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510(k) Data Aggregation
K Number
K171287Device Name
Sporview VH202 BI
Manufacturer
SPSmedical Supply Corp. A Division of Cantel Medical
Date Cleared
2018-02-01
(276 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SPSmedical Supply Corp. A Division of Cantel Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
• STERRAD® 100NX® (Standard Cycle)
Device Description
The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units. Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.
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K Number
K110152Device Name
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
Manufacturer
SPSMEDICAL SUPPLY CORP.
Date Cleared
2011-04-15
(86 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SPSMEDICAL SUPPLY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 1, V-Pro 1 Plus and V-Pro maX sterilizers. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.
Device Description
SPSmedical Vaporized Hydrogen Peroxide (HzOn) Chemical Indicators are process indicators which are cleared for use in verifying exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro lumen and non lumen sterilization processes. Testing has been performed which validates the SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators for use in the STERIS® V-Pro flexible sterilization cycle and the STERIS® V-Pro maX sterilizer.
Indicators will identify if an item has seen H2O2 during the STERIS® V-Pro flexible sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
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K Number
K070595Device Name
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
Manufacturer
SPSMEDICAL SUPPLY CORP.
Date Cleared
2007-05-24
(83 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SPSMEDICAL SUPPLY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.
Device Description
The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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