The EOGas 4 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.

The 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes.

Device Description

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.01 (115V) or AN4000.11 (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. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN1087 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest) that is integrated into the sterilizer.

AI/ML Overview

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

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL): Achieve a minimum SAL of 10⁻⁶ (meaning no more than 1 in 1,000,000 chance of a non-sterile unit).	Achieved a minimum SAL of 10⁻⁶ for surfaces, mated surfaces, and endoscope lumens.
Effective Sterilization of Maximum Loads: Reproducibly and effectively sterilize specified maximum loads of various materials using the 3-hour cycle at 50°C.	The 3-hour cycle at 50°C reproducibly and effectively sterilizes: - 24 lbs (11 kg) of metal instruments (with or without mated surfaces). - 6.1 lbs (2.8 kg) of fabric. - 7.0 lbs (3.2 kg) of plastic devices. - Four 1.2 x 700 mm endoscopes or one 2 x 1100 mm endoscope.
Process Challenge Device (PCD) Resistance: The resistance characteristics of the Andersen process challenge device (AN7408.14) must be greater than the same biological indicator (BI) placed in the worst-case location in each of the worst-case validation loads.	The resistance characteristics of the AN7408.14 are greater than the same BI placed in the worst-case location in each of the worst-case validation loads.
Residuals (EO and ECH): Ethylene oxide (EO) or ethylene chlorohydrin (ECH) residuals remaining on even the most absorbent materials tested must meet the requirements of AAMI/ANSI/ISO 10993-7.	The majority of EO or ECH residuals met the requirements of AAMI/ANSI/ISO 10993-7.
Electromagnetic Compatibility (EMC) and Electrical Safety: Verify compliance with requirements for EMC and electrical safety.	The device was tested to verify compliance with requirements for EMC and electrical safety.
Physical Performance: EOGas 4 Ethylene Oxide Gas Sterilizer, EOGas cartridges, sterilization bags, and Humidichips must meet their performance specifications.	The device and accessories met their performance specifications.
Cycle Specification Maintenance: The EOGas 4 sterilization system must achieve and maintain cycle specifications for EO concentration, temperature, time, and relative humidity.	The system achieved and maintained cycle specifications for EO concentration, temperature, time, and relative humidity.
Repeatability and Reliability: The 3-hour cycle at 50°C must be repeatable and reliable under the indicated test load conditions.	The 3-hour cycle at 50°C was repeatable and reliable under the indicated test load conditions.

Study Information

Sample sizes used for the test set and data provenance:
- Test Set Sample Size:
  - Metal: 24 lbs (11 kg)
  - Plastic: 7.0 lbs (3.2 kg)
  - Fabric: 6.1 lbs (2.8 kg)
  - Single-lumen Endoscopes: One (1) ≥ 2.0mm ID ≤ 1100mm length OR Four (4) ≥ 1.2 mm ID ≤ 700 mm length.
  - The document states "All validated maximum loads were processed without additional devices in the sterilizer." This implies discrete tests for each load type.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of equipment validation for FDA approval typically involves prospective, controlled laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth. Sterilization validation typically relies on established scientific methods (e.g., biological indicators, chemical indicators, physical monitors) rather than expert consensus on individual results, although experts would design and review the validation protocols.
Adjudication method for the test set:
- The document does not describe an adjudication method in the context of human expert review. The "ground truth" for sterilization is determined by the inactivation of biological indicators and adherence to SAL, verified through laboratory methods.
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:
- No. This is a sterilization device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance comparisons are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "standalone" performance in this context refers to the sterilizer's ability to achieve sterility without human intervention during the sterilization cycle itself. The validation testing described (achieving SAL of 10⁻⁶, effective sterilization of loads, meeting residuals, etc.) directly assesses the standalone performance of the device. Human operators perform pre-processing (cleaning, loading) and post-processing (unloading, aeration, biological indicator interpretation), but the sterilization process is automated by the device.
The type of ground truth used:
- Biological Indicators (BIs): Specifically, Bacillus atrophaeus biological indicators (AN2203) are mentioned, inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest). The inactivation of these resistant microorganisms serves as the primary "ground truth" for sterility.
- Simulated-use testing: This involved using instruments with mated surfaces and endoscope lumens, confirming effectiveness in conditions mimicking actual use.
- In-use testing: Confirmed the ability of the cycle to sterilize single-lumen endoscopes used clinically in a hospital setting.
- Chemical Analysis: Process residue analysis for EO and ECH residuals against AAMI/ANSI/ISO 10993-7 standards.
- Physical Monitoring: Verification of EO concentration, temperature, time, and relative humidity.
The sample size for the training set:
- This concept is not applicable here as this is not a machine learning or AI device. The validation involves testing against predefined loads and parameters, not "training" a model.
How the ground truth for the training set was established:
- As this is not a machine learning device, the concept of a "training set" and its ground truth establishment does not apply. The device's performance is validated through direct empirical testing against established sterilization standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2015

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

Re: K150646

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 20, 2015 Received: October 22, 2015

Dear Dr. 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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin | Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150646

Device Name

EOGas 4 Ethylene Oxide Gas Sterilizer, AN4000.01 and AN4000.11

Indications for Use (Describe)

The 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes. The critical process parameters for the cycle are summarized in Table 1.

			Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer
EO Amount	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 g ± 5%	50°C + 3°C	35-70%	3 hours	3.5 hours

Maximum loads of specific materials and devices that have been validated are listed in Table 2. All validated maximum loads were processed without additional devices in the sterilizer.

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

Device Type	Maximum Load	Device Examples	Required Aeration
Metal	24 lbs (11 kg)	Surgical instruments,delicate sharps, including thosewith hinges and mated surfaces	Metal instruments do not absorb EO;Follow pouch or wrap manufacturer'sinstructions (Example: Tyvek® pouches andSterisheet® wrap require $\ge$ 6 hours at 50°C)
Plastic	7.0 lbs (3.2 kg)	Reusable power cords, trocars	24 hours at 50°C;
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns, towels	Follow manufacturer's instructions
Single-lumenEndoscope(s)	One (1) $\ge$ 2.0mm ID$\le$ 1100mm length;No additional devicesFour (4) $\ge$ 1.2 mm ID$\le$ 700 mm length;No additional devices	Gastrovideoscopes, gastrointestinalvideoscopesBronchoscopes, bronchovideoscopes,cystoscopes, ureteroscopes,choledocoscopes	12 hours at 50°C;Follow manufacturer's instructions

Reusable medical devices must be aerated following the instructions of the device manufacturer and the packaging material manufacturer, then released for use after sterilization of an EZTest®- Gas Biological Indicator in the Andersen EOGas 4 SteriTest process challenge device.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

5.1	Applicant's Name and AddressAndersen Sterilizers, Inc.3154 Caroline DriveHaw River, NC 27258
5.2	Contact PersonWilliam K. Andersen, BE, MD, FAAOSPresidentPhone: 336-376-8622, Fax: 336-376-5428
5.3	Date of PreparationNovember 17, 2015

5.4 Device

Proprietary Name	EOGas 4® Ethylene Oxide Gas Sterilizer
	Models AN4000.01 and AN4000.11
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, AN1087 Dosimeters®, and Humidichips®), are registered with the US Environmental Protection Agency (EPA #69340-7).

5.5 Predicate Device - Sterijet

Device Name	Sterijet Ethylene Oxide Sterilization System
510(k) number	NA
Manufacturer	Andersen Products, Inc.

The Sterijet sterilization system is a pre-amendment predicate (marketed for hospital use in the United States prior to the Medical Device Act). It has been in continuous use for commercial ethylene oxide sterilization since the early 1970's, although it was taken off the hospital market due to changes in EPA regulation of ethylene oxide-chlorofluorocarbon mixtures.

The purpose for this submission is to modify the sterilization bag and the ethylene oxide delivery method compared to the pre-amendment device. No modifications were made to the technology or intended use.

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ર્ટ રે Predicate Device - Steri-Vac 4XL

Device Name	Steri-VacTM 4XL Gas Sterilizer
510(k) number	K812867
Manufacturer	3MTM Company

The EOGas 4 Ethylene Oxide Sterilizer uses a flexible sterilization bag as a sterilization chamber, whereas the predicate device has a fixed sterilization chamber. The principles of operation, intended use, and technology are otherwise substantially equivalent.

5.7 Device Description

5.8 Indications for Use

The 3 hour cycle at 50℃ in the EOGas 4 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes. The critical process parameters for the cycle are summarized in Table 5-1.

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

Table 5-1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer

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Maximum loads of specific materials and devices that have been validated are listed in Table 5-2. All validated maximum loads were processed without additional devices in the sterilizer.

Device Type	Maximum Load	Device Examples	Required Aeration
Metal	24 lbs (11 kg)	Surgical instruments,delicate sharps, includingthose with hinges andmated surfaces	Metal instruments do notabsorb EO;Follow pouch or wrapmanufacturer's instructionsfor aeration requirements(Examples: Tyvek® pouchesand Sterisheet® wrap require$\u2265$ 6 hours aeration at 50°C).
Plastic	7.0 lbs (3.2 kg)	Reusable power cords,trocars	24 hours at 50°C; Followmanufacturer's instructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,towels	24 hours at 50°C; Followmanufacturer's instructions
Single-lumenEndoscope(s)	One (1)$\u2265$ 2.0 mm internaldiameter$\u2264$ 1100 mm length;No additional devices	Gastrovideoscopes,gastrointestinal videoscopes	12 hours at 50°C; Followmanufacturer's instructions
	Four (4)$\u2265$ 1.2 mm internaldiameter$\u2264$ 700 mm length;No additional devices	Bronchoscopes,bronchovideoscopes,cystoscopes, ureteroscopes,choledocoscopes	12 hours at 50°C; Followmanufacturer's instructions

Table 5-2. 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, then released for use after sterilization based on successful inactivation of an EZTest - Gas Biological Indicator in the Andersen EOGas 4 SteriTest process challenge device.

ર તે Substantial Equivalence Comparison

The EOGas 4 Ethylene Oxide Gas Sterilizer is substantially equivalent to the predicate devices: the Sterijet Ethylene Oxide Sterilization System and the Steri-Vac 4XL Gas Sterilizer, because all three sterilizers are intended for the same use, designed in a similar way, use the same technology, and perform substantially equivalently.

The EOGas 4 Ethylene Oxide Gas Sterilizer differs from the predicate Sterilizer in the use of a sterilization bag that is ethylene oxide impermeable and gas delivery from a cartridge rather than direct injection. The EOGas 4 Ethylene Oxide Gas Sterilizer differs from the predicate Steri-Vac 4XL sterilizer in the use of a flexible sterilization bag rather than a fixed sterilization chamber, and the use of approximately 20% of the ethylene oxide per cycle that is used in the predicate. These differences raise no issues related to safety or effectiveness of the subject device sterilization cycle. A comparison among the sterilizers is listed in Table 5-3.

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	Sterijet System	4XL Sterilizer	EOGas 4 Sterilizer	Comparison
Intended Use	Indoor ethylene oxide sterilizer in a healthcare setting			Same
Indicationsfor Use	Sterile processing ofreusable medicaldevices using ethyleneoxide	Sterilization of heatand/or moisturesensitive devicesusing ethyleneoxide	Sterilization of reusablemedical devices that aresensitive to moisture,heat, chemicalcorrosion, or radiation	Equivalent
Design	Gas injection cabinetand aeratorInjection of EO from atank; amountdepending on bag size	Similar design for exterior and cabinetUnit dose EO	Unit dose EO	Equivalent. Similardesigns with flexiblechamber and unit dose EOin the EOGas 4 sterilizer
	Flexible sterilizationchamber	Fixed sterilizationchamber
	Gas-diffusion bag	EO imperviouschamber	EO impervious bag

Technology	Use EO as sterilant;EPA registered			Same
	Critical parameters: EO concentration, RH, temperature, and time
BiologicalMonitoring	N/A	3MTM AttestTM EOPack placed in theload; resistanceequivalent to anAAMI routine syringetest pack	AN7408.14 processchallenge deviceintegrated into thesterilizer; resistancegreater than thevalidated worst-caseloads in the sterilizer	Equivalent:confirmappropriatesterilizationparametershave beenmet.
Safety	Verify compliance for electromagnetic compatibility and electricalsafety			Same
Performance	Sterilize reusable medical devices as labeled to a SAL of 10-6 withreasonable assurance of safety and effectiveness			Equivalent

Table 5-3. Comparison among the EOGas 4 Ethylene Oxide Gas Sterilizer, the Sterijet Ethylene Oxide Sterilization System, and the Steri-Vac 4XL Gas Sterilizer

રું 10 Performance Testing

The EOGas 4 Ethylene Oxide Gas Sterilizer 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".

The maximum loads of metal, fabric, plastic, and single-lumen flexible endoscopes that may be routinely sterilized in the EOGas 4 Ethylene Oxide Gas Sterilizer were defined and validated. Using the 3 hour cycle at 50°C, the EOGas 4 sterilization system reproducibly and effectively sterilizes 24 lbs of metal instruments with or without mated surfaces, 6.1 lbs of fabric, 7.0 lbs of

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plastic devices, and four 1.2 x 700 mm endoscopes or one 2 x 1100 mm endoscope, achieving a minimum sterility assurance level of 10°. All validated maximum loads were processed without additional devices in the sterilizer.

The Andersen process challenge device, consisting of a BI receptacle with a self-contained biological indicator, was developed for the 3 hr cycle 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 location in each of the worst-case validation loads.

The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of 10th for surfaces, mated surfaces, and endoscope lumens. The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces as well as endoscope lumens. In addition, in-use testing confirmed the ability of the cycle to sterilize single-lumen endoscopes used clinically in a hospital setting.

Process residue analysis showed that the majority of EO or ethylene chlorohydrin residuals remaining on even the most absorbent materials tested in the study met the requirements of AAMI/ANSI/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. The EOGas 4 Ethylene Oxide Gas Sterilizer was tested to verify compliance with requirements for electromagnetic compatibility and electrical safety.

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 3 hour cycle at 50℃ in the EOGas 4 Ethylene Oxide Gas Sterilizer was repeatable and reliable under the indicated test load conditions.

Conclusion:

The EOGas 4 Ethylene Oxide Gas Sterilizer is substantially equivalent to the predicate devices.

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).