(147 days)
No
The document describes a spectral CT system and its components, focusing on image acquisition, reconstruction, and display. While it mentions "signal analysis" and "materials analysis," these are described in terms of analyzing spectral data for material composition and attenuation, which is a standard function of spectral CT and does not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or any related terms in the document. The performance studies described are non-clinical and focus on standards compliance and image quality verification, not on the performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, AUC).
No
The device is described as a diagnostic tool for visualization and analysis, and for diagnostic imaging and screening. It does not provide treatment or therapy.
Yes
The device explicitly states its use "as a diagnostic tool for the visualization and analysis of anatomical and pathological structures" and for "diagnostic imaging in radiology, interventional radiology, and cardiology." It also mentions its intention for "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer," which is a diagnostic application.
No
The device description explicitly lists multiple hardware components including a gantry, x-ray tube, detection system, patient couch, and operator console, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Spectral CT system is an imaging device that uses X-rays to create cross-sectional images of the body. It works by transmitting X-rays through the patient's body and detecting the attenuation of those X-rays. This is an in vivo (within the living body) process, not an in vitro process.
- Intended Use: The intended use clearly states that the device is used to produce images of the body for diagnostic purposes, including visualization and analysis of anatomical and pathological structures. It also mentions low dose CT lung cancer screening. These are all applications of medical imaging, not laboratory testing of biological samples.
- Device Description: The description details components like an X-ray tube, detector system, gantry, and patient couch, which are characteristic of a CT scanner, not an IVD device.
While the device provides information about the chemical composition of body materials and contrast agents, and allows for quantification of attenuation, material density, and effective atomic number, this information is derived from the X-ray transmission data acquired from within the patient's body, not from a sample taken from the body.
Therefore, the Spectral CT system is a medical imaging device, specifically a Computed Tomography X-Ray System, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
The Spectral CT system acquires one CT dataset - composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.
This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning.
The system is also intended to be used 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
JAK
Device Description
The proposed Spectral CT System is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and 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 device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The proposed Spectral CT System includes a detector array, which has spectral capability same as the cleared to market predicate device - Philips IQon Spectral CT System (K193454).
The proposed Spectral CT System consists of main components that are similar to the cleared to market predicate device, Philips IQon Spectral CT cleared under (K193454):
Gantry -
On the rotating gantry, the main active components are:
- x-ray high voltage (HV) power supply,
- the x-ray tube,
- detection system
Patient couch
Operator console for control
Common Image Reconstruction Unit (CIRS)
In addition to the above components and the operating software, the system includes: - Workstation hardware and software for data acquisition and image display, manipulation, storage, and filming; as well as post-processing into views other than the original axial images.
- Patient supports (positioning aids) are used to position the patient.
- Spectral Reconstruction System
- Spectral CT Viewer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data (Computed Tomography X-Ray System)
Anatomical Site
body, lung
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
trained healthcare professional, radiology, interventional radiology, cardiology, oncology
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)
Non-clinical performance testing has been performed on the proposed Spectral CT system and demonstrates compliance with International and FDA recognized consensus standards and FDA guidance document(s).
Design Verification planning and testing was conducted at the sub-system and at the system level. The sub-systems are tested against the sub-system requirements specifications (SSRS) and the system level verification is conducted against the system requirement specifications (SRS). System and sub-system verification activities demonstrate the system or sub-systems meet the established system and sub-system level design input requirements. System and sub-system level requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation.
The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report. Non-clinical design validation testing demonstrates that the proposed Spectral CT system can be used as defined in its clinical workflow and intended use. The results of the summative usability validation indicate that the Spectral CT system has been found to be adequately safe and effective for the intended users, uses and use environments.
All these tests were used to support substantial equivalence of the proposed Spectral CT System and demonstrate that the proposed Spectral CT System:
• complies with the aforementioned FDA-recognized consensus standards and/or FDA device specific guidance document, and;
• Meets the acceptance criteria and is adequate for its intended use.
Summary of Clinical Performance Data: There was no clinical testing conducted for the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Philips Medical Systems Nederland B.V. % Yaara Oltchik Regulatory Affairs Project Manager Veenpluis 4-6 Best. 5684 PC THE NETHERLANDS
February 26, 2021
Re: K203020
Trade/Device Name: Spectral CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 22, 2021 Received: January 25, 2021
Dear Yaara Oltchik:
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
1
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203020
Device Name Spectral CT
Indications for Use (Describe)
The Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
The Spectral CT system acquires one CT dataset - composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.
This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning.
The system is also intended to be used 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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3
SECTION 5 510(K) SUMMARY
HA300-006-05 Revision: 01 Status: Approved Page: 1 of 6
SECTION 5 510(K) SUMMARY
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | January 18, 2021 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6, | ||
| 5684 PC BEST | ||
| The Netherlands | ||
| Establishment Registration Number: 3015777306 | ||
| Primary Contact Person: | Yaara Oltchik | |
| Regulatory Affairs Project Manager | ||
| Philips Medical Systems Technologies Ltd. | ||
| Phone: 972-50-7119670 | ||
| E-mail: yaara.oltchik@philips.com | ||
| Secondary | ||
| Person: | Contact Ilana Ben-Moshe | |
| Regulatory Affairs Site Lead | ||
| Philips Medical Systems Technologies Ltd. | ||
| Phone: +972-52-5233496 | ||
| E-mail: Ilana.Ben-Moshe@philips.com | ||
| Device: | Trade Name: | |
| Common name: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Primary Product Code: | ||
| Secondary Product Code: | Spectral CT | |
| Computed Tomography x-Ray System | ||
| Computed Tomography x-Ray System | ||
| 21CFR 892.1750 | ||
| Radiology | ||
| II | ||
| JAK | ||
| Not Applicable | ||
| Predicate Device: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Product Code: | Philips IQon Spectral CT | |
| Philips Medical Systems Nederland B.V. | ||
| K193454 | ||
| Computed Tomography x-Ray System | ||
| 21CFR §892.1750 | ||
| Radiology | ||
| Class II | ||
| JAK | ||
| Reference Device 1: | Trade Name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Name: | ||
| Classification Regulation: | ||
| Classification Panel: | ||
| Device Class: | ||
| Product Code: | Philips iCT CT System | |
| Philips Medical Systems Nederland B.V. | ||
| K162838 | ||
| Computed Tomography x-Ray System | ||
| 21CFR §892.1750 | ||
| Radiology | ||
| Class II | ||
| JAK |
4
| PHILIPS BG Diagnostic Imaging | SECTION 5 510(K) SUMMARY | HA300-006-05
Revision: 01
Status: Approved
Page: 2 of 6 | | | | | | | | | | | | | | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------|---------------|----------------------------------------|-------------------|---------|----------------------|----------------------------------|----------------------------|-----------------|-----------------------|-----------|---------------|----------|---------------|-----|
| CT/AMI | | | | | | | | | | | | | | | | | |
| Reference Device 2: | Trade Name:Philips CT Big BoreManufacturer:Philips Medical Systems Nederland B.V.510(k) Clearance:K171850Classification Name:Computed Tomography x-Ray SystemClassification Regulation:21CFR §892.1750Classification Panel:RadiologyDevice Class:Class IIProduct Code:JAK | Trade Name: | Philips CT Big Bore | Manufacturer: | Philips Medical Systems Nederland B.V. | 510(k) Clearance: | K171850 | Classification Name: | Computed Tomography x-Ray System | Classification Regulation: | 21CFR §892.1750 | Classification Panel: | Radiology | Device Class: | Class II | Product Code: | JAK |
| Trade Name: | Philips CT Big Bore | | | | | | | | | | | | | | | | |
| Manufacturer: | Philips Medical Systems Nederland B.V. | | | | | | | | | | | | | | | | |
| 510(k) Clearance: | K171850 | | | | | | | | | | | | | | | | |
| Classification Name: | Computed Tomography x-Ray System | | | | | | | | | | | | | | | | |
| Classification Regulation: | 21CFR §892.1750 | | | | | | | | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | | | | | | | | |
| Device Class: | Class II | | | | | | | | | | | | | | | | |
| Product Code: | JAK | | | | | | | | | | | | | | | | |
| Device Description: | The proposed Spectral CT System is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and 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 device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The proposed Spectral CT System includes a detector array, which has spectral capability same as the cleared to market predicate device - Philips IQon Spectral CT System (K193454). | | | | | | | | | | | | | | | | |
| | The proposed Spectral CT System consists of main components that are similar to the cleared to market predicate device, Philips IQon Spectral CT cleared under (K193454): | | | | | | | | | | | | | | | | |
| | ➤ Gantry - | | | | | | | | | | | | | | | | |
| | On the rotating gantry, the main active components are: x-ray high voltage (HV) power supply,the x-ray tube,detection system | | | | | | | | | | | | | | | | |
| | ➤ Patient couch | | | | | | | | | | | | | | | | |
| | ➤ Operator console for control | | | | | | | | | | | | | | | | |
| | ➤ Common Image Reconstruction Unit (CIRS) | | | | | | | | | | | | | | | | |
| | In addition to the above components and the operating software, the system includes: Workstation hardware and software for data acquisition and image display, manipulation, storage, and filming; as well as post-processing into views other than the original axial images.Patient supports (positioning aids) are used to position the patient.Spectral Reconstruction SystemSpectral CT Viewer. | | | | | | | | | | | | | | | | |
| Indications for Use: | The Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. | | | | | | | | | | | | | | | | |
| | The Spectral CT system acquires one CT dataset - composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the | | | | | | | | | | | | | | | | |
5
| | attenuation coefficient of different materials. This allows for the generation of images
at energies selected from the available spectrum and to provide information about
the chemical composition of the body materials and/or contrast agents. Additionally,
materials analysis provides for the quantification and graphical display of attenuation,
material density, and effective atomic number. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | This information may be used by a trained healthcare professional as a diagnostic
tool for the visualization and analysis of anatomical and pathological structures in
patients of all ages, and to be used for diagnostic imaging in radiology, interventional
radiology, and cardiology and in oncology as part of treatment preparation and
radiation therapy planning. |
| | The system is also intended to be used 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 main components (detection system, the reconstruction algorithm, and the x-ray
system) that are used in the proposed Spectral CT System have the same
fundamental design characteristics and are based on the same technologies as the
cleared to market predicate device, Philips IQon Spectral CT (K193454) |
| | The design/fundamental scientific technology of both the proposed Spectral CT
System and the cleared to market predicate device Philips IQon Spectral CT
(K193454) are the same. The design changes (e.g. larger bore size, 8 cm DMS,
modified coach and additional SW features) do not change the fundamental scientific
technology of the proposed Spectral CT System. |
| | This 510(k) submission addresses modifications that were implemented in the
cleared to market predicate device Philips IQon Spectral CT (K193454). These minor
modifications include hardware and software enhancements and additional
enhanced spectral results. The additional modifications that were implemented in the
cleared to market predicate device Philips IQon Spectral CT (K193454) include: |
| | Updated Indication for Use Statement:
Ο The indications for Use of the predicate device IQon Spectral CT
(K193454) includes a clarification of the intended use population
"in patients of all ages" to align with the recommendations of the
"Pediatric Information for X-ray Imaging Device Premarket
Notifications - Guidance for Industry and Food and Drug
Administration Staff (issued November 28, 2017)". A detailed
analysis of the proposed device and verification and/or validation
testing in reference to the guidance has shown the proposed device
Spectral CT meets the guidance recommendations therefore |
6
demonstrating the safety and effectiveness of the device for the intended use population.
Hardware changes:
- Increase of Bore Size from 70cm to 80cm O
- Increase in DMS Z coverage range from 4cm to 8cm O
- Modified Couch, including increased maximal couch speed and O acceleration, increased helical scan range and supported maximal patient weight.
- Interventional controls workflow enhancements including HW and O SW elements allowing to control the couch and system.
Added software features:
- Motion Compensated Reconstruction (MCR) (Cardiac) a O reconstruction technique for cardiac ECG-gated scans with the potential to provide compensation for cardiac motion.
- Virtual Tilt viewer (VTV) a dedicated interactive image viewer O available for interventional procedures.
Improved Spectral results:
- Spectral results for cardiac The proposed Spectral CT introduces o an improvement with spectral results intended for cardiac gated scans. This improvement is based on a modification of the previously cleared classification method to target calcified structures (rather than skeleton bones).
- Spectral results available also at 100kVp. o
The aforementioned modifications implemented in the cleared to market predicate device Philips IQon Spectral CT (K193454) do not impact device safety and effectiveness.
Based on the information provided above, the proposed Spectral CT System is considered substantially equivalent to the cleared to market predicate device Philips IQon Spectral CT System (K193454), in terms of fundamental scientific technology.
Summary of Non-Clinical Performance Data:
Non-clinical performance testing has been performed on the proposed Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA quidance document(s).
- . IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1: 2012: Medical electrical equipment - Part 1: General requirements for safety and essential performance
- . IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-1-3:2008+A1:2013: Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
7
- . IEC 60601-1-6:2010 +A1: 2013: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
- IEC 60601-2-44:2009/AMD2:2016: Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of Xray equipment for computed tomography
- . IEC 60825-1:2014 -Safety of laser products. Part 1: Equipment classification and requirements (pursuant to FDA Laser Notice 56 (May 2019) Laser Products)
- IEC 62304:2006 + A1: 2015: Medical device software Software life-cycle . processes
- IEC 62366-1:2015: Medical devices Part 1: Application of usability ● engineering to medical devices ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 14971:2007 Medical devices Application of risk management to ● medical devices
Device Specific Guidance Document:
- Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).
- Pediatric Information for X-ray Imaging Device Premarket Notifications -● Guidance for Industry and Food and Drug Administration Staff (November 28, 2017)
Design Verification planning and testing was conducted at the sub-system and at the system level. The sub-systems are tested against the sub-system requirements specifications (SSRS) and the system level verification is conducted against the system requirement specifications (SRS). System and sub-system verification activities demonstrate the system or sub-systems meet the established system and sub-system level design input requirements. System and sub-system level requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation.
The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report. Non-clinical design validation testing demonstrates that the proposed Spectral CT system can be used as defined in its clinical workflow and intended use. The results of the summative usability validation indicate that the Spectral CT system has been found to be adequately safe and effective for the intended users, uses and use environments.
All these tests were used to support substantial equivalence of the proposed Spectral CT System and demonstrate that the proposed Spectral CT System:
8
| • complies with the aforementioned FDA-recognized consensus standards
and/or FDA device specific guidance document, and;
| • Meets the acceptance criteria and is adequate for its intended use. | |
|---|---|
| Therefore, the proposed Spectral CT is substantially equivalent to the cleared to | |
| market predicate device Philips IQon Spectral CT (K193454) in terms of safety and | |
| effectiveness. | |
| Summary of Clinical | |
| Performance Data: | There was no clinical testing conducted for the submission. |
| Substantial | |
| Equivalence | |
| Conclusion: | The proposed Spectral CT System is substantially equivalent to the cleared to |
| market predicate device IQon Spectral CT (K193454) in terms of indications for use, | |
| design features and fundamental scientific technology. | |
| The proposed device Spectral CT System is an evolution of predicate device Philips | |
| IQon Spectral CT (K193454) with the introduction of additional/enhanced design | |
| changes. | |
| Additionally, substantial equivalence was demonstrated by non-clinical (verification | |
| and validation) performance tests provided in this 510(k) premarket notification. | |
| These tests demonstrate that proposed Spectral CT system complies with the design | |
| input requirements and the FDA-recognized consensus standards and that no new | |
| safety and/or effectiveness concerns were raised. Spectral CT is substantially | |
| equivalent and as safe and effective as it's cleared to market predicate device |
Philips IQon Spectral CT (K193454).