(260 days)
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No
The document describes image processing techniques like decompression, sharpening, and contrast enhancement, but does not mention AI, ML, or any related terms like deep learning or neural networks. The focus is on a change in where the image processing occurs (server-side vs. client-side), not on the introduction of intelligent algorithms for interpretation or analysis.
No.
The device is described as an aid for pathologists to review and interpret digital images of pathology slides, and its function is to create and view digital images. It is not used for direct treatment or diagnosis of a disease or condition, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides..." This aligns with the definition of a diagnostic device.
No
The device description explicitly states that the system comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS), and a Display. The UFS is a hardware component responsible for creating the digital slides. Therefore, the device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Philips IntelliSite Pathology Solution (PIPS) is intended for in vitro diagnostic use..."
- Role in Diagnosis: The intended use describes the system as an "aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue." This directly relates to the process of making a diagnosis based on biological samples.
- Specimen Type: The device is used with "surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue," which are biological specimens used in diagnostic procedures.
- Intended User: The intended user is a "qualified pathologist," who is a medical professional involved in making diagnoses.
All of these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital side creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.
Product codes
PSY
Device Description
Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two subsystems and a display component:
- Ultra Fast Scanner (UFS)
- Image Management System (IMS)
- Display
Mentions image processing
Most image processing logic (e.g. decompression, sharpening and contrast enhancement) are performed on the server side.
To reduce the network bandwidth requirements and improve scalability an option is added (configurable by a Philips service engineer) that moves the image processing logic (i.e. decompression, sharpening and contrast enhancement) from the server side to the client side.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Pathologist / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing activities have been performed to support the substantial equivalence determination for the modified IMS containing the client side rendering change, which covered:
- A pixel comparison test to determine pixel equivalence.
- Testing of requirements, risk control measures, integration and regression.
The subject device with the modified IMS subsystem did not require non-clinical validation data to demonstrate substantial equivalence to the currently marketed predicate device, as image quality was not impacted by the introduced change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 17, 2021
Philips Medical Systems Nederland B.V. Liselotte Kornmann Senior Regulatory Affairs Specialist Veenpluis 6 Best, Noord-Brabant 5684PC Netherlands
Re: K203845
Trade/Device Name: Philips IntelliSite Pathology Solution Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PSY Dated: December 24, 2020 Received: December 31, 2020
Dear Liselotte Kornmann:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Soma Ghosh -S
Soma Ghosh, Ph.D. Chief Division of Molecular Genetics and Pathology 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) K203845
Device Name Philips IntelliSite Pathology Solution
Indications for Use (Describe)
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital side creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.
Type of Use (Select one or both, as applicable)
| Residential (HUD/USDA Single Family Direct) | Other - Please describe: | ||
|---|---|---|---|
| -------------------------- | --------------------------------------------- | -------------------------- | -------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Preparation date: December 24, 2020
Company identification
Philips Medical Systems Nederland B.V. Veenpluis 6 5684PC, Best The Netherlands Establishment registration number: 3012563754
Contact person
Name: Liselotte Kornmann (primary) Title: Senior Regulatory Affairs Specialist Digital and Computational Pathology Telephone: +31611621238 Email: liselotte.kornmann@philips.com
Name: Monique Greijmans (secondary) Title: Head of Regulatory Affairs Digital and Computational Pathology Telephone: +31621929674 Email: monique.postema@philips.com
Device
Device Trade Name: Philips IntelliSite Pathology Solution Device Class: Class II Product Code: PSY Classification Regulation: 21 CFR, Part 864.3700 Classification Name: Whole Slide Imaging System Classification Panel: Pathology
Predicate device
Device Trade Name: Philips IntelliSite Pathology Solution 510(k) Number: K192259 (September 20, 2019)
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Device description
Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two subsystems and a display component:
- . Ultra Fast Scanner (UFS)
- Image Management System (IMS)
- Display
Intended use / Indications for use
The Intended Use / Indications for Use of the subject device is unchanged compared to the predicate device:
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Imagement System (IMS), the Ultra Fast Scanner (UFS) and display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.
Summary of technological characteristics
The subject device employs the same technological characteristics compared to the currently marketed predicate device, with exception of the following modification implemented in the IMS of the subject device: Introduction of client side rendering.
The table below provides a comparison of the technological characteristics between the subject device and the predicate device as per FDA's Guidance for Industry and FDA Staff entitled, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016. Other items from this Technical Performance Assessment (TPA) guidance are not impacted by the client side rendering change and remain identical to the predicate device.
| TPA description | Predicate device
(K192259) | Subject device |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Review and
Manipulation
Software -
Computer
Environment | Most image processing logic (e.g.
decompression, sharpening and
contrast enhancement) are
performed on the server side.
The programming language is C#. | To reduce the network bandwidth
requirements and improve
scalability an option is added
(configurable by a Philips service
engineer) that moves the image
processing logic (i.e. |
Comparison of the technological characteristics with predicate device
5
| TPA description | Predicate device
(K192259) | Subject device |
|-----------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | decompression, sharpening and
contrast enhancement) from the
server side to the client side.
The programming language is
JavaScript. |
Comparison of the technological characteristics with predicate device
Substantial equivalence comparison
The differences between the subject and the predicate device does not raise any new questions regarding safety or effectiveness. Based on the information provided above, the subject PIPS is substantially equivalent to the currently marketed predicate device (K192259) in terms of technological characteristics.
Summary of non-clinical performance data
Verification testing activities have been performed to support the substantial equivalence determination for the modified IMS containing the client side rendering change, which covered:
- A pixel comparison test to determine pixel equivalence. .
- Testing of requirements, risk control measures, integration and regression. .
The subject device with the modified IMS subsystem did not require non-clinical validation data to demonstrate substantial equivalence to the currently marketed predicate device, as image quality was not impacted by the introduced change.
Conclusion:
The verification executed for the modified IMS of the subject PIPS meets all product requirements and demonstrated pixel equivalence for client side rendering. The technological change identified for the IMS did not impact the safety and effectiveness of the product. Therefore, the subject PIPS, with modified IMS subsystem, is substantially equivalent to the predicate device in terms of safety and effectiveness.
Summary of clinical performance data
The subject device with the modified IMS subsystem did not require clinical performance data to demonstrate substantial equivalence to the currently marketed predicate device, as image quality was not impacted by the introduced change.
Conclusions
The subject PIPS is substantially equivalent to the predicate device in terms of Intended Use / Indications for Use, technological characteristics, and safety and effectiveness.
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Non-clinical performance tests ensured that the modification is properly introduced and the device conforms to its intended use, users and use environment. These tests were used to support substantial equivalence of the subject device, and demonstrated that it is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.