets "acceptance criteria" primarily involved non-clinical engineering and performance testing to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices and compliance with regulatory standards, rather than clinical studies of an AI algorithm's diagnostic performance.
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February 8, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. Food & Drug Administration" are written in blue.
Philips Healthcare (Suzhou) Co., Ltd % Diana Xu Associated Regulatory Affairs Manager No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K223311 Trade/Device Name: Philips CT 3500 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK
Dear Diana Xu:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 22th, 2023. Specifically, FDA is updating this SE Letter as an administrative correction because there was an inadvertent formatting error in the page header.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lu Jiang, OHT8: Office of In Vitro Diagnostics, (240) 402-5779, Lu.Jiang@fda.hhs.gov.
Sincerely,
Lu Jiang
2023.02.08
10:03:27
-05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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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December 22, 2022
Image /page/1/Picture/1 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 and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The seal features an eagle emblem.
Philips Healthcare (Suzhou) Co., Ltd % Diana Xu Associated Regulatory Affairs Manager No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou. Jiangsu 215024 CHINA
Re: K223311
Trade/Device Name: Philips CT 3500 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 27, 2022 Received: October 28, 2022
Dear Ms. Xu:
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 medical devices and radiation-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,
2022.12.22
09:52:43
Lu Jiang
-05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Philips CT 3500
Indications for Use (Describe)
The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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.
| 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 K223311
[As required by 21 CFR 807.92(c)]
| Date Prepared: | October 26, 2022 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhongyuan Road, Suzhou Industrial Park,Suzhou Jiangsu, CHINA, 215024Establishment Registration Number: 3009529630 |
| Primary ContactPerson: | Diana XuAssociated Regulatory Affairs ManagerPhone: +86-18940060508E-mail: diana.xu@philips.com |
| Secondary ContactPerson | Erhong WangSenior Manager Regulatory AffairsPhone: +86-512-67336804E-mail: ErHong.WANG@philips.com |
| Device Name: | Philips CT 3500 |
| 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: K212441, K211168Classification Regulation: 21CFR 892.1750Classification name: Computed tomography x-ray systemClassification Panel: RadiologyDevice class: Class IIProduct Code: JAK |
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Device Description: The proposed Philips CT 3500 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 analvsis and display equipment, patient and equipment supports, components, and accessories. The Philips CT 3500 has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, the proposed Philips CT 3500 may also be installed on trailer and be transported to designed locations for use. And Philips CT 3500 installed on trailer has the same intended use as installed in hospital. The key components that are used in the proposed Philips CT 3500 have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT (K212441 - April 27, 2022). CT on Trailer Kit that is used in the proposed Philips CT 3500 to install and secure the CT system on trailers have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT on trailer (K211168 - November 22, 2021). Trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. The key system modules and functionalities are: 1. Gantry. The Gantry consists of 4 main internal units: a) X-Ray Tube – produce X-ray necessary for scanning. b) High voltage generator - produce high voltage power supply to X-ray tube. consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c) A-plane: adjust the slice thickness during axial scan and monitors the changes of X-ray d) DMS (Data Measurement System) – absorb X-ray radiation by detectors and convert it to digital readout. 2. Patient Table (Couch)
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| Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. | |
|---|---|
| 3. Console | |
| It is used to operate the system and monitor the scan. The Operator console includes computer, monitor and CTBOX. | |
| 4. CT on Trailer Kit | |
| Philips CT 3500 installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. CT on Trailer Kit is used to install and secure the CT system on trailers, trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. | |
| 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. | |
| Indications for Use: | The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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. | |
| FundamentalScientificTechnology: | The proposed Philips CT 3500 is advanced continuousrotation computed tomography systems suitable for a widerange of computed tomographic (CT) applications. |
| The proposed Philips CT 3500 is used clinically as adiagnostic patient 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 imaging chain components (x-ray tube, high voltage generator and detector) of theproposed Philips CT 3500 substantially equivalent to thecurrently marketed predicate device Philips (K212441 -April27, 2022; K211168 - November 22, 2021). | |
| Based on the information provided above, the proposedPhilips CT 3500 does not raise different questions of safetyand effectiveness compared to the currently marketedpredicate device (K212441 -April 27, 2022; K211168 -November 22, 2021). | |
| Summary of Non-Clinical Performance Data: | The proposed Philips CT 3500 comply 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 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances - Requirements and tests FDA/CDRH recognition number 19-8 IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment FDA/CDRH recognition number 12-269 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability FDA/CDRH recognition number 5-132 IEC 60601-2-44 Edition 3.2: 2016, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography FDA/CDRH recognition number 12-302 IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software -- Software life cycle processes FDA/CDRH recognition number 13-79 IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices -- Part 1: Application of usability engineering to medical devices FDA/CDRH recognition number 5-129 | |
| ● | ISO 14971 Third Edition 2019-12 Medical devices –Application of risk management to medical devicesFDA/CDRH recognition number 5-125 |
| ● | ISO 10993-1 Fifth edition 2018-08 Biological evaluationof medical devices - Part 1: Evaluation and testingwithin a risk management processFDA/CDRH recognition number 2-258 |
| ● | NEMA XR 25 -2019 Computed Tomography DoseCheckFDA/CDRH recognition number 12-325 |
| ● | NEMA XR 26-2020 Access Controls for ComputedTomography – Identification, Interlocks, and Logs |
| ● | NEMA XR 28-2013 Supplemental Requirements forUser Information and System Function Related to Dosein CTFDA/CDRH recognition number 12-287 |
| ● | NEMA XR 29-2013 Standard Attributes on CTEquipment Related to Dose Optimization andManagement |
| ● | Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for SoftwareContained in Medical Devices (issued May 11, 2005,document number 337) |
| ● | Guidance for Industry and FDA Staff – Content ofPremarket Submissions for Management ofCybersecurity in Medical Devices (issued October 2,2014, document number 1825) |
| ● | Guidance for Industry and FDA Staff – Use ofInternational Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process" (issuedSeptember 4, 2020, document number 1811-R1) |
| ● | Guidance for Industry and Food and DrugAdministration Staff - Electromagnetic Compatibility(EMC) of Medical Devices: (issued June 6, 2022,document number 1400057) |
| The systems comply with industry guidance andperformance standards for Computed Tomography (CT)Equipment and Laser products (21 CFR 1020.33 and 21CFR 1040.10, respectively).The systems performed a comparison to the predicatedevice using these technological characteristics and imagequality metrics to establish that the subject device issubstantially equivalent to the predicate device for itsintended use. | |
| The systems pass the design verification, design validationand consensus standards test as nonclinical tests. Thesystem verification is conducted against the systemrequirement specifications (SRS). System verificationactivities demonstrate the system meet the establishedsystem design input requirements. System requirementsmay be verified by manual test, automated test,inspection/analysis, or any combination of the three. Non-Clinical design validation testing covered the intended useand commercial claims. Validation testing included workflowvalidation. | |
| The test results demonstrate that the proposed Philips CT3500 meets the acceptance criteria and is adequate for itsintended use. Additionally, the risk management activitiesshow that all risks are sufficiently mitigated, that no newrisks are introduced, and that the overall residual risks areacceptable. | |
| Summary of ClinicalData: | The proposed Philips CT 3500 did not require clinical studysince substantial equivalence to the legally marketedpredicate device was proven with the verification/validationtesting. |
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Substantial Equivalence
| Installed Environment Comparison | |||
|---|---|---|---|
| Proposed Philips CT3500 | Predicate DevicePhilips Incisive CT(K212441, K211168) | Conclusion | |
| Installedenvironment | In hospital, on trailer | In hospital, on trailer | Identical.Therefore,substantiallyequivalent. |
| CT on Trailer | Besides installed inhospital, the proposedPhilips CT 3500 mayalso be installed ontrailer and betransported todesignated locations foruse. And Philips CT3500 installed on trailerhas the same intendeduse as installed inhospital.The design, intendeduse, fundamentalscientific technologyand principaltechnologicalcomponents (Tube,Generator, Detector,gantry, patient tableand console) are sameas the proposed PhilipsCT 3500 in hospitalexcept for the additionof a CT on Trailer Kit tosecure the CT systemin a trailer.CT on Trailer Kitincludes:• Couch vertical lockand horizontal lockASSY,• UPS lock ASSY, | Besides installed inhospital, the proposedPhilips Incisive CT mayalso be installed ontrailer and betransported todesignated locations foruse. And Incisive CTinstalled on trailer hasthe same intended useas installed in hospital.The design, intendeduse, fundamentalscientific technologyand principaltechnologicalcomponents (Tube,Generator, Detector,gantry, patient tableand console) are sameas the Philips IncisiveCT in hospital exceptfor the addition of a CTon Trailer Kit to securethe CT system in atrailer.CT on Trailer Kitincludes:• Gantry tilt lockASSY,• Couch vertical lockASSY,• Couch horizontallock ASSY, | The proposedPhilips CT 3500Gantry has no tiltfunction. All motionparts can be fixedby on trailer kit.The design,intended use,fundamentalscientifictechnology andprincipaltechnologicalcomponents areidentical to thepredicate device.Safety andeffectiveness arenot affected.Therefore,demonstratingsubstantialequivalence. |
| Installed Environment Comparison | |||
| Proposed Philips CT3500 | Predicate DevicePhilips Incisive CT(K212441, K211168) | Conclusion | |
| • IsolationTransformer lockASSY | • UPS lock Kits,• Console fixationdevice,• IsolationTransformer lockKits |
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| Scan characteristics Comparison | |||
|---|---|---|---|
| Proposed Philips CT3500 | Predicate DevicePhilips Incisive CT(K212441, K211168) | Conclusion | |
| No. of Slices | 32/64 | 64/128 | The Philips CT3500 uses thesame DMS (20mm)as the PhilipsIncisive CT tosupport 64 slices.Therefore,demonstratingSubstantialequivalence. |
| Surview | Surview | Identical. | |
| Scan Modes | Axial ScanHelical Scan | Axial ScanHelical Scan | Therefore,substantiallyequivalent. |
| Minimum ScanTime | 0.5 sec for 360°rotation | 0.35 sec for 360°rotation | The proposedPhilips CT 3500rotation speedlower than PhilipsIncisive CT.Safety andeffectiveness arenot affected. |
| Scan characteristics Comparison | |||
| Proposed Philips CT 3500 | Predicate Device Philips Incisive CT (K212441, K211168) | Conclusion | |
| Image (Spatial) Resolution | High resolution mode:16 lp/cmStandard resolution mode: 13 lp/cm | High resolution mode:16 lp/cmStandard resolutionmode: 13 lp/cm | Therefore, demonstrating substantial equivalence.Identical.Therefore, substantially equivalent. |
| Image Noise | ≤0.18% at 120kV,CTDIcenter(head) ≤ 33mGy, 10mm image thickness, iDose4 | ≤0.18% at 120kV,CTDIcenter(head) ≤ 33mGy, 10mm image thickness, iDose4 | Identical.Therefore, substantially equivalent. |
| Slice Thicknesses | Helical:0.67mm - 5mmAxial:0.625mm – 10.0mm | Helical:0.67mm - 5mmAxial:0.625mm-10.0mm | Identical.Therefore, substantially equivalent. |
| Scan Field of View | Up to 500 mm | Up to 500 mm | Identical.Therefore, substantially equivalent. |
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical.Therefore, substantially equivalent. |
| Display | 1920 * 1080 | 1920 * 1080 | Identical.Therefore, substantially equivalent. |
| Scan characteristics Comparison | |||
| Proposed Philips CT3500 | Predicate DevicePhilips Incisive CT(K212441, K211168) | Conclusion | |
| HostInfrastructure | Windows 10 | Windows 10 | Identical.Therefore,substantiallyequivalent. |
| Communication | Compliance withDICOM | Compliance withDICOM | Identical.Therefore,substantiallyequivalent. |
| Dose ReportingandManagement | Compliance with NEMAXR25, XR26, XR28 andXR29 | Compliance with NEMAXR25, XR28 and XR29 | Compliance withmore NEMAstandard.Safety andeffectiveness arenot affected.Therefore,substantiallyequivalent. |
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| Imaging features Comparison | ||||
|---|---|---|---|---|
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| 2D Viewer | In 2D Viewer mode operator canreview original axial images asacquired by the scanner. | Yes | Identical.Therefore,substantiallyequivalent. | |
| MPR | Use the MPR mode to viewthree-plane orthogonal images.In this mode, the three shownplanes can be easily correlated.Three orthogonal cut planes areshown:• Axial Orientation | Yes | Identical.Therefore,substantiallyequivalent. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| • Coronal Orientation• Sagittal Orientation | ||||
| 3D (Volumemode) | The volume mode is used todisplay CT scanner data in a fullvolume image. It provides basictools for image editing andgeneration of cine movies. | Yes | Identical.Therefore,substantiallyequivalent. | |
| VirtualEndoscope(Endo) | The CT Endo viewer is a reviewfunction that allows you toperform a general flythrough ofany suitable anatomicalstructure that is filled with air orwith contrast material, includinggeneral vessels, cardiacvessels, the bronchus, and thecolon. | Yes | Identical.Therefore.substantiallyequivalent. | |
| Image matrix | The Image Matrix parametersets the number of pixels thatthe reconstructed image willcontain. Select 512, 768, or1024. | Yes | IdenticalTherefore,substantiallyequivalent. | |
| O-MAR | O-MAR stands for orthopedicmetal artifact reduction. Thispost processing capabilityreduces metal induced artifactsand is directed for largeorthopedics metals that causephoton starvation of the raysthat pass through the metalobject. | Yes | Identical.Therefore,substantiallyequivalent. | |
| DoseRightIndex(DRI) | DoseRight Index (DRI) isaccording to the current scansite and body size of the patient,the mAs suitable for the patientis automatically recommended,so that the image quality canmeet the requirements of thediagnosis, and the radiationdose of the patient can be | Yes | Identical.Therefore,substantiallyequivalent. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| 3D-DOM | 3D-DOM combines angular andlongitudinal information tomodulate dose in threedimensions. Personalizes dosefor each patient by automaticallysuggesting tube current settingsaccording to the estimatedpatient diameter in the scanregion. Angular dose modulationvaries the tube current duringhelical scans according tochanges in patient shape(eccentricity) and tissueattenuation as the tube rotates. | Yes | Identical.Therefore,substantiallyequivalent. | |
| PrecisePlanning | Precise Planning canautomatically adjust the scanrange of subsequent Axial orHelical scan series, based onthe Surview Image. | iPlanning | Only the namechanges.Safety andeffectivenessare notaffected.Therefore,substantiallyequivalent. | |
| Oblique MPR | Support the adjustment ofsagittal / coronal imageconstruction in the plannedscanning phase, and finallyobtain the adjusted tiltedmultiplane image.On the basis of Insert MPR,surface reconstruction is carriedout by interpolation of axialimage and corresponding tiltedimage is generated. | Insert MPR | On the basis ofInsert MPR,Added the abilityfor users to tiltthe MPR imageSafety andeffectivenessare notaffected.Therefore,substantiallyequivalent. | |
| OnPlan | OnPlan (Touch Panel)OnPlan is a brand-new gantryoperational touch panel locatedon both sides of the gantry. TheOnPlan gantry controls are usedto active the laser marker,controls patient table | iStation (TouchPanel) | Only the namechanges.Safety andeffectivenessare notaffected. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| movements, display patientinformation and images, andconduct a new patient exam. | Therefore,substantiallyequivalent. | |||
| Precise Spine | Precise SpinePrecise Spine applicationenables the system to assist theuser to identify the lumbar diskspace automatically andcreating a batch based on theprotocol selected. | iBatchiBatch applicationenables thesystem to assistthe user to identifythe lumbar diskspaceautomatically andcreating a batchbased on theprotocol selected. | Only the namechanges.Safety andeffectivenessare notaffected.Therefore,substantiallyequivalent. | |
| Bolus Tracking | The Bolus tracking functionmaximizes the efficiency of CTscans that are enhancedthrough the use of a contrastagent. This is done by precedingthe Clinical scan with Locatorand Tracker scans. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Spiral AutoStart (SAS) | This feature enable the usage ofthe injector scan trigger. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Filming | The Filming application is usedfor viewing, rearranging,windowing and zooming imagesprior to sending them to beprinted. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Worklist | The Worklist displays patientinformation provided by theHIS/RIS. | Yes | Identical.Therefore,substantiallyequivalent. | |
| MPPS | If the patient is from the Worklistand the MPPS function isenabled, feedback regarding the | Yes | Identical. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| study status of the patient canbe sent to the hospital HIS/RIS. | Therefore,substantiallyequivalent. | |||
| Reporting | The Reporting package allowsyou to create customizedreports using pre-formattedtemplates.A template is a speciallydesigned formatting documentthat places the analyticalinformation and images that yousend from an application into anorganized report which can beprinted and saved. | Yes | Identical.Therefore,substantiallyequivalent. | |
| CCT(ContinuousCT) | Continuous CT (CCT) is ascanning mode that allows thephysician to perform extended,low-dose scans whileperforming a biopsy.The resulting images display ona remote monitor in the scanroom, providing visual feedbackduring the biopsy. | Yes | Identical.Therefore,substantiallyequivalent. | |
| BrainPerfusion | Brain Perfusion is a blood flowimaging application thatanalyzes the uptake of injectedcontrast in order to determineperfusion-related informationabout one or more regions ofinterest. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Dentalplanning | Dental application uses tocreate true-size (life size) filmimages of the mandible andmaxilla for assisting oralsurgeons in planningimplantation of prostheses.Using a special dental planningprocedure, and the images willbe created from this scan which | Yes | Identical.Therefore,substantiallyequivalent. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| can be input into the Dentalplanning application. | ||||
| Axial Gating | Axial prospective gating uses anexternal ECG gating system tosynchronize individual axialscans with the patient'sheartbeat. The ECG-triggeredscans significantly minimizeheart-motion artifacts. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Parallelworkflow | The system support Parallelworkflow using Dual monitor asbelow:- main monitor: Patients, scan,service, "show all" for scanplanning, Help.- extend monitor: Completed,viewers, Analysis, recon, filming,report | Yes | Identical.Therefore,substantiallyequivalent. | |
| Precise image | Precise image reconstruction isa recon mode where the systemuses a trained deep learningneural network to generatenoise reduction images andimprove low contrastdetectability with reduced dosecompared with standard FBPrecon mode. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Preciseposition | Precise Position is a camera-based workflow designed toassist with positioning thepatient automatically fromconsole or OnPlan, it can:• automatically select patientorientation.• automatically set verticalcentering & positioning of thepatient to the Surview start andend positions.• support editing Surview start &end range and scan direction. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| Direct results | Direct Result-With Direct Resultthe user is able to choose adesired result during scanplanning phase and get theresult for diagnosis withoutfurther intervention. | Yes | Identical.Therefore,substantiallyequivalent. | |
| CTColonoscopy(CTC) | CT Colonoscopy (CTC)application enables fast andeasy visualization of colonscans, using acquired CTimages. | Yes | Identical.Therefore,substantiallyequivalent. | |
| VesselAnalysis (VA) | Vessel Analysis (VA) offers aset of tools for general vascularanalysis. With VA the user caneasily remove bone, and extractvessels. User also can performmeasurements such asintraluminal diameter, cross-sectional lumen area, length. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Lung NoduleAnalysis (LNA) | The Lung Nodule Analysis(LNA) application assists theradiologist with the detectionand quantification of pulmonarynodules and lesions. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Dual Energy | Dual energy Viewer is anapplication for review andanalysis of CT dual-energyscans. Users need to load CTdual-energy scan data which istwo series with similar KV. Itprovides registration functionand can generate differentweighted KV images. User canuse the tools to separatematerials. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Preciseintervention | In Precise Intervention viewerthere are several tools, they willhelp you to navigate the needlesafely during the intervention. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Imaging features Comparison | ||||
| Philips CT3500 FeaturesName | Feature description | Predicate DevicePhilips IncisiveCT (K212441,K211168) | Conclusion(Function/User interface/Workflow) | |
| iDose44 | iDose4 is an iterativereconstruction technique thatimproves image quality throughartifact prevention andincreased spatial resolution atlow dose. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Cardiaccalciumscoring | The Cardiac Calcium Scoringapplication is used to quantifythe buildup of calcium plaque onthe walls of the patient'scoronary arteries and otherrelevant locations. The potentialcalcifications are highlighted bythe application during launch. | Yes | Identical.Therefore,substantiallyequivalent. | |
| AdaptiveFiltering | Adaptive filters (AF) reducepattern noise (streaks) in non-homogenous bodies, improvingoverall image quality. | Yes | Identical.Therefore,substantiallyequivalent. | |
| Precise Brain | Precise Brain application for aseries of brain tissue slices thatare parallel or vertical in theplane of the cranial CT scan. | Yes | Identical.Therefore,substantiallyequivalent. |
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| SubstantialEquivalenceConclusion: | The design, intended use, technology, and principal technologicalimaging chain components (x-ray tube, high voltage generator anddetector) of the proposed Philips CT 3500 substantially equivalent tothe currently marketed predicate device Philips Incisive CT (K212441- April 27, 2022; K211168 - November 22, 2021). Based on theinformation provided above, the proposed Philips CT 3500 does notraise different questions of safety and effectiveness compared to thecurrently marketed predicate device Philips Incisive CT (K212441 -April 27, 2022; K211168 - November 22, 2021). The proposedPhilips CT 3500 is identical to the predicate device Philips Incisive |
|---|---|
| ------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| CT (K212441 - April 27, 2022; K211168 - November 22, 2021) andtherefore is considered substantially equivalent. | |
|---|---|
| Additionally, substantial equivalence was demonstrated with non-clinical performance, V&V and consensus standards tests, whichcomplied with the requirements specified in the international andFDA-recognized consensus standards. | |
| The results of these tests demonstrate that the proposed Philips CT3500 meets the acceptance criteria and is adequate for its intendeduse. |
§ 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.