The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator 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 the 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 Rapid Readout Biological Indicator (RRBI) 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 EOCas 4 Ethylene Oxide Gas Sterilizer.

The Bionova BT110 Rapid Readout Biological Indicator (K191021) 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 culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.

Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout 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°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.

The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).

AI/ML Overview

The provided document describes the EOGas 4 Endo-SteriTest RRBI, a rapid readout biological indicator for monitoring ethylene oxide sterilization cycles. The submission seeks to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Functionality	1) Critical parameters include time, temperature, gas concentration, and relative humidity 35-90% are met; 2) Device is appropriate for monitoring the efficacy of the sterilization process claimed.	Pass
Shelf Life	Maintains performance specifications (resistance characteristics and correctly indicate pass/fail in cycles) throughout the stated shelf life of 2 years; Stability demonstrates reasonable assurance for effectiveness.	Pass
Viable Spore Population	$\ge 1.0 \times 10^6$ Bacillus atrophaeus (ATCC 9372) spores.	$\ge 1.0 \times 10^6$
Resistance Characteristics	(Implicitly) Must be greater than the same biological indicator placed in the worst-case location of endoscope validation loads.	Met (Implied by "Pass" of full functionality)
Growth Inhibition	No inhibition of viable spore growth by carrier or primary packaging materials.	Met (Implied by "Pass" of full functionality)
Holding Time Assessment	(Details not explicitly stated, but expected for BI performance)	Met (Implied by "Pass" of individual studies)
Reduced Incubation Time Validation	(Details not explicitly stated, but expected for RRBI performance)	Met (Implied by "Pass" of individual studies)
Recovery Protocols for Recovery Medium	(Details not explicitly stated, but expected for BI performance)	Met (Implied by "Pass" of individual studies)
Visual Readout Stability	(Details not explicitly stated, but expected for RRBI performance)	Met (Implied by "Pass" of individual studies)
In-Field Evaluation	(Details not explicitly stated, but expected for BI performance)	Met (Implied by "Pass" of individual studies)

Notes on Acceptance Criteria:

The document explicitly lists "Functionality" and "Shelf Life" tests with their acceptance criteria and "Pass" results.
For the individual studies performed for the Bionova BT110 Rapid Readout Biological Indicators (which is a component of the EOGas 4 Endo-SteriTest RRBI), the document states that "The results of all studies met the established acceptance criteria," without enumerating the specific criteria for each.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (e.g., number of BIs or sterilization cycles) for the "test set" studies. It mentions that "The EOGas 4 Endo-SteriTest RRBI 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 11138-1:2017 'Sterilization of health care products -Biological indicators - Part 1: General requirements'." These standards typically define the requirements for testing, including sample sizes, but the specific numbers used in this submission are not stated.

Data provenance is not explicitly mentioned but is assumed to be prospective bench testing conducted by the manufacturer as part of the validation process for regulatory submission. There is no mention of country of origin for data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a biological indicator designed to directly measure sterilization efficacy, not to be interpreted by human experts like medical images. The "ground truth" for a biological indicator is the direct observation of microbial growth (or lack thereof) after exposure to a sterilization process, relative to positive and negative controls.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the device's output (microbial growth/no growth, or fluorescent activity/no fluorescent activity) is a direct, objective measurement, not subject to subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm. The device itself (the biological indicator) is a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used for biological indicators is the viability of the Bacillus atrophaeus bacterial spores.

Failed Sterilization: Indicated by observable fluorescent activity or a color change from blue to yellow in the culture medium, signifying spore survival and growth.
Successful Sterilization: Indicated by no fluorescence and no color change, signifying spore inactivation.
Positive controls (unprocessed BIs) are expected to show growth, and negative controls (processed BIs from a successful cycle) are expected to show no growth, confirming the validity of the test.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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March 3, 2021

Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258

Re: K202879

Trade/Device Name: EOGas 4 Endo-SteriTest RRBI Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: February 3, 2021 Received: February 4, 2021

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,

Clarence W. Murray, III, Ph.D. Acting 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

510(k) Number (if known) K202879

Device Name EOGas 4 Endo-SteriTest RRBI

Indications for Use (Describe)

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 $\pm$ 5%	50°C $\pm$ 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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K202879 510(k) Summary

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

March 3, 2021

Device

Proprietary Name	EOGas 4 Endo-SteriTest RRBI
Common Name	Biological Sterilization Process Indicator
Classification	Class II (21 CFR 880.2800)
Product Code	FRC

Predicate Device

Device Name	EOGas 4 SteriTest
510(k) number	K151585
Manufacturer	Andersen Sterilizers, Inc.

The current 510(k) submission modifies the predicate device to add a process challenge device for a 6-hour gas exposure. No modifications were made to the technology or intended use.

Device Description

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indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.

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	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

Table 2 below compares the technological characteristics of the EOGas 4 Endo-SteriTest RRBI to the technological characteristics of the predicate device, EOGas 4 SteriTest (K151585).

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Element	EOGas 4 SteriTest(K151585)	EOGas 4 Endo-SteriTest RRBI(K202879)	Comparison
Intended Use	Sterilization method: EO gasProcess parameters: EOconcentration, time, temperature,and relative humidity	Sterilization method: EO gasProcess parameters: EOconcentration, time, temperature, andrelative humidity	Same
Organism	Bacillus atrophaeus (ATCC9372)	Bacillus atrophaeus (ATCC 9372)	Same
Viable SporePopulation	$≥1.0 x 10^6$	$≥1.0 x 10^6$	Same
Device Design	EZTest-Gas BI (K930683)Paper strip containing indicatororganism; Glass ampoulecontaining growth medium;Capped vial serving as a culturetube; pH indicator in medium forcolor change; Process indicatorindicating EO exposure.	Bionova BT110 RRBI (K191021)Paper strip containing indicatororganism; Glass ampoule containinggrowth medium; Capped vial servingas a culture tube; pH indicator inmedium for color change; Processindicator indicating EO exposure;Fluorescent enzymatic activitydetection.	Similar
	BI receptacle:Creates a greater challenge to thesterilization process than theworst-case location of the worst-case load in the IFU statement;For the 3-hour gas exposurePurge probe:Blue color	BI receptacle:Creates a greater challenge to thesterilization process than the worst-case location of the worst-case loadin the IFU statement;For the 6-hour gas exposurePurge probe:Gold color	Different
Materials ofConstruction	Paper, glass, polypropylene, andaluminum	Paper, glass, polypropylene, andstainless steel	Different
Configurationin Load	SCBI in a receptacle	SCBI in a receptacle	Same
Indications forUse	The EOGas 4 SteriTest consistsof a self-contained biologicalindicator inoculated with viableBacillus atrophaeus bacterialspores that is placed in adedicated BI receptacle in thesterilizer. It monitors theefficacy of the 3-hour gasexposure at 50°C in the EOGas 4Ethylene Oxide Gas Sterilizer.	The EOGas 4 Endo-SteriTest RRBIconsists of a self-containedbiological indicator inoculated withviable Bacillus atrophaeus bacterialspores that is placed in a dedicatedbiological indicator receptaclemounted on the purge probe in thesterilizer. It monitors the efficacy ofthe 6-hour gas exposure at 50°C inthe EOGas 4 Ethylene Oxide GasSterilizer.	Different

Table 2. Device Comparison

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Performance Testing

The EOGas 4 Endo-SteriTest RRBI 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 11138-1:2017 "Sterilization of health care products -Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-502).

For the Bionova BT110 Rapid Readout Biological Indicators (K191021), tests included viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition) evaluation, holding time assessment, reduced incubation time validation, recovery protocols for recovery medium, visual readout stability, and in-field evaluation. The results of all studies met the established acceptance criteria.

The EOGas 4 Endo-SteriTest RRBI 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 location of the endoscope validation loads. The performance of the EOGas 4 Endo-SteriTest RRBI in the 6-hour gas exposure at 50°C 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 RRBI

Test	Description	Result
Functionality	1) Critical parameters include time, temperature, gas concentration, andrelative humidity 35-90%;2) Device is appropriate for monitoring the efficacy of the sterilizationprocess claimed	Pass
Shelf Life	Maintains performance specifications (resistance characteristics andcorrectly indicate pass/fail in cycles) throughout the stated shelf life of 2years:Stability demonstrates reasonable assurance for effectiveness	Pass

Conclusion:

In conclusion, the EOGas 4 Endo-SteriTest RRBI is substantially equivalent to the legally marketed predicate, the 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).