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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K970230

Device Name

SPOROX

Manufacturer

RECKITT BENCKISER, INC.

Date Cleared

1997-10-29

(281 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K924334

Intended Use

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.

Device Description

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.

AI/ML Overview

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.