Clearance Strategy, Predicate Benchmarks & Clinical Equivalence.
BeatioPulse combines proven 510(k) predicate device safety with transformative on-skin edge neural network intelligence. Review our predicate mappings, international medical standards, and 150-patient clinical protocol.
What is the BeatioPulse FDA 510(k) Clearance Pathway?
The BeatioPulse™ FDA 510(k) pathway is a Class II medical device submission under 21 CFR 870.2800 (product code MWI). It establishes substantial equivalence against predicate devices (iRhythm Zio and BioIntelliSense BioButton) through bench testing and a 150-patient multi-center IRB equivalence trial adhering to IEC 60601-1, IEC 62304, and ISO 13485:2016.
FDA 510(k) Predicate Device Comparative Analysis
Direct technical mapping against cleared commercial predicates.
| Regulatory Parameter | BeatioPulse™ AI Smart Patch | Predicate 1: iRhythm Zio Patch (K121319) | Predicate 2: BioIntelliSense BioButton (K201416) |
|---|---|---|---|
| Classification & Regulation | Class II, 21 CFR 870.2800 | Class II, 21 CFR 870.2800 | Class II, 21 CFR 870.2910 |
| Product Code | MWI, DQA | MWI | DQA, DRG |
| Telemetry Modality | Real-Time Sub-800ms Cloud Relay | Post-monitoring postal mail-in (no real-time) | Periodic BLE sync to cellular hub |
| Defibrillation Proofing | 2,000V (IEC 60601-1 Type CF) | Not defibrillator-proof | Not rated for defibrillation |
| On-Device Machine Learning | INT8 Neural Network on Nordic nRF5340 | None (Server-side cloud processing only) | Heuristic trend detection |
| Continuous Wear Duration | 14 Days Continuous (IP68) | 14 Days Continuous (Water-resistant) | 16–30 Days (Continuous) |
| Patient Contact Materials | Medical LSR Silicone (ISO 10993) | Medical Adhesive Tape | Medical Grade Silicone & Adhesive |
Regulatory Harmonization & Quality Systems
Conforming to the rigorous standards required by the FDA, European MDR, and international bodies.
IEC 60601-1
Electrical SafetyType CF applied parts compliance with 2,000V defibrillation protection. Proprietary PCBA dielectric isolation barrier protects patient and clinician during emergency resuscitation.
IEC 62304 Class B
Software LifecycleRigorous software architecture, static code verification, unit test tracing, and cybersecurity hazard mitigation (FDA Post-Market Cyber Guidance).
ISO 13485:2016
Quality SystemsCleanroom manufacturing protocols, incoming component verification (AQL 0.65 Level II), pneumatic bed-of-nails ATE testing, and complete Device Master Records.
ISO 10993-5 & 10
BiocompatibilityIndependent laboratory testing proving zero cytotoxicity, zero dermal irritation, and zero delayed-type hypersensitivity across 14-day continuous human wear.
150-Patient Multi-Center IRB Equivalence Protocol
Structured clinical trial designed to deliver statistically overwhelming proof of substantial equivalence.
Patient Cohort & Sites
150 enrolled adult cardiology patients across 3 independent academic medical centers. Cohort includes patients with paroxysmal AFib, PVC burden >5%, and post-ablation surveillance.
Primary Endpoints
Non-inferiority demonstrated against simultaneous 12-lead reference Holter recordings: QRS beat detection sensitivity ≥99.0%, positive predictivity ≥99.2%, and AFib episode sensitivity ≥98.5%.
Independent Adjudication
All conflicting arrhythmia classifications adjudicated by a 3-member blinded Clinical Events Committee (CEC) of board-certified clinical electrophysiologists.
Frequently Asked 510(k) Questions
What FDA regulatory classification applies to BeatioPulse?
BeatioPulse is categorized as a Class II medical device under 21 CFR 870.2800 (Medical magnetic tape recorder / ambulatory electrocardiograph), product code MWI and DQA.
What predicate devices are selected for the 510(k) submission?
The primary predicate devices are the iRhythm Zio Patch (K121319) and the BioIntelliSense BioButton (K201416), demonstrating substantial equivalence in patient contact materials, ECG lead sensitivity, and clinical indications for use.
What medical safety standards does the patch adhere to?
The patch is engineered to IEC 60601-1 (medical electrical safety and 2,000V defibrillation protection), IEC 60601-1-2 (EMC), IEC 62304 Class B (software lifecycle), ISO 10993 (biocompatibility), and ISO 13485:2016 (quality management).
Review Our Full Regulatory Binder
Accredited institutional investors and clinical research partners can request our complete 510(k) pre-submission documentation and DMR binder.