The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

EO Exposure Time	Total Cycle Time	EO Amount	Temperature	Relative Humidity
3 hours	3.5 hours	17.6 g $\pm$ 5%	50°C $\pm$ 3°C	35-70%
6 hours	7 hours

The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

Device Description

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria	Reported Device Performance
Minimum Sterilization Parameters	The EO gas exposure time at 50°C in an EOGas 4 sterilizer must result in sterilization of the endoscope loads.	Using a 6-hour EO gas exposure in the EOGas 4 sterilizer, 6-Log biological indicators were consistently inactivated for two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load. The minimum parameters for sterilization of two duodenoscopes or colonoscopes are 518 mg/L EO, 46.4°C, and 35% RH.
Half Dose Validation	For consecutive half dose cycles and full dose cycles: EO concentration is half when half the amount of EO is used. All 6-Log Bacillus atrophaeus biological indicators, inoculated at the worst-case locations of the tested endoscopes, are inactivated.	Consecutive half dose cycles and full dose cycles were performed. The EO concentration was half when half the amount of EO was used. The cumulative lethality of half dose cycles was half the lethality of full dose cycle. The cycles consistently inactivated all 6-Log Bacillus atrophaeus biological indicators inoculated at the midpoint of the tested channels and at the elevator mechanism of duodenoscopes, as well as the water jet channel of the colonoscopes.
Simulated-Use Testing	For consecutive full dose cycles: Biological indicators with 6-Log Bacillus atrophaeus, prepared in an artificial soil and inoculated at the worst-case locations of the tested endoscopes, are inactivated.	Biological indicators with 6-Log Bacillus atrophaeus were prepared in an artificial soil and inoculated at the center of the tested channels and at the elevator mechanism of duodenoscopes as well as the water jet channel of the colonoscopes. Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested.
In-Use Testing	Duodenoscopes and colonoscopes, used on patients, cleaned but not disinfected, are sterilized using the 6-hour cycle at 50°C in an EOGas 4 sterilizer.	Duodenoscopes and colonoscopes, used on patients, were cleaned per hospital protocol but not disinfected, processed using the 6-hour EO exposure at 50°C in the EOGas 4 sterilizer; sterility was tested by a flush method per USP. All test cultures from the processed duodenoscopes and colonoscopes were sterile.
EO Residuals	After additional aeration following the cycle, EO residuals on duodenoscopes and colonoscopes are evaluated, and the residuals on the endoscopes and accessories meet the requirements of ANSI/AAMI/ISO 10993-7.	Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes wrapped in Sterisheet must aerate for an additional 6 hours after the cycle. Fujifilm ED-530XT and EC-600HL wrapped in Sterisheet must aerate for an additional 8 hours after the cycle. After 6 hours of additional aeration, EO residuals on the packaging materials met the requirements of ANSI/AAMI/ISO 10993-7.

Study Information:

Sample sizes used for the test set and data provenance:
- Minimum Sterilization Parameters: Performed to define and validate the endoscope loads. The results indicate successful inactivation of 6-Log BIs for "two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load." The exact number of each type of load tested isn't specified, but implies multiple runs for different combinations.
- Half Dose Validation: "Consecutive half dose cycles and full dose cycles were performed." No specific number of cycles or endoscopes is provided.
- Simulated-Use Testing: "Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested." Again, the exact number of cycles or endoscopes is not specified.
- In-Use Testing: "Duodenoscopes and colonoscopes, used on patients... processed using the 6-hour EO exposure." No specific number of patient-used scopes is provided.
- EO Residuals: Tested on "Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes" and "Fujifilm ED-530XT and EC-600HL." This indicates testing on a variety of endoscope models.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S., the testing would typically be conducted to U.S. regulatory standards. "In-Use Testing" mentions "used in routine endoscopic procedures in a hospital or clinic setting," suggesting prospective collection of real-world use data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes performance testing of a sterilizer, where the "ground truth" is defined by the inactivation of biological indicators and the adherence to specified chemical and physical parameters. These are objective measures and do not typically involve human "experts" establishing a subjective ground truth, as would be the case for image interpretation or diagnosis. Therefore, no information on experts for ground truth is applicable or provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, the ground truth is based on objective laboratory measurements (biological indicator cultures, chemical concentrations, temperature, humidity, and residual levels), not a subjective human assessment requiring adjudication.
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 document pertains to the validation of an ethylene oxide gas sterilizer, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a sterilizer, not an algorithm. Its performance is evaluated through its physical and biological sterilization capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the sterilization efficacy tests is primarily established by:
  - Biological Inactivation: The complete inactivation of 6-Log Bacillus atrophaeus biological indicators, confirmed by culture methods.
  - Physical Parameters: Measurement of critical process parameters (EO concentration, temperature, relative humidity, time) meeting defined specifications.
  - Chemical Residuals: Measurement of ethylene oxide residuals meeting ANSI/AAMI/ISO 10993-7 requirements.
  - Sterility Testing: For in-use testing, sterility was confirmed by a flush method per USP, indicating no microbial growth.
The sample size for the training set:
- Not applicable. This device is a physical sterilizer and does not involve AI or machine learning models that require a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set is used for this type of device validation.

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: K192978

Trade/Device Name: EOGas 4 Ethylene Oxide Gas Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: FLF Dated: October 8, 2020 Received: October 13, 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

510(k) Number (if known) K192978

Device Name EOGas 4 Ethylene Oxide Gas Sterilizer

Indications for Use (Describe)

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

EO Exposure Time	Total Cycle Time	EO Amount	Temperature	Relative Humidity
3 hours	3.5 hours	17.6 g $\pm$ 5%	50°C $\pm$ 3°C	35-70%
6 hours	7 hours

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Device Type	Maximum Load	Device Examples	Required Aeration
3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)			No additional aeration required; Follow pouch or wrap manufacturer's instructions (Example: Tyve pouches require ≥ 6 hours at 50°C)
Metal	24 lbs (11 kg)	Surgical instruments,delicate sharps,including those withhinges and matedsurfaces
Plastic	7.0 lbs (3.2 kg)	Reusable power cords,trocars, and similardevices	24 hours at 50°C;Follow manufacturer'sinstructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,towels, and similar devices
≤ 1100 mmWorkingLumenLength	One (1)≥ 2.0 mm ID biopsy channel≤ 1100 mm working length	Gastrovideoscopes,gastrointestinal videoscopes,and similar devices	8 hours at 50°C;Follow manufacturer'sinstructions
Endoscopes	Four (4)≥ 1.2 mm ID biopsy channel≤ 700 mm working length	Bronchoscopes,bronchovideoscopes, cystoscopes,ureteroscopes, choledocoscopes,and similar devices

Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)

>1100 mm	Two (2) Duodenoscopes*	Olympus TJF-Q180V,	6 hours at 50°C for
Working	≥ 2.0 mm ID biopsy channel	Olympus TJF-Q160VF ,	Olympus and Pentax
Lumen	≤ 1250 mm working length	Olympus TJF-Q190V,	endoscopes in Sterisheet
Length	≥ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel	Olympus PJF-160,
Endoscopes	Two (2) Colonoscopes*	Fujifilm ED-530XT,	8 hours at 50°C for
	≥ 3.7 mm ID biopsy channel	Pentax ED34-i10T2,	Fujifilm endoscopes
	≤ 1700 mm working length	Pentax ED-3490TK	in Sterisheet
	≥ 1.2 mm ID, ≤ 3530 mmmaximum length of any channel	Olympus CF-Q180AL,	Follow manufacturer's
		Fujifilm EC-600HL,	instructions
		Pentax EC-3490Li

One (1) duodenoscope may also be paired with one (1) colonoscope

Reusable medical devices must be aerated following the instructions of the device manufacturer and the packaging material manufacturer. Devices are released for use after sterilization based on successful inactivation of a biological indicator (BI) in the Andersen EOGas 4 SteriTest (3-hour gas exposure) or EOGas 4 Endo-SteriTest (6-hour gas exposure) process challenge devices.

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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)

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510(k) Summary K192978

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 8, 2020

Device

Proprietary Name EOGas 4 Ethylene Oxide Gas Sterilizer Common Name Ethylene oxide gas sterilizer Classification Class II (21 CFR 880.6860) Medical Specialty General Hospital Product Code FLF

The refill kits for the EOGas 4 Ethylene Oxide Gas Sterilizer, including the accessories (sterilization bags, EOGas 4 cartridges, Dosimeters, and Humidichips), are registered with the US Environmental Protection Agency (EPA #69340-7).

Predicate Device

Device Name	EOGas 4 Ethylene Oxide Gas Sterilizer
510(k) number	K150646
Manufacturer	Andersen Sterilizers, Inc.

The principles of operation for the EOGas 4 Ethylene Oxide Sterilizer, intended use, and technology are unchanged. The predicate EOGas 4 Ethylene Oxide Gas Sterilizer has the option of a 3-hour gas exposure or a 5-hour gas exposure, although only the 3-hour gas exposure is indicated for sterilization in hospitals and other human healthcare settings. To add the sterilization of duodenoscopes and colonoscopes to the indications for use, the 5-hour gas exposure was lengthened to 6 hours and a new process challenge device was developed appropriate for the longer cycle.

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Device Description

Indications for Use

The EOGas 4 Ethylene Oxide Gas Sterilizer is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

EO ExposureTime	Total CycleTime	EO Amount	Temperature	RelativeHumidity
3 hours	3.5 hours	17.6 g ± 5%	50°C ± 3°C	35-70%
6 hours	7 hours

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

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Device Type	Maximum Load	Device Examples	Required Aeration
3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe)
Metal	24 lbs(11 kg)	Surgical instruments,delicate sharps,including those withhinges and matedsurfaces	No additional aerationrequired;Follow pouch or wrapmanufacturer'sinstructions (Example:Tyvek pouches require$\ge$ 6 hours at 50°C)
Plastic	7.0 lbs(3.2 kg)	Reusable power cords,trocars, and similardevices	24 hours at 50°C;
Fabric	6.1 lbs(2.8 kg)	Reusable cloth gowns,towels, and similardevices	Follow manufacturer'sinstructions
≤ 1100 mmWorkingLumenLengthEndoscopes	One (1)$\ge$ 2.0 mm ID biopsy channel≤ 1100 mm working length	Gastrovideoscopes,gastrointestinalvideoscopes, andsimilar devices	8 hours at 50°C if inSterisheet;
	Four (4)$\ge$ 1.2 mm ID biopsy channel≤ 700 mm working length	Bronchoscopes,bronchovideoscopes,cystoscopes,ureteroscopes,choledocoscopes, andsimilar devices	Follow manufacturer'sinstructions
6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)
>1100 mmWorkingLumenLengthEndoscopes	Two (2) Duodenoscopes*$\ge$ 2.0 mm ID biopsy channel≤ 1250 mm working length$\ge$ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel	Olympus TJF-Q180V,Olympus TJF-Q160VF,Olympus TJF-Q190V,Olympus PJF-160,Fujifilm ED-530XT,Pentax ED34-i10T2Pentax ED-3490TK	6 hours at 50°C forOlympus and Pentaxendoscopes inSterisheet;
	Two (2) Colonoscopes*$\ge$ 3.7 mm ID biopsy channel≤ 1700 mm working length$\ge$ 1.2 mm ID, ≤ 3530 mmmaximum length of anychannel	Olympus CF-Q180AL,Fujifilm EC-600HL,Pentax EC-3490Li	8 hours at 50°C forFujifilm endoscopes inSterisheet;Follow manufacturer'sinstructions
	* One (1) duodenoscope may also be paired with one (1)colonoscope

Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer

Reusable medical devices must be aerated following the instructions of the device manufacturer and the packaging material manufacturer. Devices are released for use after sterilization based

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on successful inactivation of a biological indicator (BI) in the Andersen EOGas 4 SteriTest (3hour gas exposure) or EOGas 4 Endo-SteriTest (6-hour gas exposure) process challenge devices.

Technological Characteristics Comparison Table

The EOGas 4 Ethylene Oxide Gas Sterilizer is compared to the predicate device - the EOGas 4 Ethylene Oxide Gas Sterilizer (K150646), because the sterilizers are intended for the same use, designed in the way and use the same technology. The predicate EOGas 4 Ethylene Oxide Gas Sterilizer has the option of a 3-hour gas exposure or a 5-hour gas exposure. To sterilize a load consisting of two duodenoscopes or colonoscopes at a time, the 5-hour gas exposure was lengthened to 6 hours, and a process challenge device was created, the EOGas 4 Endo-SteriTest, that is appropriate for the longer gas exposure. A comparison between the sterilizers is listed in Table 3.

	SubjectEOGas 4 Sterilizer K192978	Predicate EOGas 4Sterilizer K150646	Comparison
IntendedUse	Indoor EO sterilizer in a healthcare setting with a SAL of 10-6		Same
Design	Same design for exterior and cabinet
	Same unit dose EO; Same EO impervious sterilization bag		Same
	Same flexible sterilization chamber
Technology	Use EO as sterilant; EPA registered		Same
	Critical parameters: EO concentration, RH, temperature, and time
Safety	Verify compliance for electromagnetic compatibility and electricalsafety		Same
Indicationsfor Use	3-hour gas exposure at 50°C;6-hour gas exposure at 50°C	3-hour gas exposure at 50°C;(5-hour gas exposure at 50°C;not used for healthcaresterilization)	Added a 6-hourgas exposure forsterilization ofendoscopes with> 1100 mmworking length
ProcessChallengeDevice	EOGas 4 Endo-SteriTest (K192980)EZTest-Gas BI (K930683);Bionova BT110 RRBI (K191021);BI Receptacle:Stainless steel cylinder0.020" ID x 4.50" L lumen	EOGas 4 SteriTest (K151585)EZTest-Gas BI (K930683);BI Receptacle:Stainless steel cylinder0.020" ID x 0.25" L orifice	Similar:appropriate forthe intendedlength of gasexposure
Performance	Sterilize reusable medical devices as labeled to a SAL of 10-6		Similar

Table 3. Comparison between the EOGas 4 Ethylene Oxide Gas Sterilizer and the predicate EOGas 4 Ethylene Oxide Gas Sterilizer

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Summary of Non-Clinical Testing:

Time	Purpose	Acceptance Criteria	Results
MinimumSterilizationParameters	To define andvalidate theendoscope loads thatcan be sterilized usingthe 6-hour gasexposure at 50°C inan EOGas 4 sterilizer	The EO gas exposure time at50°C in an EOGas 4 sterilizermust result in sterilization ofthe endoscope loads.	Using a 6-hour EO gas exposurein the EOGas 4 sterilizer,6-Log biological indicators wereconsistently inactivated for twoduodenoscopes, twocolonoscopes, or one colonoscopeand one duodenoscope in eachload.The minimum parameters forsterilization of twoduodenoscopes or colonoscopesare 518 mg/L EO, 46.4°C, and35% RH.
Half DoseValidation	To demonstrate therepeatability of theEOGas 4 sterilizationprocess, and that aSAL of 10-6 isachieved forduodenoscope andcolonoscopesterilization	For consecutive half dosecycles and full dose cycles:EO concentration is half whenhalf the amount of EO is used.All 6-Log Bacillus atrophaeusbiological indicators,inoculated at the worst-caselocations of the testedendoscopes, are inactivated.	Consecutive half dose cycles andfull dose cycles were performed.The EO concentration was halfwhen half the amount of EO wasused. The cumulative lethality ofhalf dose cycles was half thelethality of full dose cycle.The cycles consistentlyinactivated all 6-Log Bacillus atrophaeus biological indicatorsinoculated at the midpoint of thetested channels and at the elevatormechanism of duodenoscopes, aswell as the water jet channel ofthe colonoscopes.
Simulated-Use Testing	To demonstrate thesuccessfulsterilization ofduodenoscopes andcolonoscopes withinthe claims under aworst-case scenario	For consecutive full dosecycles:Biological indicators with 6-Log Bacillus atrophaeus ,prepared in an artificial soil andinoculated at the worst-caselocations of the testedendoscopes, are inactivated.	Biological indicators with 6-LogBacillus atrophaeus wereprepared in an artificial soil andinoculated at the center of thetested channels and at the elevatormechanism of duodenoscopes aswell as the water jet channel ofthe colonoscopes.Inactivated biological indicatorswere obtained in all cycles for allduodenoscope and colonoscopeloads tested.

In-UseTesting	To demonstrate thatthe 6-hour cycle at50°C in an EOGas 4sterilizer successfullysterilizesduodenoscopes andcolonoscopes used inroutine endoscopicprocedures in ahospital or clinicsetting	Duodenoscopes andcolonoscopes, used on thepatients, cleaned but notdisinfected, are sterilized usingthe 6-hour cycle at 50°C in anEOGas 4 sterilizer.	Duodenoscopes andcolonoscopes, used on patients,were cleaned per hospital protocolbut not disinfected, processedusing the 6-hour EO exposure at50°C in the EOGas 4 sterilizer;sterility was tested by a flushmethod per USP. All test culturesfrom the processedduodenoscopes and colonoscopeswere sterile.
EOResiduals	To demonstrate thatendoscopes and theiraccessories are safeto use if the guidanceand instructions arefollowed	After additional aerationfollowing the cycle, EOresiduals on duodenoscopes andcolonoscopes are evaluated,and the residuals on theendoscopes and accessoriesmeet the requirements ofANSI/AAMI/ISO 10993-7.	Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160,CF-Q180AL, Pentax ED34-i10T2,ED-3490TK duodenoscopes andEC-3490Li colonoscopes wrappedin Sterisheet must aerate for anadditional 6 hours after the cycle.Fujifilm ED-530XT and EC-600HL wrapped in Sterisheetmust aerate for an addition 8hours after the cycle.After 6 hours of additionalaeration, EO residuals on thepackaging materials met therequirements of ANSI/AAMI/ISO10993-7.

Table 4. Summary of Non-Clinical Testing

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The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure has been validated using applicable tests in the FDA 1993 "Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities".

Duodenoscopes used in these studies include:

Olympus TJF-Q180V ●
Olympus TJF-Q160VF ●
Olympus TJF-Q190V ●
Olympus PJF-160 ●
Fujifilm ED-530XT
Pentax ED34-i10T2
Pentax ED-3490TK ●

Colonoscopes used include:

Olympus CF-Q180AL ●
Fujifilm EC-600HL
Pentax EC-3490Li .

The maximum loads of duodenoscopes or colonoscopes that may be routinely sterilized in the

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EOGas 4 Ethylene Oxide Gas Sterilizer were defined and validated. Using a 6-hour gas exposure at 50°C, the EOGas 4 sterilization system reproducibly and effectively sterilizes two duodenoscopes, two colonoscopes, or one duodenoscope paired with one colonoscope, achieving a minimum sterility assurance level of 10-6.

The EOGas 4 Endo-SteriTest process challenge device, consisting of a BI receptacle with a selfcontained biological indicator, was developed for the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. It represents a rigorous challenge to the EOGas 4 sterilization process as it impedes gas diffusion, heating, and humidification. Its resistance characteristics are greater than the same BI placed in the worst-case locations in the two duodenoscope or two colonoscope loads.

The validation testing demonstrated that exposure to EO gas under the defined load and physical parameters achieved a minimum sterility assurance level of 106 for two duodenoscopes, two colonoscopes, or one duodenoscope paired with one colonoscope, in each load. The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulateduse testing. In addition, in-use testing confirmed the ability of the cycle to sterilize duodenoscopes or colonoscopes used clinically in a hospital setting.

Process residue analysis showed that the EO residuals remaining on the duodenoscopes or colonoscopes tested in the study, after an additional aeration of 6 hours (for Olympus duodenoscopes, Olympus colonoscopes, and Pentax duodenoscopes) or 8 hours (for Fujifilm duodenoscopes and colonoscopes), met the requirements of ANSI AAMI ISO 10993-7. demonstrating that the EOGas 4 Ethylene Oxide Gas Sterilizer and its accessories are safe to use if the guidance and instructions are followed.

Physical performance tests demonstrated that the EOGas 4 Ethylene Oxide Gas Sterilizer. EOGas cartridges, sterilization bags, and Humidichips met their performance specifications. The EOGas 4 sterilization system achieved and maintained the cycle specifications for EO concentration, temperature, time, and relative humidity. Both the sterilizer and the accessories consistently operated in accordance with predetermined criteria. The 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer was repeatable and reliable under the indicated test load conditions.

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the EOGas 4 Ethylene Oxide Sterilizer is as safe, as effective, and performs as well as or better than the legally marketed predicate EOGas 4 Ethylene Oxide Sterilizer (K150646).

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).