EOGas 4 Ethylene Oxide Gas Sterilizer

K192978 · Andersen Sterilizers, Inc. · FLF · Nov 12, 2020 · General Hospital

Device Facts

• Record ID: K192978
• Device Name: EOGas 4 Ethylene Oxide Gas Sterilizer
• Applicant: Andersen Sterilizers, Inc.
• Product Code: FLF · General Hospital
• Decision Date: Nov 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended 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.

Device Story

EOGas 4 is an ethylene oxide (EO) gas sterilizer for heat/moisture-sensitive reusable medical devices. System uses unit-dose 100% EO cartridges and gas-impervious flexible sterilization bags as chambers. Operator places devices in bag with Humidichip and appropriate Process Challenge Device (PCD); system executes automated cycle (3-hour or 6-hour exposure at 50°C). Output is sterilized medical equipment. Used in hospitals/clinics; operated by healthcare staff. Sterility verified by inactivation of biological indicators (BI) in PCDs (SteriTest or Endo-SteriTest). Post-sterilization, devices require mandatory aeration per manufacturer instructions to meet ANSI/AAMI/ISO 10993-7 residual limits. Benefits include effective sterilization of complex endoscopes without heat/moisture damage.

Clinical Evidence

Bench testing only. Validation included minimum sterilization parameter definition, half-dose repeatability studies, simulated-use testing with artificial soil, and in-use testing in hospital/clinic settings. Primary endpoint was 6-log inactivation of Bacillus atrophaeus biological indicators. Results confirmed 10^-6 sterility assurance level for specified endoscope loads. EO residual analysis confirmed compliance with ANSI/AAMI/ISO 10993-7 after specified aeration times.

Technological Characteristics

Ethylene oxide gas sterilization system; 100% EO unit dose cartridge; flexible gas-impervious sterilization bag chamber. Critical parameters: EO concentration, relative humidity (35-70%), temperature (50°C ± 3°C), and time. Connectivity: Standalone. Sterilization: Ethylene oxide gas. Compliance: ANSI/AAMI/ISO 10993-7 for residuals; electromagnetic compatibility and electrical safety standards.

Indications for Use

Indicated for sterilization of reusable medical devices sensitive to moisture, heat, chemical corrosion, or radiation. 3-hour cycle for surface sterilization of instruments (including hinges/mated surfaces) and endoscopes ≤ 1100 mm working length. 6-hour cycle for duodenoscopes and colonoscopes > 1100 mm working length.

Regulatory Classification

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.

Predicate Devices

• EOGas 4 Ethylene Oxide Gas Sterilizer (K150646)

Reference Devices

• EOGas 4 Endo-SteriTest (K192980)
• EZTest-Gas BI (K930683)
• Bionova BT110 RRBI (K191021)
• EOGas 4 SteriTest (K151585)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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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,<br>delicate sharps,<br>including those with<br>hinges and mated<br>surfaces | |
| Plastic | 7.0 lbs (3.2 kg) | Reusable power cords,<br>trocars, and similar<br>devices | 24 hours at 50°C;<br>Follow manufacturer's<br>instructions |
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns,<br>towels, and similar devices | |
| ≤ 1100 mm<br>Working<br>Lumen<br>Length | One (1)<br>≥ 2.0 mm ID biopsy channel<br>≤ 1100 mm working length | Gastrovideoscopes,<br>gastrointestinal videoscopes,<br>and similar devices | 8 hours at 50°C;<br>Follow manufacturer's<br>instructions |
| Endoscopes | Four (4)<br>≥ 1.2 mm ID biopsy channel<br>≤ 700 mm working length | Bronchoscopes,<br>bronchovideoscopes, cystoscopes,<br>ureteroscopes, choledocoscopes,<br>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 mm<br>maximum length of any<br>channel | 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 mm<br>maximum 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: [phone], Fax: [phone]

### 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

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.

### 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 Exposure<br>Time | Total Cycle<br>Time | EO Amount | Temperature | Relative<br>Humidity |
|---------------------|---------------------|-------------|-------------|----------------------|
| 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

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.

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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<br>(11 kg) | Surgical instruments,<br>delicate sharps,<br>including those with<br>hinges and mated<br>surfaces | No additional aeration<br>required;<br>Follow pouch or wrap<br>manufacturer's<br>instructions (Example:<br>Tyvek pouches require<br>$\ge$ 6 hours at 50°C) |
| Plastic | 7.0 lbs<br>(3.2 kg) | Reusable power cords,<br>trocars, and similar<br>devices | 24 hours at 50°C; |
| Fabric | 6.1 lbs<br>(2.8 kg) | Reusable cloth gowns,<br>towels, and similar<br>devices | Follow manufacturer's<br>instructions |
| ≤ 1100 mm<br>Working<br>Lumen<br>Length<br>Endoscopes | One (1)<br>$\ge$ 2.0 mm ID biopsy channel<br>≤ 1100 mm working length | Gastrovideoscopes,<br>gastrointestinal<br>videoscopes, and<br>similar devices | 8 hours at 50°C if in<br>Sterisheet; |
| | Four (4)<br>$\ge$ 1.2 mm ID biopsy channel<br>≤ 700 mm working length | Bronchoscopes,<br>bronchovideoscopes,<br>cystoscopes,<br>ureteroscopes,<br>choledocoscopes, and<br>similar devices | Follow manufacturer's<br>instructions |
| 6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe) | | | |
| >1100 mm<br>Working<br>Lumen<br>Length<br>Endoscopes | Two (2) Duodenoscopes*<br>$\ge$ 2.0 mm ID biopsy channel<br>≤ 1250 mm working length<br>$\ge$ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any<br>channel | Olympus TJF-Q180V,<br>Olympus TJF-Q160VF,<br>Olympus TJF-Q190V,<br>Olympus PJF-160,<br>Fujifilm ED-530XT,<br>Pentax ED34-i10T2<br>Pentax ED-3490TK | 6 hours at 50°C for<br>Olympus and Pentax<br>endoscopes in<br>Sterisheet; |
| | Two (2) Colonoscopes*<br>$\ge$ 3.7 mm ID biopsy channel<br>≤ 1700 mm working length<br>$\ge$ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any<br>channel | Olympus CF-Q180AL,<br>Fujifilm EC-600HL,<br>Pentax EC-3490Li | 8 hours at 50°C for<br>Fujifilm endoscopes in<br>Sterisheet;<br>Follow manufacturer's<br>instructions |
| | * One (1) duodenoscope may also be paired with one (1)<br>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.

| | Subject<br>EOGas 4 Sterilizer K192978 | Predicate EOGas 4<br>Sterilizer K150646 | Comparison |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intended<br>Use | 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 electrical<br>safety | | Same |
| Indications<br>for Use | 3-hour gas exposure at 50°C;<br>6-hour gas exposure at 50°C | 3-hour gas exposure at 50°C;<br>(5-hour gas exposure at 50°C;<br>not used for healthcare<br>sterilization) | Added a 6-hour<br>gas exposure for<br>sterilization of<br>endoscopes with<br>> 1100 mm<br>working length |
| Process<br>Challenge<br>Device | EOGas 4 Endo-SteriTest (K192980)<br>EZTest-Gas BI (K930683);<br>Bionova BT110 RRBI (K191021);<br>BI Receptacle:<br>Stainless steel cylinder<br>0.020" ID x 4.50" L lumen | EOGas 4 SteriTest (K151585)<br>EZTest-Gas BI (K930683);<br>BI Receptacle:<br>Stainless steel cylinder<br>0.020" ID x 0.25" L orifice | Similar:<br>appropriate for<br>the intended<br>length of gas<br>exposure |
| 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 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Minimum<br>Sterilization<br>Parameters | To define and<br>validate the<br>endoscope loads that<br>can be sterilized using<br>the 6-hour gas<br>exposure at 50°C in<br>an EOGas 4 sterilizer | The EO gas exposure time at<br>50°C in an EOGas 4 sterilizer<br>must result in sterilization of<br>the endoscope loads. | Using a 6-hour EO gas exposure<br>in the EOGas 4 sterilizer,<br><br>6-Log biological indicators were<br>consistently inactivated for two<br>duodenoscopes, two<br>colonoscopes, or one colonoscope<br>and one duodenoscope in each<br>load.<br><br>The minimum parameters for<br>sterilization of two<br>duodenoscopes or colonoscopes<br>are 518 mg/L EO, 46.4°C, and<br>35% RH. |
| Half Dose<br>Validation | To demonstrate the<br>repeatability of the<br>EOGas 4 sterilization<br>process, and that a<br>SAL of 10-6 is<br>achieved for<br>duodenoscope and<br>colonoscope<br>sterilization | For consecutive half dose<br>cycles and full dose cycles:<br><br>EO concentration is half when<br>half the amount of EO is used.<br><br>All 6-Log <i>Bacillus atrophaeus</i><br>biological indicators,<br>inoculated at the worst-case<br>locations of the tested<br>endoscopes, are inactivated. | Consecutive half dose cycles and<br>full dose cycles were performed.<br><br>The EO concentration was half<br>when half the amount of EO was<br>used. The cumulative lethality of<br>half dose cycles was half the<br>lethality of full dose cycle.<br><br>The cycles consistently<br>inactivated all 6-Log <i>Bacillus atrophaeus</i> biological indicators<br>inoculated at the midpoint of the<br>tested channels and at the elevator<br>mechanism of duodenoscopes, as<br>well as the water jet channel of<br>the colonoscopes. |
| Simulated-<br>Use Testing | To demonstrate the<br>successful<br>sterilization of<br>duodenoscopes and<br>colonoscopes within<br>the claims under a<br>worst-case scenario | For consecutive full dose<br>cycles:<br><br>Biological indicators with 6-<br>Log <i>Bacillus atrophaeus</i> ,<br>prepared in an artificial soil and<br>inoculated at the worst-case<br>locations of the tested<br>endoscopes, are inactivated. | Biological indicators with 6-Log<br><i>Bacillus atrophaeus</i> were<br>prepared in an artificial soil and<br>inoculated at the center of the<br>tested channels and at the elevator<br>mechanism of duodenoscopes as<br>well as the water jet channel of<br>the colonoscopes.<br><br>Inactivated biological indicators<br>were obtained in all cycles for all<br>duodenoscope and colonoscope<br>loads tested. |
| | | | |
| In-Use<br>Testing | To demonstrate that<br>the 6-hour cycle at<br>50°C in an EOGas 4<br>sterilizer successfully<br>sterilizes<br>duodenoscopes and<br>colonoscopes used in<br>routine endoscopic<br>procedures in a<br>hospital or clinic<br>setting | Duodenoscopes and<br>colonoscopes, used on the<br>patients, cleaned but not<br>disinfected, are sterilized using<br>the 6-hour cycle at 50°C in an<br>EOGas 4 sterilizer. | Duodenoscopes and<br>colonoscopes, used on patients,<br>were cleaned per hospital protocol<br>but not disinfected, processed<br>using the 6-hour EO exposure at<br>50°C in the EOGas 4 sterilizer;<br>sterility was tested by a flush<br>method per USP. All test cultures<br>from the processed<br>duodenoscopes and colonoscopes<br>were sterile. |
| EO<br>Residuals | To demonstrate that<br>endoscopes and their<br>accessories are safe<br>to use if the guidance<br>and instructions are<br>followed | After additional aeration<br>following the cycle, EO<br>residuals on duodenoscopes and<br>colonoscopes are evaluated,<br>and the residuals on the<br>endoscopes and accessories<br>meet the requirements of<br>ANSI/AAMI/ISO 10993-7. | Olympus TJF-Q180V, TJF-<br>Q160VF, TJF-Q190V, PJF-160,<br>CF-Q180AL, Pentax ED34-i10T2,<br>ED-3490TK duodenoscopes and<br>EC-3490Li colonoscopes wrapped<br>in Sterisheet must aerate for an<br>additional 6 hours after the cycle.<br>Fujifilm ED-530XT and EC-<br>600HL wrapped in Sterisheet<br>must aerate for an addition 8<br>hours after the cycle.<br>After 6 hours of additional<br>aeration, EO residuals on the<br>packaging materials met the<br>requirements of ANSI/AAMI/ISO<br>10993-7. |

## 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).