The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

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
54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

Device Description

The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.

The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.

The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.

AI/ML Overview

This FDA 510(k) summary describes the acceptance criteria and the study proving the device (EO Chex™ Indicator Tape) meets these criteria. Since this is for a physical/chemical sterilization process indicator, the "study" is a series of non-clinical performance tests rather than a clinical trial with human subjects. Thus, many of the typical questions for AI medical devices (e.g., sample size for test set, number of experts, MRMC studies) are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the EO Chex™ Indicator Tape is its conformance to the ANSI/AAMI/ISO 11140-1:2014 standard for Type 1 process indicators, along with successful performance in typical EO sterilization cycles, biocompatibility, endpoint stability, shelf-life, and adhesive tests.

Table of Acceptance Criteria and Reported Device Performance:

Test	Purpose	Acceptance Criteria	Reported Device Performance (Result)
Performance testing in BIER vessel (ANSI/AAMI/ISO 11140-1:2014 for Type 1 Indicator)	To demonstrate conformance to the requirements specified in ISO 11140-1:2014 for process indicators.	Specific Pass Conditions: - 37°C, RH 60%, EO 600mg/L, 25 min: orange-brown - 54°C, RH 60%, EO 600mg/L, 20 min: orange-brown Specific Fail Conditions (no color change or markedly different): - 37°C, RH 60%, EO 600mg/L, 3 min - 54°C, RH 60%, EO 600mg/L, 2 min - 60°C, RH ≥85%, EO - none, 90 min	Passed
Testing in EO cycles typical for healthcare use	To demonstrate that EO Chex indicator tape achieves specified end color in typical cycles.	Color change from pink to orange-brown (in specified cycles: 38°C, 736 mg/L EO, 40-80% RH, 4.5 hrs; 38°C, 759 mg/L EO, 40-80% RH, 4.5 hrs; 54°C, 600 mg/L EO, 40-60% RH, 45 min+; 55°C, 736 mg/L EO, 40-80% RH, 1 hr; 55°C, 759 mg/L EO, 40-80% RH, 1 hr).	Passed
Biocompatibility study and ink transfer test	To demonstrate that the indicator does not create biocompatibility issues for healthcare professionals and patients; and to confirm no ink transfer.	Evaluation of individual components for biocompatibility and indicators with similar formulation with long history on the market. Ink Transfer Requirement (ISO 11140-1:2014, 6.2.2): No ink transfer should be observed on unprocessed and EO processed samples.	Passed
End point stability and shelf-life study	To confirm acceptable stability of color after processing (passed/failed conditions) and to demonstrate performance parameters are met throughout the declared shelf-life using real-time exposure.	Endpoint Stability: EO Chex indicator tape processed in Pass and Fail cycles at various time points after production and at the end of shelf-life should demonstrate stable color for 180 days. Shelf-Life: Met specifications after 24 months of real-time shelf-life exposure.	Passed
Adhesive test healthcare applications	To evaluate if the adhesive is suitable for its function and does not deteriorate during the sterilization process.	The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after EO processing.	Passed

Study Details (Non-Clinical Performance Testing):

This section addresses the specific points requested, noting their applicability to a physical/chemical indicator.

Sample size used for the test set and the data provenance:
- The document does not explicitly state the numerical sample size for each test (e.g., number of indicator strips tested). However, the testing was conducted according to specified industrial standards (ANSI/AAMI/ISO 11140-1:2014), which implicitly define the required sample sizes and methodologies for such performance evaluations.
- Data Provenance: Not explicitly stated, but typical for 510(k) submissions, the testing would have been conducted by the manufacturer (Propper Manufacturing Co., Inc.) or a qualified testing lab, likely within the US, as the submitter is based in New York. The data is retrospective in the sense that it was collected prior to the 510(k) submission for the purpose of demonstrating substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. Ground truth for a chemical indicator is established by physical/chemical reactions under controlled conditions (e.g., color change based on precise exposure to sterilant). It does not involve expert human interpretation of complex data like medical images. The "ground truth" is defined by the physical/chemical properties and the specified color change according to the ISO standard.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the evaluation relies on objective color change criteria and physical performance metrics rather than subjective human interpretation requiring adjudication.
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:
- This is not applicable as the device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical indicator. Its "performance" is its ability to change color as designed, which is a standalone function in itself, but not an "algorithm."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established by objective physical and chemical criteria, specifically:
  - Defined color changes: Pink to orange-brown under specific EO sterilization conditions (Pass).
  - Absence of color change or markedly different color: Under defined challenging or insufficient sterilization conditions (Fail).
  - Adherence/physical integrity standards: For the adhesive and ink transfer.
  - Biocompatibility standards: Related to material safety.
- These are based on the requirements of ANSI/AAMI/ISO 11140-1:2014 and the manufacturer's internal specifications derived from these standards.
The sample size for the training set:
- This is not applicable. The device is a chemical indicator that operates based on material properties and chemical reactions. There is no "training set" in the machine learning sense. The development of the indicator chemistry and manufacturing process would involve internal R&D and optimization, but this is not analogous to training an AI model.
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

Summary

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June 12, 2024

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

Re: K240910

Trade/Device Name: EO Chex™ Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: April 2, 2024 Received: April 4, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number (if known) K240910

Device Name EO Chex Indicator Tape

Indications for Use (Describe)

The EO Chex indicator tape can be used in the following EO sterilization cycles:

38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure 2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure 3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer 4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure 5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

Performance

The performance of the EO Chex indicator tape meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators.

Stated Values

Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L

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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K240910 510(k) Summary

Submitted by:	Propper Manufacturing Company, Inc.
Address:	36-04 Skillman AvenueLong 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:	April 2, 2024

Device information:

Device Trade Name:	EO Chex™ Indicator Tape
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)

Description of the Device

The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.

The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.

The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.

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EO Chex™ Indicator Tape - Indications for Use

The EO Chex indicator tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
1. 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure
1. 54℃, 600 mg/L EO, 40-60% RH, 45 min or longer
1. 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure
1. 55°C, 759 mg/L EO, 40-80% RH, 1 hour exposure

Performance

The performance of the EO Chex indicator tape meets the requirements of ANSVAAMI/ISO 11140-1:2014 for Type 1 process indicators.

Stated Values:

Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L

Technological Characteristic Comparison Table

Comparison of the subject device (EO Chex™ Indicator Tape, Propper Manufacturing Co., Inc.) to Predicate device EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861.

Parameter	Subject Device	Predicate Device, K002861	Comparison
Product Name	EO Chex Indicator Tape	EO Gas Sterilization ProcessIndicator Tapes	Similar. Bothdevices are "EOIndicator Tapes"
Product GenericName	A physical/chemical sterilizationprocess indicator	A physical/chemicalsterilization process indicator	Identical
Product Code	JOJ	JOJ	Identical
SterilizationMethod	Ethylene Oxide Gas Sterilization	Ethylene OxideGas Sterilization	Identical
Intended Use	Sterilization process indicator	Sterilization process indicator	Identical
Sterilization Cycles	38°C,736 mg/L EO,40-80% RH, 4.5 hrs38°C,759 mg/L EO,40-80% RH, 4.5 hrs54°C,600 mg/L EO, 40-60% RH, 45min or longer55°C, 736 mg/L EO, 40-80% RH, 1 hr55°C, 759 mg/L EO, 40-80% RH, 1 hr	54°C(130°F), 600 mg/l EO,40-60% RH, 45 min or longer	Similar. EO-Chexindicator tape canbe used in severaladditional cycles.
Device Design	Cured crepe paper printed withindicator ink lines. The tape ismanufactured from a creped, printed,saturated paper, with a natural rubberand hydrocarbon resin adhesive on theback.	Cured crepe paper printedwith indicator ink lines. Thetape is manufactured from acreped, printed, saturatedpaper with a natural rubberadhesive on the back.	Similar design -substrate paperwith adhesive andprinted indicator.
Device Purposes	1.Designed to work as process indicators to distinguish between unprocessed and processed items after EO Gas exposure.2.The purpose includes use as a tape to wrap a sterilizable article together as a pack.	1.Designed to work as process indicators to distinguish between unprocessed and processed items after EO Gas exposure.2.The purpose includes use as a tape to wrap a sterilizable article together as a pack.	Identical.
Back Side of the Tapes	Adhesive	Adhesive	Identical
Initial Color	Pink	Brown	Different
End Point Color	Orange-brown	Green	Different
FDA Indicator	EO Process indicator	EO Process indicator	Identical
ISO Indicator Type	Type 1, process indicator	Type 1, process indicator	Identical
Single Use	Yes	Yes	Identical
Shelf Life	24 months	36 months	Similar
Indications for Use	The EO Chex indicator tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.The EO Chex indicator tape can be used in the following cycles:1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure2. 38°C, 759 mg/L EO, 40-80% RH, 4.5 hours exposure3. 54°C, 600 mg/L EO, 40-60% RH, 45 min or longer4. 55°C, 736 mg/L EO, 40-80% RH, 1 hour exposure5. 55°C, 759 mg/L EO, 40-80% RH, 1 hour exposure	The EO Sterilization Indicator Tape is for use in ethylene oxide sterilizers operating at 600 mg/L EO gas, 40-60% relative humidity, 130°F, for 45 minutes or longer. The word “gas” turns green after exposure to a EO gas sterilization process, thus providing identification of processed items.	Similar. EO Chex indicator tape can be used in several additional cycles.

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Summary of Non-clinical Testing

Provided below is the 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 BIERvessel:ANSI/AAMI/ISO 11140-1:2014 testingfor Type 1Indicator.	To demonstrate conformanceof EO Chex indicator tape tothe requirements specified inISO 11140-1:2014 forprocess indicators.	37°C, RH 60%, EO 600mg/L, 3 min: no colorchange or color markedly different compared toorange-brown37°C, RH 60%, EO 600mg/L, 25 min: orange-brown54°C, RH 60%, EO 600mg/L, 2 min: no color changeor color markedly different compared to orange-brown54°C, RH 60%, EO 600mg/L, 20 min: orange-brown60°C, RH ≥85%, EO - none, 90 min: no change	Passed
Testing in EOcycles withparameterstypical for usein healthcare.	To demonstrate that EO Chexindicator tape achievesspecified end color in typicalcycles.	Color change from pink to orange-brown	Passed
Biocompatibility study andink transfertest	To demonstrate that theindicator does not createbiocompatibility issues forhealth care professionals andpatients.The exposure to health careprofessional is minimal andwell below any identifiedtoxic thresholds for thecompounds.	Evaluation of individual components forbiocompatibility and indicators with similarformulation with long history of on the market.Testing according to ISO 11140-1:2014.Requirement: 6.2.2. No ink transfer should beobserved on unprocessed and EO processed samples.	Passed
End pointstability andshelf-life study	To confirm that EO Chexindicator tape has acceptablestability after processingwhen achieved and notachieved end point color("Pass" and "Fail"conditions).To demonstrate that EO Chexindicator tape meet theperformance parameters whentested using real-time shelf-life exposure method.	EO Chex indicator tape processed in Pass and Failcycles at various time points after production and atthe end of shelf-life should demonstrate stable colorfor 180 days.Met specifications after 24 months of real time shelf-life exposure.	Passed
Adhesive testhealthcareapplications	The purpose of the test is toevaluate if the adhesive issuitable for its function anddoes not deteriorate duringsterilization process.	The test is considered a pass if at least 95% of theindicators at different stages of shelf life remain onsurfaces of sterilization packaging materials beforeand after EO processing.	Passed

Conclusion

The conclusion drawn from the non-clinical test demonstrates that the EO Chex™ indicator tape is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K002861.

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).