(385 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization efficacy, with no mention of AI or ML.
No.
The device is a biological indicator used to monitor the efficacy of a sterilizer, not to treat a medical condition or disease.
No
The device is a self-contained biological indicator that monitors the efficacy of a sterilizer, not a diagnostic device for medical conditions. It determines if sterilization conditions were met, not if a disease or condition is present in a patient.
No
The device is a biological indicator system consisting of physical components (vial, cap, paper carrier, glass ampoule, broth, chemical indicator, reusable receptacle) and relies on biological and chemical reactions for its function, not solely software.
Based on the provided information, the EOGas 4 Endo-SteriTest is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "monitor the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer." This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device uses a biological indicator (bacterial spores) and a chemical indicator to assess whether the sterilization process was successful in killing microorganisms. It does not analyze a patient sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids, or providing information for the diagnosis, treatment, or prevention of disease.
- Performance Studies: The performance studies focus on the ability of the biological indicator to accurately reflect the sterilization process's effectiveness (e.g., spore population, resistance, growth inhibition) rather than diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV related to patient diagnosis.
- Predicate Device: The predicate device is the "EOGas 4 SteriTest," which is also a biological indicator for sterilization monitoring, not an IVD.
In summary, the EOGas 4 Endo-SteriTest is a biological indicator used for monitoring the effectiveness of an ethylene oxide sterilization process. It is a quality control tool for a medical device sterilization process, not a device used for in vitro diagnostic testing on human specimens.
N/A
Intended Use / Indications for Use
The EOGas 4 Endo-SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 6 hours | 7 hours |
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The EOGas 4 Endo-SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer.
The SCBI, the EZTest-Gas Biological Indicator, consists of a plastic vial that serves as the culture tube, and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.
Following manufacturer's instructions, the operator inserts the EZTest-Gas Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50℃. After cycle completion, the EZTest-Gas Biological Indicator is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30- 35°C for 48 hours and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EOGas 4 Endo-SteriTest has been validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions", and ANSI AAMI ISO 11138-1 "Sterilization of health care products – Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-502).
For the EZTest-Gas Biological Indicators, tests included viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition) evaluation, holding time assessment, and reduced incubation time validation. The results of all studies met the established acceptance criteria.
Under equivalent exposure conditions, the resistance characteristics of the EZTest-Gas Biological Indicators were identical when measured in a Biological Indicator Evaluator Resistometer in the presence or absence of a vacuum.
The EOGas 4 Endo-SteriTest represents a rigorous challenge to the EOGas 4 sterilization process. Its resistance characteristics are greater than the same biological indicator placed in the worst-case locations of the endoscope validation loads. The performance of the EOGas 4 Endo-SteriTest in the 6-hour gas exposure at 50 ℃ in an EOGas 4 Ethylene Oxide Gas Sterilizer is summarized in Table 3.
Table 3. Summary of bench tests performed to demonstrate safety and effectiveness of the EOGas 4 Endo-SteriTest:
- EZTest-Gas Biological Indicator Performance Characteristics:
- Viable Spore Population Assays: Determined spore population and demonstrated stability within 50% to 300% of the certified value during the claimed shelf life. Result: Meets the specifications for spore population according to 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1.
- Resistance Characteristics Study: Determined D-value using the fraction negative method. Result: Meets the specifications for resistance characteristics according to 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1.
- Growth Inhibition: Evaluated the effect of the carrier and the primary packaging materials for the intended sterilization process. Result: Compliance with 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1.
- Holding Time Assessment: A series of sub-lethal exposures and population assays to evaluate the effect of the labeled holding time on the resistance characteristics and spore recovery. Result: Compliance with 2007 FDA BI guidance.
- Recovery Protocols, Medium and Incubation Time: To validate the recovery protocols, medium, and a reduced incubation time per 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1. Result: Compliance with 2007 FDA BI guidance and ANSI/AAMI/ISO 11138-1; Data generated supports an incubation time of 48 hours for EZTest-Gas biological indicators.
- D-Value Comparison for EZTest-Gas Biological Indicator:
- D-value: Determined D-value using a fraction negative method. Result: There is no significant difference in the D-values measured in a vacuum BIER vs. an A-BIER.
- Performance Testing for the EOGas 4 Endo-SteriTest:
- Half Dose Validation: To demonstrate that the EOGas 4 Endo-SteriTest presents a rigorous challenge to the sterilization process. Result: Partial kill of biological indicators in PCD in half dose cycles, and complete kill in full dose cycles; Biological indicators at the worst-case locations in the endoscope loads are completely inactivated in both half and full dose cycles; EO concentration in the full dose cycles are twice the concentration in the half dose cycles for each endoscope load.
- Pass/Fail Results from the EOGas 4 Sterilizer: To validate EOGas 4 Endo-SteriTest against the duodenoscope and colonoscope loads indicated for processing in the EOGas 4 sterilizer. Result: Data demonstrate the EOGas 4 Endo-SteriTest correctly indicates passed and failed 6-hour gas exposures in the EOGas 4 throughout the stated shelf life.
- Endpoint Color Stability of the Chemical Indicator: To evaluate the stability of the endpoint color of the chemical indicator on the biological indicator. Result: The endpoint green/brown color was stable for at least 28 days when EZTest-Gas BIs were stored at 20-25°C or at 35-39°C after the EOGas 4 sterilization cycles.
- Shelf Life: To demonstrate the stability of the resistance characteristics and correctly indicate pass/fail in cycles throughout the stated shelf life. Result: Maintains performance specifications throughout the stated shelf life of 2 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 12, 2020
Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258
Re: K192980
Trade/Device Name: EOGas 4 Endo-SteriTest Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 28, 2020 Received: October 29, 2020
Dear William Andersen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192980
Device Name EOGas 4 Endo-SteriTest
Indications for Use (Describe)
The EOGas 4 Endo-SteriTest consists of a seff-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time |
|---|---|---|---|---|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 6 hours | 7 hours |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
510(k) Summary K192980
| Applicant's Name and
Address | Andersen Sterilizers, Inc.
3154 Caroline Drive
Haw River, NC 27258 |
|---------------------------------|--------------------------------------------------------------------------|
| Contact Person | William K. Andersen, BE, MD, FAAOS
President |
| | Phone: 336-376-8622, Fax: 336-376-5428 |
Date of Preparation
October 28, 2020
Device
Proprietary Name Common Name Classification Product Code
EOGas 4 Endo-SteriTest Biological Sterilization Process Indicator Class II (21 CFR 880.2800) FRC
Predicate Device
Device Name 510(k) number Manufacturer
EOGas 4 SteriTest K151585 Andersen Sterilizers, Inc.
This 510(k) submission modifies the predicate device to add a process challenge device for a 6hour gas exposure. No modifications were made to the technology or intended use.
Device Description
The EOGas 4 Endo-SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer.
The SCBI, the EZTest-Gas Biological Indicator, consists of a plastic vial that serves as the culture tube, and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH
5
indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.
Following manufacturer's instructions, the operator inserts the EZTest-Gas Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50℃. After cycle completion, the EZTest-Gas Biological Indicator is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30- 35°C for 48 hours and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).
Indications for Use
The EOGas 4 Endo-SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on a gold-colored purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
Critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical parameters for the 6-hour gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer
| Ethylene Oxide | Temperature | Relative
Humidity | Ethylene Oxide
Exposure Time | Total Cycle
Time |
|----------------|-------------|----------------------|---------------------------------|---------------------|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 6 hours | 7 hours |
Technological Characteristics Comparison
The technological characteristics of the EOGas 4 Endo-SteriTest are compared to the predicate device, EOGas 4 SteriTest (K151585), because both process challenge devices (PCDs) are intended for the same use, use the same technology, are designed in the same way, and perform similarly.
The EOGas 4 Endo-SteriTest differs from the predicate device in the resistance to the sterilization process. A comparison between the devices is listed in Table 2.
6
| Element | EOGas 4 SteriTest
(K151585) | EOGas 4 Endo-SteriTest
(K192980) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Sterilization method: EO gas
Process parameters: EO concentration, time,
temperature, and relative humidity | Identical |
| Organism | Bacillus atrophaeus (ATCC 9372) | Identical |
| Viable Spore
Population | ≥1.0 x $10^6$ | Identical |
| Device Design | SCBI
Paper strip containing indicator organism;
Glass ampoule containing growth medium;
Capped vial serving as a culture tube;
A pH indicator in medium for color change;
A process indicator indicating EO exposure. | SCBI
Identical |
| | BI receptacle
Creates a greater challenge to the sterilization
process than the worst-case location of the
worst-case load in the IFU statement;
For the 3-hour gas exposure | BI receptacle
Same;
Modified for a 6-hour gas exposure
used for duodenoscope and
colonoscope sterilization |
| | Purge probe
Blue color | Purge probe
Gold color |
| Materials of
Construction | Paper, glass, polypropylene, and
aluminum | Paper, glass, polypropylene, and
stainless steel |
| Configuration in
Load | SCBI in a receptacle | Identical |
| Indications for
Use | The EOGas 4 SteriTest consists of a self-
contained biological indicator inoculated with
viable Bacillus atrophaeus bacterial spores
that is placed in a dedicated BI receptacle in
the sterilizer. It monitors the efficacy of the
3-hour gas exposure at 50°C in the EOGas 4
Ethylene Oxide Gas Sterilizer. | The EOGas 4 Endo-SteriTest
consists of a self-contained
biological indicator inoculated with
viable Bacillus atrophaeus bacterial
spores that is placed in a dedicated
BI receptacle in the sterilizer. It
monitors the efficacy of the 6-hour
gas exposure at 50°C in the EOGas
4 Ethylene Oxide Gas Sterilizer. |
Table 2. Device Comparison
Summary of Non-Clinical Testing:
The EOGas 4 Endo-SteriTest has been validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions", and ANSI AAMI ISO 11138-1 "Sterilization of health care products – Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-502).
For the EZTest-Gas Biological Indicators, tests included viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition)
7
evaluation, holding time assessment, and reduced incubation time validation. The results of all studies met the established acceptance criteria.
Under equivalent exposure conditions, the resistance characteristics of the EZTest-Gas Biological Indicators were identical when measured in a Biological Indicator Evaluator Resistometer in the presence or absence of a vacuum.
The EOGas 4 Endo-SteriTest represents a rigorous challenge to the EOGas 4 sterilization process. Its resistance characteristics are greater than the same biological indicator placed in the worst-case locations of the endoscope validation loads. The performance of the EOGas 4 Endo-SteriTest in the 6-hour gas exposure at 50 ℃ in an EOGas 4 Ethylene Oxide Gas Sterilizer is summarized in Table 3.
| EOGas 4 Endo-Steritest | |||
|---|---|---|---|
| Test | Description | Acceptance Criteria | Result |
| EZTest-Gas Biological Indicator Performance Characteristics | |||
| Viable Spore | |||
| Population | |||
| Assays | Determine spore | ||
| population and | |||
| demonstrate stability | |||
| within 50% to 300% of the | |||
| certified value during the | |||
| claimed shelf life | ≥106 microorganisms per | ||
| unit; | |||
| Stable for the stated 2-year | |||
| shelf life | Meets the specifications for | ||
| spore population according | |||
| to 2007 FDA BI guidance | |||
| and ANSI/AAMI/ISO | |||
| 11138-1 | |||
| Resistance | |||
| Characteristics | |||
| Study | Determine D-value using | ||
| the fraction negative | |||
| method | D-value ≥ 3 min; | ||
| Survival/Kill Time: 15 min; | |||
| D-values remain ±20% of the | |||
| stated value for the claimed | |||
| 2-year shelf life | Meets the specifications for | ||
| resistance characteristics | |||
| according to 2007 FDA BI | |||
| guidance and | |||
| ANSI/AAMI/ISO 11138-1 | |||
| Growth | |||
| Inhibition | Evaluate the effect of the | ||
| carrier and the primary | |||
| packaging materials for the | |||
| intended sterilization | |||
| process | All exposed carriers and | ||
| packaging components are | |||
| not bacteriostatic in a worst- | |||
| case situation | Compliance with 2007 FDA | ||
| BI guidance and | |||
| ANSI/AAMI/ISO 11138-1 | |||
| Holding Time | |||
| Assessment | A series of sub-lethal | ||
| exposures and population | |||
| assays to evaluate the | |||
| effect of the labeled | |||
| holding time on the | |||
| resistance characteristics | |||
| and spore recovery | The resistance characteristics | ||
| are not altered significantly | |||
| over a 7-day hold time prior | |||
| to incubation. | Compliance with 2007 FDA | ||
| BI guidance | |||
| Recovery | |||
| Protocols, | |||
| Medium and | |||
| Incubation | |||
| Time | To validate the recovery | ||
| protocols, medium, and a | |||
| reduced incubation time | |||
| per 2007 FDA BI guidance | |||
| and ANSI/AAMI/ISO | |||
| 11138-1 | Growth of an inoculum of | ||
| 10-100 spores of Bacillus | |||
| atrophaeus after being | |||
| subjected to the sterilization | |||
| process. | Compliance with 2007 FDA | ||
| BI guidance and | |||
| ANSI/AAMI/ISO 11138-1; | |||
| Data generated supports an | |||
| incubation time of 48 hours | |||
| for EZTest-Gas biological | |||
| indicators. | |||
| D-Value Comparison for EZTest-Gas Biological Indicator | |||
| D-value | Determine D-value using a fraction negative method | D-values are within 20% of the original stated values for all lots of biological indicators tested. | There is no significant difference in the D-values measured in a vacuum BIER vs. an A-BIER. |
| Performance Testing for the EOGas 4 Endo-SteriTest | |||
| Half Dose Validation | To demonstrate that the EOGas 4 Endo-SteriTest presents a rigorous challenge to the sterilization process | Device is appropriate for monitoring the efficacy of the sterilization process claimed | Partial kill of biological indicators in PCD in half dose cycles, and complete kill in full dose cycles; Biological indicators at the worst-case locations in the endoscope loads are completely inactivated in both half and full dose cycles; EO concentration in the full dose cycles are twice the concentration in the half dose cycles for each endoscope load. |
| Pass/Fail Results from the EOGas 4 Sterilizer | To validate EOGas 4 Endo-SteriTest against the duodenoscope and colonoscope loads indicated for processing in the EOGas 4 sterilizer | Correctly indicate pass/fail in cycles | Data demonstrate the EOGas 4 Endo-SteriTest correctly indicates passed and failed 6-hour gas exposures in the EOGas 4 throughout the stated shelf life. |
| Endpoint Color Stability of the Chemical Indicator | To evaluate the stability of the endpoint color of the chemical indicator on the biological indicator | Stability to provide reasonable assurance of effectiveness | The endpoint green/brown color was stable for at least 28 days when EZTest-Gas BIs were stored at 20-25°C or at 35-39°C after the EOGas 4 sterilization cycles. |
| Shelf Life | To demonstrate the stability of the resistance characteristics and correctly indicate pass/fail in cycles throughout the stated shelf life | Stability of the D-Value and spore population; Correctly indicate pass/fail in cycles | Maintains performance specifications throughout the stated shelf life of 2 years |
Table 3. Summary of bench tests performed to demonstrate safety and effectiveness of the EOGas 4 Endo-SteriTest
8
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the EOGas 4 Endo-SteriTest is as safe, as effective, and performs as well as or better than the legally marketed EOGas 4 SteriTest (K151585).