OK Plus Indicator

K222137 · Propper Manufacturing Co., Inc. · JOJ · Dec 5, 2022 · General Hospital

Device Facts

• Record ID: K222137
• Device Name: OK Plus Indicator
• Applicant: Propper Manufacturing Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Dec 5, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

Single-use chemical indicator; reactive steam-sensitive ink printed on paper substrate (4" x 9/16"). Placed inside sterilization containment (packs, pouches, trays) by healthcare personnel. During steam sterilization, ink chemistry reacts to critical parameters (time, temperature, saturated steam); color shifts from off-white to black upon cycle completion. If parameters are insufficient, color remains light brown/brown. Provides visual confirmation of sterilization conditions; allows healthcare providers to verify pack processing status before use. Benefits patient by ensuring medical instruments have undergone required sterilization cycle.

Clinical Evidence

Bench testing only. Performance verified via half-cycle criterion in Steam BIER vessel. Testing included: dry heat oven exposure (no color change), correlation with biological indicators, single parameter variation, and performance in hospital/table-top sterilizers. Biocompatibility evaluated per ISO 11140-1:2014. Shelf-life stability confirmed for 48 months.

Technological Characteristics

Reactive steam indicator ink on paper substrate. Dimensions: 4" x 9/16" (or 8" x 9/16"). Sensing principle: chemical color change reaction to steam, temperature, and time. Non-electronic, passive device. Conforms to ANSI/AAMI/ISO 11140-1:2014. Shelf life: 4 years.

Indications for Use

Indicated for monitoring steam sterilization efficacy in healthcare settings. Used in gravity and vacuum-assisted cycles (121°C–135°C). Intended for placement inside packs, pouches, or trays as an independent monitor of critical sterilization parameters (time, temperature, saturated steam).

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Chemdye CD29 indicator (K191021)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K222137 510(k) Summary

| Submitted by:<br>Address: | Propper Manufacturing Company, Inc.<br>36-04 Skillman Avenue,<br>Long Island City, New York 11101 |
|-------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone:<br>Fax:<br>E-mail: | [phone] x149<br>[phone]<br>[e-mail] |
| 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

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.

#### 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,<br>k191021 | Identical |
| Product<br>generic<br>name | A physical/chemical sterilization<br>process indicator | A physical/chemical<br>sterilization process<br>indicator | Identical |
| Product<br>code | JOJ | JOJ | Identical |
| Sterilization<br>method | Steam sterilization | Steam sterilization | Identical |
| Intended use | Sterilization process indicator | Sterilization process<br>indicator | Identical |
| Types of | Gravity and pre-vacuum. | Gravity and Dynamic air | Identical |
| sterilization | | removal (pre-vacuum) | |
| cycles | | | |
| Sterilization<br>cycles | 121°C-30 min gravity<br>132°C-4 min pre-vacuum<br>132°C-10 min pre-vacuum<br>134°C-3.5 min pre-vacuum<br>134°C-4 min pre-vacuum<br>135°C-3 min pre-vacuum | 121°C-30 min gravity<br>132°C-15 min gravity<br>132°C-25 min gravity<br>135°C-10 min gravity<br>132°C-4 min pre-vacuum<br>135°C-3 min pre-vacuum | Similar. |
| End-point<br>specification | 121°C-15 min<br>132°C-4min<br>134°C-3min<br>135°C-2.9 min | 121°C-15 min<br>134°C-3.5 min | Similar |
| Device<br>design | Paper strip printed with indicator<br>ink | Paper strip printed with<br>indicator ink | Identical |
| Operational<br>principle | Color change chemistry | Color change chemistry | Identical |
| Initial color | Off-white | Light yellow | Similar |
| End point<br>color | Black | Black | Identical |
| Indicator<br>type | Internal indicator | Internal Indicator | Identical |
| Single use | Yes | Yes | Identical |
| Shelf life | 4 years | 5 years | Similar |
| Indications<br>for use | The OK Plus indicator is a<br>chemical indicator designed for<br>monitoring the efficacy of steam<br>sterilization process. The<br>indicator responds to all critical<br>sterilization parameters. The OK<br>Plus indicator changes color<br>from off-white to black to<br>indicate that the conditions of the<br>cycle have been met. The<br>indicator is intended to be placed<br>in each pack, pouch, tray or<br>other containment device to<br>function as an independent<br>monitor of critical parameters for<br>the following sterilization cycles:<br><br>121°C-30 min gravity<br>132°C-4 min pre-vacuum<br>132°C-10 min pre-vacuum<br>134°C-3.5 min pre-vacuum<br>134°C-4 min pre-vacuum | Terragene Chemdye® CD29 is<br>a chemical process indicator<br>intended for monitoring the<br>efficacy of steam sterilization<br>processes. The chemical<br>indicator changes from yellow<br>to dark brown/black to indicate<br>that the conditions of the cycle<br>have been met.<br><br>121°C-30 min gravity<br>132°C-15 min gravity<br>132°C-25 min gravity<br>135°C-10 min gravity<br>121°C-30 min gravity<br>132°C-4 min pre-vacuum<br>135°C-3 min pre-vacuum | Similar.<br>The difference is<br>in the sterilization<br>cycles |

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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 |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Performance<br>testing in Steam<br>BIER vessel | Demonstrate conformance of<br>OK Plus Indicator with the half-<br>cycle requirements.<br>The indicator should<br>demonstrate end-point color<br>when bacteria/spores are<br>deactivated. | Color changes - end-point colors:<br><br>121°C - 15 min 00 s - black<br>132°C - 4 min 00 s - black<br>134°C - 3 min 00 s - black<br>135°C - 2 min 54 s - black | Passed |
| Testing in Dry<br>Heat oven | Confirm that OK Plus indicator<br>does not change color in<br>absence of Stam. | When tested in cycles at 140°C+/-2°C and time<br>30+/1 min as per ANSI/AAMI/ISO 11140-<br>1:2014 the OK Plus indicator should not<br>achieve end color.<br><br>Also, OK Plus indicator should not<br>demonstrate color change to the end point in<br>180°C - 60 min dry heat typical cycle which it<br>sufficient to kill biological indicator spores. | Passed |
| Testing against<br>biological<br>indicator | Establish correlation between<br>performance of OK Plus<br>indicator and Steam Biological<br>indicator | The OK Plus indicator should not achieve<br>end-point color before the biological indicator<br>is inactivated. | Passed |
| Single parameter<br>variation testing | Confirm that OK Plus indicator<br>is sensitive to critical<br>sterilization parameters. | Variation of one parameter while other ones<br>are maintained steady. OK Plus indicator<br>should not reach specified end-point black<br>color. | Passed |
| Testing in cycles<br>with parameters<br>typical for<br>healthcare | Demonstrate OK Plus indicator<br>achieves specified end color in<br>typical cycles in hospital-size<br>and table-top sterilizers. | Color change from off-white to black. | Passed |

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| Bio-compatibility<br>study and ink<br>transfer test | Demonstrate that the indicator<br>does not create biocompatibility<br>issues to health care<br>professionals and patients. | Evaluation of individual components for<br>biocompatibility and review of<br>biocompatibility of indicators with similar<br>formulation with history on the market.<br><br>Testing according to ISO 11140-1:2014.<br>Requirement: 6.2.2. No ink transfer should be<br>observed on unprocessed and Steam processed<br>samples. | Passed |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| End-point<br>stability and<br>shelf- life study | Confirm that OK Plus indicator<br>has acceptable stability after<br>processing when achieved and<br>not achieved end point color<br>("Pass" and "Fail" conditions).<br><br>Demonstrate that OK Plus<br>indicator maintains its<br>performance when tested using<br>real-time shelf-life exposure<br>method | OK Plus indicators processed in Pass and Fail<br>cycles at various time points after production<br>and at the end of shelf life should demonstrate<br>stable color for at least 6 months.<br><br>Meet specifications after real-time 48 months<br>shelf-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.