Philips Medical Systems Nederland B.V. · Class II · Cleared Dec 10, 2024
| K-number | K242848 |
| Device name | Philips IntelliSite Pathology Solution 5.1 |
| Applicant | Philips Medical Systems Nederland B.V. |
| Product code | PSY |
| Device class | Class II |
| Decision date | Dec 10, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 864.3700 |
The Philips IntelliSite Pathology Solution 5.1 is an automated digital slide creation, viewing, and management system for in vitro diagnostic use. It aids pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded tissue. The system comprises scanners (Ultra-Fast Scanner, Pathology Scanner SG20/SG60/SG300), an Image Management System, and a clinical display (PP27QHD or Beacon C411W).
The proposed device is identical to the predicate device except for the introduction of a new optional clinical display: the Beacon C411W instead of the Barco PP27QHD. Both displays are Color LCD with Thin Film Transistor technology and identical pixel pitch (0.2331 mm × 0.2331 mm) and nearly identical physical dimensions. The key difference is the calibration software: Beacon QA Manager 1.1 replaces MediCal QAWeb Agent 1.13.12.
IEC 60601-1 Edition 3.2 (2020) for medical electrical equipment safety and essential performance; IEC 60601-1-6 (4th Ed) for usability; IEC 62471:2006 for photobiological safety; ISO 14971:2019 for risk management. Non-clinical performance testing included spatial resolution, pixel defects, artifacts, temporal response, luminance, grayscale, luminance uniformity, chromaticity stability, and color gamut volume measurements per FDA's Technical Performance Assessment Guidance.
The new display has substantially equivalent technological characteristics to the predicate display with matching pixel pitch, similar physical dimensions, and identical display technology (Color LCD, Thin Film Transistor). Bench testing demonstrated the new display meets all relevant safety and performance standards and maintains the same luminance, grayscale, and color characteristics critical for pathological image interpretation. Since the display change does not alter the device's intended use, intended patient population, mechanism of action, or fundamental safety and effectiveness profile, and non-clinical testing confirms performance parity, substantial equivalence is established.
View the full FDA submission: accessdata.fda.gov