(281 days)
Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.
Sporox is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in Sporox, ® exerts i s germicide via a strong oxidation reaction of cellular components.
The provided text describes Reckitt & Colman Inc.'s Sporox, a 7.5% hydrogen peroxide solution intended as a liquid chemical sterilant and high-level disinfectant. The submission (K970230) compares Sporox to the predicate device, Cidex Formula 7.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Germicidal Activity: | Sporocidal: Demonstrated using appropriate AOAC methods. |
| - Bactericidal | Demonstrated using appropriate AOAC methods. |
| - Fungicidal | Demonstrated using appropriate AOAC methods. |
| - Virucidal | Demonstrated using appropriate AOAC methods. |
| - Sporicidal | Demonstrated using appropriate AOAC methods. |
| - Tuberculocidal | Demonstrated using appropriate AOAC methods. |
| Biocompatibility/Toxicity: | Demonstrated for product safety by meeting FDA guidance on biocompatibility testing. |
| - Acute Dermal Toxicity | Testing conducted. |
| - Acute Oral Toxicity | Testing conducted. |
| - Primary Skin Irritation | Testing conducted. |
| - In-vitro Hemolysis | Testing conducted. |
| - Primary Eye Irritation | Testing conducted. |
| - Neutral Red Uptake Bioassay | Testing conducted. |
| - 28-day Oral Toxicity | Testing conducted. |
| Stability (Unopened): Minimum two years | Demonstrated minimum of two years stability when unopened and stored according to label. |
| Reuse Period: Minimum 21 days | Demonstrated 21 days reuse when used at 20℃ according to label. |
| Device/Material Compatibility: Compatibility with medical devices/materials as per labeling. | Demonstrated compatibility through studies with actual devices (simulated/clinical use) and rigorous evaluation of plastics, metals, elastomers exposed to Sporox for 500 hours at 20°C (equivalent to 1000 disinfectant cycles). |
| Residue Levels: Extremely low levels, below toxic/harmful effects. | Demonstrated extremely low residues, significantly below levels expected to induce toxic or harmful effects, consistent with FDA guidance. |
| High-Level Disinfection Contact Time: Specific conditions for heat-sensitive medical equipment. | 30 minutes at 20℃ to high-level disinfect. |
| Minimum Effective Concentration (MEC): | 6% (nominal is 7.5%). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the specific tests, particularly for the germicidal activity assays, toxicity studies, or material compatibility evaluations in terms of number of devices or organism cultures.
- Provenance: The studies were conducted by Reckitt & Colman Inc. and involved standardized in vitro (e.g., AOAC methods for germicidal activity, biocompatibility tests) and in vivo (toxicity) studies.
- Actual Use Testing: Involves both "endoscopes after patient use" and "inoculated endoscopes." This suggests prospective or real-world application data, as well as controlled laboratory simulations.
- Clinical Setting: Documentation of Sporox use by the Mayo Clinic in the clinical setting was submitted, which implies retrospective clinical use data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the various tests. The nature of the device (chemical sterilant/disinfectant) means ground truth is often established by:
- Laboratory assays: Measured against established scientific standards (e.g., AOAC methods for log reduction, specified toxicity endpoints).
- Clinical outcomes: For actual use testing, the "ground truth" would be the observed efficacy (sterilization/disinfection) and safety (lack of adverse effects) in a real-world or simulated clinical setting.
- Compliance with guidance: Adherence to FDA guidance on biocompatibility and residue testing implies using established scientific protocols and benchmarks.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method like 2+1 or 3+1. These methods are typically used for interpreting subjective medical images or clinical findings. For chemical germicide testing, the results are generally objective and quantifiable (e.g., log reduction, chemical residue levels, observed toxicity endpoints), which do not typically require a panel adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for evaluating the impact of AI-assisted diagnostic tools on human reader performance, typically in imaging. This device is a chemical disinfectant/sterilant, not a diagnostic tool requiring human interpretation of data where AI assistance would be applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance evaluation of Sporox is standalone (device-only performance). The entire suite of tests (germicidal activity, toxicity, stability, material compatibility, residue testing) evaluates the inherent properties and effectiveness of the Sporox chemical solution itself, without requiring human intervention in the performance evaluation beyond preparing the solution and conducting the tests. The "actual use testing" also assesses the device in a standalone capacity within the context of clinical reprocessing.
7. The Type of Ground Truth Used
The ground truth used is a combination of:
- Expert Consensus/Standardized Methods: For germicidal activity, "appropriate AOAC use dilution, fungicidal, tuberculocidal and sporicidal methods" establish the ground truth for microbial inactivation based on widely accepted scientific standards.
- Laboratory Benchmarks/Endpoints: For toxicity and biocompatibility studies, "FDA's guidance on biocompatibility testing" and specific endpoints (e.g., irritation, hemolysis) serve as the ground truth for safety.
- Observed Efficacy and Safety: For actual use testing, the ground truth is the observed sterility/disinfection and lack of adverse effects during reprocessing of endoscopes and in the Mayo Clinic clinical setting.
- Chemical Analysis: For residue testing, the ground truth involves quantifiable chemical levels compared against safe thresholds based on expert toxicological assessment.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Sporox is a chemical germicide; it is not an AI/machine learning algorithm that requires training data. The data gathered from the various tests (germicidal, toxicity, stability, compatibility, residue) are for validation and characterization of the chemical product's performance against predefined criteria, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.