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510(k) Data Aggregation
K Number
K141244Device Name
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
Manufacturer
Date Cleared
2014-09-09
(118 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, product code STS-05R, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372. product code STNS-65R) is intended for use in testing the efficacy of chemiclave sterilization.
Performance characteristics are established for exposure at 132ºC for 20 minutes in a MDT Harvey Chemiclave model EC5500 chemiclave sterilizer. Vapo-Steril Solution is the sterilant utilized in the MDT Harvey Chemiclave sterilizer. The solution was cleared under 510(k) number K984270. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg.
A reduced incubation time of 72 hours for chemiclave sterilization at 132°C has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple and incubated at 58° - 62°C.
Device Description
The Biological Indicator Spore Strips are typically used in a dental office but may be used by other small healthcare offices which utilize chemiclave processes to sterilize instruments. The spore strips are utilized to verify the chemiclave exposures were effective at killing the Geobacillus stearothermophilus bacterial spores present on the strips in high volume.
Modification to K113221 are to include chemiclave sterilization at 132°C for 20 minutes in a Harvey model EC5500. The predicate device was not specific to sterilizer type or model number but rather is legally marketed for use in monitoring the chemiclave process. Specificity of the chemiclave model in no way affects the safety or effectiveness of the device.
NAMSA Biological Indicator Spore Strips are easy to use; simply place the spore strips in the most difficult area to sterilize and process the load as normal. After exposure, remove the spore strips and aseptically transfer to growth medium and incubated. After incubation if no signs of bacterial growth are present, the sterilization cycle was effect.
The spore strips may be aseptically transferred to standard media such as Tryptic Soy Broth (TSB) and incubated for a minimum of 7 days. Growth will be indicated by the presence of turbidity. Conversely, the strips may be cultured using TSB which has been modified with a pH indicator (Bromocresol Purple) for a reduced incubation time of 72 hours. Growth will be indicated by a change in color of the media from purple to yellow and/or presence of turbidity.
Biological Indicator Spore Strips consist of a 1.25" x 0.25" filter paper strip which has been inoculated with either single species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 per strip), or dual species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 and Bacillus atrophaeus ATCC® 9372 at a population level of 106 per strip). The spore strips are individually packaged in a 30# glassine pouch.
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K Number
K132291Device Name
NAMSA CHEMICAL PROCESS
Manufacturer
Date Cleared
2014-05-20
(301 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAMSA Chemical Process Indicator Strip for Steam, REF TST4-S is intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator:
- 121°C for 30 minutes (gravity cycle) .
- 134℃ for 3 minutes (pre-vacuum) .
Device Description
The NAMSA Chemical Process Indicator Strip for Steam utilizes NAMSA indicating ink SSI-10-YBI that when exposed to high temperature steam turns from an initial yellow color to a permanent dark brown/black signal color. The intended use for the NAMSA Chemical Process Indicator Strip for Steam processes is a Process Indicator intended for use by health care facilities to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a permanent dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals:
- 121℃ for 30 minutes (gravity cycle) ●
- 134℃ for 3 minutes (pre-vacuum) .
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K Number
K113221Device Name
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
Manufacturer
Date Cleared
2012-04-27
(178 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
Device Description
The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine pouch.
Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
The media containing the spore strip should be incubated at the organism's growth temperature. Media should be monitored daily for visible signs of growth and results recorded.
When standard media is utilized, incubate strips for a minimum of 7 days. Growth will be indicated by the presence of turbidity. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
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K Number
K113302Device Name
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
Manufacturer
Date Cleared
2012-01-20
(73 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
Device Description
The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
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K Number
K983451Device Name
CHALLENGE TEST PACK
Manufacturer
Date Cleared
1999-04-23
(205 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.
Device Description
Not Found
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K Number
K962649Device Name
SPORTROL RAPID STERILITY INDICATOR
Manufacturer
Date Cleared
1997-09-26
(445 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENCE ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.
Device Description
RSI, Rapid Indicator
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