(806 days)
3MTM Attest™ Biological Indicator, STERRAD® BI Test Pack
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No
The device description and performance studies detail a purely biological and chemical indicator system. There is no mention of any computational analysis, algorithms, or learning processes.
No.
This device is designed to monitor the effectiveness of a sterilization process, not to treat a medical condition or ailment.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to diagnose a medical condition in a patient.
No
The device is a physical biological indicator with a chemical indicator, designed to be placed in a sterilizer and then incubated. It is not software.
Based on the provided information, the STERRAD® CycleSure™ Biological Indicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a sterilization process (STERRAD® Sterilizer cycles). This is a quality control function for a medical device (the sterilizer), not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains bacterial spores and growth medium. Its function is to determine if the sterilization process successfully killed the spores. This is a test of the sterilization process itself, not a test of a patient sample.
- Lack of Patient Interaction: The device does not interact with a patient or analyze a biological sample from a patient.
- Regulatory Classification (Implied): While not explicitly stated, devices used for monitoring sterilization processes are typically classified differently than IVD devices. The mention of "Class A per EN867-1" for the chemical indicator component further suggests a classification related to sterilization indicators, not IVDs.
In summary, the STERRAD® CycleSure™ Biological Indicator is a quality control tool for a sterilization process, not a device used for in vitro diagnostic testing on human specimens.
N/A
Intended Use / Indications for Use
The STERRAD® CycleSure™ Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
Product codes
FRC
Device Description
The STERRAD® CycleSure™ Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 106 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.
After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to seal the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).
The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Chemical Indicator Validation:
Effects of a simulated heavy load, no load, presence of plasma, and absence of hydrogen peroxide on the performance of the chemical indicator component of the STERRAD® CycleSure™ Biological Indicator were evaluated by observing the color of the chemical indicators before and after processing in the STERRAD® Sterilization System. The results indicate that the chemical indicator component successfully changes color from red to yellow when processed in the STERRAD® 100 Sterilization System under maximum and minimum exposure to hydrogen peroxide. The chemical indicator did not change color when water was substituted for hydrogen peroxide, demonstrating that the color change is due to the chemical reaction between dye and hydrogen peroxide molecules.
Chemical Indicator Stability Validation:
Color stability of the chemical indicator was evaluated before and after processing. Unprocessed chemical indicators maintain their red color for at least 24 months when stored at 15°C to 25°C. Post-processing color stability demonstrates that the indicator color is stable for at least 7 months after processing. Functionality studies with indicators aged up to 24 months at 30°C/75% R.H. successfully changed color from red to yellow upon processing.
Population and Performance Characteristics Determination:
The spore population and performance characteristics were determined using a Biological Indicator Evaluation Resistometer (BIER Vessel) following ISO 11138-1.
Incubation Time Determination:
Testing was conducted using CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986). Three different lots of STERRAD® CycleSure™ Biological Indicator (each using a different spore crop and media lot), each consisting of one hundred samples, were tested. The sterilization cycle parameters were reduced to obtain 30-80% surviving samples for each lot. Processed Biological Indicators were incubated for 7 days at 55-60° C and observed daily. The minimum incubation time required was determined to be 48 hours.
Bacteriostasis:
Bacteriostasis testing was performed in the STERRAD® 100 Sterilizer (minimum hydrogen peroxide exposure, 6 mg/L) and STERRAD® 50 Sterilizer (maximum hydrogen peroxide exposure, two injections at 14.3 mg/L).
- STERRAD® 100 Sterilizer: Twenty samples prepared with uninoculated glass fiber discs (10 processed, 10 unprocessed controls). Ten additional samples without glass fiber discs served as positive controls. All samples were inoculated with
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
K 994055
ADVANCED STERILIZATION PRODUCTS® a Johnnon Johnson company REGULATORY AFFAIRS DEPARTMENT
FEB 1 3 2002
510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Kevin Corrigan, R.A.C. Director of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900
Submission Date
February 6, 2002
Trade Name
STERRAD® CycleSure™ Biological Indicator
Common Name
Biological Indicator
Classification Name
Class II
Legally Marketed Equivalent Device Name(s)
3MTM Attest™ Biological Indicator STERRAD® BI Test Pack
DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • IRVINE, CA 92618 • (949) 581-5799 • FAX (949) 789-3900
1
Description of Device
The STERRAD® CycleSure™ Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 106 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.
After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to seal the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).
The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.
Statement of Intended Use
The STERRAD® CycleSure™ Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
Summary of Nonclinical Tests
Chemical Indicator Validation
Effects of a simulated heavy load, no load, presence of plasma, and absence of hydrogen peroxide on the performance of the chemical indicator component of the STERRAD® CycleSure™ Biological Indicator were evaluated by observing the color of the chemical indicators before and after processing in the STERRAD® Sterilization System.
The results of these performance studies indicate that the chemical indicator component of the STERRAD® CycleSure™ Biological Indicator successfully changes color from red to yellow when processed in the STERRAD® 100 Sterilization System under maximum and minimum exposure to hydrogen peroxide.
2
Additionally, the chemical indicator did not change color when water was substituted for hydrogen peroxide in the injection phase of the cycle. This demonstrates that the color change of the chemical indicator is due to the chemical reaction between the dye and hydrogen peroxide molecules during the diffusion phase and not due to the plasma phase of the STERRAD® 100 Sterilization Process.
Chemical Indicator Stability Validation
Color stability of the chemical indicator component of the STERRAD® CycleSure™ Color stabling of has evaluated before and after processing in the STERRAD® Sterilization System. The results of stability studies indicate that the unprocessed chemical indicators maintain their red color for at least 24 months when stored at the storage temperatures specified in the product labeling (15°C to 25°C).
Post-processing color stability of the chemical indicator was also evaluated after processing in the STERRAD® Sterilization System. Stability results, based upon real time aging, demonstrate that the indicator color is stable for at least 7 months after processing in a STERRAD® Sterilizer.
In addition to the stability studies, functionality studies were conducted to evaluate the ability of the chemical indicator, following aging at 30°C/75% R.H., to change color when processed in the STERRAD® Sterilization Systems. Chemical indicators from three different lots, aged up to 24 months, successfully changed color from red to yellow upon processing.
Population and Performance Characteristics Determination
The spore population and performance characteristics of the STERRAD® CycleSure™ Biological Indicators were determined using a Biological Indicator Evaluation Resistometer (BIER Vessel) following the in accordance with ISO 11138-1.
Incubation Time Determination
Testing was conducted using CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986). Three different lots of STERRAD® CycleSure™ Biological Indicator (each using a different spore crop and media lot), each consisting of one hundred samples, were tested to determine the required incubation time. The sterilization cycle parameters were reduced in order to obtain 30-80% surviving samples for each lot tested. Processed STERRAD® CycleSure™ Biological Indicators were incubated for 7 days at 55-60° C. Samples were observed and the results were recorded on a daily basis. Based on the results from this testing, the minimum incubation time required for the STERRAD® CycleSure™ Biological Indicator was determined to be 48 hours.
3
Bacteriostasis
Bacteriostasis testing was performed in the STERRAD® 100 Sterilizer to represent the minimum hydrogen peroxide exposure conditions (6 mg/L injected) and in the STERRAD® 50 Sterilizer to represent the maximum hydrogen peroxide exposure conditions (two injections at 14.3 mg/L injected).
STERRAD® 100 Sterilizer
Twenty STERRAD® CycleSure™ Biological Indicator samples were prepared with uninoculated glass fiber discs. Ten samples were processed in the STERRAD®100 Sterilization System as test samples and ten were unprocessed as negative controls. Ten additional STERRAD® CycleSure™ Biological Indicator samples were prepared without the glass fiber discs for positive controls, this sample set also remained unprocessed. All samples were inoculated with