AN1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour or 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

Device Description

The AN1036 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 4 Ethylene Oxide Gas Sterilizer.

The AN1036 Dosimeter contains a proprietary pH indicator in a glass capillary tube that is sealed on one end and mounted on a plastic tray. It is calibrated for a 50℃ sterilization temperature and responds to ethylene oxide concentration and sterilization time. With exposure to ethylene oxide, the indicator turns from yellow-orange to a dark blue color from the open end toward the closed end. The extent of the color change is proportional to cumulative ethylene oxide exposure. The cycle-specific calibration marks represent adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1036 Dosimeter after 3-hour gas exposures or at the center of the endoscope lumens after 6-hour gas exposures. The AN1036 Dosimeter is not a replacement for a biological indicator.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the AN1036 Dosimeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Chemical Indicator	Critical parameters with pass/fail criteria; Able to correctly indicate pass/fail results from the EOGas 4 Sterilizer	AN1036 Dosimeters respond to EO concentration, sterilization time, and temperature, at a relative humidity of 35-90%. AN1036 Dosimeters correctly indicate pass/fail in various endoscope loads. A correlation exists between the extent the blue color travels and cumulative EO exposure.
Biocompatibility	Provides reasonable assurance for safety	AN1036 Dosimeter is not a direct or indirect patient-contacting device. None of the major ingredients is hazardous. No chemicals leach out of the AN1036 Dosimeters during the sterilization cycle. Without any additional aeration, the residual EO detected in Dosimeters met ISO 10993-7 requirements.
Endpoint Color Stability	Stability demonstrates reasonable assurance for effectiveness	Endpoint blue color is stable for 28 days at 20-25°C or 4 days at 50°C after 6-hour gas exposures.
Shelf Life	Maintains performance specifications throughout the stated shelf life	Data supports claimed shelf life of 3 years.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state a specific numerical sample size for the test set used in the "Chemical Indicator" performance evaluation. It mentions that "AN1036 Dosimeters correctly indicate pass/fail in various endoscope loads."
Data Provenance: The studies were conducted by Andersen Sterilizers, Inc. as part of their 510(k) submission. The data is retrospective in the sense that it's a report of completed testing, but it's not specified if the data itself was collected retrospectively from past clinical cases or specifically generated for this submission through controlled laboratory experiments. Given the nature of a chemical indicator, it's highly likely it was generated through controlled laboratory testing. The country of origin for the data is implicitly the United States, as Andersen Sterilizers, Inc. is located in North Carolina, and the submission is to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" for a chemical indicator's performance would typically be established based on instrumental measurements of ethylene oxide concentration, temperature, and time parameters, and the known biological inactivation levels corresponding to those parameters, rather than expert interpretation of the indicator itself.

4. Adjudication method for the test set:

This information is not explicitly provided. For a chemical indicator, the "adjudication" would likely involve objective measurements and comparison against established physical/chemical standards, rather than a human consensus process.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is involved. The AN1036 Dosimeter is a chemical indicator, not an AI device.

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

This question is not applicable. The AN1036 Dosimeter is a chemical indicator that works passively based on chemical reactions. It is not an algorithm or an AI system that performs independently.

7. The type of ground truth used:

The ground truth for the "Chemical Indicator" test is based on the proper functioning of the EOGas 4 Ethylene Oxide Gas Sterilizer under specified critical parameters (Ethylene Oxide concentration, Temperature, Relative Humidity, EO Exposure Time, Total Cycle Time). The indicator's response (extent of color change) is correlated with "adequate cumulative EO exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator." This implies a biological indicator equivalency as the ultimate ground truth, verified under controlled physical and chemical parameters.

8. The sample size for the training set:

This information is not applicable. The AN1036 Dosimeter is a physical chemical indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for a chemical indicator.

Summary

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November 12, 2020

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

Re: K200334

Trade/Device Name: AN1036 Dosimeter Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 26, 2020 Received: October 29, 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

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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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200334

Device Name AN1036 Dosimeter

Indications for Use (Describe)

AN 1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.

Critical process parameters for the cycles are summarized in Table 1.

Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer

Ethylene Oxide	Temperature	Relative Humidity	EO Exposure Time	Total Cycle Time
17.6 g ± 5%	50°C ± 3°C	35-70%	3 hours	3.5 hours
			6 hours	7 hours

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K200334

Applicant's Name and Address

Andersen Sterilizers, Inc. Establishment Registration Number 3004634710 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 26, 2020

Device

Proprietary Name AN1036 Dosimeter Common Name Indicator, Physical/Chemical Sterilization Process Classification Class II (21 CFR 880.2800) Chemical Indicator Product Code 101

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	AN1087 Dosimeter
510(k) number	K150645
Manufacturer	Andersen Sterilizers, Inc.

The predicate AN1087 Dosimeters were cleared for use with 3-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization system manufactured by Andersen Sterilizers, Inc.

The sterilization time claim of the predicate device was modified in order to indicate the AN1087 Dosimeters for use in 6-hour gas exposures in the EOGas 4 Ethylene Oxide Gas Sterilization System. No modifications were made to the manufacturing method, technology, or intended use.

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Device Description

The AN1036 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 4 Ethylene Oxide Gas Sterilizer.

Indications for Use

Critical process parameters for the cycles are summarized in Table 5-1.

Ethylene Oxide	Temperature	RelativeHumidity	Ethylene OxideExposure Time	Total Cycle Time
17.6 g ± 5%	50°C ± 3°C	35-90%	3 hours	3.5 hours
			6 hours	7 hours

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

Technological Characteristics Comparison

The subject AN1036 Dosimeter is compared to the predicate AN1087 Dosimeter (K150645): there is no difference in intended use, design principles, technical characteristics, or performance between the devices.

The difference between the predicate AN1087 and subject AN1036 Dosimeters is the addition of a calibration mark suitable for a 6-hour gas exposure.

A comparison between the indicators is listed in Table 5-2.

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	Predicate AN1087 Dosimeter(K150645)	Subject AN1036 Dosimeter(K200334)	Comparison
Intended Use	Chemical indicator forcumulative EO exposure in theEOGas 4 Ethylene Oxide GasSterilizer	Chemical indicator forcumulative EO exposure in theEOGas 4 Ethylene Oxide GasSterilizer	Identical
Design	A pH indicator changes colorwhen exposed to EO;The extent of the color changesis proportional to cumulativeEO exposure;Calibrated for use at 50±3°C;One calibration mark for use in3-hour gas exposures	A pH indicator changes colorwhen exposed to EO;The extent of the colorchanges is proportional tocumulative EO exposure;Calibrated for use at 50±3°C;Two calibration marks for usein both 3-hour and 6-hour gasexposures	Identical
Technology	Chemical reactions with EOchange the pH, and thereforethe color, of the indicator ink	Chemical reactions with EOchange the pH, and thereforethe color, of the indicator ink	Identical
Performance	Indicates cumulative EOexposure	Indicates cumulative EOexposure	Identical
Shelf Life	3 years	3 years	Identical
EndpointSpecifications	Endpoint blue color is stablefor 28 days at 20-25°C and 3days at 50°C.	Endpoint blue color is stablefor 28 days at 20-25°C and 4days at 50°C.	Similar

Table 5-2. Comparison between the subject AN1036 Dosimeter and the predicate AN1087 Dosimeter (K150645)

Summary of Non-clinical Testing:

The AN1036 Dosimeters were validated using applicable tests in:

1. FDA 2003 guideline, "Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff"; and
1. ANSI AAMI ISO 11140-1, "Sterilization of health care products Chemical Indicators -Part 1: General requirements" (FDA Recognition Number 14-460).

The performance of the AN1036 Dosimeter was characterized in an Andersen Chemical Indicator Evaluator Resistometer as well as in the EOGas 4 Ethylene Oxide Gas Sterilizer using 3- and 6-hour gas exposures at 50°C. The critical parameters to which the AN1036 responds include temperature, time, and ethylene oxide gas concentration in a relative humidity-controlled environment. The AN1036 indicates adequate cumulative EO exposure in the cycle for all validated loads in the EOGas 4 Ethylene Oxide Gas Sterilizer. Using the AN1036 Dosimeter at various stages of shelf life, the distance the blue line travels is stable for a minimum of 28 days after the sterilization cycle when AN1036 Dosimeters are stored at room temperature (20-25°C) and 4 days when stored at 50°C. Real-time shelf life testing with the AN1036 Dosimeter supports a shelf life of 3 years.

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Performance testing is summarized in Table 5-3.

Test	Purpose	Acceptance Criteria	Results
ChemicalIndicator	To validate AN1036Dosimeter as achemical indicator perANSI/AAMI/ISO11140-1 and FDAChemical Indicatorguidance	Critical parameterswith pass/fail criteria;Able to correctlyindicate pass/failresults from the EOGas4 Sterilizer	AN1036 Dosimeters respond toEO concentration, sterilizationtime, and temperature, at arelative humidity of 35-90%.AN1036 Dosimeters correctlyindicate pass/fail in variousendoscope loads.A correlation exists between theextent the blue color travels andcumulative EO exposure.
Biocompatibility	To demonstrate theAN1036 Dosimetersare safe to use	Provides reasonableassurance for safety	AN1036 Dosimeter is not a director indirect patient-contactingdevice.
			None of the major ingredients ishazardous.
			No chemicals leach out of theAN1036 Dosimeters during thesterilization cycle.
			Without any additional aeration,the residual EO detected inDosimeters met ISO 10993-7requirements.
Endpoint ColorStability	To evaluate thestability of theendpoint color	Stability demonstratesreasonable assurancefor effectiveness	Endpoint blue color is stable for28 days at 20-25°C or 4 days at50°C after 6-hour gas exposures.
Shelf Life	Evaluate the ability tocorrectly indicatepass/fail in cyclesthrough the shelf life	Maintains performancespecificationsthroughout the statedshelf life	Data supports claimed shelf lifeof 3 years

Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the AN1036 Dosimeter

Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the AN1036 Dosimeter device is as safe, as effective, and performs as well as or better than the legally marketed AN1087 Dosimeter (K150645).

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).