Electronic Labeling (e-Label)
Hyper Insight-ICH™
Disclaimer: Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
1. Device Identification
- Product Name: Hyper Insight-ICH™
- Device Type: Radiological Computer-Assisted Triage and Notification Software
- Regulation Number: 21 CFR 892.2080
- FDA Product Code: QAS
- 510(k) Number: K240353, cleared July 1, 2024
- Version: v1.0.0
- Date of Release: June 30, 2023 (company release info unrelated to FDA)
2. Intended Use / Indications for Use
- Hyper Insight-ICH™ is a software-only device intended to aid in the prioritization and triage of non-contrast head CT images for patients suspected of intracranial hemorrhage (ICH).
- The device analyzes images and notifies qualified clinicians of suspected ICH findings to assist in workflow prioritization.
- It is not intended to replace the interpretation of a qualified medical professional nor to provide a diagnosis.
3. Warnings and Precautions
- For use by qualified radiologists and clinicians only.
- Do not use the notification results as the sole basis for diagnosis or treatment.
- Ensure image quality and patient metadata accuracy before processing.
- Performance may be affected by atypical anatomy or non-standard scanning protocols.
4. Performance Summary (Clinical Validation)
- Trial Design: multicenter retrospective study (13 U.S. sites)
- AUC: 0.9864
- Sensitivity: 95.45 % (95 % CI 91.55–97.90)
- Specificity: 98.47 % (95 % CI 95.59 – 99.68)
- Average Notification Time: 16.4 ± 5.5 s
5. Version Control and Updates
- Each software release includes a revision history and update log.
- To ensure continued compliance, verify that your installation matches the current FDA-cleared version listed at www.purple-ai.co/ich/e-label.
6. Regulatory and Legal Information
- FDA Clearance: 510(k) K240353 – Cleared July 1, 2024
- Device Classification: Class II
- U.S. Distribution: Prescription Use Only (21 CFR 801.109)
- Liability Statement: Clinical responsibility rests with the treating physician.
7. Company Info
- Marketed by Purple AI Inc.
- 510(k) submitter: SK Inc.
- Email: purpleai@purple-ai.co
- Support: purpleai@purple-ai.co
- Website: www.purple-ai.co/ich/e-label
- Address: 3rd Floor, 18, Tehran-ro, 20-gil, Gangnam-gu, Seoul, Korea (06235)
8. System Requirements
- Operating System: Windows 10 (64-bit) or later / Linux (Ubuntu 20.04 or later)
- Hardware: ≥ 16 vCPU, ≥ 64 GB RAM, SSD: ≥ 1TB, No GPU Required
- Integration: Supports PACS/RIS via DICOM C-STORE and C-ECHO protocols
9. Installation and Activation
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