The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterlization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The 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:

*Gravity: 121 C/250 F - 30 minutes

Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes
Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes
Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes
Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes

*Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer:

121 C/250 F - 15 minutes
132 C/270 F - 4 minutes
134 C/273 F - 3 minutes
135 C/275 F - 2.9 minutes

Device Description

The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam 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. OK Plus indicators are sold in boxes of 250 strips.

The indicator responds to all 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 off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.

AI/ML Overview

The provided text describes the acceptance criteria and the results of a study for the "OK Plus Indicator" device, a chemical indicator for steam sterilization monitoring.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Purpose	Acceptance Criteria	Result
Performance testing in Steam BIER vessel	Demonstrate conformance with half-cycle requirements. Indicator should show end-point color when bacteria/spores are deactivated.	Color changes - end-point colors: 121°C - 15 min 00 s - black; 132°C - 4 min 00 s - black; 134°C - 3 min 00 s - black; 135°C - 2 min 54 s - black	Passed
Testing in Dry Heat oven	Confirm that indicator does not change color in absence of steam.	When tested in cycles at 140°C+/-2°C and time 30+/1 min as per ANSI/AAMI/ISO 11140-1:2014, the indicator should not achieve end color. Also, should not demonstrate color change to end point in 180°C - 60 min dry heat typical cycle.	Passed
Testing against biological indicator	Establish correlation between performance of OK Plus indicator and Steam Biological indicator.	The OK Plus indicator should not achieve end-point color before the biological indicator is inactivated.	Passed
Single parameter variation testing	Confirm that OK Plus indicator is sensitive to critical sterilization parameters.	Variation of one parameter while other ones are maintained steady. OK Plus indicator should not reach specified end-point black color.	Passed
Testing in cycles typical for healthcare	Demonstrate OK Plus indicator achieves specified end color in typical hospital-size and table-top sterilizers.	Color change from off-white to black.	Passed
Biocompatibility study and ink transfer	Demonstrate that the indicator does not create biocompatibility issues and no ink transfer occurs.	Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation. Testing according to ISO 11140-1:2014 (Requirement: 6.2.2. No ink transfer should be observed on unprocessed and Steam processed samples).	Passed
End-point stability and shelf-life study	Confirm acceptable stability after processing ("Pass" and "Fail" conditions) and maintenance of performance over shelf life.	OK Plus 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 6 months. Meet specifications after real-time 48 months shelf-life exposure.	Passed

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

The document does not explicitly state the specific sample sizes used for each individual test in the "Summary of non-clinical testing" section. It broadly discusses "testing" and "cycles" without providing numerical quantities for the indicators tested in each scenario. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

This information is not provided in the document. The device's performance is assessed based on objective color changes and correlation with established standards (like biological indicators), rather than expert interpretation of a ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. The assessment of the indicator's performance is based on a clear, objective color change (off-white to black) as per pre-defined criteria, not subjective human adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. This type of study is typically for diagnostic imaging devices where human interpretation is a key component. The OK Plus indicator is a chemical indicator with an objective color change.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The studies described are inherently "standalone" in the context of the device's function. The OK Plus indicator's performance is evaluated based on its chemical reaction and color change under specific conditions, without requiring human intervention for its primary function of indicating sterilization efficacy. The "result" column indicates whether the indicator "Passed" or "Failed" specific criteria, demonstrating its inherent performance.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on:

Physical/Chemical Standards: Defined temperature, time, and steam conditions (e.g., 121°C - 15 min 00 s for black color).
ANSI/AAMI/ISO 11140-1:2014: International standards for chemical indicators.
FDA Guidance: "Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003."
Correlation with Biological Indicators: The "inactivation" of biological indicators serves as a biological ground truth for sterilization efficacy.

8. Sample Size for the Training Set:

This information is not provided. Chemical indicators are typically not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical formulation, and verification is done through rigorous testing, not a training/validation split.

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

As there is no mention of a "training set" in the context of this chemical indicator, the establishment of ground truth for a training set is not applicable. The device's efficacy is proven by meeting the predetermined performance criteria against established chemical and biological standards.

Summary

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December 5, 2022

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

Re: K222137

Trade/Device Name: OK Plus Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, Dated: October 24, 2022 Received: October 27, 2022

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 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,

Christopher K. Dugard -2

for Clarence W. Murray, III, Ph.D. 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 (if known) K222137

Device Name OK Plus Indicator

Indications for Use (Describe)

*Gravity: 121 C/250 F - 30 minutes

Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes
Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes
Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes
Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes

*Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer:

121 C/250 F - 15 minutes
132 C/270 F - 4 minutes
134 C/273 F - 3 minutes
135 C/275 F - 2.9 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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K222137 510(k) Summary

Submitted by:Address:	Propper Manufacturing Company, Inc.36-04 Skillman Avenue,Long Island City, New York 11101
Contact Name:	Andrew Sharavara, Ph.D., Chief Technical Officer
Telephone:Fax:E-mail:	(800) 832-4300 x149(718) 482-8909as@proppermfg.com
Date Submitted:	July 15, 2022

Device information:

Device Trade Name:	OK Plus TM 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 OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterilization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The 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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*Gravity: 121° C/250° F - 30 minutes * Vacuum assisted (prevacuum): 132° C/270° F - 4 minutes * Vacuum assisted (prevacuum): 132° C/270° F - 10 minutes * Vacuum assisted (prevacuum): 134° C/273° F - 3.5 minutes * Vacuum assisted (prevacuum): 134° C/273° F - 4 minutes * Vacuum assisted (prevacuum): 135° C/275° F - 3 minutes

The OK Plus indicator has the following Stated Values determined in Resistometer:

- 121° C/250° F 15 minutes
- 132° C/270° F 4 minutes
- 134° C/273° F 3 minutes
- 135° C/275° F 2.9 minutes

Performance

The performance of the OK Plus indicator was verified using half-cycle criterion.

The indicator also meets several requirements of ANSI/AAMI/ISO 11140-1:2014 for chemical indicators and the requirements of FDA Guidance for Industry and FDA Staff: Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003. It includes conformance with general requirements on the design, verification of sensitivity to steam - dry heat testing, ink transfer, shelf life and stability, as well as ink color change in large chamber hospital type and small chamber table-top sterilizers.

Comparison to Legally Marketed Predicate Device

Comparison of the subject device (OK Plus indicator. Propper Manufacturing Co., Inc) to Predicate device (Chemdye CD29 indicator, K191021, Terragene S.A.).

	Subject device	Predicate device	Comparison
Product name	OK Plus indicator	Chemdye CD29 indicator,K191021	Identical
Productgenericname	A physical/chemical sterilizationprocess indicator	A physical/chemicalsterilization processindicator	Identical
Productcode	JOJ	JOJ	Identical
Sterilizationmethod	Steam sterilization	Steam sterilization	Identical
Intended use	Sterilization process indicator	Sterilization processindicator	Identical
Types of	Gravity and pre-vacuum.	Gravity and Dynamic air	Identical
sterilization		removal (pre-vacuum)
cycles
Sterilizationcycles	121°C-30 min gravity132°C-4 min pre-vacuum132°C-10 min pre-vacuum134°C-3.5 min pre-vacuum134°C-4 min pre-vacuum135°C-3 min pre-vacuum	121°C-30 min gravity132°C-15 min gravity132°C-25 min gravity135°C-10 min gravity132°C-4 min pre-vacuum135°C-3 min pre-vacuum	Similar.
End-pointspecification	121°C-15 min132°C-4min134°C-3min135°C-2.9 min	121°C-15 min134°C-3.5 min	Similar
Devicedesign	Paper strip printed with indicatorink	Paper strip printed withindicator ink	Identical
Operationalprinciple	Color change chemistry	Color change chemistry	Identical
Initial color	Off-white	Light yellow	Similar
End pointcolor	Black	Black	Identical
Indicatortype	Internal indicator	Internal Indicator	Identical
Single use	Yes	Yes	Identical
Shelf life	4 years	5 years	Similar
Indicationsfor use	The OK Plus indicator is achemical indicator designed formonitoring the efficacy of steamsterilization process. Theindicator responds to all criticalsterilization parameters. The OKPlus indicator changes colorfrom off-white to black toindicate that the conditions of thecycle have been met. Theindicator is intended to be placedin each pack, pouch, tray orother containment device tofunction as an independentmonitor of critical parameters forthe following sterilization cycles:121°C-30 min gravity132°C-4 min pre-vacuum132°C-10 min pre-vacuum134°C-3.5 min pre-vacuum134°C-4 min pre-vacuum	Terragene Chemdye® CD29 isa chemical process indicatorintended for monitoring theefficacy of steam sterilizationprocesses. The chemicalindicator changes from yellowto dark brown/black to indicatethat the conditions of the cyclehave been met.121°C-30 min gravity132°C-15 min gravity132°C-25 min gravity135°C-10 min gravity121°C-30 min gravity132°C-4 min pre-vacuum135°C-3 min pre-vacuum	Similar.The difference isin the sterilizationcycles

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The OK Plus indicator has the
following Stated Values
determined in Resistometer:
121°C/250°F - 15 min
132°C/270°F - 4 min
134°C/273°F - 3 min
135°C/275°F -2.9 min

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 SteamBIER vessel	Demonstrate conformance ofOK Plus Indicator with the half-cycle requirements.The indicator shoulddemonstrate end-point colorwhen bacteria/spores aredeactivated.	Color changes - end-point colors:121°C - 15 min 00 s - black132°C - 4 min 00 s - black134°C - 3 min 00 s - black135°C - 2 min 54 s - black	Passed
Testing in DryHeat oven	Confirm that OK Plus indicatordoes not change color inabsence of Stam.	When tested in cycles at 140°C+/-2°C and time30+/1 min as per ANSI/AAMI/ISO 11140-1:2014 the OK Plus indicator should notachieve end color.Also, OK Plus indicator should notdemonstrate color change to the end point in180°C - 60 min dry heat typical cycle which itsufficient to kill biological indicator spores.	Passed
Testing againstbiologicalindicator	Establish correlation betweenperformance of OK Plusindicator and Steam Biologicalindicator	The OK Plus indicator should not achieveend-point color before the biological indicatoris inactivated.	Passed
Single parametervariation testing	Confirm that OK Plus indicatoris sensitive to criticalsterilization parameters.	Variation of one parameter while other onesare maintained steady. OK Plus indicatorshould not reach specified end-point blackcolor.	Passed
Testing in cycleswith parameterstypical forhealthcare	Demonstrate OK Plus indicatorachieves specified end color intypical cycles in hospital-sizeand table-top sterilizers.	Color change from off-white to black.	Passed

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Bio-compatibilitystudy 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 Steam processedsamples.	Passed
End-pointstability andshelf- life study	Confirm that OK Plus indicatorhas acceptable stability afterprocessing when achieved andnot achieved end point color("Pass" and "Fail" conditions).Demonstrate that OK Plusindicator maintains itsperformance when tested usingreal-time shelf-life exposuremethod	OK Plus indicators processed in Pass and Failcycles at various time points after productionand at the end of shelf life should demonstratestable color for at least 6 months.Meet specifications after real-time 48 monthsshelf-life exposure.	Passed

Conclusion

The OK Plus indicator for steam sterilization is substantially equivalent to the predicate device. OK Plus indicator is as safe, as effective, and performs as well as or better than the legally marketed 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).