(153 days)
Unknown
The summary describes image processing and an algorithm for assessing positioning quality, but does not explicitly mention AI or ML, nor does it provide details about training or test sets that would definitively indicate the use of these technologies.
No.
The device provides feedback on patient positioning quality for X-ray images and is explicitly stated not to be for diagnostic purposes or as a basis for repeating an image, which distinguishes it from a therapeutic device directly involved in treatment or therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "Philips Radiology Smart Assistant is not intended for diagnostic purposes."
Yes
The device is described as a "software package" that runs on "general purpose computing hardware." It receives images from existing X-ray systems and provides feedback based on image analysis, without including or modifying the X-ray hardware itself.
Based on the provided information, the Philips Radiology Smart Assistant is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use explicitly states that the device is "not intended for diagnostic purposes." IVDs are specifically designed to be used for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device processes and displays medical images (X-rays) and provides feedback on patient positioning. It does not analyze biological samples or provide information about a patient's health status based on such analysis.
- Functionality: The core function is to assess the technical quality of an X-ray image based on positioning parameters (collimation, rotation, inhalation state). This is a quality control function related to image acquisition, not a diagnostic test performed on a biological sample.
While the device uses medical images and is used in a clinical setting, its purpose is to improve the quality of image acquisition, not to diagnose a disease or condition based on the analysis of a biological specimen.
N/A
Intended Use / Indications for Use
Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.
Product codes
KPR, JAA
Device Description
Philips Radiology Smart Assistant is a software package intended to be used by qualified healthcare professionals. The software is used with general purpose computing hardware for the processing, display of images, and patient positioning feedback within a clinical environment. Philips Radiology Smart Assistant software supports receiving and displaying images from X-ray systems.
The system supports receiving, sending, storing, acceptance and displaying of medical images received from the following modality types via DICOM: DX as well as hospital/radiology information systems.
Philips Radiology Smart Assistant includes a post-processing patient positioning feedback function for posterior-anterior (PA) chest X-ray images. The patient positioning assessment is intended to provide a qualified healthcare professional with timely feedback on the quality of acquired X-ray images that do not suffice the positioning quality standards of clinical guidelines. The quality check comprises an assessment of the following parameters:
- Collimation
- Patient Rotation
- Patient Inhalation State
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-Ray, DX
Anatomical Site
posterior-anterior (PA) chest
Indicated Patient Age Range
Not intended to be used on pediatric population
Intended User / Care Setting
qualified healthcare professionals / clinical environment
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
Clinical performance testing was conducted on previously acquired posteroanterior (PA) chest X-ray images in order to demonstrate the performance of the Philips Radiology Smart Assistant in providing patient positing feedback. The algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians using standard diagnostic metrics. The results of the clinical performance study support the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues. The clinical performance study demonstrates that the Philips Radiology Smart Assistant is safe and effective for the specified intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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December 13, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH % Connie Pascual Sr. Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY
Re: K212186
Trade/Device Name: Philips Radiology Smart Assistant Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, JAA Dated: November 12, 2021 Received: November 15, 2021
Dear Connie Pascual:
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 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
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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
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Indications for Use
510(k) Number (if known) K212186
Device Name Philips Radiology Smart Assistant
Indications for Use (Describe)
Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | November 12, 2021 |
|---|---|
| Manufacturer: | Philips Medical Systems DMC GmbH |
| Roentgenstrasse 24-26 | |
| 22335 Hamburg | |
| GERMANY | |
| Establishment Registration Number: 3003768251 | |
| Primary Contact Person: | Connie Pascual |
| Regulatory Affairs Manager | |
| Phone: +1 (978) 659-2440 | |
| E-mail: connie.pascual@philips.com | |
| Secondary Contact Person: | Ann Lebar |
| Phone: +1 (414) 217-6244 | |
| E-mail: ann.lebar@philips.com | |
| Device Name: | Philips Radiology Smart Assistant |
| Classification: | |
| Classification Name: | System, X-Ray, Stationary |
| Classification Regulation: | 21 CFR 892.1680 |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product code: | KPR, JAA |
| Trade Name/Device Name: | Philips Radiology Smart Assistant |
| Primary Predicate Device: | |
| Manufacturer: | Philips Medical Systems DMC GmbH |
| 510(k) Clearance: | K210692 |
| Classification Regulation: | 21 CFR Part 892.1680 |
| Classification Name: | System, X-Ray, Stationary |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | KPR |
| Trade Name/Device Name: | DigitalDiagnost |
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| Reference Device: | Philips Healthcare Informatics, Inc. |
|---|---|
| 510(k) Clearance: | K182926 |
| Classification Regulation: | 21 CFR 892.2050 |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | LLZ |
| Trade Name/Device Name: | IntelliSpace Radiology |
Device description:
Philips Radiology Smart Assistant is a software package intended to be used by
qualified healthcare professionals. The software is used with general purpose
computing hardware for the processing, display of images, and patient positioning
feedback within a clinical environment. Philips Radiology Smart Assistant software
supports receiving and displaying images from X-ray systems.
The system supports receiving, sending, storing, acceptance and displaying of
medical images received from the following modality types via DICOM: DX as well
as hospital/radiology information systems.
Philips Radiology Smart Assistant includes a post-processing patient positioning
feedback function for posterior-anterior (PA) chest X-ray images. The patient
positioning assessment is intended to provide a qualified healthcare professional
with timely feedback on the quality of acquired X-ray images that do not suffice the
positioning quality standards of clinical guidelines. The quality check comprises an
assessment of the following parameters:
- Collimation
- Patient Rotation
- Patient Inhalation State
Indications for
Use:
Philips Radiology Smart Assistant is intended to provide patient positioning
feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a
software which informs Healthcare Professionals regarding patient positioning
quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is
not intended for diagnostic purposes. It is not intended to be used as the basis for
repeating an image.
Fundamental
Scientific
Technology:
The proposed device, Philips Radiology Smart Assistant, is a software accessory to
currently marketed parent predicate device, DigitalDiagnost (K210692). This
software is used with general purposed computing hardware for the processing and
display of images throughout a clinical environment by healthcare professionals.
The Philips Radiology Smart Assistant provides post-processing patient positioning
feedback for PA chest X-ray images.
At a high level the Philips Radiology Smart Assistant and the parent predicate
device (K210692) are based on the following equivalent elements:
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- Similar Intended Use
- Prescription Only
- Compatibility with standard radiological images
- Processes and displays digital radiographic images
The following technological differences exist between the proposed and parent predicate device:
- Anatomy of interest is PA chest images only
- Patient Positioning Feedback feature
- . Not intended to be used on pediatric population
Summary of technological characteristics:
The presented technological differences are considered low risk, providing additional features such as the Patient Positioning Feedback for the purposes of training and education for healthcare professionals. This new functionality has been verified and validated, and does not raise new questions on safety and/or effectiveness. This new features has not changed the intended use and operational principles of the parent predicate device. Therefore, Philips Radiology Smart Assistant is substantially equivalent to the currently marketed parent predicate device, DigitalDiagnost (K210692).
Non-clinical performance testing has been performed on the Philips Radiology Smart Summary of Assistant and demonstrates compliance with the following international and FDA-Non-Clinical recognized consensus standards and FDA guidance document: Performance Data:
- ' EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
- I IEC 82304-1:2016 Health Software – General requirements for product safety
- 트 IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- 트 NEMA-PS 3.1 – PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- I Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical characteristics claims, the requirement specifications and the risk management results.
Non-Clinical verification and or validation test results demonstrate that the Philips Radiology Smart Assistant:
- Complies with the aforementioned international and FDA-recognized ● consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, the Philips Radiology Smart Assistant is substantially equivalent to the primary currently marketed and predicate device, DigitalDiagnost (K210692) in terms of safety and effectiveness.
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Summary of The Philips Radiology Smart Assistant did require a clinical study based upon the following attributes: Clinical Data:
- Main Feature Patient Positioning Feedback ●
- . Indications for use
Clinical performance testing was conducted on previously acquired posteroanterior (PA) chest X-ray images in order to demonstrate the performance of the Philips Radiology Smart Assistant in providing patient positing feedback. The algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians using standard diagnostic metrics. The results of the clinical performance study support the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues. The clinical performance study demonstrates that the Philips Radiology Smart Assistant is safe and effective for the specified intended use.
The Philips Radiology Smart Assistant is a software accessary that is substantially Substantial equivalent to its predicate parent device, DigitalDiagnost (K210692), in terms of Equivalence similar intended use and different technological characteristics that do not raise Conclusion: different questions of safety and effectiveness. A clinical performance study was performed to demonstrate the performance of the patient positioning feedback algorithm. Substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 82304, IEC 62366 and EN ISO 14971. The results of these tests demonstrate that Philips Radiology Smart Assistant met the acceptance criteria and is adequate for the specified intended use.