(270 days)
Not Found
No
The summary describes a system for creating, viewing, and managing digital pathology slides, including scanners, image management software, and a display. While it mentions image processing and performance studies related to image quality and diagnostic agreement, there is no mention of AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on the technical aspects of digital slide creation and viewing, and the clinical study compares digital viewing to traditional microscopy, not to an AI-assisted diagnosis.
No
The device is described as an aid to the pathologist for reviewing and interpreting digital images of pathology slides, intended for in vitro diagnostic use. It does not directly treat or prevent a disease or condition.
Yes
The device is explicitly stated as being "intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides."
No
The device description explicitly states that the system comprises hardware components including scanners (Ultra Fast Scanner, Pathology Scanner SG20, SG60, SG300) and a display (PP27QHD), in addition to the software (Image Management System).
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 PIPS 5.1 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."
- Role in Diagnosis: The device is intended to be used by a pathologist as an "aid to the pathologist to review and interpret digital images," which is a crucial step in the diagnostic process.
- Specimen Type: The device is used with "surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue," which are biological specimens used for diagnostic purposes.
- Intended User: The intended user is a "Pathologist," a medical professional involved in diagnosis.
- Care Setting: The intended care setting is "in vitro diagnostic use," further reinforcing its IVD nature.
The device is designed to process and present information derived from biological specimens (tissue slides) to assist a qualified professional in making a diagnosis, which aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and PP27QHD Display. The PIPS 5.1 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 5.1.
Product codes
PSY
Device Description
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component:
-
- Subsystems:
- a. A scanner in any combination of the following scanner models
- i. Ultra Fast Scanner (UFS)
- ii. Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300
- b. Image Management System (IMS) 4.2
-
- Display PP27QHD
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Whole Slide Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / in vitro diagnostic use
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
The equivalence between the subject device and the predicate device has been supported by bench testing data based on pixelwise comparison. A pixelwise comparison test has been performed to compare images reproduced by the predicate device and the subject device for the same iSyntax file to demonstrate identical image reproduction for UFS Images. The subject device was tested as operating with the intended components, including the scanner, image management system and display.
Scanned images, on the predicate device, from 42 FFPE tissue qlass slides from different anatomic locations were used as the test input. Three regions of interest (ROI) from each of the scanned images were selected. For each ROI, the differences between the views generated by the subject and predicate device were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric ΔE for each corresponding pixel pair. Each location has been processed and sampled at 20x and 40x magnification level on both the predicate and subject device. The client workstation, according to device specification, with PP27QHD display has been used to capture ROIs and to perform the pixelwise comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two studies were conducted with the PIPS 5.1 device: Analytical studies to support device precision and clinical study to support the clinical performance of the device.
1. Precision study
Device precision was evaluated for its proposed intended use. The study was divided into the following three sub-studies:
- Scans from the same scanner (intra-system precision)
- Scans from different scanners at the same site (inter-system precision)
- Scans from different scanners located at different sites read by different pathologists (Inter-site reproducibility)
Intra-system study results: Overall Number of Comparison Pairs: 3600, Number of Pairwise Agreements: 3178, Agreement Rate: 88.3%, 95% CI: (86.7; 89.9)
Inter-system study results: Overall Number of Comparison Pairs: 3610, Number of Pairwise Agreements: 3445, Agreement Rate: 95.4%, 95% CI: (94.4; 96.5)
Inter-site study results: Overall Number of Comparison Pairs: 1228, Number of Pairwise Agreements: 1114, Agreement Rate: 90.7%, 95% CI: (88.4; 92.9)
The data show that the studies met the acceptance criterion of the lower limit of the 95% confidence interval (CI) of the Average Positive Agreement exceeding 85%.
2. Clinical Study:
A study was conducted to demonstrate that viewing, reviewing and diagnosing digital images of surgical pathology FFPE tissue slides using the PIPS 5.1 is non-inferior to using optical (light) microscopy. The primary endpoint was the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (main) diagnosis, which is based on the original sign-out diagnosis rendered at the institution, using an optical (light) microscope. By the study protocol, a total of 952 cases consisting of multiple organ and tissue types were to be enrolled. Cases were divided over three sites. In total 11 pathologists divided over three sites read all the cases assigned to the site using both the MO and the MD modalities in a randomized order and with a washout period of four weeks in between. Three adjudicators reviewed the reader diagnosis against the sign out diagnosis and determined whether the diagnosis was concordant, minor discordant or major discordant. After adjudication, the major discordance rate per modality was calculated. The clinical study successfully met the primary endpoint of the study by demonstrating that viewing, reviewing, and diagnosing surgical pathology tissue slides by a pathologist supported by using PIPS 5.1 was non-inferior to using an optical microscope. The overall difference in major discordance rate (compared to the main diagnosis) for digital-optical was 0.1% with a 95% confidence interval of (-1.01%; 1.18%). As the upper limit of this confidence interval was less than the non-inferiority margin of 4%, manual digital diagnosis by a pathologist using the subject PIPS 5.1 is non-inferior to diagnosis by a pathologist using the optical microscope.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision Study Agreement Rates:
Intra-system: 88.3% (95% CI: (86.7; 89.9))
Inter-system: 95.4% (95% CI: (94.4; 96.5))
Inter-site: 90.7% (95% CI: (88.4; 92.9))
Clinical Study Major Discordance Rate:
Overall difference in major discordance rate (compared to the main diagnosis) for digital-optical was 0.1% with a 95% confidence interval of (-1.01%; 1.18%).
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
June 24, 2024
Philips Medical Systems Nederland B.V. Liselotte Kornmann Associate Director Regulatory Affairs Veenpluis 6 Best, Noord Brabant 5684PC Netherlands
Re: K233204
Trade/Device Name: Philips IntelliSite Pathology Solution 5.1 Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: PSY Dated: September 28, 2023 Received: September 28, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shyam Kalavar -S
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233204
Device Name Philips IntelliSite Pathology Solution 5.1
Indications for Use (Describe)
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20. Pathology Scanner SG60, Pathology Scanner SG300 and PP27QHD Display. The PIPS 5.1 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 5.1.
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
510(k) Summary
Philips IntelliSite Pathology Solution 5.1
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR ઠુક્ષ્ઠ07.92.
Preparation date: June 21, 2024
Company identification
Philips Medical Systems Nederland B.V. Veenpluis 6 5684PC. Best The Netherlands Establishment registration number: 3012563754
Contact person
Name: Liselotte Kornmann Title: Associate Director Regulatory Affairs Digital and Computational Pathology Telephone: +31611621238 Email: liselotte.kornmann@philips.com
Device
Device Trade Name: Philips IntelliSite Pathology Solution 5.1 Device Class: Class II Product Code: PSY Classification Requlation: 21 CFR, Part 864.3700 Classification Name: Whole Slide Imaging System Classification Panel: Pathology 510(k) Submission Number: K233204
Predicate device
Device Trade Name: Philips IntelliSite Pathology Solution 5.1 510(k) Number: K203845 (September 17, 2021)
Device description
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component:
-
- Subsystems:
- a. A scanner in any combination of the following scanner models
- i. Ultra Fast Scanner (UFS)
- ii. Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300
- b. Image Management System (IMS) 4.2
-
- Display PP27QHD
4
Intended Use / Indications for Use
Compared to the predicate device, the Intended Use / Indications for Use of the subject device is updated to reflect the new Pathology Scanner models and IMS and is as follows:
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and PP27QHD Display. The PIPS 5.1 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 safequards to assure the validity of the interpretation of images obtained using PIPS 5.1.
Summary of Intended Use / Indications for Use
The difference between the subject and the predicate device does not alter the intended use of the device nor do they raise any new questions regarding safety or effectiveness. Both the subject and predicate devices have the same intended 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.
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:
- · Addition of a new Pathology Scanner SG with the following variants:
- Pathology Scanner SG20 o
- Pathology Scanner SG60 o
- Pathology Scanner SG300 o
- Update of Image Management System 4.1 (IMS 4.1) to IMS 4.2 to support the ● previously cleared Ultra Fast Scanner (UFS) in K203854 and Pathology scanners SG20/SG60/SG300.
- . The three pathology scanner SG models share the same imaging pipeline, which is implemented in the scan engine (Second Generation Scanner Engine-SGSE). Based on the System Design Specification documents, the differences between the three SG models are mainly the slide feeders and housing.
| Item | Predicate device PIPS
(K203845) | Subject device PIPS 5.1
(K233204) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, | The Philips IntelliSite Pathology
Solution (PIPS) 5.1 is an automated
digital slide creation, viewing, and
management system. The PIPS 5.1 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 5.1 is not
intended for use with frozen section, |
| Item | Predicate device PIPS
(K203845) | Subject device PIPS 5.1
(K233204) |
| | cytology, or non-FFPE
hematopathology specimens. | 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. | The PIPS 5.1 comprises the Image
Management System (IMS) 4.2, the
Ultra Fast Scanner (UFS), Pathology
Scanner SG20, Pathology Scanner
SG60, Pathology Scanner SG300 and
PP27QHD Display. The PIPS 5.1 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 5.1. |
| Specimen type | Surgical pathology slides prepared
from formalin-fixed, paraffin-
embedded tissue | Same |
| Principle of
operation | The technician loads the slides into the
WSI scanner. The scanner scans the
slides and generates WSI image for
each slide. The technician performs
Quality Control (QC) on scanned WSI
images and rescan the slide when QC
is failed. The acquired WSI images are
stored in an end user provided image
storage attached to the local network.
During review, the pathologist opens
WSI images acquired with the WSI
scanner from the image storage,
performs further QC and reads WSI
images of the slides to make a
diagnosis | Same |
| Device
components | UFS, IMS and color monitor display | UFS, Pathology Scanner SG, IMS and
color monitor display |
| Whole Slide
Imaging
Scanner | UFS with loading capacity of 300 | UFS with loading capacity of 300
Pathology Scanner SG with loading
capacity of 300, 60, 20 |
| Image File
Format | iSyntax | Same |
| End User's
Interface | The IMS Image Processing Pipeline is
designed to process UFS iSyntax data | The IMS Image Processing Pipeline is
designed to process both UFS and
Pathology Scanner SG iSyntax data |
| Monitor Display | PP27QHD | Same |
Comparison of technological characteristics
5
Comparison of technological characteristics
The differences between the subject and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided above, the subject device PIPS 5.1 is substantially equivalent to the currently marketed predicate device (K203845) in terms of technological characteristics.
6
Performance Data
A. Summary of non-clinical performance data
Verification testing activities have been performed to support the substantial equivalence determination for the subject device PIPS 5.1 (including the new Pathology Scanner SG and modified IMS for Pathology Scanner SG support). Performance characteristics of the subject device PIPS 5.1 are equivalent to those of the predicate device PIPS (K203845).
- Technical studies were conducted to evaluate the performance of the new Pathology Scanner SG and modified IMS for Pathology Scanner SG support, as recommended in FDA's guidance, Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.
| TPA item | Performance data description |
|---|---|
| Slide Feeder | Information was provided on the configuration of the slide feed mechanism, |
| including a physical description of the slide, the number of slides in queue (carrier), | |
| and the class of automation. Information was provided on the user interaction with | |
| the slide feeder, including hardware, software, feedback mechanisms, and Failure | |
| Mode and Effects Analysis (FMEA). | |
| Light Source | Descriptive information associated with the light source was provided. Testing |
| information was provided to verify the spectral distribution of the light that is | |
| incident on the slide to the slide is to verify that the color reproducibility of the | |
| Pathology Scanner SG is within predefined limits. The tests passed their | |
| acceptance criteria. | |
| Imaging optics | An optical schematic with all optical elements identified from slide (object plane) to |
| image sensor (micro camera) was provided. Descriptive information regarding the | |
| microscope objective, auxiliary lens(es), and the magnification of imaging optics | |
| was provided. Testing information regarding the magnification, relative irradiance, | |
| optical distortions, and chromatic aberrations was provided. The tests passed their | |
| acceptance criteria. | |
| Mechanical | |
| scanner | |
| Movement | Information and specifications on the configuration of the stage, method of |
| movement, control of movement of the stage, and FMEA was provided. Test data | |
| to determine positioning accuracy and repeatability for the X-Y and Z stages was | |
| provided. The tests passed their acceptance criteria. | |
| Digital Imaging | |
| sensor | Information and specifications on the sensor type, pixel information, responsivity |
| specifications, noise specifications, readout rate, and digital output format were | |
| provided. Testing to determine the correct functioning of the digital image sensor. | |
| The tests passed their acceptance criteria. | |
| Image | |
| Processing | |
| Software | Information and specifications on the exposure control, white balance, color |
| correction, sub-sampling, pixel-offset correction, shading (flat-field) correction, and | |
| pixel-defect correction were provided. | |
| Image | |
| composition | Information and specifications on the scanning method and focus, was provided. |
| Test data to analyze the image composition performance was provided. The tests | |
| passed their acceptance criteria. | |
| Image file | |
| formats | Information and specifications on the compression method, compression ratio, file |
| format, and file organization were provided. | |
| Image Review | |
| Manipulation | |
| Software | Information and specifications for continuous panning, continuous zooming, |
| discrete Z-axis displacement, comparison of slides in multiple windows, annotation | |
| tools, image enhancement, color correction, tracking of visited areas, digital | |
| bookmarks, and shared viewing sessions was provided. Test data to analyze the | |
| image review manipulation software was provided. The tests passed their | |
| acceptance criteria. | |
| Display | No changes have been introduced for the PP27QHD display. Tests results for this |
| display in previous 510(k) remain valid. | |
| Computer | |
| Environment | Information and specifications on the computer hardware, operating system, |
| memory, hard disk, graphics card, graphics card driver, color management | |
| settings, color profile, display interface and network were provided. | |
| TPA item | Performance data description |
| Color | |
| Reproducibility | Test data to quantify the accuracy and precision of the color transformation from |
| the slide to the display monitor was provided. The tests passed their acceptance | |
| criteria | |
| Spatial | |
| Resolution | Test data to evaluate the spatial resolution of the image acquisition phase was |
| provided. The tests passed their acceptance criteria. | |
| Focusing Test | Test data to demonstrate that the focus quality is clinically acceptable for a variety |
| of histologic preparations, including different tissue types, stain intensities, | |
| specimen thicknesses, and stain types was provided. The tests passed their | |
| acceptance criteria. | |
| Whole Slide | |
| Tissue | |
| Coverage | detected by device was provided. The tests passed their acceptance criteria. Test data to demonstrate that the entire tissue specimen on the clinical slide is |
| Stitching Error | Test data to evaluate the stitching quality of the high resolution image of the |
| Pathology Scanner SG. The tests passed their acceptance criteria. | |
| Turnaround | |
| Time | Test data to evaluate the average time required to execute zooming and panning |
| operations, and to refresh the display in response to user input was provided. The | |
| tests passed their acceptance criteria. |
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Electrical safety testing was conducted in accordance with IEC61010-1 with passing results. Electromagnetic compatibility testing was conducted in accordance with IEC 61326-2-6 for laboratory use of in vitro diagnostic equipment with passing results. Electromagnetic compatibility testing was conducted in accordance with IEC 60601-1-2. The test results showed "pass" for emissions and immunity.
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Human factors studies were designed around user tasks, and use scenarios performed by users were conducted. For all user groups, tasks were successfully completed.
3. Pixelwise comparison with the predicate device:
The equivalence between the subject device and the predicate device has been supported by bench testing data based on pixelwise comparison. A pixelwise comparison test has been performed to compare images reproduced by the predicate device and the subject device for the same iSyntax file to demonstrate identical image reproduction for UFS Images. The subject device was tested as operating with the intended components, including the scanner, image management system and display.
Scanned images, on the predicate device, from 42 FFPE tissue qlass slides from different anatomic locations were used as the test input. Three regions of interest (ROI) from each of the scanned images were selected. For each ROI, the differences between the views generated by the subject and predicate device were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric ΔE for each corresponding pixel pair. Each location has been processed and sampled at 20x and 40x magnification level on both the predicate and subject device. The client workstation, according to device specification, with PP27QHD display has been used to capture ROIs and to perform the pixelwise comparison.
The color differences of all pixels within each ROI were reported. The image data of all ROIs were also provided for verification. The test results demonstrated that all image pairs are identical with zero ΔE. The subject device has been found to adequately reproduce digital pathology images at the pixel level with respect to its intended use.
B. Summary of analytical and clinical performance data
Two studies were conducted with the PIPS 5.1 device: Analytical studies to support device precision and clinical study to support the clinical performance of the device.
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1. Precision study
Device precision was evaluated for its proposed intended use. The study was divided into the following three sub-studies:
- . Scans from the same scanner (intra-system precision)
- Scans from different scanners at the same site (inter-system precision) ●
- Scans from different scanners located at different sites read by different pathologists ● (Inter-site reproducibility)
Intra-system study results
| System | Number of
Comparison Pairs | Number of
Pairwise Agreements | Agreement Rate | |
|-----------|-------------------------------|----------------------------------|----------------|--------------|
| | | | % | 95% CI |
| Overall | 3600 | 3178 | 88.3 | (86.7; 89.9) |
| Scanner 1 | 1210 | 1054 | 87.1 | (84.1; 90.0) |
| Scanner 2 | 1190 | 1049 | 88.2 | (85.6; 90.7) |
| Scanner 3 | 1200 | 1075 | 89.6 | (86.6; 92.4) |
Inter-system study results
| Systems
compared | Number of
Comparison Pairs | Number of
Pairwise Agreements | Agreement Rate | |
|--------------------------|-------------------------------|----------------------------------|----------------|--------------|
| | | | % | 95% CI |
| Overall | 3610 | 3445 | 95.4 | (94.4; 96.5) |
| Scanner 1 –
Scanner 2 | 1200 | 1144 | 95.3 | (94.0; 96.6) |
| Scanner 1 –
Scanner 3 | 1207 | 1152 | 95.4 | (94.1; 96.7) |
| Scanner 2 –
Scanner 3 | 1203 | 1149 | 95.5 | (94.2; 96.7) |
Inter-site study results
| Sites
compared | Number of
Comparison Pairs | Number of
Pairwise Agreements | Agreement Rate | |
|-------------------|-------------------------------|----------------------------------|----------------|--------------|
| | | | % | 95% CI |
| Overall | 1228 | 1114 | 90.7 | (88.4; 92.9) |
| Site 1 – Site 2 | 407 | 368 | 90.4 | (87.5; 93.1) |
| Site 1 – Site 3 | 406 | 371 | 91.4 | (88.5; 94.1) |
| Site 2 – Site 3 | 415 | 375 | 90.4 | (87.5; 93.1) |
The data show that the studies met the acceptance criterion of the lower limit of the 95% confidence interval (CI) of the Average Positive Agreement exceeding 85%.
2. Clinical Study:
A study was conducted to demonstrate that viewing, reviewing and diagnosing digital images of surgical pathology FFPE tissue slides using the PIPS 5.1 is non-inferior to using optical (light) microscopy. The primary endpoint was the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (main) diagnosis, which is based on the original sign-out diagnosis rendered at the institution, using an optical (light) microscope. By the study protocol, a total of 952 cases consisting of multiple organ and tissue types were to be enrolled. Cases were divided over three sites. In total 11 pathologists divided over three sites read all the cases assigned to the site using both the MO and the MD modalities in a randomized order and with a washout period of four weeks in between. Three adjudicators reviewed the reader diagnosis against the sign
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out diagnosis and determined whether the diagnosis was concordant, minor discordant or major discordant. After adjudication, the major discordance rate per modality was calculated. The clinical study successfully met the primary endpoint of the study by demonstrating that viewing, reviewing, and diagnosing surgical pathology tissue slides by a pathologist supported by using PIPS 5.1 was non-inferior to using an optical microscope. The overall difference in major discordance rate (compared to the main diagnosis) for digital-optical was 0.1% with a 95% confidence interval of (-1.01%; 1.18%). As the upper limit of this confidence interval was less than the non-inferiority margin of 4%, manual digital diagnosis by a pathologist using the subject PIPS 5.1 is non-inferior to diagnosis by a pathologist using the optical microscope.
The acceptance criterion was as follows: The manual digital method would be declared noninferior to the manual optical method if the upper bound of the 95% two-sided confidence interval for the manual digital – manual optical difference in major discordance rate is less than 4%.
Substantial equivalence conclusion
The subject PIPS 5.1 is substantially equivalent to the predicate device Philips IntelliSite Pathology Solution (K203845) in terms of Intended Use / Indications for Use, technological characteristics, and safety and effectiveness.
Non-clinical and clinical performance tests demonstrated that the modifications are 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.