The Anprolene AN75 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 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces.

Device Description

The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are 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 (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.

AI/ML Overview

This document describes the Anprolene AN75 Ethylene Oxide Gas Sterilizer, its indications for use, and a comparison to predicate devices, along with performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Achieve a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces.	Successfully achieved a minimum SAL of $10^{-6}$ for surfaces, including mated surfaces, for all validated maximum loads.
Sterilize 24 lbs of metal instruments with or without mated surfaces.	Successfully sterilized 24 lbs of metal instruments with or without mated surfaces.
Sterilize 3.0 lbs of fabric.	Successfully sterilized 3.0 lbs of fabric.
Sterilize 3.5 lbs of plastic devices.	Successfully sterilized 3.5 lbs of plastic devices.
Meet requirements of AAMI/ANSI/ISO 10993-7 for EO residuals after recommended aeration.	EO residuals on the most absorbent materials met the requirements of AAMI/ANSI/ISO 10993-7 after recommended aeration.
Comply with requirements for electromagnetic compatibility and electrical safety.	Verified compliance for electromagnetic compatibility and electrical safety.
Gas cartridges and sterilization bags maintain performance specifications (physical characteristics, released EO amount, EO concentration, inactivation of biological indicators) throughout a 5-year shelf life.	AN7514 cartridges maintain performance specifications throughout the stated shelf life of 5 years.
Reproducibility and effectiveness of the 12-hour cycle at 20-29°C.	The 12-hour cycle at 20-29°C was repeatable and reliable under the indicated test load conditions.
Maintain critical cycle specifications (EO concentration, temperature, time, relative humidity).	The Anprolene AN75 sterilization system achieved and maintained the cycle specifications for EO concentration, temperature, time, and relative humidity.

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

The document does not explicitly state a numerical sample size for the "test set" in terms of specific units tested. However, it indicates:

"The maximum loads of metal, fabric, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated."
"All validated maximum loads were processed without additional devices in the sterilizer."
"The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces."
"The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces."

The data provenance is not explicitly mentioned (e.g., country of origin). The study appears to be prospective validation testing conducted by the manufacturer to demonstrate the sterilizer's performance according to established guidelines.

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

This information is not provided in the document. The "ground truth" for sterilization effectiveness is typically established through recognized biological indicators and laboratory analyses, rather than expert human assessment for individual sterilization cycles.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves objective performance metrics (e.g., SAL achievement, residual levels, physical parameters) rather than subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an ethylene oxide gas sterilizer, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

This is not applicable. The device is a physical sterilizer, not an algorithm. The performance evaluation focuses on the sterilizer's ability to achieve sterility without human intervention on a per-cycle basis, beyond loading and operating the device following instructions.

7. The Type of Ground Truth Used

The ground truth used for assessing the sterilization effectiveness primarily relies on:

Sterility Assurance Level (SAL) of $10^{-6}$: This is a widely accepted microbiological standard for sterilization, achieved through the inactivation of biological indicators.
Inactivation of an EZTest®- Gas Biological Indicator: Specifically, the document mentions "successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device."
AAMI/ANSI/ISO 10993-7: For process residue analysis, ground truth is based on meeting the requirements of this standard for ethylene oxide residuals.
Physical Performance Specifications: For the sterilizer components, cartridges, and bags, ground truth is adherence to predetermined physical performance specifications (e.g., EO amount, concentration, temperature, relative humidity, electrical safety).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical sterilizer and not an AI/machine learning model, so there is no "training set" in that context. The validation involves testing the physical device's performance under various conditions and loads.

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

This information is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

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.

October 31, 2017

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

Re: K170432

Trade/Device Name: Anprolene AN75 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 4, 2017 Received: October 6, 2017

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. 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 of medical device-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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

{1}------------------------------------------------

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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170432

Device Name Anprolene AN75 Ethylene Oxide Gas Sterilizer

Indications for Use (Describe)

The Anprolene AN75 Ethylene Oxide Gas Sterlizer 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 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

EO Amount	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 $g$ ± 5%	20-29°C (68-84°F)	35-70%	12 hours	14 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 Anprolene AN75 Ethylene Oxide Gas Sterilizer

Device Type	Maximum Load	Device Examples	Required Aeration
Metal	24 lbs (11 kg)	Delicate sharps and surgicalinstruments, including thosewith hinges and mated surfaces	Metal instruments do not absorb EO;Follow pouch or wrap manufacturer'sinstructions (Example: Sterisheet® wrap=require ≥ 6 hours at 20-29°C).
Plastic	3.5 lbs (1.6 kg)	Reusable power cords, trocars	Follow manufacturer's instructions;24 hours at 20-29°C
Fabric	3.0 lbs (1.4 kg)	Reusable cloth gowns, towels	Follow manufacturer's instructions;24 hours at 20-29°C.

Reusable medical devices must be aerated following the instructions of device manufacturers, then released for use after sterilization based on successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|× 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)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

Applicant's Name and Address	Andersen Sterilizers, Inc.Establishment Registration Number 30046347103154 Caroline DriveHaw River, NC 27258
Contact Person	William K. Andersen, BE, MD, FAAOSPresidentPhone: 336-376-8622, Fax: 336-376-5428
Date of Preparation	October 27, 2017
Device

Proprietary Name Anprolene AN75 Ethylene Oxide Gas Sterilizer Common Name Ethylene oxide gas sterilizer Classification Class II (21 CFR 880.6860) Medical Specialty General Hospital Product Code FLF

Anprolene is a registered trademark of Andersen Sterilizers, Inc. The refill kits for the Anprolene AN75 Ethylene Oxide Gas Sterilizer, including the accessories (sterilization bags, AN7514 cartridges, and AN87 Dosimeter®), are registered with the US Environmental Protection Agency (EPA#69340-9).

Primary Predicate Device - EOGas 4 Sterilizer

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

For the subject device, the sterilization temperature, sterilization time, and post-sterilization ventilation time were modified from the predicate device. The Anprolene AN75 Ethylene Oxide Sterilizer operates at 20-29°C with an exposure time of 12 hours and ventilation of 2 hours, whereas the primary predicate device operates at 50±3°C with an exposure time of 3 hours and 30 minute ventilation. The principles of operation, intended use, and technology are otherwise substantially equivalent.

{5}------------------------------------------------

Pre-amendment Device - B-2270/AN70 Anprolene Sterilizer

Device Name B-2270/AN70 Anprolene Sterilizer Ethylene Oxide Sterilization System 510(k) number NA Manufacturer Andersen Products, Inc.

The Andersen B-2270/AN70 Anprolene Sterilizer is a pre-amendment predicate device. It was in commercial distribution and clinical use in the United States prior to May 28, 1976.

For the subject device, the material composition of the sterilization bag, the ethylene oxide delivery method, and the sterilization cabinet design of the pre-amendment device were modified. No modifications were made to the technology or intended use.

Device Description

Indications for Use

The 12 hour cycle at 20-29℃ in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

EO Amount	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 g ± 5%	20-29°C (68-84°F)	35-70%	12 hours	14 hours

{6}------------------------------------------------

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.

Device Type	Maximum Load	Device Examples	Required Aeration
Metal	24 lbs (11 kg)	Delicate sharps and surgicalinstruments, includingthose with hinges andmated surfaces	Metal instruments do notabsorb EO;Follow pouch or wrapmanufacturer's instructions(Examples: Sterisheet® wraprequire ≥ 6 hours at 20-29°C).
Plastic	3.5 lbs (1.6 kg)	Reusable power cords,trocars	Follow manufacturer'sinstructions;24 hours at 20-29°C.
Fabric	3.0 lbs (1.4 kg)	Reusable cloth gowns,towels	Follow manufacturer'sinstructions;24 hours at 20-29°C.

Table 2. Load and material types validated in the Anprolene AN75 Ethylene Oxide Gas Sterilizer

Reusable medical devices must be aerated following the instructions of device manufacturers and packaging material manufacturers, then released for use after sterilization based on successful inactivation of an EZTest - Gas Biological Indicator in the Anprolene SteriTest process challenge device.

Substantial Equivalence Comparison

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is substantially equivalent to the predicate devices: the B-2270/AN70 Anprolene Sterilizer and the EOGas 4 Ethylene Oxide Gas Sterilizer, because all three sterilizers are intended for the same use, designed in a similar way, use similar technology, and perform substantially equivalently.

The Anprolene AN75 Ethylene Oxide Gas Sterilizer differs from the predicate B-2270/AN70 Anprolene sterilizer in the use of a sterilization bag that is ethylene oxide impermeable, gas delivery from an ampoule in a cartridge rather than an ampoule in a gas release bag, and a ventilated sterilization cabinet surrounding the sterilization bag. Compared to the predicate EOGas 4 sterilizer, the Anprolene AN75 Ethylene Oxide Gas Sterilizer has a gas exposure of 12 hours at 20-29℃ rather than 3 hours at 50±3℃. Ventilation after sterilization is 2 hours for the subject Anprolene AN75 sterilizer, and 30 minutes for the predicate EOGas 4 sterilizer. 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 3.

{7}------------------------------------------------

Table 3: Comparison among the Anprolene AN75 Ethylene Oxide Gas Sterilizer, the B-2270/AN70 Anprolene Ethylene Oxide Gas Sterilizer, and the EOGas 4 Ethylene Oxide Gas Sterilizer

	Predicate EOGas 4Sterilizer (K150646)	PredicateB-2270/AN70AnproleneSterilizer	Subject AnproleneAN75 Sterilizer	Comparison
Intended Use	Indoor ethylene oxide sterilizer in a healthcare setting			Same
Indicationsfor Use	Intended for use in hospitals and other human healthcare settings			Same
	Designed to sterilize reusable medical devices that are sensitive tomoisture, heat, chemical corrosion, or radiation			Same
	3 hour EO exposure at$50\pm3$ °C with 0.5 hrmandatory ventilation	12 hour EO exposure at 20-29°C with 2 hrsmandatory ventilation
	For surface sterilizationand sterilization ofsingle-lumen flexibleendoscopes	For surface sterilization, including matedsurface		Equivalent
Design	Ventilated cabinet	Stainless steelcontainer	Ventilated cabinet	Equivalent
	Unit dose EO incartridge	Unit dose EO ingas release bag	Unit dose EO incartridge
	Flexible sterilization chamber
	EO impermeablesterilization bag	Gas-diffusionsterilization bag	EO impermeablesterilization bag
Technology	Use EO as sterilant; EPA registered			Same
	Critical parameters: EO concentration, RH, temperature, and time
BiologicalMonitoring	EOGas 4 SteriTest	AN80 Steritest	Anprolene SteriTest	Equivalent
Safety	Verified compliance forelectromagneticcompatibility andelectrical safety; HumanFactors evaluation forsafety and effectiveness.	N/A	Verified compliance forelectromagneticcompatibility andelectrical safety; HumanFactors evaluation forsafety and effectiveness.	Same
Performance	Sterilize reusablemedical devices asdefined in the sterilizerlabeling to a SAL of 10-6with reasonableassurance of safety andeffectiveness	Sterilizereusable medicaldevices asdefined in thesterilizerlabeling	Sterilize reusablemedical devices asdefined in the sterilizerlabeling to a SAL of 10-6with reasonableassurance of safety andeffectiveness	Equivalent

{8}------------------------------------------------

Performance Testing

The Anprolene AN75 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, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated. Using the 12 hour cycle at 20-29°C, the Anprolene AN75 sterilization system reproducibly and effectively sterilizes 24 lbs of metal instruments with or without mated surfaces, 3.0 lbs of fabric, and 3.5 lbs of plastic devices, achieving a minimum sterility assurance level (SAL) of 10-6. All validated maximum loads were processed without additional devices in the sterilizer. A compatible carrier for EO sterilization (a perforated metal basket) was used to hold the metal and plastic devices, for the convenience of handling relatively large quantities of devices.

The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of 10 for surfaces, including mated surfaces. The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces.

Process residue analysis showed that after recommended aeration. EO residuals on the most absorbent materials tested in the study met the requirements of AAMI/ANSI/ISO 10993-7. demonstrating that the Anprolene AN75 Ethylene Oxide Gas Sterilizer and its accessories are safe to use if the guidance and instructions are followed. The Anprolene AN75 Ethylene Oxide Gas Sterilizer was tested to verify compliance with requirements for electromagnetic compatibility and electrical safety.

Physical performance tests demonstrated that the Anprolene AN75 Ethylene Oxide Gas Sterilizer, gas cartridges, and sterilization bags met their performance specifications. The Anprolene AN75 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 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer was repeatable and reliable under the indicated test load conditions.

Shelf Life testing demonstrated that the AN7514 cartridges maintain performance specifications (physical characteristics, released EO amount, EO concentration, and inactivation of biological indicators) throughout the stated shelf life of 5 years, demonstrating reasonable assurance for effectiveness.

Conclusion

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is substantially equivalent to the preamendment predicate Andersen B-2270/AN70 Anprolene Sterilizer, and the predicate EOGas 40 Ethylene Oxide Gas 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).