The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed units or loads. The indicator dots turn from white to dark brown/black when sterilization conditions, thus providing an indication of processed items.

The Steam-Dot process indicator can be used in the following steam sterilization cycles:

*Gravity: 121 C/250 F - 30 minutes

- Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
- Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
- Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
- Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
- Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes

Device Description

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

The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "Steam-Dot Process Indicator." The document outlines the device's indications for use, performance criteria, and the results of non-clinical testing to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator	121°C-10 min: dark brown or black color121°C-2 min: no color change or color markedly different compared to dark brown or black134°C-2 min: dark brown or black color134°C-0.3 min: no color change or color markedly different compared to dark brown or black140°C-30 min Dry heat: no color change	Passed
FDA Guidance for industry for chemical indicators. Steam process indicator performance test.	121°C-10 min: dark brown or black color121°C-2 min: no color change or color markedly different compared to dark brown or black132-135°C-2 min: dark brown or black color132-135°C-20sec: no color change or color markedly different compared to dark brown or black140°C-30 min Dry heat: no color change	Passed
Testing in hospital type sterilizers in gravity and pre-vacuum 510k cleared cycles.	Color change from white to dark brown or black	Passed
Biocompatibility study and ink transfer test	Individual components should not create biocompatibility issues.Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and steam processed indicators.	Passed
End point stability and shelf-life study	Steam-Dot 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 110 days.Meet specifications after real-time 48 months shelf-life exposure.	Passed

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

The document does not specify the exact sample sizes (e.g., number of indicators or test runs) used for each test. It broadly states that the "performance of the Steam-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators and the requirements of FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003."

The provenance of the data is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that it's a 510(k) submission, the testing would be prospective and conducted under controlled laboratory conditions, likely in the US or in a facility adhering to US regulatory standards for medical device testing.

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

This information is not applicable and not provided in the document. The "ground truth" for a chemical indicator like the Steam-Dot is based on the physical and chemical reaction of the indicator ink to specific temperature, time, and steam exposure parameters, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. There are no human "experts" establishing a subjective ground truth in this context; rather, instrumental measurements of physical parameters and observable color changes define the outcome.

4. Adjudication method for the test set

Not applicable. As described above, the determination of "pass" or "fail" for the chemical indicator is objective, based on measurable physical parameters and a defined color change endpoints. There is no subjective interpretation requiring an adjudication process by multiple reviewers.

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

Not applicable. This device is a chemical indicator that changes color to confirm exposure to sterilization conditions. It is not an AI-powered diagnostic device or an imaging system requiring human interpretation or assistance from AI. Therefore, an MRMC study is irrelevant for this product.

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

Not applicable. This is not an algorithm-only device. Its function is based on a chemical reaction, not a computational algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device is based on defined physical and chemical parameters of steam sterilization as established by international standards (ANSI/AAMI/ISO 11140-1:2014) and regulatory guidance (FDA Guidance for industry for chemical indicators). This involves exposing the indicators to precise temperature, time, and steam conditions in controlled laboratory settings and observing the specified color change. It is an objective, laboratory-defined ground truth, not reliant on expert consensus, pathology, or clinical outcomes data.

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not an AI/machine learning model that requires a training set. Its function is based on a chemical formulation and its reaction to sterilization conditions.

9. 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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May 19, 2021

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

Re: K210553

Trade/Device Name: Steam-Dot Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 19, 2021 Received: February 25, 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.

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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 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.

for Clarence W. Murray, III, PhD Acting 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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4. Indications for Use Statement

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Indications for Use

510(k) Number (if known)

K210553

Device Name Steam-Dot Process Indicator

Indications for Use (Describe)

The Steam-Dot process indicator can be used in the following steam sterilization cycles:

*Gravity: 121 C/250 F - 30 minutes

- Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
- Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
- Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
- Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
- Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes

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)

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510(k) Summary K210533

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510(k) Summary

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:	February 19, 2021

Device information:

Device Trade Name:	Steam-Dot™ Process Indicator
Classification Name:	Physical/Chemical Sterilization Process Indicator
Common Name:	Steam Sterilization Indicator
Product Code:	JOJ
Classification:	Class II (21 C.F.R. 880.2800)

Description of the Device

Indications for Use

The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from white to dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

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The Steam-Dot process indicators can be used in the following steam sterilization cycles:

*Gravity: 121°C/250°F - 30 minutes * Vacuum assisted (pre-vacuum): 132°C/270°F - 3 minutes * Vacuum assisted (pre-vacuum): 132°C/270°F - 4 minutes * Vacuum assisted (pre-vacuum): 134°C/273°F - 3 minutes * Vacuum assisted (pre-vacuum): 134°C/273°F - 4 minutes *Vacuum assisted (pre-vacuum): 135°C/275°F - 3 minutes

Performance

The performance of the Steam-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators and the requirements of FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003.

Technological Characteristics Comparison Table

Comparison of the subject device (Steam-Dot process indicator, Propper Manufacturing Co., Inc) to Predicate device (Process indicator tape for steam sterilization, Canadian Technical Tape, Ltd).

	Subject device (K210553)	Predicate device (K140940)	Comparison
Product name	Steam-Dot TM Process Indicator	Process indicator tape for steam sterilization	Similar. Both use “Process indicator” according to Intended use
Product generic name	A physical/chemical sterilization process indicator	A physical/chemical sterilization process indicator	Identical
Product code	JOJ	JOJ	Identical
Sterilization method	Steam sterilization	Steam sterilization	Identical
Intended use	Sterilization process indicator	Sterilization process indicator	Identical
Sterilization method	The Steam-Dot indicator is intended for use as a steam sterilization cycle process indicator in gravity and pre- vacuum steam sterilizers.	The tape is intended for use as a steam sterilization cycle process indicator in gravity and pre- vacuum steam sterilizers.	Identical
Sterilization cycles	121°C-30 min gravity132°C-3 min pre-vacuum132°C-4 min pre-vacuum134°C-3 min pre-vacuum134°C-4 min pre-vacuum135°C-3 min pre-vacuum	121°C-30 min gravity132°C-4 min pre-vacuum135°C-3 min pre-vacuum	Similar. Steam-Dot Process Indicator can be used in additional cycles: 132°C-3 min pre-vacuum, 134°C-3 min pre- vacuum 134°C-4 min pre-vacuum.
End-pointspecification	121°C-10 min132°C-135°C-2 min	121°C-10 min132°C-135°C-2 min	Identical
Devicedesign	Paper dots printed with indicator ink	Crepe paper printed withindicator ink lines	Similar
Back side ofindicators	Adhesive	Adhesive	Identical
Indicatoragent	Sulfur, lead carbonate hydroxideand magnesium oxide	Sulfur, lead carbonate hydroxideand magnesium oxide	Identical
Initial color	White	White	Identical
End pointcolor	Black, Dark brown	Black, Dark brown	Identical
Performance	ANSI/AAMI/ISO 11140-1:2014	ANSI/AAMI/ISO 11140-1:2005(R)2010	Identicalrequirementsfor Processindicator.
ISO Indicatortype	Type 1	Type 1	Identical
Single use	Yes	Yes	Identical
Shelf life	4 years	3 years	Similar
Indicationsfor use	The Steam-Dot process indicatorfor steam sterilization is designedfor use by a health care providerto demonstrate that the unit orload has been exposed to a steamsterilization process, and todistinguish between processed andunprocessed units or loads.The indicator dots turn fromwhite to dark brown/black whenexposed to steam sterilizationconditions, thus providing anindication of processed items.The Steam-Dot process indicatorcan be used in the followingsteam sterilization cycles:Gravity: 121°C/250°F - 30 minPre-vacuum: 132°C/270°F -3minPre-vacuum: 132°C/270°F -4minPre-vacuum: 134°C/273°F -3 minPre-vacuum: 134°C/273°F -4 minPre-vacuum: 135°C/275°F -3 min	The Process Indicator Tape forSteam Sterilization is indicatedfor use in holding sterilizationpacks together and can be used ingravity sterilizers operating at121°C for 30 minutes or pre-vacuum sterilizers operating at132°C for 4 minutes and 135°Cfor 3 minutes. The indicatorstripes turn dark brown/blackwhen exposed to steamsterilization conditions, thusproviding an indication ofprocessed items.	SimilarSteam-DotProcess Indicatorcan be used inadditional cycles:132°C-3 min pre-vacuum, 134°C-3min pre-vacuum134°C-4 min pre-vacuum.The predicatedevice is aprocess indicatortape that changescolor in thepresence of thesterilant atGravity: 121°Cfor 30 minutesand Pre-Vacuum:132°C for 4minutes and135°C for 3minutes
Test	Purpose	Acceptance Criteria	Result
ANSI/AAMI/ISO 11140-1:2014 testingfor Type 1indicator.	To demonstrate conformanceof Steam-Dot indicator to therequirements specified inISO 11140-1:2014 forprocess indicators.	121°C-10 min: dark brown or black color121°C-2 min: no color change or colormarkedly different compared to dark brown orblack134°C-2 min: dark brown or black color134°C-0.3 min: no color change or colormarkedly different compared to dark brown orblack140°C-30 min Dry heat: no color change	Passed
FDA Guidancefor industry forchemicalindicators.Steam processindicatorperformancetest.	To demonstrate conformanceof Steam-Dot indicator to therequirements specified in theFDA Guidance for industryfor process indicators.	121°C-10 min: dark brown or black color121°C-2 min: no color change or colormarkedly different compared to dark brown orblack132-135°C-2 min: dark brown or black color132-135°C-20sec: no color change or colormarkedly different compared to dark brown orblack140°C-30 min Dry heat: no color change	Passed
Testing inhospital typesterilizers ingravity and pre-vacuum 510kcleared cycles.	To demonstrate that Steam-Dot Process indicatorachieves specified end colorin typical cycles in hospitalsterilizers.	Color change from white to dark brown orblack	Passed
Biocompatibility study and inktransfer test	To demonstrate that theindicator does not createbiocompatibility issues tohealth care professionals andpatients.	Individual components should not createbiocompatibility issues.Testing according to ISO 11140-1:2014.Requirement: 6.2.2. No ink transfer should beobserved on unprocessed and steam processedindicators.	Passed
End pointstability andshelf- life study	To confirm that Steam-Dotprocess indicator hasacceptable stability afterprocessing when achievedand not achieved end pointcolor ("Pass" and "Fail"conditions).To demonstrate that Steam-Dot indicator meets theperformance parameterswhen tested using real-timeshelf-life exposure method	Steam-Dot indicators processed in Pass andFail cycles at various time points afterproduction and at the end of shelf life shoulddemonstrate stable color for 110 days.Meet specifications after real-time 48 monthsshelf-life exposure.	Passed

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Summary of Non-Clinical Testing

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Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Steam-Dot process indicator is as safe, as effective, and performs as well as or better than the legally marketed device K140940.

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).