(171 days)
Vapo Solution™ is an alcohol solution intended to be used only in Harvey Chemiclave sterilizers to sterilize medical and dental surgical instrument. Vapo Solution™ is intended to be a direct substitute for Vapo-Steril®. Vapo Solution™ is recommended for use in the following Chemiclave models: 4000, 5500, 6000 and models covered under K924380 and K943654.
Vapo Solution™ is compatible with Chemiclave cycle parameters as follows:
- Model 4000, 5000, 5500, 6000, EM5000, EM5500, and EM6000
- Operating pressure: 20-40 psi (1.41 2.82 kg/cm²)
- Operating Temperature: 132 +2 ℃ (270 + 5 0r)
- Maximum load: Bagged instruments:
- 6" Chamber (models 4000, 5000, EM5000) 0.6 Kg (1.3 lbs)
- 8" Chamber (models 5500, EM5500) 1.2 Kg (2.6 lbs)
- 10" Chamber (models 6000, EM6000) 2.4 Kg (5.3 lbs)
- Maximum load: Unwrapped instruments:
- 6" Chamber (models 4000, 5000, EM5000) 0.75 Kg (1.7 lbs)
- 8" Chamber (models 5500, EM5500) 1.4 Kg (3.1 lbs)
- 10" Chamber (models 6000, EM6000) 2.8 Kg (6.2 lbs)
- Model 7000 and 8000
- Operating pressure: approximately 25 psi
- Operating Temperature: 132 ± 2°C (270 ±5°F)
- Maximum load: Bagged instruments:
- 8" Chamber (model 7000) 1.2 Kg (2.6 lbs)
- 10" Chamber (model 8000) 2.4 Kg (5.3 lbs)
- Maximum load: Unwrapped instruments:
- 8" Chamber (model 7000) 1.4 Kg (3.1 lbs)
- 10" Chamber (model 8000) 2.8 Kg (6.2 lbs)
Vapo Solution™ is compatible with but not limited to the following instruments and material types:
- Surgical and cutting instruments, handpieces, and similar items.
- Plastics that can tolerate in excess of 132 °C. i.e. Polysulfone, Phenolic, Nylon, Teflon, Polyethylene, Polyacetal, Polypropylene. Note: Polycarbonate is not chemically compatible.
- Rubber components made of Silicone, Fluorosilicone
Vapo Solution™ is not compatible with the following materials:
- Linen, textiles or fabrics These are incompatible with the chemical vapor process.
- Liquids and agars These are incompatible with high temperature processing (132°C).
- Items contained in tightly woven packs or wraps, or sealed containers These cause poor vapor penetration.
- Plastics which cannot tolerate temperatures in excess of 132ºC.
- Polycarbonate - Chemically incompatible.
- Nylon tubing and bags Inhibits penetration of chemical vapors.
Vapo Solution™ is not recommended for use for "flash" sterilization cycles.
A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers.
The provided text describes a 510(k) submission for a sterilization solution, not a medical device in the typical sense of needing performance metrics like sensitivity or specificity. Therefore, the information requested in the prompt, which is geared towards diagnostic or AI-powered devices, is not directly applicable.
However, I can extract the relevant "acceptance criteria" and "performance data" as presented in the document, interpreting "acceptance criteria" as what the manufacturer aimed to demonstrate for substantial equivalence and "reported device performance" as the data provided to support that claim.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the claim of "substantial equivalence" to the predicate device, MDT Harvey Vapo-Steril® solution. Specifically, the device (Vapo Solution™) had to demonstrate comparable efficacy in killing spores.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent or better efficacy in killing Bacillus stearothermophilus spores compared to the predicate device (Vapo-Steril® solution). | **"fresh" solutions (4,000 tests overall): |
| "Statistical analysis indicates that the Vapo Solution™ is equal to or better than the predicate. Vapo-Steril® solution in killing spore strips of Bacillus stearothermophilus when tested according to method used for such testing."** | |
| Specific results for different models: | |
| • Model 5000-6": Vapo Solution™: 219 +growth / 680 tests completed; Vapo-Steril solution®: 222 +growth / 670 tests completed. | |
| • Model 5500-8": Vapo Solution™: 119 +growth / 650 tests completed; Vapo-Steril solution®: 183 +growth / 640 tests completed. | |
| • Model 6000-10": Vapo Solution™: 261 +growth / 680 tests completed; Vapo-Steril solution®: 328 +growth / 680 tests completed. |
"One-year old solution (600 additional tests): Same comparative results."
"Two-year old solution (600 tests): Same comparative results."
Conclusion: "From non-clinical tests, the Model 5000 shows no significant difference in survivors for the two solutions; the Models 5500 and 6000 show a significant difference in survivors at shorter cycle times (Vapo Solution™ has fewer survivors), but no significant difference at longer cycle times. The two solutions are substantially the same in efficacy." |
| Non-toxic performance. | "A study conducted in dental offices using an analogous alcohol solution containing 0.23% formaldehyde reported the following: 15 min STEL ave. 0.81 ppm (OSHA 2.0 ppm); 8-hour average 0.029 ppm (OSHA TWA 1.0 ppm). 29 CFR 1910.1048 >0.1 ppm considered a Health Hazard." (This indicates the levels were below OSHA hazardous thresholds.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Efficacy Tests: "4,000 independent tests were performed using 'fresh' solutions; 600 additional tests using one-year old solutions; 600 tests using two-year old solutions." This totals 5,200 tests.
- For the "fresh" solutions, the breakdown per model is: 680 tests (Vapo Solution™) + 670 tests (Vapo-Steril®) for Model 5000; 650 tests (Vapo Solution™) + 640 tests (Vapo-Steril®) for Model 5500; 680 tests (Vapo Solution™) + 680 tests (Vapo-Steril®) for Model 6000. These specific tests total 4,000.
- Toxicology: "A study conducted in dental offices" – no specific sample size (number of offices or measurements) provided, but it implies real-world usage.
- Data Provenance: Not explicitly stated (e.g., country of origin). The efficacy tests are described as "independent tests," suggesting controlled laboratory conditions rather than clinical data from patients. The toxicology study was "conducted in dental offices," indicating a real-world, prospective measurement of air quality during use. The studies appear to be prospective as they involved performing tests with the solutions and measuring outcomes.
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)
This information is not applicable as the ground truth for sterilization efficacy is typically established through direct microbiological culture results (presence/absence of Bacillus stearothermophilus growth), not expert consensus on interpretations of images or patient data. For toxicology, the ground truth is established by chemical measurement against OSHA standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of complex data (e.g., medical images) to establish a consensus ground truth. Here, the ground truth is based on objective scientific measurements (spore growth, chemical concentration).
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
This information is not applicable. MRMC studies are relevant for diagnostic devices that involve human interpretation, often assisted by AI. This submission is for a sterilization solution, which does not involve human "readers" or AI assistance in its direct function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a chemical solution, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Efficacy Tests: The ground truth for efficacy was the direct measurement of Bacillus stearothermophilus spore growth on spore strips after sterilization cycles. The absence of growth indicates successful sterilization (killing of spores).
- Toxicology: The ground truth for toxicology was quantitative measurement of formaldehyde levels in the air of dental offices, compared against established OSHA safety standards.
8. The sample size for the training set
This information is not applicable. This is a chemical product, not a machine learning device that requires a training set. The performance data presented are for validation/testing, not training.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.