(26 days)
SPOROX® II has the same intended use as SPOROX®. SPOROX® II is intended to be used as a ready-to-use liquid chemical sterilant for the sterilization or high level disinfection of heat sensitive medical equipment for which alternative methods of terminal reprocessing are not suitable or available.
SPOROX® II 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 II ® Sterilizing & 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 II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.
SPOROX® II is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in SPOROX® II, exerts its germicide via a strong oxidation reaction with cellular components.
This document describes the premarket notification (510(k)) for SPOROX® II, a liquid chemical sterilant/high-level disinfectant. It does not contain information about an AI/ML powered medical device. Therefore, it is not possible to describe acceptance criteria, a study proving the device meets those criteria, or other details typically associated with AI/ML device evaluations.
The provided text details the substantial equivalence of SPOROX® II to a predicate device, SPOROX®, for its intended use as a liquid chemical sterilant and high-level disinfectant for heat-sensitive medical equipment. The evaluation focused on antimicrobial efficacy, stability, safety, and material compatibility.
To address your request by interpreting the closest analogous information available:
The "acceptance criteria" and "device performance" in this context relate to demonstrating substantial equivalence to the predicate device, SPOROX® (K970230).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (SPOROX® II) |
|---|---|---|
| Antimicrobial Efficacy | Equivalent antimicrobial efficacy to the predicate device, SPOROX®. This implies a certain level of germicidal activity (sterilization/high-level disinfection) against relevant microorganisms as per AOAC and EPA methodology. | "Reckitt & Colman Inc. has conducted confirmatory testing that demonstrated SPOROX® II has equivalent antimicrobial efficacy to the predicate device, SPOROX®. The studies utilized appropriate AOAC and EPA methodology." |
| Stability | Minimum of two years stability when unopened and stored according to label instructions. Product can be reused for up to 21 days when used at 20°C according to label instructions. | "The Company also conducted stability studies demonstrating that SPOROX® II like SPOROX® has a minimum of two years stability if unopened and stored according to label instructions, and that the product can be reused for up to 21 days when used at 20°C according to label instructions." |
| Safety Profile (Toxicology) | Substantially equivalent safety profile to SPOROX® for acute dermal toxicity, acute oral toxicity, primary eye irritation, primary skin irritation, skin sensitization, in-vitro hemolysis, neutral red uptake cytotoxicity assay, and 28-day repeat dose oral toxicity testing. | "These tests demonstrated that SPOROX® II has a substantially equivalent safety profile to SPOROX® for use as a liquid chemical sterilant and a high level disinfectant." |
| Material Compatibility | Compatibility with a number of different plastics, metals, and elastomers commonly used in medical devices (as noted in the product label). Additionally, compatibility with materials made with copper and brass, consistent with FDA's Guidance on Premarket Notification for Liquid Chemical Sterilants and High Level Disinfectants. (Exposure to 7.3% hydrogen peroxide for 500 hours at 20℃, equivalent to 1000 disinfectant cycles). | "The Company confirmed compatibility with medical devices equivalent to the predicate device, by conducting a rigorous evaluation on a number of different plastics, metals, and elastomers commonly used in medical devices and noted in the product label. In addition, the Company determined compatibility with materials made with copper and brass which is consistent with FDA's Guidance on The Content and Format of Premarket Notification on [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants. The materials were exposed to a SPOROX® II solution, containing 7.3% hydrogen peroxide content for 500 hours at 20℃ (equivalent to 1000 disinfectant cycles)." |
| Intended Use | Same intended use as SPOROX®: ready-to-use liquid chemical sterilant for sterilization or high-level disinfection of heat-sensitive medical equipment. | "SPOROX® II has the same intended use as SPOROX®." |
| Technological Characteristics (Formulation) | Same active ingredients as SPOROX® (hydrogen peroxide). Differences only in the inactive ingredients of the corrosion inhibitor system (improved in SPOROX® II). | "SPOROX® II is similar to the predicate device SPOROX®. SPOROX® II has the same active ingredients as SPOROX®. The only difference between the two products is in the inactive ingredients of the corrosion inhibitor system." |
Since this is a submission for a chemical disinfectant, the following questions are not applicable to the provided document:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. The "tests" here refer to chemical, biological (microbial), and material compatibility studies, not a "test set" of patient data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. "Ground truth" in this context would implicitly be the established scientific methods and accepted standards (e.g., AOAC and EPA methodologies) for evaluating disinfectants, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This refers to expert review processes for AI/ML ground truth establishment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is entirely irrelevant for a chemical disinfectant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For antimicrobial efficacy: Established microbiological standards and results from AOAC and EPA methods.
- For stability: Chemical analysis over time and functional testing of reuse claims.
- For safety: Live animal testing (e.g., acute dermal/oral, irritation), in-vitro cell assays, and 28-day repeat dose oral toxicity.
- For material compatibility: Observation of materials (plastics, metals, elastomers) after prolonged exposure to the solution.
8. The sample size for the training set
- Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model to train or associated ground truth.
§ 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.