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510(k) Data Aggregation
(176 days)
HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.
HaloGUARD™ Protective Disc with CHG is a sterile, single use disposable disc infused with the antibacterial agent chlorhexidine gluconate (CHG).
The provided text describes a 510(k) premarket notification for the "HaloGUARD™ Protective Disc with CHG", which is a medical device intended to cover insertion sites on adult patients. The submission argues for substantial equivalence to a predicate device, the "BIOPATCH Protective Disk with CHG".
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for K200641, the HaloGUARD™ Protective Disc with CHG, is based on a determination of substantial equivalence to a predicate device (BIOPATCH Protective Disk with CHG). Therefore, the "acceptance criteria" are primarily a demonstration that the subject device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The device performance is assessed through various non-clinical tests rather than specific clinical outcome metrics against predefined numerical targets.
| Acceptance Criteria Category | Specific Criteria / Demonstrated Performance |
|---|---|
| Indications for Use | HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include: IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters, and percutaneous devices. This is substantially equivalent to the predicate's use for absorbing exudate and covering wounds caused by various percutaneous medical devices. |
| Material | Medical grade foam impregnated with CHG with a film backing. Substantially equivalent to predicate. |
| Antibacterial Agent | Chlorhexidine gluconate (CHG). Substantially equivalent to predicate. |
| Sterilization Method | E-beam Radiation (35 kGy). Predicate uses Ethylene Oxide. This is a difference but deemed acceptable through testing. |
| Sterility Assurance Level | 10⁻⁶. Substantially equivalent to predicate. |
| Shelf Life | Six (6) months. Predicate has two (2) years. This is a difference but a shorter shelf life is often acceptable if supported by data. |
| Biocompatibility | HaloGUARD™ Protective Disc with CHG is safe and effective for prolonged contact ( > 24 hours up to 30 days) with breached or compromised surfaces. Evaluated endpoints: Cytotoxicity, Irritation, Material-Mediated Pyrogenicity, Sensitization, Subacute Systemic Toxicity. Results demonstrate substantial equivalence. |
| Performance (Bench) | Met functional requirements. Evaluated aspects: Absorbency Factor, Antimicrobial Efficacy (4 log reduction and 7-day study) (USP ), Appearance, CHG Concentration Determination. Demonstrates substantial equivalence. |
| Wound Healing | Does not delay the natural wound healing response. Evaluated via an animal study (ISO 10993-6). Results demonstrate substantial equivalence. |
| Safety and Effectiveness | Overall conclusion that the device is substantially equivalent to the predicate, sharing similar design, indications, and technology, and raising no new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- The document primarily describes non-clinical (bench and animal) testing. It does not mention a "test set" in the context of human patient data.
- For bench testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided for these tests (Absorbency Factor, Antimicrobial Efficacy, Appearance, CHG Concentration Determination).
- For biocompatibility testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided.
- For animal study: "representative finished, sterilized devices" were used for the wound healing study. No specific numerical sample size (number of animals) is provided, nor is the country of origin of the study. This would be a prospective study on animals.
- The document states: "Clinical testing was not required to support substantial equivalence." This means no human patient data (test set) was used.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed. The "ground truth" for the non-clinical tests is established by the respective test methodologies and standards (e.g., USP , ISO standards).
4. Adjudication Method for the Test Set
- Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. Clinical testing was not required.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical disc, not an algorithm or AI-based product.
7. Type of Ground Truth Used
- For biocompatibility: Ground truth is established by the specified ISO and USP standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation).
- For performance bench testing: Ground truth is established by internal test methods and USP for antimicrobial efficacy (measuring log reduction).
- For animal study (wound healing): Ground truth is established by ISO 10993-6 (Tests for Local Effects After Implantation).
8. Sample Size for the Training Set
- Not applicable as this is not an AI/ML device that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is not an AI/ML device.
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