The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure
38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure
55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
55°C. 600 mg/l EO. 60% RH. 4 hours exposure
The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
54℃, 42 min, EO 600 mg/l, RH 60±10%
37℃,75 min. EO 600 mg/l. RH 60±10%
55°C, 36 min, EO 736 mg/l, RH 50±10%
37°C, 75 min, EO 736 mg/l, RH 50±10%
55°C, 35 min, EO 759 mg/l, RH 50±10%
37°C, 75 min, EO 759 mg/l, RH 50±10%

Device Description

The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.

AI/ML Overview

The acceptance criteria and the study proving the device meets these criteria are detailed in the "Summary of Non-Clinical Testing" section of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Performance testing in EO BIER vessel	Color changes:- Pass Condition (Green): - 54°C, 42 min, EO 600 mg/l, RH 60% - 37°C, 75 min, EO 600 mg/l, RH 60% - 55°C, 36 min, EO 736 mg/l, RH 50% - 37°C, 73 min, EO 736 mg/l, RH 50% - 55°C, 35 min, EO 759 mg/l, RH 50% - 37°C, 73 min, EO 759 mg/l, RH 50%- Fail Condition (Brown, Brown-red, Brown-yellow): - 49°C, 33.6min, EO 510 mg/l, RH 60% - 32°C, 60 min, EO 510 mg/l, RH 60% - 50°C, 28.8min, EO 625mg/l, RH 50% - 32°C, 58.4min, EO 625mg/l, RH 50% - 50°C, 28 min, EO 645 mg/l, RH 50% - 32°C, 58.4min, EO 645mg/l, RH 50%	Passed
Testing in "No EO Gas" cycles	When tested in cycle with temperature 60°C±2°C, RH≥85%, time 90 min±1min, the indicator should not achieve end-point color.	Passed
Testing against biological indicator	The integrator does not achieve end-point color before the biological indicator is inactivated and demonstrates parallel performance to the biological indicator.	Passed
Single parameter variation testing	Variation of one parameter while other ones are maintained steady. Gas-Chex Indicator should not reach specified end-point green color.	Passed
Testing in cycles with parameters typical for healthcare	Color change from brown-red to green.	Passed
Biocompatibility study and ink transfer test	Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation with history on the market.Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples.	Passed
End-point stability and shelf-life study	Gas-Chex indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 3 months.Meet specifications after real-time 36 months shelf-life exposure.	Passed

Detailed Information on the Study:

Sample size used for the test set and the data provenance:
- The document does not specify the exact number of individual Gas-Chex Indicators or test runs used for each test. Instead, it states that various conditions (e.g., specific temperatures, EO concentrations, RH, and exposure times) were tested.
- Data Provenance: The tests were performed to demonstrate conformance with FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003. These are laboratory-based, non-clinical tests conducted in controlled environments (Ethylene Oxide BIER vessel). The specific country of origin is not explicitly stated for the testing location, but the applicant company is located in Long Island City, New York, USA. The study design is prospective in nature as it involves planned testing under specific conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (chemical indicator for sterilization) does not typically involve human expert interpretation of complex data for ground truth establishment.
- The "ground truth" is established by the known, objective physical and chemical parameters of the sterilization cycles (e.g., temperature, time, EO concentration, RH) and the expected color change response of the indicator based on its design and the established standards (e.g., ISO 11140-1:2014 and FDA guidance). The color change itself (brown-red to green, or remaining brown-red/brown-yellow) is a direct, observable, and objective outcome.
- Therefore, no human experts are described as being used in an "adjudication" sense to establish fundamental ground truth for the device's performance in these non-clinical tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method from human experts is described since the assessment of the chemical indicator's color change is a direct observation against defined criteria (e.g., "green" for pass, "brown, brown-red, brown-yellow" for fail). This is a purely objective assessment against pre-defined color states.
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 MRMC comparative effectiveness study was done. This type of study is not applicable to a chemical sterilization indicator, which is a passive device with a direct visual output, rather than an AI-driven diagnostic or interpretative tool that assists human readers.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. The device is a chemical indicator that changes color; there is no algorithm involved. Its performance is inherent to its chemical formulation and physical design.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on the known, controlled physical and chemical parameters of the Ethylene Oxide sterilization cycles (temperature, Ethylene Oxide concentration, relative humidity, and exposure time) generated in a Resistometer (BIER vessel). The expected outcome (color change to green for successful sterilization parameters, or no change/partial change for insufficient parameters) is derived from established sterilization science and regulatory standards for chemical indicators.
The sample size for the training set:
- Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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January 20, 2022

Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101

Re: K212592

Trade/Device Name: Gas-Chex Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: December 20, 2021 Received: December 23, 2021

Dear Andrew Sharavara:

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 mediation-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,

Clarence W. Murray, III, PhD 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

510(k) Number: K212592

Device Name Gas-Chex Indicator

Indications for Use (Describe)

1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure 5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
  The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:

54℃, 42 min, EO 600 mg/l, RH 60±10% 37℃,75 min. EO 600 mg/l. RH 60±10%

55°C, 36 min, EO 736 mg/l, RH 50±10% 37°C, 75 min, EO 736 mg/l, RH 50±10%

55°C, 35 min, EO 759 mg/l, RH 50±10% 37°C, 75 min, EO 759 mg/l, RH 50±10%

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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510(k) Summarv K212592

Submitted by:	Propper Manufacturing Company, Inc.
Address:	36-04 Skillman Avenue,Long Island City, New York 11101
Contact Name:	Andrew Sharavara, Ph.D., Chief Technical Officer
Telephone:	(800) 832-4300 x149
Fax:	(718) 482-8909
E-mail:	as@proppermfg.com
Date Submitted:	August 12, 2021

Device information:

Device Trade Name:	Gas-Chex® Indicator
Classification Name:	Physical/Chemical Sterilization Process Indicator
Common Name:	Ethylene Oxide Gas Sterilization Indicator
Product Code:	JOJ
Classification:	Class II (21 C.F.R. 880.2800)
510k number	K212592

Description of the Device

The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.

Indications for Use

The Gas-Chex® Indicator is an integrating indicator designed to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex® Indicator is intended to be placed in each pack, pouch, tray, or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

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37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/1 EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/1 EO, 40-80% RH, 4.5 hours exposure 5. 55°C. 736 mg/l EO. >35% RH. 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C, 600 mg/l EO, 60% RH, 4 hours exposure

The Gas-Chex® Indicator has the following minimum Stated Values determined in a Resistometer:

54℃, 42 min, EO 600 mg/1, RH 60±10% 37℃,75 min, EO 600 mg/1, RH 60±10% 55℃,36 min, EO 736 mg/1, RH 50±10% 37℃,73 min, EO 736 mg/1, RH 50±10% 55℃, 35 min, EO 759 mg/l, RH 50±10% 37℃, 73 min, EO 759 mg/1, RH 50±10%

Performance

The performance of the Gas-Chex® Indicator complies with FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003 for integrating indicators.

Technological Characteristics Comparison to Legally Marketed Predicate Device

Comparison of the subject device (Gas-Chex Indicator, Propper Manufacturing Co., Inc) to Predicate device (Integron IT12, K191021, by Terragene S.A.).

	Subject device	Predicate device	Comparison	design	indicator ink
Product name	Gas-Chex Indicator	Integron IT12 integrator,K191021		Initial color	Brown-red	Purple	Similar
Productgeneric name	A physical/chemical sterilizationprocess indicator	A physical/chemicalsterilization process indicator	Identical	End point color	Green	Green	Identical
Product code	JOJ	JOJ	Identical	Indicator category	Integrating indicator	ISO Integrator	Similar. Both indicators are designed to respond to all critical parameters over a specified range.
Sterilizationmethod	Ethylene Oxide gas sterilization	Ethylene Oxide gassterilization	Identical	Single use	Yes	Yes	Identical
Intended use	Sterilization process indicator	Sterilization process indicator	Identical	Shelf life	36 months	36 months	Identical
Sterilizationcycles	37°C,736 mg/l EO, ≥35% RH, 3hrs37°C,759 mg/l EO, ≥35% RH, 3hrs38°C,736 mg/l EO, 40-80% RH, 4.5 hrs38°C,759 mg/l EO, 40-80% RH, 4.5 hrs55°C,736 mg/l EO, ≥35% RH, 1 hr55°C,759 mg/l EO, ≥35% RH, 1 hr55°C,600 mg/l EO, 60% RH, 4 hrs	55°C, 600 mg/l EO, 60% RH,240min	Identical withadditional cycles forGas-Chex Indicator	Indications for use	The Gas-Chex Indicator is designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:37°C,736 mg/l EO, ≥35% RH, 3hrs37°C,759 mg/l EO, ≥35% RH, 3hrs38°C,736 mg/l EO, 40-80% RH, 4.5 hrs38°C,759 mg/l EO, 40-80% RH, 4.5 hrs55°C,736 mg/l EO, ≥35% RH, 1 hr55°C,759 mg/l EO, ≥35% RH, 1 hr55°C,600 mg/l EO, 60% RH, 4 hrsThe Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:54°C, 42 min, EO 600 mg/l, RH 60±10%37°C, 75 min, EO 600 mg/l, RH 60±10%55°C, 36 min, EO 736 mg/l, RH 50±10%37°C, 73 min, EO 736 mg/l, RH 50±10%55°C, 35 min, EO 759 mg/l, RH 50±10%37°C, 73 min, EO 759 mg/l, RH 50±10%	The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:55°C for 240 minutes, 600 mg/l, RH 60 %.SV 37°C/75 min,SV 54°C/30 min,SV 55°C/28 min.	Similar. Gas-Chex indicator can be used in several additional cycles.Stated value at 37°C is identical.Gas-Chex indicator has longer stated value time in BIER vessel at 54°C which is within typical performance range and conforms to the requirement not to achieve end point before biological indicator spore death.
Device	Paper strip printed with indicator ink	Paper strip printed with	Identical

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Propper BI-OK® EO Gas Biological Test Pack, K972747, was used as a reference device for stability and shelf-life review because this reference device includes EO sterilization record card – a paper sheet printed with EO indicator ink very similar to the ink of Gas-Chex Indicator.

Terragene ChemDye CD16 EO Multivariable process indicator, K191021, was used as a reference device for color change comparison.

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Summary of Non-Clinical Testing

Provided below is the summary of non-clinical testing that was performed to demonstrate that the subject device met the acceptance criteria for each standard or test method.

Test	Purpose	Acceptance Criteria	Result
Performancetesting in EOBIER vessel	Demonstrate conformance ofGas-Chex Indicator with theFDA guidance for industry andFDA Staff: Pre-marketnotification [510(k)]submissions for chemicalindicators, 2003 for integratingindicators.	Color changes:54°C, 42 min, EO 600 mg/l, RH 60%: green49°C, 33.6min, EO 510 mg/l, RH 60%:brown, brown-red, brown-yellow37°C, 75 min, EO 600 mg/l, RH 60%: green32°C, 60 min, EO 510 mg/l, RH 60%:brown, brown-red, brown-yellow55°C, 36 min, EO 736 mg/l, RH 50%: green50°C, 28.8min, EO 625mg/l, RH 50%:brown, brown-red, brown-yellow37°C, 73 min, EO 736 mg/l, RH 50%: green32°C, 58.4min, EO 625mg/l, RH 50%:brown, brown-red, brown-yellow55°C, 35 min, EO 759 mg/l, RH 50%: green50°C, 28 min, EO 645 mg/l, RH 50%:brown, brown-red, brown-yellow37°C, 73 min, EO 759 mg/l, RH 50%: green32°C, 58.4min, EO 645mg/l, RH 50%:brown, brown-red, brown-yellow	Passed
Testing in "NoEO Gas" cycles	Confirm that Gas-Chexindicator does not change colorin absence of Ethylene Oxidegas	When tested in cycle with temperature60°C±2°C, RH≥85%, time 90 min±1min, theindicator should not achieve end point color.	Passed
Testing againstbiologicalindicator	Establish correlation betweenperformance of Gas-Chexindicator and EO Biologicalindicator	The integrator does not achieve end-pointcolor before the biological indicator isinactivated and demonstrates parallelperformance to the biological indicator.	Passed
Single parametervariation testing	Confirm that Gas-Chexindicator is sensitive to criticalsterilization parameters.	Variation of one parameter while other onesare maintained steady. Gas-Chex Indicatorshould not reach specified end-point greencolor.	Passed
Testing in cycleswith parameterstypical forhealthcare	Demonstrate Gas-Chexindicator achieves specified endcolor in typical cycles.	Color change from brown-red to green.	Passed
Biocompatibilitystudy and inktransfer test	Demonstrate that the indicatordoes not create biocompatibilityissues to health careprofessionals and patients.	Evaluation of individual components forbiocompatibility and review ofbiocompatibility of indicators with similarformulation with history on the market.Testing according to ISO 11140-1:2014.Requirement: 6.2.2. No ink transfer should beobserved on unprocessed and EO processedsamples.	Passed
End-pointstability andshelf- life study	Confirm that Gas-Chexindicator has acceptablestability after processing whenachieved and not achieved endpoint color ("Pass" and "Fail"conditions).Demonstrate that Gas-Chexindicator maintains itsperformance when tested usingreal-time shelf-life exposuremethod.	Gas-Chex indicators processed in Pass andFail cycles at various time points afterproduction and at the end of shelf life shoulddemonstrate stable color for at least 3 months.Meet specifications after real-time 36 monthsshelf-life exposure.	Passed

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Conclusion

The conclusion drawn from the nonclinical test demonstrate that the Gas-Chex Indicator is as safe, as effective, and performs as well as or better that the legally marketed predicate device, K191021.

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).