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510(k) Data Aggregation
K Number
K984270Device Name
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
Manufacturer
ROGER L. GOODMAN, D.D.S., P.C.
Date Cleared
1999-05-20
(171 days)
Product Code
MED, 80M
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
ROGER L. GOODMAN, D.D.S., P.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers.
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