1. Device Identification
Regulatory Listing
- Classification: Class II Medical Device (21 CFR 880.6850 – Liquid Bandage/Skin Protectant)
- Product Codes: KZG (Topical Antiseptic), FSH (Sterile Applicator)
- 510(k) Number: K230418 (substantial equivalence to predicate K201255)
- Intended Use: Rapid microbial reduction on intact skin prior to invasive procedures.
UDI & Labeling
- GS1-compliant Device Identifier (DI) for each applicator SKU
- Production Identifier (PI): Lot #, expiration, manufacturing date
- Labeling follows 21 CFR 801, 21 CFR 830 UDI, IFU accessible via eIFU portal
2. Quality System Compliance
| Requirement | Regulation | Clenivax™ Program |
|---|---|---|
| Quality Management System | 21 CFR Part 820 / ISO 13485:2016 | Certified ISO 13485 facility; annual FDA QSIT audits with zero major observations. |
| Risk Management | ISO 14971:2019 | Product Risk Management File with residual risk evaluation < ALARP; FMEA updated Q1 2026. |
| Process Validation | 21 CFR 820.75 | Validated EO sterilization, filling, and assembly processes; PQ annually. |
| Document Control | 21 CFR 820.40 | Electronic QMS with revision-controlled IFUs, SOPs, DMR, DHR. |
Full Quality System documentation (DMR, DHR, CAPA logs) furnished upon execution of mutual NDA and supplier quality agreement.
3. Sterilization & Biocompatibility
EO Sterilization
- Validated per ISO 11135:2014 – Overkill method
- SAL 10⁻⁶ achieved; biological indicators (Bacillus atrophaeus) used each cycle
- EO residuals monitored per ISO 10993-7; limits < permitted daily exposure
- Routine dose audits quarterly, requalification annually
Biocompatibility
- ISO 10993-5 Cytotoxicity (MEM Elution) – Pass
- ISO 10993-10 Sensitization & Irritation – Pass
- ISO 10993-11 Systemic Toxicity (acute) – Pass
- ISO 10993-6 Implantation (limited exposure) – Pass
Packaging Validation
- ISO 11607-1/-2 transit & distribution testing (ISTA 3A)
- Real-time and accelerated aging (ASTM F1980) support 36-month shelf life
- Seal integrity per ASTM F1929 / burst ASTM F1140
4. Chemistry & Microbiology
- Formulation: 2% Chlorhexidine gluconate in 70% Isopropyl Alcohol; inactive components USP grade.
- Microbial Efficacy: ASTM E2315 time-kill, EN 12791 surgical hand antisepsis surrogate, EN 13727 bactericidal, EN 13624 yeasticidal.
- USP <61> / <62>: No growth detected; meets USP microbial limits for topical solutions.
- Stability: Real-time stability study (25°C/60% RH) confirmation to 36 months; accelerated (40°C/75% RH) supportive.
5. Post-Market Surveillance
Clenivax™ maintains a proactive PMS program compliant with FDA requirements and international vigilance obligations.
- Medical Device Reporting (MDR) per 21 CFR 803 with electronic submission gateway.
- Trend analysis of complaints and nonconformances; CAPA triggered at pre-defined thresholds.
- Global Unique Device Identification Database (GUDID) submissions complete.
- Field Safety Corrective Action (FSCA) procedure aligned with EU MDR for international markets.
6. Available Technical Files
Regulatory
- 510(k) Summary (Public)
- Letter-to-File for annual design updates
- FDA Establishment Registration & Listing certificates
Sterility & Quality
- Sterilization Validation Report (VAL-EO-CLX-2025)
- Certificate of Analysis per lot (COA-####)
- Environmental monitoring trending (ISO Class 7 cleanroom)
Clinical & Usability
- Summative usability study report (IEC 62366)
- Human factors validation of applicator grip and flow control
- Clinical literature dossier (60+ peer-reviewed studies)
References
- FDA. Guidance for Industry: Content of Premarket Notifications for Topical Antiseptic Drug Products. 2020.
- ISO 11135:2014 Sterilization of health-care products—Ethylene oxide.
- ISO 10993 series – Biological evaluation of medical devices.
- USP 43-NF 38. General Chapters <61>, <62>, <71>.