(385 days)
No
The description focuses on the physical sterilization process parameters and validation studies, with no mention of AI or ML technologies.
No.
This device is designed to sterilize medical devices, not to provide therapeutic treatment to patients.
No
The device is an ethylene oxide gas sterilizer, designed to sterilize medical devices. Sterilization is a processing function, not a diagnostic one.
No
The device description clearly states it is a physical sterilizer (model AN4000.60 or AN4000.61) that uses ethylene oxide gas and a sterilization chamber. This indicates it is a hardware device, not software-only.
Based on the provided text, the EOGas 4 Ethylene Oxide Gas Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as sterilizing reusable medical devices. This is a process performed on medical devices themselves, not on biological samples taken from a patient.
- Device Description: The description focuses on the sterilization process using ethylene oxide gas within a chamber. This aligns with a sterilization device, not a device used for testing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment
- Using reagents or assays to detect specific substances in samples
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. While it plays a crucial role in healthcare, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FLF
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.
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
healthcare facilities
hospital or clinic setting
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)
Minimum Sterilization Parameters: To define and validate the endoscope loads that can be sterilized using the 6-hour gas exposure at 50°C in an EOGas 4 sterilizer. Using a 6-hour EO gas exposure in the EOGas 4 sterilizer, 6-Log biological indicators were consistently inactivated for two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load. The minimum parameters for sterilization of two duodenoscopes or colonoscopes are 518 mg/L EO, 46.4°C, and 35% RH.
Half Dose Validation: To demonstrate the repeatability of the EOGas 4 sterilization process, and that a SAL of 10-6 is achieved for duodenoscope and colonoscope sterilization. Consecutive half dose cycles and full dose cycles were performed. The EO concentration was half when half the amount of EO was used. The cumulative lethality of half dose cycles was half the lethality of full dose cycle. The cycles consistently inactivated all 6-Log Bacillus atrophaeus biological indicators inoculated at the midpoint of the tested channels and at the elevator mechanism of duodenoscopes, as well as the water jet channel of the colonoscopes.
Simulated-Use Testing: To demonstrate the successful sterilization of duodenoscopes and colonoscopes within the claims under a worst-case scenario. Biological indicators with 6-Log Bacillus atrophaeus were prepared in an artificial soil and inoculated at the center of the tested channels and at the elevator mechanism of duodenoscopes as well as the water jet channel of the colonoscopes. Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested.
In-Use Testing: To demonstrate that the 6-hour cycle at 50°C in an EOGas 4 sterilizer successfully sterilizes duodenoscopes and colonoscopes used in routine endoscopic procedures in a hospital or clinic setting. Duodenoscopes and colonoscopes, used on patients, were cleaned per hospital protocol but not disinfected, processed using the 6-hour EO exposure at 50°C in the EOGas 4 sterilizer; sterility was tested by a flush method per USP. All test cultures from the processed duodenoscopes and colonoscopes were sterile.
EO Residuals: To demonstrate that endoscopes and their accessories are safe to use if the guidance and instructions are followed. Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes wrapped in Sterisheet must aerate for an additional 6 hours after the cycle. Fujifilm ED-530XT and EC-600HL wrapped in Sterisheet must aerate for an addition 8 hours after the cycle. After 6 hours of additional aeration, EO residuals on the packaging materials met the requirements of ANSI/AAMI/ISO 10993-7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K192980, K930683, K191021, K151585
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
§ 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).
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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT. Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
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.
3
| Device Type | Maximum Load | Device Examples | Required Aeration |
|---|---|---|---|
| 3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe) | No additional aeration required; Follow pouch or wrap manufacturer's instructions (Example: Tyve pouches require ≥ 6 hours at 50°C) | ||
| Metal | 24 lbs (11 kg) | Surgical instruments, | |
| delicate sharps, | |||
| including those with | |||
| hinges and mated | |||
| surfaces | |||
| Plastic | 7.0 lbs (3.2 kg) | Reusable power cords, | |
| trocars, and similar | |||
| devices | 24 hours at 50°C; | ||
| Follow manufacturer's | |||
| instructions | |||
| Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns, | |
| towels, and similar devices | |||
| ≤ 1100 mm | |||
| Working | |||
| Lumen | |||
| Length | One (1) | ||
| ≥ 2.0 mm ID biopsy channel | |||
| ≤ 1100 mm working length | Gastrovideoscopes, | ||
| gastrointestinal videoscopes, | |||
| and similar devices | 8 hours at 50°C; | ||
| Follow manufacturer's | |||
| instructions | |||
| Endoscopes | Four (4) | ||
| ≥ 1.2 mm ID biopsy channel | |||
| ≤ 700 mm working length | Bronchoscopes, | ||
| bronchovideoscopes, cystoscopes, | |||
| ureteroscopes, choledocoscopes, | |||
| and similar devices |
Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer
6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe)
| >1100 mm | Two (2) Duodenoscopes* | Olympus TJF-Q180V, | 6 hours at 50°C for |
|---|---|---|---|
| Working | ≥ 2.0 mm ID biopsy channel | Olympus TJF-Q160VF , | Olympus and Pentax |
| Lumen | ≤ 1250 mm working length | Olympus TJF-Q190V, | endoscopes in Sterisheet |
| Length | ≥ 1.2 mm ID, ≤ 3530 mm | ||
| maximum length of any | |||
| 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 | |||
| 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.
4
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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5
510(k) Summary K192978
Applicant's Name and Address
Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258
Contact Person
William K. Andersen, BE, MD, FAAOS President Phone: 336-376-8622, Fax: 336-376-5428
Date of Preparation
October 8, 2020
Device
Proprietary Name EOGas 4 Ethylene Oxide Gas Sterilizer Common Name Ethylene oxide gas sterilizer Classification Class II (21 CFR 880.6860) Medical Specialty General Hospital Product Code FLF
The refill kits for the EOGas 4 Ethylene Oxide Gas Sterilizer, including the accessories (sterilization bags, EOGas 4 cartridges, Dosimeters, and Humidichips), are registered with the US Environmental Protection Agency (EPA #69340-7).
Predicate Device
| Device Name | EOGas 4 Ethylene Oxide Gas Sterilizer |
|---|---|
| 510(k) number | K150646 |
| Manufacturer | Andersen Sterilizers, Inc. |
The principles of operation for the EOGas 4 Ethylene Oxide Sterilizer, intended use, and technology are unchanged. The predicate EOGas 4 Ethylene Oxide Gas Sterilizer has the option of a 3-hour gas exposure or a 5-hour gas exposure, although only the 3-hour gas exposure is indicated for sterilization in hospitals and other human healthcare settings. To add the sterilization of duodenoscopes and colonoscopes to the indications for use, the 5-hour gas exposure was lengthened to 6 hours and a new process challenge device was developed appropriate for the longer cycle.
6
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
Time | Total Cycle
Time | EO Amount | Temperature | Relative
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.
7
| Device Type | Maximum Load | Device Examples | Required Aeration |
|---|---|---|---|
| 3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe) | |||
| Metal | 24 lbs | ||
| (11 kg) | Surgical instruments, | ||
| delicate sharps, | |||
| including those with | |||
| hinges and mated | |||
| surfaces | No additional aeration | ||
| required; | |||
| Follow pouch or wrap | |||
| manufacturer's | |||
| instructions (Example: | |||
| Tyvek pouches require | |||
| $\ge$ 6 hours at 50°C) | |||
| Plastic | 7.0 lbs | ||
| (3.2 kg) | Reusable power cords, | ||
| trocars, and similar | |||
| devices | 24 hours at 50°C; | ||
| Fabric | 6.1 lbs | ||
| (2.8 kg) | Reusable cloth gowns, | ||
| towels, and similar | |||
| devices | Follow manufacturer's | ||
| instructions | |||
| ≤ 1100 mm | |||
| Working | |||
| Lumen | |||
| Length | |||
| Endoscopes | One (1) | ||
| $\ge$ 2.0 mm ID biopsy channel | |||
| ≤ 1100 mm working length | Gastrovideoscopes, | ||
| gastrointestinal | |||
| videoscopes, and | |||
| similar devices | 8 hours at 50°C if in | ||
| Sterisheet; | |||
| Four (4) | |||
| $\ge$ 1.2 mm ID biopsy channel | |||
| ≤ 700 mm working length | Bronchoscopes, | ||
| bronchovideoscopes, | |||
| cystoscopes, | |||
| ureteroscopes, | |||
| choledocoscopes, and | |||
| similar devices | Follow manufacturer's | ||
| instructions | |||
| 6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe) | |||
| >1100 mm | |||
| Working | |||
| Lumen | |||
| Length | |||
| Endoscopes | Two (2) Duodenoscopes* | ||
| $\ge$ 2.0 mm ID biopsy channel | |||
| ≤ 1250 mm working length | |||
| $\ge$ 1.2 mm ID, ≤ 3530 mm | |||
| maximum length of any | |||
| channel | Olympus TJF-Q180V, | ||
| Olympus TJF-Q160VF, | |||
| Olympus TJF-Q190V, | |||
| Olympus PJF-160, | |||
| Fujifilm ED-530XT, | |||
| Pentax ED34-i10T2 | |||
| Pentax ED-3490TK | 6 hours at 50°C for | ||
| Olympus and Pentax | |||
| endoscopes in | |||
| Sterisheet; | |||
| Two (2) Colonoscopes* | |||
| $\ge$ 3.7 mm ID biopsy channel | |||
| ≤ 1700 mm working length | |||
| $\ge$ 1.2 mm ID, ≤ 3530 mm | |||
| maximum length of any | |||
| channel | Olympus CF-Q180AL, | ||
| Fujifilm EC-600HL, | |||
| Pentax EC-3490Li | 8 hours at 50°C for | ||
| Fujifilm endoscopes in | |||
| Sterisheet; | |||
| Follow manufacturer's | |||
| instructions | |||
| * One (1) duodenoscope may also be paired with one (1) | |||
| colonoscope |
Table 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer
Reusable medical devices must be aerated following the instructions of the device manufacturer and the packaging material manufacturer. Devices are released for use after sterilization based
8
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
EOGas 4 Sterilizer K192978 | Predicate EOGas 4
Sterilizer K150646 | Comparison |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intended
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
safety | | Same |
| Indications
for Use | 3-hour gas exposure at 50°C;
6-hour gas exposure at 50°C | 3-hour gas exposure at 50°C;
(5-hour gas exposure at 50°C;
not used for healthcare
sterilization) | Added a 6-hour
gas exposure for
sterilization of
endoscopes with
1100 mm
working length |
| Process
Challenge
Device | EOGas 4 Endo-SteriTest (K192980)
EZTest-Gas BI (K930683);
Bionova BT110 RRBI (K191021);
BI Receptacle:
Stainless steel cylinder
0.020" ID x 4.50" L lumen | EOGas 4 SteriTest (K151585)
EZTest-Gas BI (K930683);
BI Receptacle:
Stainless steel cylinder
0.020" ID x 0.25" L orifice | Similar:
appropriate for
the intended
length of gas
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
9
Summary of Non-Clinical Testing:
| Time | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Minimum | |||
| Sterilization | |||
| Parameters | To define and | ||
| validate the | |||
| endoscope loads that | |||
| can be sterilized using | |||
| the 6-hour gas | |||
| exposure at 50°C in | |||
| an EOGas 4 sterilizer | The EO gas exposure time at | ||
| 50°C in an EOGas 4 sterilizer | |||
| must result in sterilization of | |||
| the endoscope loads. | Using a 6-hour EO gas exposure | ||
| in the EOGas 4 sterilizer, |
6-Log biological indicators were
consistently inactivated for two
duodenoscopes, two
colonoscopes, or one colonoscope
and one duodenoscope in each
load.
The minimum parameters for
sterilization of two
duodenoscopes or colonoscopes
are 518 mg/L EO, 46.4°C, and
35% RH. |
| Half Dose
Validation | To demonstrate the
repeatability of the
EOGas 4 sterilization
process, and that a
SAL of 10-6 is
achieved for
duodenoscope and
colonoscope
sterilization | For consecutive half dose
cycles and full dose cycles:
EO concentration is half when
half the amount of EO is used.
All 6-Log Bacillus atrophaeus
biological indicators,
inoculated at the worst-case
locations of the tested
endoscopes, are inactivated. | Consecutive half dose cycles and
full dose cycles were performed.
The EO concentration was half
when half the amount of EO was
used. The cumulative lethality of
half dose cycles was half the
lethality of full dose cycle.
The cycles consistently
inactivated all 6-Log Bacillus atrophaeus biological indicators
inoculated at the midpoint of the
tested channels and at the elevator
mechanism of duodenoscopes, as
well as the water jet channel of
the colonoscopes. |
| Simulated-
Use Testing | To demonstrate the
successful
sterilization of
duodenoscopes and
colonoscopes within
the claims under a
worst-case scenario | For consecutive full dose
cycles:
Biological indicators with 6-
Log Bacillus atrophaeus ,
prepared in an artificial soil and
inoculated at the worst-case
locations of the tested
endoscopes, are inactivated. | Biological indicators with 6-Log
Bacillus atrophaeus were
prepared in an artificial soil and
inoculated at the center of the
tested channels and at the elevator
mechanism of duodenoscopes as
well as the water jet channel of
the colonoscopes.
Inactivated biological indicators
were obtained in all cycles for all
duodenoscope and colonoscope
loads tested. |
| | | | |
| In-Use
Testing | To demonstrate that
the 6-hour cycle at
50°C in an EOGas 4
sterilizer successfully
sterilizes
duodenoscopes and
colonoscopes used in
routine endoscopic
procedures in a
hospital or clinic
setting | Duodenoscopes and
colonoscopes, used on the
patients, cleaned but not
disinfected, are sterilized using
the 6-hour cycle at 50°C in an
EOGas 4 sterilizer. | Duodenoscopes and
colonoscopes, used on patients,
were cleaned per hospital protocol
but not disinfected, processed
using the 6-hour EO exposure at
50°C in the EOGas 4 sterilizer;
sterility was tested by a flush
method per USP. All test cultures
from the processed
duodenoscopes and colonoscopes
were sterile. |
| EO
Residuals | To demonstrate that
endoscopes and their
accessories are safe
to use if the guidance
and instructions are
followed | After additional aeration
following the cycle, EO
residuals on duodenoscopes and
colonoscopes are evaluated,
and the residuals on the
endoscopes and accessories
meet the requirements of
ANSI/AAMI/ISO 10993-7. | Olympus TJF-Q180V, TJF-
Q160VF, TJF-Q190V, PJF-160,
CF-Q180AL, Pentax ED34-i10T2,
ED-3490TK duodenoscopes and
EC-3490Li colonoscopes wrapped
in Sterisheet must aerate for an
additional 6 hours after the cycle.
Fujifilm ED-530XT and EC-
600HL wrapped in Sterisheet
must aerate for an addition 8
hours after the cycle.
After 6 hours of additional
aeration, EO residuals on the
packaging materials met the
requirements of ANSI/AAMI/ISO
10993-7. |
Table 4. Summary of Non-Clinical Testing
10
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
11
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).