(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.
{0}------------------------------------------------
MAY 20 1999
510(K) SUMMARY
| [2] | Roger L. Goodman, D.D.S., P.C.October 1, 1997200 Temple StreetMason, Michigan 48854-1837Contact Person: Roger L. Goodman | (517) 676-5200 | FAX: (517)676-5442 | ||||
|---|---|---|---|---|---|---|---|
| [3] | Name of device: Vapo Solution™ for use only in Chemiclave SterilizersTrade name: Vapo Solution™ for use only in Chemiclave SterilizersCommon name: Alcohol Solution for use only in Chemiclave SterilizersClassification name: 21 CFR 880.6890Product code: 80MLRDevice classification: Class II | ||||||
| [4] | Equivalence to: MDT Harvey Vapo-Steril® solution for use only in Harvey Chemiclave® sterilizers | ||||||
| [5] | Description of device: A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers. | ||||||
| [6] | Intended use of Device: Vapo Solution™, a generic substitute for Harvey Vapo-Steril® solution, is used in sterilizing dental and surgical instruments in MDT Harvey Chemiclave® sterilizers. The unsaturated chemical vapor is analogous to steam vapor in autoclave sterilizers. | ||||||
| [7] | Technological characteristics: Vapo Solution™ and Harvey Vapo-Steril® solution have identical active ingredients of 72.38% ethyl alcohol and 0.23% formaldehyde: and substantially the same inert ingredients of 27.39% | ||||||
| [8] | Performance Data: 4,000 independent tests were performed using 'fresh' solutions; 600 additional tests using one-year old solutions; 600 tests using two-year old solutions. | ||||||
| Model 5000-6" | Model 5500-8" | Model 6000-10" | |||||
| tests completed | +growth | tests completed | +growth | tests completed | +growth | ||
| Vapo Solution™ | 680 | 219 | 650 | 119 | 680 | 261 | |
| Vapo-Steril solution® | 670 | 222 | 640 | 183 | 680 | 328 | |
| 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. | |||||||
| [9] | 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.One-year old solution: Same comparative results.Two-year old solution: Same comparative results. | ||||||
| [10] | Toxicology: | 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. |
@MDT. Harvey, and Chemiclave are registered trademarks of MDT Corp. @Vapo-Stcril is a registered trademark of MDT Biologic Company.
This summury of 510(k) safety und effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
MAY 20 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Roger L. Goodman, D.D.S., P.C. 200 Temple Street Mason, MI 48854
Re: K984270
Trade Name: Vapo-Solution for use in MDT Harvey Chemiclave Sterilizers Models 5000, 5500 and 6000 Regulatory Class: Unclassified Product Code: MED Dated: November 25, 1998 Received: November 30, 1998
Dear Dr. Goodman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Dr. Goodman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Philip J. Phillips
Philin J Deputy Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Device Namo: VAPO SQLUTION™
Indications for Use:
Vapo Solution™ is un alcohol solution intended to be used only in Harvey Chemiclave sterifizes to sterilizes to sterilize medical and dental surgical instrument. Varo Solution™ is intential 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 Chemicluye cycle parameters as tollows:
- Model 4000, SOON, SSOO, 6000, EMSOON, EMSSOO, und 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.c. Polysultione, Phonolic, Nylon, Teflor, . Polycthylene, Polycact, Polypropylenc. Note: Polycarbonate is not chemically compaithe.
- . Rubber components made of Silicone, Fluorosilicone
(PLEASE IN NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Fivaluation (ODF)
Phi Phit
(Division Sign-off)
Division of Dental, Infection Control,
and General Hospital Devices
Proscription 113c (Per 21 CFR 801.109)
Over-the-counter 1.50
(Optional livemat 1-2.96)
{4}------------------------------------------------
510(k) Number (if known) K984270
Device Name: VAPO SOLUTION™
Indications for Use:
Vapo Solution™ is not compatible with the following matcrials:
- Lincn, toxtiles 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 containcrs These cause poor . vapor penetration.
- Plastics which cannot tolerate temperatures in excess of 132ºC. .
- . Polycarbonate - Chemically incompatible.
- Nylon tubing and bags Inhibits penctration of chemical vapors. .
Vapo Solution™ is not recommended for use for "flash" sterilization cycles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Ollice of Device Evaluation (ODF) Cal, Infection Control. General Mospital Devices 510(k) Numbe
Prescription I lso (Per 21 CFR 801.109)
Over-the-counter I Jses_______________________________________________________________________________________________________________________________________________________
§ 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.