Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention

What You Need to Know? 👇

What are the FDA classification and product codes for Foley catheters?

Foley catheters are classified as Class II medical devices under 21 CFR 876.5130. The product codes are 78 EZL for retention type balloon catheters and 78 MJC for antimicrobial urological catheters and accessories.

What biocompatibility testing is required for Foley catheters in 510(k) submissions?

For short-term externally communicating devices contacting mucosa, minimum biocompatibility testing includes mucosal irritation, sensitization, cytotoxicity, acute systemic toxicity, and implantation tests on the final sterilized device.

What clinical data is required for antimicrobial Foley catheters?

Antimicrobial catheters require randomized, controlled clinical studies demonstrating statistically significant infection rate reduction compared to conventional catheters, including patient UTI history, urine cultures, and correlation between collection bag and catheter tip cultures.

Which catheters fall outside ASTM F 623-89 standard scope?

Catheters with three lumens, balloons ≥30 cm³, shaft sizes <12 Fr or >26 Fr, pediatric catheters, and non-urethral applications (nephrostomy, suprapubic) are excluded and may require additional clinical data.

What antimicrobial information must be included in device labeling?

Labeling must include antimicrobial concentration, chemistry characterization, pharmacology/toxicology data, spectrum of activity, mechanism of action, hypersensitivity warnings, clinical results summary, and reuse cycle validation for reusable devices.

What performance testing is required for hydrophilic-coated Foley catheters?

Testing must include coefficient of friction testing per ASTM D 1894, demonstration that coating doesn’t alter underlying materials, and shelf life testing showing coating stability under storage and shipping conditions.

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What You Need to Do 👇

Recommended Actions

1. Determine if the catheter falls within standard scope or requires additional data
2. Prepare comprehensive device description including materials and dimensions
3. Conduct required performance testing per ASTM F 623-89
4. Complete biocompatibility testing suite
5. Develop and validate sterilization process
6. For antimicrobial catheters:
   • Design and conduct clinical trials
   • Complete antimicrobial effectiveness testing
   • Generate elution profile data
7. Prepare detailed labeling including all required elements
8. Document substantial equivalence to predicate devices
9. Compile comprehensive 510(k) submission including all test data and documentation

Key Considerations

Clinical testing

• Randomized controlled clinical studies required for antimicrobial catheters to demonstrate:
  • Statistically significant decrease in infection rates compared to conventional catheters
  • Safety and effectiveness data
  • Duration of use data
  • Support for any additional claims including reprocessing
• Patient history documentation including UTI history and medications
• Urine culture data requirements

Non-clinical testing

• Flow rate testing through drainage lumen
• Balloon resistance to rupture (7-day test)
• Balloon retention force testing
• Balloon inflation maintenance testing
• Manufacturing tolerances verification
• Balloon deflation reliability testing

Labelling

• Must include caution statement per 21 CFR 801.109(b)(1)
• Device identification and specifications
• Intended use statement
• Directions for use including insertion/removal procedures
• Maximum indwelling time
• Antimicrobial information (if applicable)
• Contraindications, precautions, warnings
• Reprocessing instructions (if reusable)

Biocompatibility

• Testing required for short-term externally communicating devices:
  • Mucosal irritation
  • Sensitization
  • Cytotoxicity
  • Acute systemic toxicity
  • Implantation

Safety

• Sterility information including:
  • Sterilization method
  • Validation method
  • Packaging materials
  • Sterility assurance level
  • Residuals testing (if applicable)

Other considerations

• Antimicrobial properties:
  • Elution profile data
  • Spectrum of activity against clinical isolates
  • Potential adverse effects analysis
  • Pharmacological profile
  • Shelf life testing
  • Coating uniformity and stability

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Relevant Guidances 🔗

• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Submission Requirements for Terminally Sterilized Medical Devices

Related references and norms 📂

• ASTM F 623-89: Standard Performance Specification for Foley Catheters
• ASTM D 1894: Standard Test Method for Static and Kinetic Coefficients of Friction

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Original guidance

• Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
• HTML
• Issue date: 1994-09-11
• Last changed date: 2020-03-17
• Status: FINAL
• Official FDA topics: Medical Devices, Antimicrobial Resistance, Premarket
• ReguVirta ID: dc261ca70d722be37a9b910515c24ec2