(784 days)
Endo-Spor Plus™ liquid chemical germicide is intended for the disinfection and sterilization of endoscopic instruments and other heat labile medical and dental instruments.
Endo-Spor Plus™Hyprocide™is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.
The liquid chemical germicide Endo-Spor Plus™ contains the active ingredients hydrogen peroxide and peracetic acid. The germicide can be used as a high level disinfectant with a contact time of 15 minutes at 20℃ under reuse conditions of up to 14 days.
Here's a breakdown of the acceptance criteria and the study details for the Endo-Spor Plus™/Hyprocide™ Liquid Chemical Germicide, based on the provided text:
Acceptance Criteria and Device Performance
Note: The document does not explicitly state "acceptance criteria" as a separate, quantitative table. Instead, it presents performance results as meeting specific efficacy requirements for various tests. The table below synthesizes this information.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Microbicidal Efficacy: | |
| - Sporicidal efficacy (B. subtilis, C. sporogenes) | Meets sporicidal efficacy requirements |
| - Tuberculocidal efficacy ($M.$ bovis) | Stressed solution is tuberculocidal |
| - Bactericidal efficacy ($P.$ aeruginosa, $S.$ aureus, $S.$ choleraesius) | Stressed solution is bactericidal |
| - Virucidal efficacy (Herpes Simplex I, Poliovirus Type II, HIV Type I) | Stressed solution is virucidal |
| - Fungicidal efficacy ($T.$ mentagrophytes) | Stressed solution is fungicidal |
| Minimal log reduction for M. bovis (simulated use) | 6-log reduction on interior and exterior surfaces |
| Minimal log reduction for C. sporogenes (simulated use) | 6-log reduction |
| No surviving microorganisms after clinical use | No surviving microorganisms on any tested endoscope |
| Residue: | |
| No detectable residual hydrogen peroxide/peracetic acid | No detectable hydrogen peroxide or peracetic acid |
| Toxicology: | |
| Non-irritating (primary dermal) | Non-irritating |
| Dermal LD50 >2 g/kg body weight (acute dermal) | Dermal LD50 >2 g/kg body weight |
| Non-sensitizing (skin sensitization) | Non-sensitizing |
| Non-mutagenic (Ames test) | Non-mutagenic |
| Oral LD50 >5 g/kg body weight (acute oral) | Oral LD50 >5 g/kg body weight |
| Minimal ocular irritation (no specific threshold stated, but adverse outcome noted) | Irreversible Irritation (2 of 6 rabbits) |
| Material Compatibility: | |
| No corrosion or visible damage after simulated cleaning cycles | No corrosion or other visible damage to endoscope components |
| Adhesion of adhesives maintained (at specified temperatures) | Reduced adhesion at elevated temperatures (attributed to temp, not solution) |
Study Details
-
Sample size used for the test set and the data provenance:
- Simulated Use Test: Not explicitly stated for each organism.
- For M. bovis and C. sporogenes contaminated endoscopes, the results refer to 6-log reductions, implying a sufficient number of tests to establish this.
- Clinical Testing: 15 flexible fiberoptic endoscopic retrograde cholangiopancreatography (ERCP) endoscopes.
- Residue Testing: A "series of Olympus endoscopes." (Specific number not given).
- Toxicology Testing:
- Primary Dermal Irritation: Not specified, but standard tests involve multiple animals (e.g., rabbits).
- Acute Dermal Toxicity: Not specified.
- Ocular Irritation: 6 rabbits.
- Acute Oral Toxicity: Not specified.
- Skin Sensitization: Not specified.
- Mutagenicity (Ames test): Not specified, typically uses bacterial strains grown in cultures.
- Material Compatibility: "a variety of metallic, plastic and rubber endoscope components" (specific number of components/tests not given) and "a number of different adhesives."
- Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely part of US regulatory submissions, but the actual lab locations are not provided. The studies appear to be prospective experimental studies.
- Simulated Use Test: Not explicitly stated for each organism.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (liquid chemical germicide) relies on laboratory efficacy testing against standardized microorganisms and physical/chemical properties rather than human expert interpretation of images or clinical findings. Therefore, neither a number of experts nor their qualifications for establishing ground truth in the traditional sense (e.g., radiologists reading images) is applicable or provided. The "ground truth" here is the direct, measurable outcome of the microbiological, chemical, and biological tests.
-
Adjudication method for the test set:
- Not applicable as the study involves objective laboratory measurements and efficacy validation, not subjective expert assessment requiring adjudication.
-
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 not an AI/imaging device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/imaging device. Its "standalone" performance is its microbicidal efficacy and material compatibility as tested in the lab.
-
The type of ground truth used:
- Microbiological Efficacy: Laboratory culture results and log reduction measurements.
- Residue Testing: Chemical analytical measurements (detectable levels of hydrogen peroxide/peracetic acid).
- Toxicology: In vivo animal model observations for irritation, toxicity, and sensitization, and in vitro Ames test for mutagenicity.
- Material Compatibility: Visual inspection for damage, weight change, flexibility, adhesion, and corrosion.
-
The sample size for the training set:
- Not applicable. This is not a machine learning device. The "training" for a chemical germicide comes from chemical formulation and established microbiological testing protocols.
-
How the ground truth for the training set was established:
- Not applicable. (See #7). The "ground truth" for the effectiveness of the chemical components is based on established scientific principles of germicidal action and empirical data from chemical and microbiological research, not on a "training set" in the machine learning sense. The performance data presented are for the final product evaluation.
§ 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.