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510(k) Data Aggregation
(71 days)
SULTAN SPOROX TEST VIAL, MODEL 75195
Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Sultan Sporox Test Vial, Model 75195." This document grants market clearance based on substantial equivalence to predicate devices. It does not present a study or acceptance criteria for a new device's performance in the way a clinical trial report or a performance study summary would.
Therefore, I cannot extract the requested information using the format specified in your prompt because the provided document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a test set, data provenance, or sample sizes for testing or training.
- Information on expert ground truth establishment or adjudication methods.
- Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance studies.
- Specific types of ground truth used (beyond implying the test vials detect hydrogen peroxide concentration).
The document is a regulatory approval, confirming that the device is "substantially equivalent" to existing devices already on the market. It doesn't detail the performance studies that would typically be required for a novel device or for establishing performance criteria beyond what is already accepted for the predicate device.
To answer your prompt, I would need a document that describes the design and results of a performance study for the device, including specific metrics, methodologies, and outcomes.
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(26 days)
SPOROX II STERILIZING & DISINFECTING SOLUTION
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.
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(281 days)
SPOROX
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.
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(88 days)
SPOROX TEST STRIPS
SPOROX® Test Strips provide a rapid, convenient, semi-quantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX™ Sterilizing and Disinfecting Solution. The SPOROX® Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.
The SPOROX™ Test Strips consist of a 0.2 x 0.2 inch reagentcontaining pad attached to one end of a 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed in the sample. The strip is rotated to a vertical position for five seconds with the pad up to allow excess sample to drain by gravity and then is covered with a chamber to prevent sample evaporation. The reagent pad is observed 15 minutes after immersion. If the pad is completely brown/black, the SPOROX™ Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0% (the minimum effective concentration or MEC). If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad. The reagent pad contains iodide and starch plus a reducing compound that prevents visible reaction when the hydrogen peroxide concentration is at or below the MEC. When the peroxide level is in sufficient excess of the MEC, the surplus oxidizes the iodide to iodine which in turn forms a dark-colored complex with the starch.
Here's an analysis of the provided text regarding the SPOROX® Test Strips, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Specificity: No false PASS results at hydrogen peroxide concentrations at or below the Minimum Effective Concentration (MEC) of 6.0%. (Implied: 100% specificity at 6.05% H2O2 as a critical threshold implying below 6.0% should also be 100% specific) | At 6.05% hydrogen peroxide, 0 out of 168 results were PASS, giving a test specificity (lack of false PASS results) of 1.00 (100%). This confirms that at concentrations just above the MEC threshold, the device correctly indicates a failure to pass (i.e. not effective concentration), which fulfills the requirement of not giving false PASS results when the concentration is at or below 6.0%. |
| Sensitivity/Accuracy for Effective Concentrations: Ability to indicate "PASS" when hydrogen peroxide concentration is effectively above the MEC (e.g., 6.58% and 7.00%). | At 6.58% hydrogen peroxide, 41 out of 84 results were PASS (48.8%). |
| At 7.00% hydrogen peroxide, 165 out of 168 results were PASS (98.2%). | |
| Mechanism of Indication: Distinct white area forms in the center of the pad when hydrogen peroxide concentration is 6.0% or less. | "If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad." The study implicitly validates this by demonstrating 0 PASS results at 6.05%, suggesting correct visual indication of "FAIL" (white area). |
| Mechanism of Indication: Pad is completely brown/black when hydrogen peroxide concentration is greater than 6.0%. | "If the pad is completely brown/black, the SPOROX™ Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0%." The study implicitly validates this by the high rate of "PASS" (brown/black) results at 7.00%. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For 6.05% hydrogen peroxide: 168 results
- For 6.58% hydrogen peroxide: 84 results
- For 7.00% hydrogen peroxide: 168 results
- Total individual tests/readings: 168 + 84 + 168 = 420 results.
- The study used SPOROX™ Test Strips from three trial production lots.
- Data Provenance: The document does not explicitly state the country of origin. It describes a "blind study" involving "seven participants" testing "SPOROX™ standards assayed by a titrimetric procedure." This suggests a controlled laboratory setting, likely in the US where Serim Research Corporation is based. The study is prospective in the sense that the experiment was designed and executed to test the performance of the strips under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Ground Truth Establishment: The ground truth was established by "SPOROX™ standards assayed by a titrimetric procedure." This is an objective chemical assay/measurement.
- Number of Experts: Zero experts were used to establish the ground truth for the test set, as it was based on a direct chemical measurement (titrimetric procedure) rather than expert opinion.
- Qualifications of Experts: Not applicable, as expert consensus was not the ground truth method.
4. Adjudication Method for the Test Set
- Adjudication Method: The document does not describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple human readers. Instead, the study involved "seven participants in blind studies" using the test strips and reporting their results against the known concentrations (ground truth) established by the titrimetric procedure. It implies individual participants' readings were compared directly to the titrimetric ground truth. There is no mention of a process to adjudicate disagreements among the seven participants if they read the same strip differently (though this is less likely for a clear pass/fail strip).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a formal MRMC comparative effectiveness study as typically understood in medical imaging (comparing AI-assisted human readers to non-AI-assisted human readers) was not performed.
- Effect Size: Not applicable, as no MRMC study was conducted. The study evaluated the performance of the device itself, not the impact of AI assistance on human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a way. The device (SPOROX® Test Strip) is the "algorithm" in this context. Its "performance" is its ability to chemically react and display a visual result (brown/black or white spot) based on the hydrogen peroxide concentration. The "seven participants" are effectively the "readers" of this visual output. The study measures the accuracy of this device's visual output against a known chemical standard. While humans interpret the final visual output, the core performance being evaluated is the chemical reaction and visual change of the strip itself, independent of complex human interpretation or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was "SPOROX™ standards assayed by a titrimetric procedure." This represents an objective chemical measurement or reference standard.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not explicitly mention a separate "training set" or a sample size for one. The study described appears to be a verification/validation study used to demonstrate the device's performance, not a study involving iterative training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no separate training set or associated ground truth establishment process is described. The device operates based on a fundamental chemical reaction, not a machine learning algorithm requiring a separate training phase with labeled data in the context of this submission.
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