(55 days)
Not Found
Yes
The summary explicitly states that the device uses a "trained deep learning neural network" for image reconstruction, which is a form of artificial intelligence/machine learning.
No
The device is described as a Computed Tomography X-Ray System intended for diagnostic imaging, including screening for lung cancer. Its purpose is to produce images, not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These scanners are intended to be used for diagnostic imaging..."
No
The device description clearly outlines numerous hardware components including an X-Ray Tube, High voltage generator, A-plane, DMS, Patient Table, and Console, in addition to the software.
Based on the provided text, the Philips CT 3500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Philips CT 3500 Function: The Philips CT 3500 is a Computed Tomography X-Ray System. It produces images of the internal structures of the body using X-rays and computer reconstruction. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for producing images of the head and body for diagnostic imaging and low dose CT lung cancer screening. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
Therefore, the Philips CT 3500 falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked "Not Found".
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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) 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray transmission data / Computed Tomography X-Ray System
Anatomical Site
Head and body, head, whole body, cardiac, vascular, lung, brain, mandible and maxilla.
Indicated Patient Age Range
patients of all ages.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). System verification activities demonstrate the system meet the established system design input requirements. System requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation. The test results demonstrate that the proposed Philips CT 3500 meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
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
3
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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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and the overall appearance is clean and modern.
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, 215024 | |
| Establishment Registration Number: 3009529630 | |
| Primary Contact | |
| Person: | Diana Xu |
| Associated Regulatory Affairs Manager | |
| Phone: +86-18940060508 | |
| E-mail: diana.xu@philips.com | |
| Secondary Contact | |
| Person | Erhong Wang |
| Senior Manager Regulatory Affairs | |
| Phone: +86-512-67336804 | |
| E-mail: ErHong.WANG@philips.com | |
| Device Name: | Philips CT 3500 |
| Classification: | Classification name: Computed tomography x-ray system |
| Classification Regulation: 21CFR 892.1750 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product Code: JAK | |
| Predicate Device: | Trade name: Philips Incisive CT |
| Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. | |
| 510(k) Clearance: K212441, K211168 | |
| Classification Regulation: 21CFR 892.1750 | |
| Classification name: Computed tomography x-ray system | |
| Classification Panel: Radiology | |
| Device class: Class II | |
| Product Code: JAK |
5
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)
6
| 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. | |
| Fundamental | |
| Scientific | |
| Technology: | The proposed Philips CT 3500 is advanced continuous |
| rotation computed tomography systems suitable for a wide | |
| range of computed tomographic (CT) applications. | |
| The proposed Philips CT 3500 is used clinically as a | |
| diagnostic patient imaging device that produces images that | |
| correspond to tissue density. The quality of the images | |
| depends on the level and amount of X-ray energy delivered | |
| to 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 the | |
| proposed Philips CT 3500 substantially equivalent to the | |
| currently marketed predicate device Philips (K212441 -April | |
| 27, 2022; K211168 - November 22, 2021). | |
| Based on the information provided above, the proposed | |
| Philips CT 3500 does not raise different questions of safety | |
| and effectiveness compared to the currently marketed | |
| predicate 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 devices | |
| FDA/CDRH recognition number 5-125 | |
| ● | ISO 10993-1 Fifth edition 2018-08 Biological evaluation |
| of medical devices - Part 1: Evaluation and testing | |
| within a risk management process | |
| FDA/CDRH recognition number 2-258 | |
| ● | NEMA XR 25 -2019 Computed Tomography Dose |
| Check | |
| FDA/CDRH recognition number 12-325 | |
| ● | NEMA XR 26-2020 Access Controls for Computed |
| Tomography – Identification, Interlocks, and Logs | |
| ● | NEMA XR 28-2013 Supplemental Requirements for |
| User Information and System Function Related to Dose | |
| in CT | |
| FDA/CDRH recognition number 12-287 | |
| ● | NEMA XR 29-2013 Standard Attributes on CT |
| Equipment Related to Dose Optimization and | |
| Management | |
| ● | Guidance for Industry and FDA Staff – Guidance for the |
| Content of Premarket Submissions for Software | |
| Contained in Medical Devices (issued May 11, 2005, | |
| document number 337) | |
| ● | Guidance for Industry and FDA Staff – Content of |
| Premarket Submissions for Management of | |
| Cybersecurity in Medical Devices (issued October 2, | |
| 2014, document number 1825) | |
| ● | Guidance for Industry and FDA Staff – Use of |
| International Standard ISO 10993-1, "Biological | |
| evaluation of medical devices - Part 1: Evaluation and | |
| testing within a risk management process" (issued | |
| September 4, 2020, document number 1811-R1) | |
| ● | Guidance for Industry and Food and Drug |
| Administration Staff - Electromagnetic Compatibility | |
| (EMC) of Medical Devices: (issued June 6, 2022, | |
| document number 1400057) | |
| The systems comply with industry guidance and | |
| performance standards for Computed Tomography (CT) | |
| Equipment and Laser products (21 CFR 1020.33 and 21 | |
| CFR 1040.10, respectively). | |
| The systems performed a comparison to the predicate | |
| device using these technological characteristics and image | |
| quality metrics to establish that the subject device is | |
| substantially equivalent to the predicate device for its | |
| intended use. | |
| The systems pass the design verification, design validation | |
| and consensus standards test as nonclinical tests. The | |
| system verification is conducted against the system | |
| requirement specifications (SRS). System verification | |
| activities demonstrate the system meet the established | |
| system design input requirements. System requirements | |
| may be verified by manual test, automated test, | |
| inspection/analysis, or any combination of the three. Non- | |
| Clinical design validation testing covered the intended use | |
| and commercial claims. Validation testing included workflow | |
| validation. | |
| The test results demonstrate that the proposed Philips CT | |
| 3500 meets the acceptance criteria and is adequate for its | |
| intended use. Additionally, the risk management activities | |
| show that all risks are sufficiently mitigated, that no new | |
| risks are introduced, and that the overall residual risks are | |
| acceptable. | |
| Summary of Clinical | |
| Data: | 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. |
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Substantial Equivalence
| Installed Environment Comparison | |||
|---|---|---|---|
| Proposed Philips CT | |||
| 3500 | Predicate Device | ||
| Philips Incisive CT | |||
| (K212441, K211168) | Conclusion | ||
| Installed | |||
| environment | In hospital, on trailer | In hospital, on trailer | Identical. |
| Therefore, | |||
| substantially | |||
| equivalent. | |||
| CT on Trailer | Besides installed in | ||
| hospital, the proposed | |||
| Philips CT 3500 may | |||
| also be installed on | |||
| trailer and be | |||
| transported to | |||
| designated locations for | |||
| use. And Philips CT | |||
| 3500 installed on trailer | |||
| has the same intended | |||
| use as installed in | |||
| hospital. | |||
| The design, intended | |||
| use, fundamental | |||
| scientific technology | |||
| and principal | |||
| technological | |||
| components (Tube, | |||
| Generator, Detector, | |||
| gantry, patient table | |||
| and console) are same | |||
| as the proposed Philips | |||
| CT 3500 in hospital | |||
| except for the addition | |||
| of a CT on Trailer Kit to | |||
| secure the CT system | |||
| in a trailer. | |||
| CT on Trailer Kit | |||
| includes: | |||
| • Couch vertical lock | |||
| and horizontal lock | |||
| ASSY, | |||
| • UPS lock ASSY, | 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 design, intended | |||
| use, fundamental | |||
| scientific technology | |||
| and principal | |||
| technological | |||
| components (Tube, | |||
| Generator, Detector, | |||
| gantry, patient table | |||
| and console) are same | |||
| as the Philips Incisive | |||
| CT in hospital except | |||
| for the addition of a CT | |||
| on Trailer Kit to secure | |||
| the CT system in a | |||
| trailer. | |||
| CT on Trailer Kit | |||
| includes: | |||
| • Gantry tilt lock | |||
| ASSY, | |||
| • Couch vertical lock | |||
| ASSY, | |||
| • Couch horizontal | |||
| lock ASSY, | The proposed | ||
| Philips CT 3500 | |||
| Gantry has no tilt | |||
| function. All motion | |||
| parts can be fixed | |||
| by on trailer kit. | |||
| The design, | |||
| intended use, | |||
| fundamental | |||
| scientific | |||
| technology and | |||
| principal | |||
| technological | |||
| components are | |||
| identical to the | |||
| predicate device. | |||
| Safety and | |||
| effectiveness are | |||
| not affected. | |||
| Therefore, | |||
| demonstrating | |||
| substantial | |||
| equivalence. | |||
| Installed Environment Comparison | |||
| Proposed Philips CT | |||
| 3500 | Predicate Device | ||
| Philips Incisive CT | |||
| (K212441, K211168) | Conclusion | ||
| • Isolation | |||
| Transformer lock | |||
| ASSY | • UPS lock Kits, | ||
| • Console fixation | |||
| device, | |||
| • Isolation | |||
| Transformer lock | |||
| Kits |
12
| Scan characteristics Comparison | |||
|---|---|---|---|
| Proposed Philips CT | |||
| 3500 | Predicate Device | ||
| Philips Incisive CT | |||
| (K212441, K211168) | Conclusion | ||
| No. of Slices | 32/64 | 64/128 | The Philips CT |
| 3500 uses the | |||
| same DMS (20mm) | |||
| as the Philips | |||
| Incisive CT to | |||
| support 64 slices. | |||
| Therefore, | |||
| demonstrating | |||
| Substantial | |||
| equivalence. | |||
| Surview | Surview | Identical. | |
| Scan Modes | Axial Scan | ||
| Helical Scan | Axial Scan | ||
| Helical Scan | Therefore, | ||
| substantially | |||
| equivalent. | |||
| Minimum Scan | |||
| Time | 0.5 sec for 360° | ||
| rotation | 0.35 sec for 360° | ||
| rotation | The proposed | ||
| Philips CT 3500 | |||
| rotation speed | |||
| lower than Philips | |||
| Incisive CT. | |||
| Safety and | |||
| effectiveness are | |||
| not affected. | |||
| Scan characteristics Comparison | |||
| Proposed Philips CT 3500 | Predicate Device Philips Incisive CT (K212441, K211168) | Conclusion | |
| Image (Spatial) Resolution | High resolution mode:16 lp/cm | ||
| Standard resolution mode: 13 lp/cm | High resolution mode: | ||
| 16 lp/cm | |||
| Standard resolution | |||
| mode: 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 - 5mm | |||
| Axial: | |||
| 0.625mm – 10.0mm | Helical: | ||
| 0.67mm - 5mm | |||
| Axial: | |||
| 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 CT | |||
| 3500 | Predicate Device | ||
| Philips Incisive CT | |||
| (K212441, K211168) | Conclusion | ||
| Host | |||
| Infrastructure | Windows 10 | Windows 10 | Identical. |
Therefore,
substantially
equivalent. |
| Communication | Compliance with
DICOM | Compliance with
DICOM | Identical.
Therefore,
substantially
equivalent. |
| Dose Reporting
and
Management | Compliance with NEMA
XR25, XR26, XR28 and
XR29 | Compliance with NEMA
XR25, XR28 and XR29 | Compliance with
more NEMA
standard.
Safety and
effectiveness are
not affected.
Therefore,
substantially
equivalent. |
13
14
| Imaging features Comparison | ||||
|---|---|---|---|---|
| Philips CT | ||||
| 3500 Features | ||||
| Name | Feature description | Predicate Device | ||
| Philips Incisive | ||||
| CT (K212441, | ||||
| K211168) | Conclusion | |||
| (Function/ | ||||
| User interface/ | ||||
| Workflow) | ||||
| 2D Viewer | In 2D Viewer mode operator can | |||
| review original axial images as | ||||
| acquired by the scanner. | Yes | Identical. | ||
| Therefore, | ||||
| substantially | ||||
| equivalent. | ||||
| MPR | Use the MPR mode to view | |||
| three-plane orthogonal images. | ||||
| In this mode, the three shown | ||||
| planes can be easily correlated. | ||||
| Three orthogonal cut planes are | ||||
| shown: | ||||
| • Axial Orientation | Yes | Identical. | ||
| Therefore, | ||||
| substantially | ||||
| equivalent. | ||||
| Imaging features Comparison | ||||
| Philips CT | ||||
| 3500 Features | ||||
| Name | Feature description | Predicate Device | ||
| Philips Incisive | ||||
| CT (K212441, | ||||
| K211168) | Conclusion | |||
| (Function/ | ||||
| User interface/ | ||||
| Workflow) | ||||
| • Coronal Orientation | ||||
| • Sagittal Orientation | ||||
| 3D (Volume | ||||
| mode) | The volume mode is used to | |||
| display CT scanner data in a full | ||||
| volume image. It provides basic | ||||
| tools for image editing and | ||||
| generation of cine movies. | Yes | Identical. | ||
| Therefore, | ||||
| substantially | ||||
| equivalent. | ||||
| Virtual | ||||
| Endoscope | ||||
| (Endo) | The CT Endo viewer is a review | |||
| function that allows you to | ||||
| perform a general flythrough of | ||||
| any suitable anatomical | ||||
| structure that is filled with air or | ||||
| with contrast material, including | ||||
| general vessels, cardiac | ||||
| vessels, the bronchus, and the | ||||
| colon. | Yes | Identical. | ||
| Therefore. | ||||
| substantially | ||||
| equivalent. | ||||
| Image matrix | The Image Matrix parameter | |||
| sets the number of pixels that | ||||
| the reconstructed image will | ||||
| contain. Select 512, 768, or |
-
| Yes | Identical
Therefore,
substantially
equivalent. | |
| O-MAR | O-MAR stands for orthopedic
metal artifact reduction. This
post processing capability
reduces metal induced artifacts
and is directed for large
orthopedics metals that cause
photon starvation of the rays
that pass through the metal
object. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| DoseRight
Index
(DRI) | DoseRight Index (DRI) is
according to the current scan
site and body size of the patient,
the mAs suitable for the patient
is automatically recommended,
so that the image quality can
meet the requirements of the
diagnosis, and the radiation
dose of the patient can be | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Imaging features Comparison | | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| 3D-DOM | 3D-DOM combines angular and
longitudinal information to
modulate dose in three
dimensions. Personalizes dose
for each patient by automatically
suggesting tube current settings
according to the estimated
patient diameter in the scan
region. Angular dose modulation
varies the tube current during
helical scans according to
changes in patient shape
(eccentricity) and tissue
attenuation as the tube rotates. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Precise
Planning | Precise Planning can
automatically adjust the scan
range of subsequent Axial or
Helical scan series, based on
the Surview Image. | iPlanning | Only the name
changes.
Safety and
effectiveness
are not
affected.
Therefore,
substantially
equivalent. | |
| Oblique MPR | Support the adjustment of
sagittal / coronal image
construction in the planned
scanning phase, and finally
obtain the adjusted tilted
multiplane image.
On the basis of Insert MPR,
surface reconstruction is carried
out by interpolation of axial
image and corresponding tilted
image is generated. | Insert MPR | On the basis of
Insert MPR,
Added the ability
for users to tilt
the MPR image
Safety and
effectiveness
are not
affected.
Therefore,
substantially
equivalent. | |
| OnPlan | OnPlan (Touch Panel)
OnPlan is a brand-new gantry
operational touch panel located
on both sides of the gantry. The
OnPlan gantry controls are used
to active the laser marker,
controls patient table | iStation (Touch
Panel) | Only the name
changes.
Safety and
effectiveness
are not
affected. | |
| Imaging features Comparison | | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| | movements, display patient
information and images, and
conduct a new patient exam. | | Therefore,
substantially
equivalent. | |
| Precise Spine | Precise Spine
Precise Spine application
enables the system to assist the
user to identify the lumbar disk
space automatically and
creating a batch based on the
protocol selected. | iBatch
iBatch application
enables the
system to assist
the user to identify
the lumbar disk
space
automatically and
creating a batch
based on the
protocol selected. | Only the name
changes.
Safety and
effectiveness
are not
affected.
Therefore,
substantially
equivalent. | |
| Bolus Tracking | The Bolus tracking function
maximizes the efficiency of CT
scans that are enhanced
through the use of a contrast
agent. This is done by preceding
the Clinical scan with Locator
and Tracker scans. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Spiral Auto
Start (SAS) | This feature enable the usage of
the injector scan trigger. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Filming | The Filming application is used
for viewing, rearranging,
windowing and zooming images
prior to sending them to be
printed. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Worklist | The Worklist displays patient
information provided by the
HIS/RIS. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| MPPS | If the patient is from the Worklist
and the MPPS function is
enabled, feedback regarding the | Yes | Identical. | |
| Imaging features Comparison | | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| | study status of the patient can
be sent to the hospital HIS/RIS. | | Therefore,
substantially
equivalent. | |
| Reporting | The Reporting package allows
you to create customized
reports using pre-formatted
templates.
A template is a specially
designed formatting document
that places the analytical
information and images that you
send from an application into an
organized report which can be
printed and saved. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| CCT
(Continuous
CT) | Continuous CT (CCT) is a
scanning mode that allows the
physician to perform extended,
low-dose scans while
performing a biopsy.
The resulting images display on
a remote monitor in the scan
room, providing visual feedback
during the biopsy. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Brain
Perfusion | Brain Perfusion is a blood flow
imaging application that
analyzes the uptake of injected
contrast in order to determine
perfusion-related information
about one or more regions of
interest. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Dental
planning | Dental application uses to
create true-size (life size) film
images of the mandible and
maxilla for assisting oral
surgeons in planning
implantation of prostheses.
Using a special dental planning
procedure, and the images will
be created from this scan which | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Imaging features Comparison | | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| | can be input into the Dental
planning application. | | | |
| Axial Gating | Axial prospective gating uses an
external ECG gating system to
synchronize individual axial
scans with the patient's
heartbeat. The ECG-triggered
scans significantly minimize
heart-motion artifacts. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Parallel
workflow | The system support Parallel
workflow using Dual monitor as
below:
- main monitor: Patients, scan,
service, "show all" for scan
planning, Help. - extend monitor: Completed,
viewers, Analysis, recon, filming,
report | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Precise image | Precise image reconstruction is
a recon mode where the system
uses a trained deep learning
neural network to generate
noise reduction images and
improve low contrast
detectability with reduced dose
compared with standard FBP
recon mode. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Precise
position | Precise Position is a camera-
based workflow designed to
assist with positioning the
patient automatically from
console or OnPlan, it can:
• automatically select patient
orientation.
• automatically set vertical
centering & positioning of the
patient to the Surview start and
end positions.
• support editing Surview start &
end range and scan direction. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| | Imaging features Comparison | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| Direct results | Direct Result-With Direct Result
the user is able to choose a
desired result during scan
planning phase and get the
result for diagnosis without
further intervention. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| CT
Colonoscopy
(CTC) | CT Colonoscopy (CTC)
application enables fast and
easy visualization of colon
scans, using acquired CT
images. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Vessel
Analysis (VA) | Vessel Analysis (VA) offers a
set of tools for general vascular
analysis. With VA the user can
easily remove bone, and extract
vessels. User also can perform
measurements such as
intraluminal diameter, cross-
sectional lumen area, length. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Lung Nodule
Analysis (LNA) | The Lung Nodule Analysis
(LNA) application assists the
radiologist with the detection
and quantification of pulmonary
nodules and lesions. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Dual Energy | Dual energy Viewer is an
application for review and
analysis of CT dual-energy
scans. Users need to load CT
dual-energy scan data which is
two series with similar KV. It
provides registration function
and can generate different
weighted KV images. User can
use the tools to separate
materials. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Precise
intervention | In Precise Intervention viewer
there are several tools, they will
help you to navigate the needle
safely during the intervention. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| | Imaging features Comparison | | | |
| Philips CT
3500 Features
Name | Feature description | Predicate Device
Philips Incisive
CT (K212441,
K211168) | Conclusion
(Function/
User interface/
Workflow) | |
| iDose44 | iDose4 is an iterative
reconstruction technique that
improves image quality through
artifact prevention and
increased spatial resolution at
low dose. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Cardiac
calcium
scoring | The Cardiac Calcium Scoring
application is used to quantify
the buildup of calcium plaque on
the walls of the patient's
coronary arteries and other
relevant locations. The potential
calcifications are highlighted by
the application during launch. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Adaptive
Filtering | Adaptive filters (AF) reduce
pattern noise (streaks) in non-
homogenous bodies, improving
overall image quality. | Yes | Identical.
Therefore,
substantially
equivalent. | |
| Precise Brain | Precise Brain application for a
series of brain tissue slices that
are parallel or vertical in the
plane of the cranial CT scan. | Yes | Identical.
Therefore,
substantially
equivalent. | |
15
16
17
18
19
20
21
| Substantial
Equivalence
Conclusion: | The design, intended use, technology, and principal technological
imaging chain components (x-ray tube, high voltage generator and
detector) of the proposed Philips CT 3500 substantially equivalent to
the currently marketed predicate device Philips Incisive CT (K212441
- April 27, 2022; K211168 - November 22, 2021). Based on the
information provided above, the proposed Philips CT 3500 does not
raise different questions of safety and effectiveness compared to the
currently marketed predicate device Philips Incisive CT (K212441 -
April 27, 2022; K211168 - November 22, 2021). The proposed
Philips CT 3500 is identical to the predicate device Philips Incisive |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
22
| | CT (K212441 - April 27, 2022; K211168 - November 22, 2021) and
therefore is considered substantially equivalent. |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additionally, substantial equivalence was demonstrated with non-
clinical performance, V&V and consensus standards tests, which
complied with the requirements specified in the international and
FDA-recognized consensus standards. |
| | The results of these tests demonstrate that the proposed Philips CT
3500 meets the acceptance criteria and is adequate for its intended
use. |