The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The Steri-Dot process indicator can be used in the following EO sterilization cycles:

37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure
54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
55°C, 759 mg/l EO, ≥35% RH, l hour exposure
55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure

Device Description

The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react 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 purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.

AI/ML Overview

The provided document describes the Steri-Dot® Process Indicator, a chemical indicator for Ethylene Oxide (EO) gas sterilization. The information primarily focuses on non-clinical testing to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Summary of Non-clinical Testing" table.

Test	Purpose	Acceptance Criteria	Result
ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator.	To demonstrate conformance of Steri-Dot indicator to the requirements specified in ISO 11140-1:2014 for process indicators.	37°C, RH 60%, EO 600mg/l, 3 min: no color change or color markedly different compared to green 37°C, RH 60%, EO 600mg/l, 25 min: green color 54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green 54°C, RH 60%, EO 600mg/l, 20 min: green color 60°C, RH ≥85%, EO - none, 90 min: no change	Passed
Testing in EO cycles with parameters used in healthcare sterilization.	To demonstrate that Steri-Dot Process indicator achieves specified end color in typical cycles.	Color change from purple-red to green	Passed
Biocompatibility study and ink transfer test	To demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients. The exposure to health care professional is minimal and well below any identified toxic thresholds for the compounds.	Evaluation of individual components for biocompatibility and indicators with similar formulation with long history of 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	To confirm that Steri-Dot process indicator has acceptable stability after processing when achieved and not achieved end point color (parameters when tested using real-time shelf-life exposure method).	Criteria not explicitly stated in the provided text for this row.	Implied Passed, as overall conclusion is positive.
Adhesive test – healthcare applications	The purpose of the test is to evaluate if the adhesive is suitable for its function and does not deteriorate during 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 Steri processing.	Passed

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

The document describes non-clinical laboratory testing of a device rather than a study involving human data or a "test set" in the context of AI/machine learning. Therefore:

Sample size: Not explicitly stated in terms of number of indicators tested for each condition. The testing is described as fulfilling the requirements of ISO standards and demonstrating performance.
Data provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the Steri-Dot Process Indicator itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this document. The device is a chemical indicator that changes color. The "ground truth" for its performance is determined by the physical chemical reaction and visual observation based on established standards (e.g., ISO 11140-1:2014). There is no mention of expert readers or human interpretation of complex images/data to establish ground truth as would be the case for an AI medical device.

4. Adjudication Method for the Test Set

This section is not applicable. As it's a chemical indicator with a clear color change endpoint, there is no ambiguity requiring an adjudication method by multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

This section is not applicable. An MRMC study is relevant for AI devices where human readers interpret medical images or data. The Steri-Dot Process Indicator is a chemical indicator, not an AI-powered diagnostic tool. There are no human readers involved in its direct "performance" evaluation beyond visual confirmation of the chemical reaction.

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

This section is not applicable. The Steri-Dot Process Indicator is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its material composition and chemical reaction, not a computational model.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on:

Standardized Chemical Reaction: The chemical indicator's color change in response to specific sterilization parameters (temperature, humidity, EO concentration, exposure time).
Compliance with International Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators. This standard defines the expected color changes under various exposure and non-exposure conditions to ethylene oxide.
Visual Observation: The "result" column in the table simply states "Passed," implying that the visual color change (or lack thereof) met the specified acceptance criteria.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical device, not an AI model requiring a training set.

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

This section is not applicable for the same reason as point 8.

In summary: The provided document is a 510(k) summary for a physical chemical indicator. It details the product's function, mechanism, and non-clinical performance testing against established ANSI/AAMI/ISO standards. Many of the questions you posed (e.g., sample size for AI test/training sets, expert consensus, MRMC studies) are primarily relevant for AI/software as a medical device (SaMD) rather than a simple chemical indicator. The "acceptance criteria" and "study proving device meets acceptance criteria" here refer to laboratory testing demonstrating compliance with performance standards for physical chemical indicators.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2021

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

Re: K210866

Trade/Device Name: Steri-Dot Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: March 19, 2021 Received: March 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

{1}------------------------------------------------

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 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 (OS) 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210866

Device Name Steri-Dot Process Indicator

Indications for Use (Describe)

The Steri-Dot process indicator can be used in the following EO sterilization cycles:

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. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure 4. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 5. 55°C, 759 mg/l EO, ≥35% RH, l hour exposure 6. 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summarv For K210866

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:	June 21, 2021

Device information:

Device Trade Name:	Steri-Dot® Process 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)

Description of the Device

Indications for Use

The Steri-Dot® process indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

{4}------------------------------------------------

The Steri-Dot process indicator can be used in the following EO sterilization cycles:

1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
1. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
1. 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer
1. 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
1. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
1. 55°C, 600 mg/1 EO, 40-60% RH, 4 hours exposure

Performance

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

Technological Characteristic Comparison Table

Comparison of the subject device (Steri-Dot process indicator, Propper Manufacturing Co., Inc) to Predicate device (EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861).

Product name	Steri-Dot Process Indicator	EO Gas SterilizationProcess Indicator Tapes,K002861	Similar. Bothdevices have"processindicator" in thenames accordingto Intended use.	Device purposes	1.Designed to work as processindicators to distinguish betweenunprocessed and processed itemsafter EO Gas exposure.	g/m2 paper, with a naturalrubber, C-5 tackifier,antioxidant adhesive on theback.1.Designed to work asprocess indicators todistinguish betweenunprocessed and processeditems after EO Gasexposure.2. The purpose includes useas a tape to wrap asterilizable article togetheras a pack.	are different.1. Identical.2. Significantdifference.
Product genericname	A physical/chemical sterilizationprocess indicator	A physical/chemicalsterilization processindicator	Identical	Back side ofindicators	Adhesive	Adhesive	Identical
Product code	JOJ	JOJ	Identical
Sterilizationmethod	Ethylene Oxide gas sterilization	Ethylene Oxide gassterilization	Identical	Initial color	Purple-red	Brown	Similar
Intended use	Sterilization process indicator	Sterilization processindicator	Identical	End point color	Green	Green	Identical
Sterilizationmethod	Ethylene Oxide Gas sterilization.	Ethylene Oxide Gassterilization	Identical	FDA indicator	Process indicator	Process indicator	Identical
Sterilizationcycles	37°C, 736 mg/l EO, ≥35% RH, 3 hrs37°C, 759 mg/l EO, ≥35% RH, 3 hrs54°C, 600 mg/l EO, 40-60% RH, 45min or longer54°C, 736 mg/l EO, ≥35% RH, 1 hour55°C, 759 mg/l EO, ≥35% RH, 1 hour55°C, 600 mg/l EO, 40-60% RH, 4 hrs	54°C(130°F), 600 mg/l EO,40-60% RH, 45 min orlonger	Similar. Steri-Dot processindicator can beused in severaladditionalcycles.	ISO Indicator type	Type 1, process indicator	Type 1, process indicator	Identical
Device design	Paper dots with adhesive backingprinted with indicator ink	Cured crepe paper printedwith indicator ink lines.The tape is manufacturedfrom a creped, printed,saturated and backsized 42	Similar design –substrate paperwith printedindicator.Substrate papers	Single use	Yes	Yes	Identical
Shelf life	42 months	36 months	Similar
Indications foruse	The Steri-Dot® process indicator forEO gas sterilization is designed foruse by a health care provider todemonstrate that the unit or load hasbeen exposed to an EO gassterilization process, and todistinguish between processed andunprocessed units or loads. Theindicator dots turn from purple-red togreen when exposed to EO gassterilization conditions, thusproviding an indication of processeditems.The Steri-Dot process indicator canbe used in the following EOsterilization cycles:37°C, 736 mg/l EO, ≥35% RH, 3 hrs37°C, 759 mg/l EO, ≥35% RH, 3 hrs54°C, 600 mg/l EO, 40-60% RH, 45min or longer54°C, 736 mg/l EO, ≥35% RH, 1 hr55°C, 759 mg/l EO, ≥35% RH, 1 hr55°C, 600 mg/l EO, 40-60% RH, 4hrs	The EO SterilizationIndicator Tape is for use inethylene oxide sterilizersoperating at 600 mg/l EOgas, 40-60% relativehumidity, 130°F, for 45minutes or longer. Theword "gas" turns greenafter exposure to a EO gassterilization process, thusproviding identification ofprocessed items.	Similar. Steri-Dot processindicator can beused in severaladditionalcycles.

{5}------------------------------------------------

Proper BI-OK® EO Gas Biological Test Pack, K972747, was used as a reference device
for stability and shelf-life review because the reference device includes EO sterilization

{6}------------------------------------------------

record card – a paper sheet printed with EO indicator ink similar to the ink of Steri-Dot process indicator.

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
ANSI/AAMI/ISO11140-1:2014 testingfor Type 1 indicator.	To demonstrateconformance of Steri-Dotindicator to therequirements specified inISO 11140-1:2014 forprocess indicators.	37°C, RH 60%, EO 600mg/l, 3 min: no colorchange or color markedly different comparedto green37°C, RH 60%, EO 600mg/l, 25 min: green color54°C, RH 60%, EO 600mg/l, 2 min: no colorchange or color markedly different comparedto green54°C, RH 60%, EO 600mg/l, 20 min: green color60°C, RH ≥85%, EO - none, 90 min: no change	Passed
Testing in EOcycles withparameters used inhealthcaresterilization.	To demonstrate thatSteri-Dot Processindicator achievesspecified end color intypical cycles.	Color change from purple-red to green	Passed
Biocompatibilitystudy and inktransfer test	To demonstrate that theindicator does not createbiocompatibility issues tohealth care professionalsand patients.The exposure to healthcare professional isminimal and well belowany identified toxicthresholds for thecompounds.	Evaluation of individual components forbiocompatibility and indicators with similarformulation with long history of on themarket.Testing according to ISO 11140-1:2014.Requirement: 6.2.2. No ink transfer shouldbe observed on unprocessed and EOprocessed samples.	Passed
End point stabilityand shelf- life study	To confirm that Steri-Dot process indicatorhas acceptable stabilityafter processing whenachieved and notachieved end point color(
	parameters when testedusing real-time shelf-lifeexposure method.
Adhesive test –healthcareapplications	The purpose of the test isto evaluate if the adhesiveis suitable for its functionand does not deteriorateduring sterilizationprocess.	The test is considered a pass if at least 95% ofthe indicators at different stages of shelf liferemain on surfaces of sterilization packagingmaterials before and after Steri processing.	Passed

{7}------------------------------------------------

Conclusion

The conclusion drawn from the nonclinical test demonstrate that the Steri-Dot process indicator is as safe, as effective, and performs as well as or better that the legally marketed predicate device.

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).