K Number

Device Name

Andersen EOGas 4 SteriTest

Manufacturer

Andersen Sterilizers, Inc.

Date Cleared

2015-11-18

(160 days)

Product Code

FRC

Regulation Number

880.2800

Intended Use

The Andersen EOGas 4 SteriTest consists of a self-contained biological indicator inoculated with viable Bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Device Description

The Andersen EOGas 4® SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable BI receptacle. It is designed for monitoring the efficacy of the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure. Following manufacturer's instructions, the operator inserts the Andersen EOGas 4 SteriTest into the reusable BI receptacle on the purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 3 hour cycle at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K930683

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a biological indicator that relies on the growth or lack of growth of bacterial spores and a chemical indicator for determining sterilization efficacy. There is no mention of AI or ML in the description or performance studies.

Therapeutic

No.
This device is a biological indicator used to monitor the effectiveness of a sterilization cycle, not to treat a health condition.

Diagnostic

This device is a biological indicator used to monitor the effectiveness of a sterilization process, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

The device is a biological indicator consisting of physical components (vial, cap, paper carrier, glass ampoule, broth, chemical indicator) and requires incubation and visual interpretation, not software processing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to monitor the efficacy of a sterilization cycle in an ethylene oxide gas sterilizer. This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
Device Description: The device contains bacterial spores and a culture medium. Its function is to determine if the sterilization process killed the spores. This is a test of the sterilization equipment's performance, not a test of a patient's biological state.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) from a patient.
- Providing information about a patient's health status, disease, or condition.
- Being used in a clinical laboratory setting for patient diagnosis or monitoring.

The device is a biological indicator used to validate a sterilization process, which falls under the category of medical device quality control, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Critical process parameters for the cycle are summarized below 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	35-90%	3 hours	3.5 hours

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

FRC

Device Description

The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.

Following manufacturer's instructions, the operator inserts the Andersen EOGas 4 SteriTest into the reusable BI receptacle on the purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 3 hour cycle at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to vellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).

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

Not Found

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)

The Andersen EOGas 4 SteriTest has been validated using applicable tests in FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions", and AAMI/ANSI/ISO 11138-1 "Sterilization of health care products - Biological indicators - Part 1: General requirements" (FDA Recognition Number 14-296).

For the EZTest - Gas Biological Indicators, tests include viable spore population assay, resistance characteristics study, carrier and primary packaging materials (growth inhibition) evaluation, holding time assessment, and reduced incubation time validation. The results of all studies met the established acceptance criteria when applicable.

We also demonstrated that under the same exposure conditions, the resistance characteristics of the EZTest - Gas Biological Indicators were the same when measured in a Biological Indicator Evaluator Resistometer in the presence or absence of vacuum.

The Andersen EOGas 4 SteriTest represents a rigorous challenge to the EOGas 4 sterilization process. Its resistance characteristics are greater than the same EZTest-Gas Biological Indicator placed in the worst-case locations of the maximum fabric, metal, plastic, and endoscope validation loads. The performance of the Andersen EOGas 4 SteriTest in the 3 hour cycle at 50 C in an EOGas 4 Ethylene Oxide Gas Sterilizer is summarized in Table 5-3.

Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the Andersen EOGas 4 SteriTest

Test	Description	Result
Functionality	1) Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%; 2) Device is appropriate for monitoring the efficacy of the sterilization process claimed	Pass
Shelf Life	Maintains performance specifications (resistance characteristics and correctly indicate pass/fail in cycles) throughout the stated shelf life of 2 years; Stability demonstrates reasonable assurance for effectiveness	Pass

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.

K930683

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.

Not Found

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

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.

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: K151585

Trade/Device Name: Andersen EOgas 4 Steritest Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC 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

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 I. 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151585

Device Name Andersen EOGas 4 SteriTest

Indications for Use (Describe)

Critical process parameters for the cycle are summarized below 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	35-90%	3 hours	3.5 hours

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)

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

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510(k) Summarv

| 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
Common Name
Classification
Product Code | Andersen EOGas 4® SteriTest
Biological Sterilization Process Indicator
Class II (21 CFR 880.2800)
FRC | |
| 5.5 | Predicate Device | Device Name
510(k) number
Manufacturer | EZTest - Gas Biological Indicators
K930683
Mesa Laboratories Inc. | |

This 510(k) submission modifies the indications for use of the predicate device in order to include it as a component in a process challenge device. No modifications were made to the technology or intended use.

5.6 Device Description

vellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no color change or turbidity indicates conditions for sterilization were achieved (cycle passed).

5.7 Indications for Use

The Andersen EOGas 4 SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1.

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

| Ethylene Oxide | Temperature | Relative
Humidity | Ethylene Oxide
Exposure Time | Total Cycle
Time |
|----------------|-------------|----------------------|---------------------------------|---------------------|
| 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours |

ર જ Device Comparison

The technological characteristics of the Andersen EOGas 4 SteriTest are substantially equivalent to the predicate device - EZTest - Gas Biological Indicators, because both indicators are intended for the same use, use the same technology, are designed in the same way, and perform substantially equivalently.

The Andersen EOGas 4 SteriTest differs from the predicate device in the configuration used in a load. The difference raises no issues related to safety or effectiveness of the subject device in the sterilization cvcle. A comparison between the devices is listed in Table 5-2.

Element	EZTest - Gas BI	EOGas 4 SteriTest
Intended Use	Sterilization method: EO gas
Process parameters: EO concentration, time,
temperature, and relative humidity	Identical
Organism	Bacillus atrophaeus (ATCC 9372)	Identical
Viable Spore
Population	$\geq 1.0 x 10^6$	Identical
Device Design	Paper strip containing indicator organism;
Glass ampoule containing growth medium;
Capped vial serving as a culture tube;
A pH indicator in medium for color change;
A process indicator indicating EO exposure	Identical for the BI;
Additionally, a BI receptacle is
added to create a greater
challenge to the sterilization
process.
Materials of
Construction	Paper, glass, and polypropylene	Paper, glass, polypropylene, and
aluminum
Configuration in
Load	SCBI placed within the load	SCBI in a receptacle

Table 5-2. Device Comparison

Indications for Use	Not available	The Andersen EOGas 4 SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.
---------------------	---------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

ર તે Performance Testing

Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the Andersen EOGas 4 SteriTest

Test	Description	Result
Functionality	1) Critical parameters include temperature, time, and gas concentration under a
relative humidity of 35-90%;

Device is appropriate for monitoring the efficacy of the sterilization process
claimed | Pass |
| Shelf Life | Maintains performance specifications (resistance characteristics and correctly
indicate pass/fail in cycles) throughout the stated shelf life of 2 years;
Stability demonstrates reasonable assurance for effectiveness | Pass |

In conclusion, the Andersen EOGas 4 SteriTest is substantially equivalent to the legally marketed predicate, the EZTest - Gas Biological Indicator.