K172174 · Philips Medical Systems Nederland B.V. · PSY · Oct 4, 2017 · Pathology
Device Facts
Record ID
K172174
Device Name
Philips IntelliSite Pathology Solution
Applicant
Philips Medical Systems Nederland B.V.
Product Code
PSY · Pathology
Decision Date
Oct 4, 2017
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 864.3700
Device Class
Class 2
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.
Device Story
PIPS is an automated digital pathology system comprising an Image Management System (IMS), Ultra Fast Scanner (UFS), and display. The UFS scans glass slides containing FFPE tissue to create high-resolution digital images. Pathologists use the system to view and interpret these images on a display, replacing manual light microscopy. The system facilitates digital slide management and review. The current version (2.6.1) introduces a new display (PP27QHD) with integrated temporal/spatial dithering and automated calibration via a built-in front sensor. The system is intended for clinical use by pathologists to support diagnostic decision-making. Benefits include digital workflow efficiency and remote viewing capabilities while maintaining diagnostic accuracy equivalent to conventional microscopy.
Clinical Evidence
No clinical data was required or submitted. Substantial equivalence was established through non-clinical verification and validation testing, including design validation surveys with user representatives and performance testing of the new display component.
Technological Characteristics
System comprises UFS, IMS, and 27” color LCD display. UFS: 0.25 µm/pixel resolution, CCD cameras, LED illumination, 300-slide capacity. Display: 2560 x 1440 resolution, 3.6 MP, 60 Hz, white LED backlight, built-in front sensor for calibration. Connectivity: 100 Mbit/sec or 1 Gbit Ethernet. Software: Proprietary iSyntax format. Calibration: Automated UFS calibration every 4 hours/200 slides; display calibrated via QAWeb agent.
Indications for Use
Indicated for use by pathologists to review and interpret digital images of FFPE tissue slides for in vitro diagnostic purposes. Not for use with frozen section, cytology, or non-FFPE hematopathology specimens.
Regulatory Classification
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.
Special Controls
A whole slide imaging system must comply with the following special controls: (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; (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: (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 factors 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: The intended use statement must include the information described in paragraph (i) (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 paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (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.
*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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
K172174
B. Purpose for Submission:
New display PP27QHD
C. Manufacturer and Instrument Name:
Philips Medical Systems Nederland B.V.
Philips IntelliSite Pathology Solution (PIPS)
D. Type of Test or Tests Performed:
Digital pathology whole slide imaging system
E. System Descriptions:
1. Device Description:
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, management, viewing and analysis system.
The PIPS consists of two subsystems and a display:
- Ultra Fast Scanner (UFS) (for software UFS 1.7.1.1, for hardware 4522 010 50003)
- Image Management System (IMS) (for software IMS 2.6.1)
- Display (PP27QHD)
The UFS consists of optical, mechanical, electronic and software elements to scan FFPE tissue mounted on glass slides at a resolution of 0.25 µm per pixel, which is equivalent to a 40x objective, to create digital Whole Slide Images (WSI). The UFS has a capacity of 300 slides (15 glass slide racks with up to 20 slides per rack). After the slide racks are loaded into the UFS, the UFS automatically detects and starts scanning the slides. CCD cameras are used to capture color images from the back-lit tissue specimen. An LED light source employs top-lit illumination to capture the barcode and back-lit illumination for tissue scanning. The stage (STG) and Image Capturing Unit (ICU) are fixed to each other and to the base frame to ensure correct positioning of the slide and to suppress external disturbances. Proprietary software is used for image processing during acquisition.
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Philips' proprietary format, iSyntax, is used to store and transmit the images between the UFS and the IMS.
The IMS is a software only subsystem to be used with the Display. Functionality of the IMS includes the ability to view images, organize workload, and annotate and bookmark scanned images. The user manual for PIPs specifies compatible computer environment hardware and software that is not included as part of the system.
The display is a custom developed 27” color LCD flat panel medical display. The dithering functionality is implemented on the display itself (PP26QHD). The dithering operations in the display system do not affect the image characteristics, as both the display PS27QHDCR and the display PP27QHD (MMPC-4127F1) use the same temporal dithering schematic and the same 256 pseudo random sequence. The display has the following specifications:
- 3.6 Megapixel
- Resolution 2560 x 1440
- Backlight: White LED
- Frame rate: 60 Hz; Refresh rate: 60 Hz
- Connectivity: 100 Mbit/sec or 1 Gbit Ethernet connection to internet/intranet
The different subsystems of the PIPS are connected over an IT network at the user site. The IT hardware/software that supports the IMS Application Server & Storage software is not provided as part of the PIPS, but may be located in a central server room separate from the workstation with the IMS viewing software and Display. The communication of data between UFS and IMS is via a customer provided wired network or a direct connected cable between these subsystems. PIPS includes a display that has been validated as part of the pivotal clinical study.
The PIPS allows pathologists to view and evaluate digital images of formalin-fixed, paraffin-embedded (FFPE) tissue slides that would otherwise be appropriate for manual visualization by conventional brightfield (light) microscopy. The PIPS does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.
2. Principles of Operation:
The PIPS device is an automated system designed for scanning and digitizing surgical pathology slides prepared from FFPE tissue. These digitized images can then be reviewed and interpreted by pathologists for clinical (patient care) purposes.
Prior to scanning the slide on the UFS, the technician conducts quality control of the slides per the laboratory’s standards. The technician then places the slides into racks, which are loaded into the UFS. The handler in the UFS automatically moves a slide from the storage area to the scanning area. A macro image is generated that includes the slide label and a low power image of the entire slide. The system then determines regions of
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interest in the tissue to scan, which are subsequently scanned at high resolution (0.25 µm per pixel). After the slide is scanned, it is returned to the same slot of the same rack from which it was originally obtained.
The images scanned in the UFS are compressed using Philips’ proprietary iSyntax format and are transmitted to the IMS subsystem. The images can be reviewed through the IMS only. The IMS allows the user to identify, organize and execute the worklist. The pathologist selects the first slide, navigates around the slide and views the images at the desired magnification. The pathologist is responsible for ensuring the validity of the interpretation of the digital images obtained from the PIPS.
3. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X ☐ or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ X ☐
4. Specimen Identification:
The FFPE tissue specimen is identified on the scanned images by patient-specific barcodes and/or patient identifying information present on the glass slides.
5. Specimen Sampling and Handling:
Specimen sampling, which includes FFPE tissues, is performed by clinicians. Biopsy specimens are processed by trained healthcare professionals.
6. Calibration:
The UFS performs a series of automatic calibrations. Each whole slide image (WSI) displays a flag that indicates if the scanner was in a calibrated or un-calibrated state, thereby providing a visual indicator to the viewer of the WSI. Users also may manually initiate a calibration, if desired. By default, calibrations are triggered every 4 hours (or 200 slides). Depending on circumstances, this frequency can result in a calibration in the middle of a run. To prevent such an event, the user may manually initiate the calibration process prior to scanning a batch (e.g., during slide processing).
Manual calibration may also be initiated if the UFS detects that the instrument is not calibrated during a slide scan. The system will display a message to the operator requesting whether the user wishes to accept the slide as is or re-calibrate and rescan the
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slide. As a precautionary measure, the system displays a warning message on images that were scanned using an un-calibrated scanner. In addition to the automated calibration within the UFS, routine field service visits are planned to calibrate the UFS.
The display is calibrated using a built-in front sensor. Calibrations are initiated by the QAWeb agent and performed as a background activity. The IMS subsystem does not require calibration.
7. Quality Control:
It is the responsibility of the laboratory staff to conduct and maintain quality control of the slides per their laboratory standards (e.g., staining, cover-slipping, barcode placement) prior to loading the slides into the UFS. After completing a scan, the operator is instructed by the instructions for use to check image data and image quality using the IMS Viewer. In addition to calibrations, quality checks for the display are initiated by the QAWeb agent and performed as a background activity.
8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X ☐ or No ☐
F. Regulatory Information:
1. Regulation section:
21 CFR 864.3700
2. Classification:
Class II (special controls)
3. Product code:
PSY
4. Panel:
88 - Pathology
G. Intended Use:
1. Indication(s) for Use:
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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.
2. Special Conditions for Use Statement(s):
For in vitro diagnostic (IVD) use only
For prescription use only
H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
Philips IntelliSite Pathology Solution (PIPS)
DEN160056
2. Comparison with Predicate Device:
| Similarities | | |
| --- | --- | --- |
| Item | Device
PIPS (2.6.1) | Predicate
PIPS (2.5) |
| Intended use
/Indication 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. | Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Device PIPS (2.6.1) | Predicate PIPS (2.5) |
| | 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. | |
| Ultra Fast Scanner (UFS) (for software UFS1.7.1.1 | The UFS consists of optical, mechanical, electronic and software elements to scan FFPE tissue mounted on glass slides at a resolution of 0.25 μm per pixel, which is equivalent to a 40x objective, to create digital Whole Slide Images (WSI). The UFS has a capacity of 300 slides (15 glass slide racks with up to 20 slides per rack). After the slide racks are loaded into the UFS, the UFS automatically detects and starts scanning the slides. CCD cameras are used to capture color images from the back-lit tissue specimen. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device PIPS (2.6.1) | Predicate PIPS (2.5) |
| Display | Temporal and spatial dithering is implemented in the medical display Supported color spaces including sRGB: | Temporal and spatial dithering is implemented on the graphics board sRGB is supported |
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| Differences | | |
| --- | --- | --- |
| Item | Device
PIPS (2.6.1) | Predicate
PIPS (2.5) |
| | - DICOM
- Native
Calibration and quality checks performed using a built-in sensor and QAWeb Agent software
Supported display interface including USB 2.0:
- DVI-D dual-link | Calibration and quality checks performed using LCD sensor and Nucleus software
Display Port (DP)
Universal Serial Bus (USB 2.0) |
I. Special Control/Guidance Document Referenced (if applicable):
The special controls as described in 21 CFR 864.3700(b).
FDA Guidance document: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. Guidance for Industry and Food and Drug Administration Staff. April 20, 2016.
ANSI/AAMI/ISO 15223-1: Symbols for use in the labeling of medical devices
ANSI/AAMI ES60601- 1:2005/(R)2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
AAMI ANSI IEC 62366-1:2015: Medical devices - Application of usability engineering to medical devices
ASTM D4169-14: Standard Practice for Performance Testing of Shipping Containers and Systems
IEC 62304:2006 (edition 1.0): Medical device software - Software life-cycle processes
IEC 61010-1:2010: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2- 101:2015: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 60601-1-2 (4th Ed): Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
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IEC 62471: 2006: Photobiological Safety Of Lamps And Lamp Systems
## J. Performance Characteristics:
### 1. Analytical Performance:
a. Accuracy:
Not applicable
b. Precision/Reproducibility:
Not applicable
c. Linearity:
Not applicable
d. Carryover:
Not applicable
e. Interfering Substances:
Not applicable
### 2. Other Supportive Instrument Performance Data Not Covered Above:
#### Display Equivalency Study:
Technical performance testing for the PP27QHD display was performed. The new display was compared to the display that is part of the predicate device PIPS (2.5). Testing included assessment of the following parameters: luminance, color, noise, resolution, pixel defects, artifacts, temporal response, grayscale, and specular and diffuse coefficients. All testing results demonstrated that the PP27QHD display is equivalent to the predicate device display.
Luminance: The PP27QHD and the predicate device use the same LCD panel. The luminance remains within the specified range of $350\mathrm{cd} / \mathrm{m}^2 \pm 10\%$, and the luminance stability is within approximately $0.4\%$.
Color: The color scale response when sRGB calibrated and the sRGB gamut are similar between the PP27QHD and the predicate device. The color stability over time is within the specified maximum deviation of 0.0050 in both x and y.
Noise: The PP27QHD and the predicate device use the same LCD panel and therefore the
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noise and the noise power spectrum are identical. The RMS (image variance) for multiple video levels of both luminance and color as measured on gray fields were the same.
Resolution: The MTF of the display system was measured according to the method described by Hans Roehrig et al. (2004) [Hans Roehrig, Jerry Gaskill, Jiahua Fan, Ananth Poolla, Chadwick Martin, "In-field evaluation of the modulation transfer function of electronic display devices", Proc. SPIE 5367, Medical Imaging 2004: Visualization, Image-Guided Procedures, and Display, (5 May 2004)]. The MTF of the camera system was approximately 98% at the display's Nyquist frequency. The spatial resolution of the panel is 109 dpi (dots per inch).
Artifacts: The PP27QHD and the predicate are flat panel displays. There is no problem of impedance matching in a purely digital system, ringing and ghosting are not present. This is identical for the PP27QHD and the predicate device.
Temporal response: The PP27QHD and the predicate device use the same LCD panel and therefore the temporal response is identical. The response time is approximately 12 ms and the maximum response time is 24 ms.
Grayscale: There is no difference in greyscale behavior between the PP27QHD and the predicate device when calibrated to sRGB (default setting).
Specular and diffuse coefficients: The same LCD panel is used in both the predicate and the PP27QHD and therefore the specular and diffuse coefficients in functions of wavelength are identical.
## K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable, and the special controls for this device type.
## L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
