(30 days)
Not Found
No
The summary describes a system for creating, viewing, and managing digital pathology slides. It mentions image processing capabilities (implied by "digital slide creation, viewing, and management") but explicitly states "Not Found" for mentions of AI, DNN, or ML. The performance studies focus on display characteristics, not algorithmic performance related to image analysis or interpretation.
No
This device is intended for in vitro diagnostic use as an aid to the pathologist for reviewing and interpreting digital images, not for direct treatment or therapy of a patient.
Yes.
Explanation: 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 prepared from formalin-fixed paraffin embedded (FFPE) tissue." This directly indicates its diagnostic purpose.
No
The device description explicitly states that the system comprises an Image Management System (IMS), an Ultra Fast Scanner (UFS), and a display, indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Philips IntelliSite Pathology Solution (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 direct statement is the primary indicator that the device is intended for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
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 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 sub-systems and a display component:
- . Image Management System (IMS)
- Ultra Fast Scanner (UFS)
- . Display
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned glass slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist
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 was performed on the display of the proposed device and demonstrate compliance with the following international and FDA-recognized consensus standards:
- IEC 60601-1-2 (4th Ed)
- ANSI/AAMI ES60601-1:2005/(R)2012 ●
- ISO 14971:2007 Medical devices – Application of risk management to medical devices
- IEC 62471: 2006; EN 62471: 2008 (Photobiological Safety Of Lamps And Lamp System) ●
Following the TPA guidance, the below mentioned sub-set of tests were performed to verify that the technological characteristics of the display were not affected by the new panel.
- Spatial resolution
- Pixel defects
- Temporal response
- Grayscale ●
- Luminance uniformity and Mura test
- Stability of luminance and chromaticity ●
- Specular and diffuse reflection coefficients
- Gray tracking
- Color scale response
- sRGB (standard Red Green Blue) color gamut ●
Conclusion:
The verification for the modified display showed that the proposed device has similar technological characteristics compared to the predicate device following the TPA quidance and is in compliance with aforementioned international and FDA-recognized consensus standards. The proposed device conforms to its intended use and user needs. Therefore, the proposed device with modified display is substantially equivalent to the predicate device in terms of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
September 20, 2019
Liselotte Kornmann, Sr. Regulatory Affairs Specialist Philips Electronics Nederland B.V. Veenpluis 6 5684 PC. Best The Netherlands
Re: K192259
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: August 15, 2019 Received: August 21, 2019
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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,
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
2
Indications for Use
510(k) Number (if known)
Device Name Philips IntelliSite Pathology Solution
Indications for Use (Describe)
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 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 ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
This 510(k) Summary is prepared in accordance with 21 CFR §807.92.
General information
Preparation date
August 08, 2019
Company identification
Philips Electronics Nederland B.V. Veenpluis 6 5684PC, Best The Netherlands Establishment registration number: 3012563754
Contact person
Primary contact person: Liselotte Kornmann Senior Regulatory Affairs Specialist Pathology Solutions Phone: +316 11621238 Email: liselotte.kornmann@philips.com
Secondary contact person: Monique Postema-Greijmans Head of Regulatory Affairs Pathology Solutions Phone: +316 21929674 Email: monique.postema@philips.com
ldentification of the device and classification
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
4
Predicate device
Device Trade Name: Philips IntelliSite Pathology Solution Manufacturer: Philips Electronics Nederland B.V. 510(k) Number: K172174 (October 4, 2017) Device Class: Class II Product Code: PSY Classification Regulation: 21 CFR, Part 864.3700 Classification Name: Whole Slide Imaging System Classification Panel: Pathology
Device description
Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. PIPS consists of two sub-systems and a display component:
- . Image Management System (IMS)
- Ultra Fast Scanner (UFS)
- . Display
Intended use / Indications for Use
The Intended Use / Indications for Use of the proposed 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 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.
Comparison of technological characteristics with the predicate device
The proposed device has the same technological characteristics compared to the predicate device, with exception of the following minor modification implemented in the proposed device: A new panel for display PP27QHD. The new panel has similar technological characteristics and pixel resolution as compared to the predicate device.
Table 5.1 below provides a comparison of the technological characteristics between the proposed device with the predicate device as per FDA's Guidance for Industry and FDA Staff
5
entitled, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" (hereafter referred to as TPA guidance), dated April 20, 2016. Other TPA items related to the display are not impacted by the new panel and remain identical to the predicate device.
| TPA Description | Predicate device
(K172174) | Proposed device | |
|-----------------------------------------------------------|-------------------------------|------------------------------------------------------|------------------------------------------------------|
| Technological
characteristics of the
display device | Panel type | Color LCD | Color LCD |
| | Manufacturer of
Panel | Bi-Search Korea Inc./LG
display Co., Ltd. | Innolux Corporation |
| | Technology | IPS technology with a-Si
Thin Film Transistor | IPS technology with a-Si
Thin Film Transistor |
| | Physical display
size | 648,5 mm x 423 mm x 91,3
mm (with backlight disc) | 648,5 mm x 423 mm x 91,3
mm (with backlight disc) |
| Table 1 Comparison of technological characteristics with predicate device | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------------------------------------------------- |
The differences between the proposed device and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) premarket notification, the proposed device is substantially equivalent to the currently marketed predicate device in terms of fundamental scientific technology and technological characteristics.
Summary of non-clinical performance data
Non-clinical performance testing was performed on the display of the proposed device and demonstrate compliance with the following international and FDA-recognized consensus standards:
- IEC 60601-1-2 (4th Ed)
- ANSI/AAMI ES60601-1:2005/(R)2012 ●
- ISO 14971:2007 Medical devices – Application of risk management to medical devices
- IEC 62471: 2006; EN 62471: 2008 (Photobiological Safety Of Lamps And Lamp System) ●
Following the TPA guidance, the below mentioned sub-set of tests were performed to verify that the technological characteristics of the display were not affected by the new panel.
- Spatial resolution
- Pixel defects
- Temporal response
- Grayscale ●
- Luminance uniformity and Mura test
- Stability of luminance and chromaticity ●
- Specular and diffuse reflection coefficients
- Gray tracking
- Color scale response
- sRGB (standard Red Green Blue) color gamut ●
6
Conclusion:
The verification for the modified display showed that the proposed device has similar technological characteristics compared to the predicate device following the TPA quidance and is in compliance with aforementioned international and FDA-recognized consensus standards. The proposed device conforms to its intended use and user needs. Therefore, the proposed device with modified display is substantially equivalent to the predicate device in terms of safety and effectiveness.
Summary of clinical performance data
The proposed device with the new display panel did not require clinical performance data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:
- Intended Use / Indications for Use,
- Technological characteristics,
- Non-clinical performance testing, and
- Safety and effectiveness ●
These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.
Conclusions
The proposed PIPS with modified display is substantially equivalent to the predicate device in terms of Intended Use/Indications for Use, technological characteristics, and safety and effectiveness.
The modification in the display of the proposed device is within the controls and predetermined specifications. Additionally, non-clinical performance tests (verification testing) ensured that the modifications are properly introduced. These tests were used to support substantial equivalence of the proposed device, and demonstrated that it is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.