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.

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).

AI/ML Overview

The provided text describes the acceptance criteria and the results of studies conducted for the EOGas 4 Endo-SteriTest, a biological indicator for ethylene oxide sterilization.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
EZTest-Gas Biological Indicator Performance Characteristics
Viable Spore Population Assays	≥ 10^6 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 (D-value)	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	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	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	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 (in vacuum BIER vs. A-BIER)	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	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	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	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	Stability of the D-Value and spore population; Correctly indicate pass/fail in cycles throughout the stated shelf life	Maintains performance specifications throughout the stated shelf life of 2 years

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes (number of biological indicators, number of runs, etc.) for each individual test. It mentions that "lots of biological indicators" were tested for D-value comparison, and refers to "half dose cycles" and "full dose cycles" for the half-dose validation. It does not provide information on the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a biological indicator for sterilization. Its performance is evaluated through microbial growth/inactivation and chemical indicator changes, not by human expert interpretation of images or other data typically requiring expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The ground truth for this device is based on objective biological and chemical responses, not subjective expert judgment that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a biological indicator for monitoring sterilization efficacy, not an AI-assisted diagnostic device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is a standalone device in the context of it generating its own result (color change, microbial growth/no growth). Its performance is evaluated directly through its biological and chemical responses to sterilization conditions, independent of human intervention for its core function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this biological indicator is primarily the inactivation or survival of Bacillus atrophaeus bacterial spores when subjected to defined sterilization conditions, and the physical/chemical change of an indicator. This is an objective, measurable biological and chemical response, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth establishment process in that context. The "ground truth" for evaluating the BI's performance is established by microbiological standards for spore inactivation.

Summary

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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

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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

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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.

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510(k) Summary K192980

Applicant's Name andAddress	Andersen Sterilizers, Inc.3154 Caroline DriveHaw River, NC 27258
Contact Person	William K. Andersen, BE, MD, FAAOSPresident
	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

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indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.

Indications for Use

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	RelativeHumidity	Ethylene OxideExposure Time	Total CycleTime
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.

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Element	EOGas 4 SteriTest(K151585)	EOGas 4 Endo-SteriTest(K192980)
Intended Use	Sterilization method: EO gasProcess parameters: EO concentration, time,temperature, and relative humidity	Identical
Organism	Bacillus atrophaeus (ATCC 9372)	Identical
Viable SporePopulation	≥1.0 x $10^6$	Identical
Device Design	SCBIPaper 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.	SCBIIdentical
	BI receptacleCreates a greater challenge to the sterilizationprocess than the worst-case location of theworst-case load in the IFU statement;For the 3-hour gas exposure	BI receptacleSame;Modified for a 6-hour gas exposureused for duodenoscope andcolonoscope sterilization
	Purge probeBlue color	Purge probeGold color
Materials ofConstruction	Paper, glass, polypropylene, andaluminum	Paper, glass, polypropylene, andstainless steel
Configuration inLoad	SCBI in a receptacle	Identical
Indications forUse	The EOGas 4 SteriTest consists of a self-contained biological indicator inoculated withviable Bacillus atrophaeus bacterial sporesthat is placed in a dedicated BI receptacle inthe sterilizer. It monitors the efficacy of the3-hour gas exposure at 50°C in the EOGas 4Ethylene Oxide Gas Sterilizer.	The EOGas 4 Endo-SteriTestconsists of a self-containedbiological indicator inoculated withviable Bacillus atrophaeus bacterialspores that is placed in a dedicatedBI receptacle in the sterilizer. Itmonitors the efficacy of the 6-hourgas exposure at 50°C in the EOGas4 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)

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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 SporePopulationAssays	Determine sporepopulation anddemonstrate stabilitywithin 50% to 300% of thecertified value during theclaimed shelf life	≥106 microorganisms perunit;Stable for the stated 2-yearshelf life	Meets the specifications forspore population accordingto 2007 FDA BI guidanceand ANSI/AAMI/ISO11138-1
ResistanceCharacteristicsStudy	Determine D-value usingthe fraction negativemethod	D-value ≥ 3 min;Survival/Kill Time: 15 min;D-values remain ±20% of thestated value for the claimed2-year shelf life	Meets the specifications forresistance characteristicsaccording to 2007 FDA BIguidance andANSI/AAMI/ISO 11138-1
GrowthInhibition	Evaluate the effect of thecarrier and the primarypackaging materials for theintended sterilizationprocess	All exposed carriers andpackaging components arenot bacteriostatic in a worst-case situation	Compliance with 2007 FDABI guidance andANSI/AAMI/ISO 11138-1
Holding TimeAssessment	A series of sub-lethalexposures and populationassays to evaluate theeffect of the labeledholding time on theresistance characteristicsand spore recovery	The resistance characteristicsare not altered significantlyover a 7-day hold time priorto incubation.	Compliance with 2007 FDABI guidance
RecoveryProtocols,Medium andIncubationTime	To validate the recoveryprotocols, medium, and areduced incubation timeper 2007 FDA BI guidanceand ANSI/AAMI/ISO11138-1	Growth of an inoculum of10-100 spores of Bacillusatrophaeus after beingsubjected to the sterilizationprocess.	Compliance with 2007 FDABI guidance andANSI/AAMI/ISO 11138-1;Data generated supports anincubation time of 48 hoursfor EZTest-Gas biologicalindicators.
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

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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).

Regulation Number and Section

§ 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).