AN1087 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 3 hour sterilization cycle at 50°C in the Andersen Sterilizers EOGas 4 Ethylene Oxide Gas Sterilizer.

Device Description

The AN1087 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 40 Ethylene Oxide Gas Sterilizer.

The AN1087 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°C 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 the cumulative ethylene oxide exposure. The calibration mark represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1087 Dosimeter. The AN1087 Dosimeter is not a replacement for a biological indicator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AN1087 Dosimeter. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the document, but rather as "Pass" for each test. The performance is described qualitatively.

Test	Acceptance Criteria (Implied)	Reported Performance
Functionality	1. Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%.2. Performance parallels that of a biological indicator.3. A correlation between the extent of the blue color formed and the cumulative EO exposure.4. A correlation between the measured vs. calculated EO exposure.	Pass
Biocompatibility	Non-toxic ingredients; Provides reasonable assurance for safety. (Implies no adverse biological reactions as a non-patient-contacting device).	Pass
Endpoint Color Stability	Stable for at least 28 days at 20-25°C and 3 days at 50°C; Stability demonstrates reasonable assurance for effectiveness.	Pass
Shelf Life	Maintains performance specifications throughout the stated shelf life of 3 years.	Pass

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

The document does not explicitly state the sample size used for individual tests. The studies were performed in an "Andersen Chemical Indicator Evaluator Resistometer" and an "EOGas 4 Ethylene Oxide Gas Sterilizer." The provenance of the data is not specified beyond being generated by the manufacturer, Andersen Sterilizers, Inc. It's a regulatory submission, so likely pre-market testing. The document does not specify if the studies were retrospective or prospective, but given the context of a 510(k) submission, they would typically be prospective pre-market validation studies.

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

This information is not provided in the document. The "ground truth" for the dosimeter's performance appears to be based on its intended function to "verify adequate cumulative ethylene oxide exposure" in relation to a 6-Log Bacillus atrophaeus biological indicator (though the dosimeter is not a replacement for it). The assessment of "Pass" for functionality, stability, and shelf life would likely be based on internal criteria and measured physical/chemical properties, not expert human interpretation in the sense of medical image analysis.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a chemical indicator, the "adjudication" is likely based on objective chemical and physical measurements rather than human consensus or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable to the AN1087 Dosimeter. This device is a chemical indicator, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related improvement in human readers would be relevant or performed.

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

This is not applicable to the AN1087 Dosimeter. It is a physical chemical indicator, not an algorithm. Its "standalone" performance is its intrinsic ability to change color in response to EO exposure, which is what the functionality tests evaluate.

7. The Type of Ground Truth Used

The ground truth used for evaluating the AN1087 Dosimeter's performance is primarily physical and chemical measurements related to ethylene oxide exposure, temperature, time, and relative humidity. The document mentions that the dosimeter's calibration mark "represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator." This implies that the effectiveness of sterilization (as measured by a biological indicator) serves as a benchmark for the dosimeter's "ground truth" for adequate exposure, even though the dosimeter itself is not a biological indicator. For other tests like stability and shelf life, the ground truth is the maintenance of its calibrated color change properties over time and under specified conditions.

8. The Sample Size for the Training Set

This is not applicable in the context of machine learning. The AN1087 Dosimeter is a chemical indicator that operates based on a direct chemical reaction, not a machine learning algorithm that requires a "training set."

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

This is not applicable as there is no "training set" for this chemical indicator. The "calibration" of the dosimeter for a 50°C sterilization temperature and its response to EO concentration and time would have been established through a series of experiments and measurements by the manufacturer.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

November 19, 2015

Andersen Sterilizers, Inc. William K. Andersen, BE, MD, FAAOS President 3154 Caroline Dr Haw River, NC 27258

Re: K150645

Trade/Device Name: AN1087 Dosimeter Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ 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

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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Indications for Use

510(k) Number (if known) K150645

Device Name AN1087 Dosimeter

Indications for Use (Describe)

AN1087 Dosimeter is a single-use color change chemical indicator that is callbrated for sterlization temperature and used to verify adequate cumulative ethylene oxide exposure in the 3 hour sterilization cycle at 50°C in the Andersen Sterilizers EOGas 4 Ethylene Oxide Gas Sterilizer.

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

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

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)

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510(k) Summary

5.1 Applicant's Name and Address	Andersen Sterilizers, Inc.3154 Caroline DriveHaw River, NC 27258
5.2 Contact Person	William K. Andersen, BE, MD, FAAOSPresidentPhone: 336-376-8622; Fax: 336-376-5428
5.3 Date of Preparation	October 20, 2015
5.4 Device	Proprietary NameCommon NameClassificationProduct Code	AN1087 Dosimeter®Indicator, Physical/Chemical Sterilization ProcessClass II (21 CFR 880.2800) Chemical IndicatorJOJ

The AN1087 Dosimeter is part of the refill kit for the EOGas 4 Ethylene Oxide Gas Sterilizer registered with the US Environmental Protection Agency (EPA #69340-7).

5.5 Pre-amendment Device

AN87 Dosimeter® Device Name 510(k) number NA Manufacturer Andersen Sterilizers, Inc.

The AN87 Dosimeter was legally marketed prior to the Medical Device Act, and has been in continuous use with Andersen ethylene oxide sterilization systems since the early 1970's. No 510(k) number exists for the AN87 Dosimeter.

The purpose for this submission is to modify the sterilization temperature claim of the preamendment device - AN87 Dosimeter. No modifications were made to the technology or intended use.

5.6 Device Description

The AN1087 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 40 Ethylene Oxide Gas Sterilizer.

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exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1087 Dosimeter. The AN1087 Dosimeter is not a replacement for a biological indicator.

5.7 Indications for Use

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

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

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

5.8 Substantial Equivalence Comparison

The AN1087 Dosimeter is substantially equivalent to the pre-amendment device - AN87 Dosimeter, because there is no difference in intended use, design, technical characteristics, and performance between them. The slight difference between two Dosimeters is the sterilization temperature indicated for use, but the difference raises no issues related to safety or effectiveness because they are calibrated and validated at the sterilization temperatures claimed. A comparison between the indicators is listed in Table 5-2.

	AN87 Dosimeter	AN1087 Dosimeter	Comparison
IntendedUse	Chemical indicator forcumulative EO exposure	Chemical indicator forcumulative EO exposure	Equivalent
Design	A pH indicator changes colorwhen exposed to EO;The extent of the color changesis proportional to cumulativeEO exposure;Calibrated for use at 23±3°C.	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.	Equivalent
Technology	Chemical reactions with EOchanges the pH and thus thecolor of the indicator ink	Chemical reactions with EOchanges the pH and thus thecolor of the indicator ink	Equivalent
Performance	Accurately indicated EOexposure;	Accurately indicated EOexposure;	Equivalent

Table 5-2. Comparison between AN1087 Dosimeter and the pre-amendment device

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5.9 Performance Testing

The performance of the AN1087 Dosimeter was characterized in an Andersen Chemical Indicator Evaluator Resistometer as well as in an EOGas 4 Ethylene Oxide Gas Sterilizer using the 3 hour cycle at 50 C. Performance testing is summarized in Table 5-3.

			Table 5-3. Summary of bench tests performed to demonstrate safety and effectiveness of the
AN1087 Dosimeter

Test	Description	Result
Functionality	1) Critical parameters include temperature, time, and gasconcentration under a relative humidity of 35-90%;2) Performance parallels that of a biological indicator;3) A correlation between the extent of the blue color formed andthe cumulative EO exposure;4) A correlation between the measured vs. calculated EO exposure.	Pass
Biocompatibility	Not direct or indirect patient-contacting devices;Non-toxic ingredients;Provides reasonable assurance for safety	Pass
Endpoint ColorStability	Stable for at least 28 days at 20-25°C and 3 days at 50°C;Stability demonstrates reasonable assurance for effectiveness	Pass
Shelf Life	Maintains performance specifications throughout the stated shelflife of 3 years	Pass

In conclusion, the bench performance testing demonstrates that the AN1087 Dosimeter performs as intended to indicate cumulative EO exposure, and provides reasonable assurance of safety and effectiveness, equivalent to the legally marketed pre-amendment device, the AN87 Dosimeter.

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).