Type 5 Integrating Indicator for Steam (CSPN-15)

K242860 · True Indicating, LLC · JOJ · Jan 17, 2025 · General Hospital

Device Facts

• Record ID: K242860
• Device Name: Type 5 Integrating Indicator for Steam (CSPN-15)
• Applicant: True Indicating, LLC
• Product Code: JOJ · General Hospital
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

Device Story

Chemical indicator strip for steam sterilization monitoring; consists of white polyester substrate with acrylic adhesive and paper substrate; printed with water-based steam-indicating ink (pink to dark brown/black) and covered with clear polyester laminate. Placed inside sterilization packs/trays by healthcare personnel. Operates via chemical reaction to critical process variables (time, temperature, steam); ink transitions color to conceal the word "NOT" when integration condition is reached, calibrated to kill time of 10^5 Geobacillus stearothermophilus spores. Provides visual confirmation of sterilization cycle effectiveness; aids clinical decision-making by verifying exposure of goods to required sterilization parameters.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 11140-1:2014 and FDA guidance. Testing included resistometer studies (confirming alignment with biological indicator performance, correlation coefficient ≥ 0.9), hospital steam sterilizer testing, dry heat testing, end-point stability (6 months), and side-by-side testing with biological indicators. All tests met acceptance criteria.

Technological Characteristics

Polyester/paper substrate with acrylic adhesive; sulfide-based chemical indicator ink (ISPN-01); clear polyester overlaminate. Sensing principle: chemical reaction to steam, time, and temperature. Form factor: indicator strip. No energy source, software, or connectivity.

Indications for Use

Indicated for use as an independent monitor of critical parameters (time, temperature, steam) in steam sterilization cycles (gravity displacement and dynamic air removal) for medical packs, pouches, containers, and trays.

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

• Terragene Integron® IT26-1YS (K191021)

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.

January 17, 2025

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

Re: K242860

Trade/Device Name: Type 5 Integrating Indicator for Steam (CSPN-15) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 20, 2024 Received: September 20, 2024

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows the name "Stephen A. Anisko -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Stephen A. Anisko" followed by the date "2025.01.17 14 -05'00'". The image appears to be a digital signature.

Stephen A. Anisko -S Date: 2025.01.17 14:10:30

for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control 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

Submission Number (if known)

K242860

Device Name

Type 5 Integrating Indicator for Steam (CSPN-15)

Indications for Use (Describe)

The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;

Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.

Minimum Stated Values as determined in a resistometer:

SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

Type of Use (Select one or both, as applicable)

scription Use (Part 21 CFR 801 Subpart D)

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: <a href="mailto:[e-mail]">[e-mail]</a> |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Tom Riha<br>Chief Scientific Officer<br>P: 248-982-6492<br>F: 419-470-8899<br>E: <a href="mailto:[e-mail]">[e-mail]</a> |
| Prepared on: | January 14, 2025 |
| Device Name: | Type 5 Integrating Indicator for Steam (CSPN-15) |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital |
| Predicate Devices:<br>(Legally Marketed) | Terragene Integron® IT26-1YS (K191021) |
| Device Description: | The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white<br>polyester substrate with acrylic adhesive married to a paper substrate. The<br>paper substrate (with acrylic adhesive) has True Indicating water-based steam<br>indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed.<br>After printing, the top layer of the Type 5 Integrating Indicator strip is covered<br>with a clear colorless polyester laminate with acrylic adhesive. The Integrating<br>Indicators have been designed for Steam sterilization processes, ensuring the<br>effectiveness of sterilization by monitoring all critical process variables (time,<br>temperature and steam). The pink indicating ink was developed to turn to dark<br>and conceal the word "NOT" when a theoretical spore population reaches its kill<br>time, indicating integration condition has been reached. This condition is<br>calibrated with the kill time of a 105 Geobacillus stearothermophilus spore<br>population, calculated in BIER (Biological Indicator Evaluator Resistometer). |
| Indications for Use: | The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed<br>to chemically react over time with the critical parameters of steam sterilization<br>cycle within a specified tolerance. The integrating indicator strip is intended to be<br>placed in each pack, pouch, container, tray or other containment device to<br>function as an independent monitor of critical parameters for the following<br>sterilization cycles: |
| | Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for<br>25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; |
| | Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3<br>minutes. |
| | Minimum Stated Values as determined in a resistometer:<br>SV121°C/16.5 min., SV132°C/2.0min, SV134°C/1.4 min. SV135°C/1.2 min |

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#### Operational The Type 5 Integrating Indicator for Steam CSPN-15 is intended for use Principles: with individual units, (e.g. packs, pouches, containers, trays, or containment devices) to demonstrate that the goods have been exposed to the critical parameters of a steam sterilization process.

The Type 5 Integrating Indicator for Steam CSPN-15 will transition from an initial color of pink (product code CSPN-15) to a dark brown/black signal color and conceal the word "NOT" when exposed to high temperature steam at various time and temperature intervals.

| Feature | Subject Device<br>True Indicating Type 5 Integrating<br>Indicator for Steam CSPN-15 | Predicate Device<br>Terragene Integron® IT26-1YS<br>(K191021) | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Integrating indicator for steam<br>sterilization | Integrating indicator for steam<br>sterilization | Identical |
| Product Code | JOJ | JOJ | Identical |
| FDA<br>Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Identical |
| Indications for<br>Use (IFU) | The True Indicating Type 5 Integrating<br>Indicator for Steam CSPN-15 is<br>designed to chemically<br>react over time with the critical<br>parameters of steam sterilization cycle<br>within a specified tolerance. The<br>integrating indicator strip is intended to<br>be placed in each pack, pouch,<br>container, tray or other<br>containment device to function as an<br>independent monitor of critical<br>parameters for the following<br>sterilization cycles:<br>Gravity Displacement: 121° C for 30<br>minutes, 132° C for 15 minutes, 132°<br>C for 25 minutes, 132° C for 3<br>minutes, 132° C for 10 minutes;<br>Dynamic Air Removal (Vacuum<br>Assist): 132° C for 4 minutes, 135° C<br>for 3 minutes.<br>Minimum Stated Values as determined<br>in a resistometer:<br>SV121°C/16.5 min., SV132°C/2.0min,<br>SV134°C/1.4 min. SV135°C/1.2 min. | The integrator Terragene Integron®<br>IT26-1YS is designed to chemically<br>react over time with the critical<br>parameters of steam sterilization cycle<br>within a specified tolerance. The<br>integrating indicator strip is intended to<br>be placed in each pack, pouch,<br>container, tray or other containment<br>device to function as an independent<br>monitor of critical parameters for the<br>following sterilization cycles:<br>Gravity Displacement: 121° C for 30<br>minutes, 132° C for 15 minutes, 132° C<br>for 25 minutes, 135° C for 10 minutes;<br>Dynamic Air Removal (Vacuum Assist):<br>132° C for 4 minutes, 135° C for 3<br>minutes.<br>SV121° C/16.5 min. SV132° C/2.0 min,<br>SV135° C/1.2 min. | Similar |
| Device Design | Paper Strip printed with pink<br>chemical indicator ink with polyester<br>overlaminate applied over the top of<br>the indicating ink strip | Paper strip printed with yellow<br>chemical indicator ink with polyester<br>overlaminate applied over the top of<br>the indicating ink strip | Similar |
| Indicator<br>Agent | Sulfide based chemical to yield<br>color transition | Sulfide based chemical to yield<br>color transition | Similar |
| Endpoint<br>Specification | Dark brown/black color change | Dark brown/black color change | Identical |
| End Point<br>Stability | 6 Month | 6 Months | Identical |
| Shelf Life | 48 Months | 60 Months | Similar |

#### Technological Characteristic Comparison Table

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Summarv of Nonclinical Tests: Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes using multiple lots of True Indicating Chemical Indicator for Steam CSPN-15 over the range of the shelf

- life: ● Performance Exposure Studies were conducted per ISO 11140-1:2014 for a Type 5 Integrator for Steam, and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
- . End Point Stability of the achieved signal color was evaluated for a period of months 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 side-by-side with a biological indicator utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
- Shelf-life of product code CSPN-15 per Guidance for Industry and FDA ● Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols

#### Summary of Nonclinical Testing - Type 5 Integrating Indicator for Steam CSPN-15

Testing was conducted on the Type 5 Integrating Indicator for Steam CSPN-15 following the FDA quidance 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 (Type 5 Integrator for Steam)

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# Summary of Nonclinical Testing Table

| Name of Test | Purpose | Acceptance Criteria | Subject<br>Device<br>Result |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Steam<br>Resistometer<br>Testing | To identify and test the<br>pass/fail criteria for each<br>critical parameter and<br>provide the pass/fail results<br>to show how the Type 5<br>Integrating Indicator reacts<br>to the critical parameters in<br>the sterilization cycle for<br>which it is intended<br>according to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization<br>of health care products -<br>Chemical indicators - Part 1:<br>General requirements and<br>Premarket Notification<br>[510(k)] Submissions for<br>Chemical Indicators -<br>Guidance for Industry and<br>FDA Staff. Integrator<br>temperature coefficient and<br>correlation coefficient are<br>calculated to confirm<br>alignment to biological<br>indicator performance. | Pass result (end signal color<br>achieved for all product<br>codes) at the value for each<br>temperature claimed:<br>121°C for 16.5 minutes<br>132°C for 2.0 minutes<br>134°C for 1.4 minutes<br>135°C for 1.2 minutes<br>Fail result (end signal color<br>not achieved) at the value<br>for each temperature<br>claimed:<br>120°C for 14.025 minutes<br>131°C for 1.7 minutes<br>133°C for 1.19 minutes<br>134°C for 1.02 minutes<br>Integrator temperature<br>coefficient | PASS |
| | | 10 - 27 °C<br>Correlation coefficient<br>$\geq$ 0.9 | PASS |
| Hospital Steam<br>Sterilizer Testing | Determine if the Type 5<br>Integrating indicator reach<br>specified endpoint color of<br>dark brown/black when<br>combined with a sterilization<br>load and exposed to the<br>sterilization cycle for which it<br>is 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<br>for all product codes) at the value<br>for each temperature claimed in<br>combination of a sterilization load:<br>Gravity Displacement: 121° C for<br>30 minutes, 132° C for 15<br>minutes, 132° C for 25 minutes,<br>132° C for 3 minutes, 135° C for<br>10 minutes;<br>Dynamic Air Removal (Vacuum<br>Assist): 132° C for 4 minutes,<br>135° C for 3 minutes. | PASS |
| Dry Heat Testing | Demonstrate that the<br>Chemical Indicator for Steam<br>does not change color<br>following a dry heat cycle<br>according to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization of<br>health care products -<br>Chemical indicators - Part 1:<br>General requirements and<br>Premarket Notification [510(k)]<br>Submissions for Chemical<br>Indicators - Guidance for<br>Industry and FDA Staff | Fail result when exposed to dry<br>heat alone for 30 minutes (±1<br>minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of time<br>that an exposed Chemical<br>Indicator for Steam retains<br>its post-exposure signal<br>color per Guidance for<br>Industry and Staff -<br>Chemical Indicator (CI)<br>Premarket Notification<br>[510(k)] Submission | 6 Months | PASS |
| Side-by-Side Testing<br>with a Biological<br>Indicator | Confirm Integrators are<br>parallel (or more robust) in<br>performance to biological<br>indicators (BI). | Chemical Integrator does not<br>reach endpoint before Bls are<br>inactivated | PASS |
| Offset/Transference | Demonstrate the chemical<br>indicators do not bleed or<br>offset to substrate which it's<br>applied according to<br>ANSI/AAMI/ISO 11140-<br>1:2014 Sterilization of health<br>care products - Chemical<br>indicators - 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 |

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## K242860 - 510(k) Summary

Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device, the True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Terragene Integron® IT26-1YS (K191021), Class II (21 CFR 880.2800), product code JOJ.