(444 days)
Vapocide" is a sterilant solution intended to be used only in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment. Vapocide is intended to be a direct substitute for Vapo-Sterli. Vapocide is recomended for use in the following Chemiclave series sterilizer models: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, 6000, 7000, 8000, and in Chemiclave cycle parameters as follows. Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, - Operating pressure: 20-40 psi (1.41-2.82 kg/cm²) - Temperature: 132 ± 2°C (270 ± 5°F) - Maximum load: models with 8 and 10 in. diameter chambers Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 + 6, -0°C - Maximum load: 3.3 pounds (1.5 kg) Vapocide is compatible with but not limited to the following material types; - Surgical and cutting instruments, handpieces, and similar items - Plastic materials recommended are: Polysulfone, Phenolic, Epoxy, Polyphenylene, Oxide, Polyester, Polypropylene Vapocide" is not compatible with the following materials: - Linen, textiles or fabrics - Liquids and agars - Items contained in tightly woven packs or wraps - Plastics that cannot tolerate temperature in excess of 132ºC (270ºF) - Nylon tubing & bags inhibit penetration of chemical vapors Vapocide is not recommended for use for "flash" sterilization cycles.
Vapocide™ is a liquid sterilant solution designed for use in Harvey Chemiclave sterilizers only. Vapocide™ and the Harvey Chemiclave function as a sustem to sterilize medical and dental surgical instruments and equipment. Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave which is a unsaturated chemical vapor sterilizer. Unsaturated chemical vapor sterilizers function by using heat, water, and chemical synergism to sterilize medical and dental equipment. Vapocide™ is made of formaldehyde and ethanol. This formulation when heated under pressure, results in a relatively unsaturated and totally effective sterilization vapor which does not have deleterious effects one mark surfaces.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Vapocide™ Liquid Chemical Sterilant.
Important Note: The provided document is a 510(k) Summary from 1997. The level of detail regarding acceptance criteria, study design, and statistical analysis is significantly less comprehensive than what would be expected for a modern medical device submission. Many of the specific details requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, training set details) are simply not present in this type of summary from that era.
Acceptance Criteria and Reported Device Performance for Vapocide™ Liquid Chemical Sterilant
The acceptance criteria for Vapocide™ are primarily based on its performance as a sterilant, specifically its sporicidal effectiveness and material compatibility, when used in conjunction with Harvey Chemiclave Sterilizers. The device aims to demonstrate substantial equivalence to the predicate device, Vapo-Steril.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Sterilization Effectiveness | Must be sporicidal, effectively killing highly resistant bacterial spores (e.g., Bacillus stearothermophilus). Must achieve sterilization under specified conditions (temperature, pressure, cycle time). | Comparative Testing (Vapocide™ vs. Vapo-Steril): Performed using a modified AOAC Sporicidal Test Protocol. (Details of equivalence not explicitly stated, but implied positive outcome for equivalence claim). |
AOAC Sporicidal Testing: Demonstrated sporicidal effectiveness of Vapocide™.
Simulated Use Testing: Successfully sterilized Bacillus stearothermophilus spores placed on turbines inside dental handpieces in the Chemiclave with Vapocide™. Results confirmed effectiveness under specified conditions.
Biological Indicator Evaluation: Confirmed that existing biological indicators are effective for monitoring sterilization with Vapocide™. |
| Material Compatibility | Must not cause corrosion, pitting, crazing, or cracking on medical/dental instruments upon repeated processing. | Demonstrated material compatibility with various medical and dental instruments (e.g., orthopedic pliers, hand instruments, carbon steel burrs, high-speed handpieces, plastic resin cassettes) after repeated processing, as evaluated by scanning electron microscope and steriomicroscopic equipment. Specific materials not compatible were also identified (linen, liquids, tightly woven packs, plastics unable to tolerate >132ºC, nylon tubing & bags). |
| Residue / Safety (Formaldehyde) | Must not leave significant or harmful formaldehyde residues on sterilized instruments. | Objective was to determine if formaldehyde residues remained on surfaces after processing with Vapocide™. (Implied acceptable levels, as no negative finding is reported). |
| Packaging Penetration | Chemical vapors must effectively penetrate typical sterilization packaging. | Demonstrated ability of unsaturated chemical vapors from Vapocide™ to penetrate typical sterilization packaging during the Harvey Chemiclave process. |
| Toxicity Profile | Must meet safety standards for potential skin irritation, ocular irritation, sensitization, mutagenicity, and acute dermal toxicity. | Skin Irritation: Not a primary dermal irritant in albino rabbits.
Ocular Irritation: Produced transient irritation in six rabbits, resolved by 14 days.
Sensitization: Did not produce allergenic contact dermatitis in guinea pigs.
Mutagenicity: 1% solution did not produce a mutagenic effect in the Ames Spot test.
Acute Dermal Toxicity: Dermal LD50 in rabbits considered to be >2 g/kg. |
| Substantial Equivalence | Must be substantially equivalent in shelf-life, appearance, viscosity, chemical properties (formaldehyde concentration), and microbiology claims to Vapo-Steril. | Shelf-life, Appearance, Viscosity: Both Vapocide™ and Vapo-Steril have a 2-year shelf-life and are clear, colorless liquids. Chemical Properties: Both use formaldehyde (0.23%) and ethanol. Microbiology Claims: Both are sterilants and sporicidal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the summary document for any of the performance tests. The AOAC Sporicidal Test Protocol is a standard method, so its inherent sample sizes would have been followed, but specific numbers are not provided.
- For Simulated Use Testing, it mentions "inoculated dental Handpieces" but no number.
- For Material Compatibility, it lists categories of instruments (e.g., "orthopedic pliers, hand instruments, carbon steel burrs, high speed Handpieces, plastic resin cassettes") but does not quantify the number of items tested within each category or the total.
- For Toxicity Testing:
- Skin Irritation: Albino rabbits (number not specified, but typically 3-6 for such tests).
- Ocular Irritation: Six rabbits.
- Sensitization: Guinea pigs (number not specified).
- Mutagenicity: Five tester strains of auxotrophic Salmonella typhimurium.
- Acute Dermal Toxicity: Rabbits (number not specified, but typically 5-10 for LD50 tests).
- Data Provenance: The studies were conducted by "Sterilization Technical Services" and "Gibraltar Laboratories." The document doesn't specify countries of origin for these facilities, but given the US FDA submission, it's highly probable these are US-based laboratories. The data appears to be prospective as it describes specific testing performed to evaluate Vapocide™.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The testing was performed by contract laboratories (Sterilization Technical Services, Gibraltar Laboratories). It's assumed their personnel (e.g., microbiologists, toxicologists) established the "ground truth" based on standard protocols, but no specific number or detailed qualifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This type of device (chemical sterilant) doesn't typically involve human reader adjudication like image analysis AI devices. The "ground truth" for sporicidal efficacy is determined by laboratory culture methods (e.g., absence of growth), and for material compatibility, by visual inspection or microscopy by qualified personnel.
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
- MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a chemical sterilant. MRMC studies are typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and the AI assists in this interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. Vapocide™ is a chemical sterilant, not an algorithm. Its "performance" is inherently "standalone" in the sense that the chemical itself performs the sterilization, with the human component being proper use in the Chemiclave.
7. The Type of Ground Truth Used
The ground truth for the various tests was established through:
- Microbiological Culture: For sporicidal effectiveness, the ground truth is the presence or absence of microbial growth after exposure to the sterilant, indicating successful sterilization or failure. This is standard for sterilization validation.
- Direct Observation/Microscopy: For material compatibility, the ground truth was visual and microscopic assessment for damage (corrosion, pitting, crazing, cracking).
- Chemical Analysis: For residue testing, the ground truth would be quantitative chemical analysis for formaldehyde.
- Biological Assays (in vivo/in vitro): For toxicity studies, the ground truth was determined by standardized animal models or in vitro assays (e.g., skin/ocular irritation in rabbits, sensitization in guinea pigs, mutagenicity in bacteria).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. Vapocide™ is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As Vapocide™ is not an AI/ML device, there is no training set or ground truth in that context.
§ 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.