Predicate Devices

Not Found

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ethylene oxide gas sterilizer with no mention of AI or ML capabilities. The validation focuses on physical parameters and biological indicators, not algorithmic performance.

Therapeutic

No
The device is described as a sterilizer for reusable medical devices, not a device used for treating patients.

Diagnostic

No.

This device is an ethylene oxide gas sterilizer used to sterilize medical devices, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical sterilizer unit (model AN4000.01 or AN4000.11) that uses ethylene oxide gas cartridges and sterilization bags. It also mentions hardware components like a dosimeter and a biological indicator integrated into the sterilizer. This is a hardware device with potentially integrated software for control, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to sterilize reusable medical devices. This is a process performed on medical devices themselves, not on biological specimens from a human body for diagnostic purposes.
Device Description: The description details a sterilizer that uses ethylene oxide gas to sterilize medical devices. It mentions monitoring the sterilization process using a biological indicator, which is a quality control measure for the sterilization process, not a diagnostic test on a patient sample.
Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.

The device is a medical device used in healthcare settings for the sterilization of other medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. The critical process parameters for the cycle are summarized in Table 1.

Product codes (comma separated list FDA assigned to the subject device)

FLF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals and other human healthcare settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 plastic devices, and four 1.2 x 700 mm endoscopes or one 2 x 1100 mm endoscope, achieving a minimum sterility assurance level of 10-6. 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 10-6 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°C in the EOGas 4 Ethylene Oxide Gas Sterilizer was repeatable and reliable under the indicated test load conditions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Minimum sterility assurance level of 10-6 for surfaces, mated surfaces, and endoscope lumens.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Sterijet Ethylene Oxide Sterilization System, K812867

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple helix-like design extending from the profiles.

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

1

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

2

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 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. 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 those
with hinges and mated surfaces	Metal instruments do not absorb EO;
Follow pouch or wrap manufacturer's
instructions (Example: Tyvek® pouches and
Sterisheet® 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-lumen
Endoscope(s)	One (1) $\ge$ 2.0mm ID
$\le$ 1100mm length;
No additional devices
Four (4) $\ge$ 1.2 mm ID
$\le$ 700 mm length;
No additional devices	Gastrovideoscopes, gastrointestinal
videoscopes
Bronchoscopes, 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 Address
Andersen Sterilizers, Inc.
3154 Caroline Drive
Haw River, NC 27258 |
|-----|-------------------------------------------------------------------------------------------------------------|
| 5.2 | Contact Person
William K. Andersen, BE, MD, FAAOS
President
Phone: 336-376-8622, Fax: 336-376-5428 |
| 5.3 | Date of Preparation
November 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.

5

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

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.

5.8 Indications for Use

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℃ 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 | Relative
Humidity | EO Exposure
Time | Total Cycle
Time |
|-------------|-------------|----------------------|---------------------|---------------------|
| 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
Metal	24 lbs (11 kg)	Surgical instruments,
delicate sharps, including
those with hinges and
mated surfaces	Metal instruments do not
absorb EO;
Follow pouch or wrap
manufacturer's instructions
for aeration requirements
(Examples: Tyvek® pouches
and 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; Follow
manufacturer's instructions
Fabric	6.1 lbs (2.8 kg)	Reusable cloth gowns,
towels	24 hours at 50°C; Follow
manufacturer's instructions
Single-lumen
Endoscope(s)	One (1)
$\u2265$ 2.0 mm internal
diameter
$\u2264$ 1100 mm length;
No additional devices	Gastrovideoscopes,
gastrointestinal videoscopes	12 hours at 50°C; Follow
manufacturer's instructions
	Four (4)
$\u2265$ 1.2 mm internal
diameter
$\u2264$ 700 mm length;
No additional devices	Bronchoscopes,
bronchovideoscopes,
cystoscopes, ureteroscopes,
choledocoscopes	12 hours at 50°C; Follow
manufacturer'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
Indications
for Use	Sterile processing of
reusable medical
devices using ethylene
oxide	Sterilization of heat
and/or moisture
sensitive devices
using ethylene
oxide	Sterilization of reusable
medical devices that are
sensitive to moisture,
heat, chemical
corrosion, or radiation	Equivalent
Design	Gas injection cabinet
and aerator
Injection of EO from a
tank; amount
depending on bag size	Similar design for exterior and cabinet
Unit dose EO	Unit dose EO	Equivalent. Similar
designs with flexible
chamber and unit dose EO
in the EOGas 4 sterilizer
	Flexible sterilization
chamber	Fixed sterilization
chamber
	Gas-diffusion bag	EO impervious
chamber	EO impervious bag

Technology	Use EO as sterilant;
EPA registered			Same
	Critical parameters: EO concentration, RH, temperature, and time
Biological
Monitoring	N/A	3MTM AttestTM EO
Pack placed in the
load; resistance
equivalent to an
AAMI routine syringe
test pack	AN7408.14 process
challenge device
integrated into the
sterilizer; resistance
greater than the
validated worst-case
loads in the sterilizer	Equivalent:
confirm
appropriate
sterilization
parameters
have been
met.
Safety	Verify compliance for electromagnetic compatibility and electrical
safety			Same
Performance	Sterilize reusable medical devices as labeled to a SAL of 10-6 with
reasonable 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

8

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.