Chemical Indicator for Steam

K220778 · True Indicating, LLC · JOJ · Dec 2, 2022 · General Hospital

Device Facts

• Record ID: K220778
• Device Name: Chemical Indicator for Steam
• Applicant: True Indicating, LLC
• Product Code: JOJ · General Hospital
• Decision Date: Dec 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods. The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators: Gravity: 121°C/250 F - 30 minutes (wrapped/porous) Pre-vacuum: 132°C/270 F - 3 minutes (unwrapped/nonporous) Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous) Pre-vacuum: 134°C/273 F - 4 minutes (wrapped/porous) Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)

Device Story

Chemical indicator for steam sterilization; paper strip printed with bismuth-based chemical indicator ink; polyester overlaminate applied over ink. Used with individual materials (pouches, packs, trays) to confirm steam exposure. Upon exposure to specific high-temperature steam cycles (gravity or pre-vacuum), indicator transitions from initial color (yellow, pink, or blue) to permanent dark brown/black. Used in clinical or healthcare settings; provides visual confirmation to healthcare personnel that items have undergone sterilization. Benefits patient by ensuring processed goods are distinguishable from unprocessed ones, reducing risk of using non-sterile equipment.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 11140-1:2014 and FDA guidance. Studies included steam resistometer testing, hospital steam sterilizer testing with various loads, dry heat testing, end-point stability, and offset/transference testing. All tests met acceptance criteria.

Technological Characteristics

Paper strip substrate; bismuth-based chemical indicator ink; polyester overlaminate. Sensing principle: chemical color transition upon steam exposure. Dimensions/form factor: strip. Connectivity: none. Sterilization: N/A (device is an indicator).

Indications for Use

Indicated for use by healthcare providers or in over-the-counter settings to verify that individual materials (pouches, packs, trays) have been exposed to steam sterilization processes, distinguishing processed from unprocessed goods.

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

• Lead-free Chemical Indicators for Steam Sterilization (K181788)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 2, 2022

True Indicating LLC Thomas Riha Chief Scientific Officer 946 Kane St Toledo, Ohio 43612

Re: K220778

Trade/Device Name: Chemical Indicator for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 12, 2022 Received: November 1, 2022

Dear Thomas Riha:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Christopher K. Dugard -S

for 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

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# Indications for Use

510(k) Number (if known) K220778

Device Name Chemical Indicator for Steam

Indications for Use (Describe)

The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.

The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:

Gravity: 121°C/250 F - 30 minutes (wrapped/porous)

Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)

Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)

Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)

Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)

| 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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#

| Submitter: | True Indicating LLC<br>946 Kane Street<br>Suite A<br>Toledo, OH 43612<br>P: 419 476 7119<br>F: 419 470 8899<br>E: [e-mail] |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Tom Riha<br>Chief Scientific Officer<br>P: 248 982 6492<br>F: 419 470 8899<br>E: [e-mail]<br><br>Julie Wheeler<br>President<br>P:419 304 6535<br>F: 419 470 8899<br>[e-mail] |
| Prepared on: | November 28, 2022 |
| Device Name: | Chemical Indicator for Steam |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital |
| Predicate Devices:<br>(Legally Marketed) | Lead-free Chemical Indicators for Steam Sterilization (K181788) |
| Description of Device: | The True Indicating Lead-Free Chemical Indicator for Steam product codes<br>CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to<br>dark), all turn a permanent dark brown/black color when exposed to high<br>temperature steam. |
| Indications for Use: | The Chemical Indicator for Steam is intended for use with individual materials<br>(i.e. pouches, packs, trays) to demonstrate the material has been exposed to a<br>steam sterilization process to distinguish between processed and unprocessed<br>goods.<br><br>The Chemical Indicator for Steam can transition from an initial color of yellow and<br>turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark<br>brown/black color for Product Code: CSPN-US, and blue to a dark brown/black<br>color for Product Code: CSBN-US when exposed to high temperature steam at<br>the following time and temperature intervals as process indicators:<br><br>Gravity: 121°C/250 F - 30 minutes (wrapped/porous)<br>Pre-vacuum: 132°C/270 F - 3 minutes (unwrapped/nonporous)<br>Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)<br>Pre-vacuum: 134°C/273 F - 4 minutes (wrapped/porous)<br>Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load) |
| Operational<br>Principles: | The Chemical Indicator for Steam is intended for use with individual units, (e.g.<br>packs, containers) to demonstrate that the goods have been exposed to a steam<br>sterilization process and to distinguish between processed and unprocessed<br>goods |

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## Technological Characteristic Comparison Table

| Feature | Subject Device<br>(K220778) | Predicate Device<br>(K181788) | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Process indicator for steam<br>sterilization | Process indicator for steam<br>sterilization | Same |
| Product Code | JOJ | JOJ | Same |
| Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for<br>Use (IFU) | The Chemical Indicator for<br>Steam is intended for use with<br>individual materials (i.e.<br>pouches, packs, trays) to<br>demonstrate the material has<br>been exposed to a steam<br>sterilization process to<br>distinguish between processed<br>and unprocessed goods.<br>The Chemical Indicator for<br>Steam can transition from an<br>initial color of yellow and turn to<br>a dark brown/black color for<br>Product Code: CSYN-US, pink<br>to a dark brown/black color for<br>Product Code: CSPN-US, and<br>blue to a dark brown/black color<br>for Product Code: CSBN-US<br>when exposed to high<br>temperature steam at the<br>following time and temperature<br>intervals as process indicators:<br>Gravity: 121°C/250 F - 30<br>minutes (wrapped/porous)<br>Pre-vacuum: 132°C/270 F -<br>3 minutes (unwrapped/nonporous)<br>Prevacuum: 132°C/270 F -<br>4 minutes (wrapped/porous)<br>Prevacuum: 134°C/273 F -<br>4 minutes (wrapped/porous)<br>Prevacuum: 135°C/275 F -<br>3 minutes (wrapped/porous and<br>unwrapped/nonporous, mixed<br>load) | The Kem Medical Lead-free<br>Chemical Indicators for Steam<br>Sterilization are designed for use<br>by a health care provider to<br>demonstrate that the unit or load<br>has been exposed to a steam<br>sterilization process, and to<br>distinguish between processed<br>and unprocessed units or loads.<br>Use the Kem Medical Lead-free<br>Chemical Indicators for Steam<br>Sterilization in the validated<br>steam sterilization processes<br>described below:<br>Gravity: 121°C/250 F - 30 minutes<br>(wrapped/porous)<br>Gravity: 132°C/270 F - 3 minutes<br>(unwrapped/nonporous)<br>Gravity: 132°C/270 F - 15 minutes<br>(wrapped/porous)<br>Gravity: 135°C/275 F - 3 minutes<br>(unwrapped/nonporous)<br>Gravity: 135°C/275 F - 10 minutes<br>(wrapped/porous or<br>unwrapped/nonporous, mixed<br>load) Vacuum assisted<br>(prevacuum): 132°C/270 F - 3<br>minutes (unwrapped/nonporous)<br>Vacuum assisted (prevacuum):<br>132°C/270 F - 4 minutes<br>(wrapped/porous)<br>Vacuum assisted (prevacuum):<br>134°C/273 F - 4 minutes<br>(wrapped/porous)<br>Vacuum assisted (prevacuum):<br>135°C/275 F - 3 minutes<br>(wrapped/porous or<br>unwrapped/nonporous, mixed<br>load) | Similar |
| Device Design | Paper Strip printed with<br>Bismuth based chemical<br>indicator ink with polyester<br>overlaminate applied over<br>the entire indicating ink strip | Paper dot/strip/card printed<br>with bismuth sulfide based<br>chemical indicator ink | Similar |
| Feature | Subject Device<br>(K220778) | Predicate Device<br>(K181788) | Comparison |
| Indicator<br>Agent | Bismuth based chemical to yield<br>color transition | Bismuth based chemical to yield<br>color transition | Same |
| Endpoint<br>Specification | Dark brown/black color change | Dark brown/black color change | Same |
| End Point<br>Stability | 1 Month | 6 Months | Similar |
| Shelf Life | 30 Months | 12 Months | Similar |

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#### Summary of Nonclinical Tests:

Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes usinq multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life:

- Performance Exposure Studies were conducted per ISO 11140-1
- . End Point Stability of the achieved signal color was evaluated for a period of days per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification [510(k)] Submissions.
- Offset-Transference testing was conducted per ISO 11140-1 ●
- . Simulated Use (Healthcare Steam Cycles) - Steam Exposure cycles were tested utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols

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# Summary of Nonclinical Testing – Chemical Indicator for Steam

Testing was conducted on the Chemical Indicator for Steam following the FDA guidance and the standards below:

- Guidance for Industry and FDA Staff, Chemical Indicator (CI) Premarket Notification [510(k)] ● Submissions,
- . ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General requirements

| Name of Test | Purpose | Acceptance Criteria | Subject<br>Device<br>Result |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Steam<br>Resistometer<br>Testing | To test the pass/fail<br>criteria for each critical<br>cycle parameter and<br>provide the pass/fail<br>results to show how the<br>chemical indicator reacts<br>to the critical parameters<br>in the sterilization cycle for<br>which it is intended<br>according to<br>ANSI/AAMI/ISO 11140-<br>1:2014 Sterilization of<br>health care products -<br>Chemical indicators - Part<br>1: General requirements<br>and Premarket Notification<br>[510(k)] Submissions for<br>Chemical Indicators -<br>Guidance for Industry and<br>FDA Staff. | Pass result (signal color<br>achieved for all product codes)<br>at the value for each<br>temperature claimed:<br>121°C for 10 minutes<br>134°C for 2 minutes<br>135°C for 2 minutes<br>Fail result (signal color not<br>achieved for all product codes)<br>at the value for each<br>temperature claimed:<br>121°C for 2 minutes<br>134°C for 0.3 minutes<br>135°C for 0.3 minutes | PASS |
| Hospital<br>Steam<br>Sterilizer<br>Testing | Determine if the chemical<br>indicators reach specified<br>endpoint color of dark<br>brown/black when<br>combined with a<br>sterilization load and<br>exposed to the sterilization<br>cycle for which it is<br>intended according to<br>Premarket Notification<br>[510(k)] Submissions for<br>Chemical Indicators -<br>Guidance for Industry and<br>FDA Staff. | Pass result (signal color achieved for<br>all product codes) at the value for<br>each temperature claimed in<br>combination of a sterilization load:<br>• Gravity: 121°C/250 F - 30 minutes<br>(wrapped/porous)<br>• Vacuum assisted<br>(prevacuum): 132°C/270 F -<br>3 minutes<br>(unwrapped/nonporous)<br>• Vacuum assisted<br>(prevacuum): 132°C/270 F -<br>4 minutes (wrapped/porous)<br>• Vacuum assisted (prevacuum):<br>134°C/273 F - 4 minutes<br>(wrapped/porous)<br>• Vacuum assisted (prevacuum):<br>135°C/275 F - 3 minutes<br>(wrapped/porous and | PASS |
| Name of Test | Purpose | Acceptance Criteria | Subject<br>Device<br>Result |
| Dry Heat Testing | Demonstrate that the<br>Chemical Indicator for<br>Steam does not change<br>color following a dry<br>heat cycle according to<br>ANSI/AAMI/ISO 11140-<br>1:2014 Sterilization of<br>health care products -<br>Chemical indicators -<br>Part 1: General<br>requirements and<br>Premarket Notification<br>[510(k)] Submissions<br>for Chemical Indicators -<br>Guidance for Industry<br>and FDA Staff | Fail result when exposed to<br>dry heat alone for 30 minutes<br>(±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of<br>time that an exposed<br>Chemical Indicator for<br>Steam retains its post-<br>exposure signal color<br>per Guidance for<br>Industry and Staff -<br>Chemical Indicator (CI)<br>Premarket Notification<br>[510(k)] Submission | 1 Month | PASS |
| Offset/Transference | Demonstrate the<br>chemical indicators do<br>not bleed or offset to<br>substrate which it's<br>applied according to<br>ANSI/AAMI/ISO 11140-<br>1:2014 Sterilization of<br>health care products -<br>Chemical indicators -<br>Part 1: General<br>requirements. | The chemical indicators shall<br>not offset or bleed, penetrate<br>the substrate to which it is<br>applied, or materials in which it<br>is in contact before, during or<br>after the sterilization cycles for<br>which it is designed | PASS |

## Summary of Nonclinical Testing Table

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Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K220778, the Chemical Indicator for Steam, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K181788.