Ultraphon Chemical Indicator (TRO-T and TRO-B)

K233413 · True Indicating, LLC · JOJ · Jun 26, 2024 · General Hospital

Device Facts

• Record ID: K233413
• Device Name: Ultraphon Chemical Indicator (TRO-T and TRO-B)
• Applicant: True Indicating, LLC
• Product Code: JOJ · General Hospital
• Decision Date: Jun 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

Device Story

Single-use, 26mm diameter chemical indicator disc; available in Tyvek® (TRO-T) or polypropylene (TRO-B) substrates. Contains hydrogen peroxide-sensitive chemical ink. Placed inside trophon® EPR or trophon® 2 HLD chambers during ultrasound probe disinfection. Principle of operation: chemical ink transitions from red to yellow upon exposure to hydrogen peroxide concentrations above the established MEC. Provides visual confirmation to healthcare personnel that the disinfection cycle occurred. Benefits patient by ensuring ultrasound probes undergo required HLD, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance for chemical indicators and liquid chemical sterilants. Testing included endpoint color verification, endpoint stability (30 days), offset/transference (ISO 11140-1), and performance in the presence of contaminated probes. Quantitative analysis via X-Rite spectrophotometer confirmed sensitivity, specificity, accuracy, and precision (>0.95 for all metrics).

Technological Characteristics

Substrates: Tyvek® (TRO-T) or Biaxially Oriented Polypropylene (BOPP) (TRO-B). Sensing principle: pH-reacting chemical indicator ink. Form factor: 26 mm diameter disc. Shelf life: 58 months. Endpoint stability: 1 month. Complies with ANSI/AAMI/ISO 11140-1:2014.

Indications for Use

Indicated for monitoring high-level disinfection (HLD) processes in Nanosonics trophon® EPR and trophon® 2 chambers for ultrasound probes. Used to verify exposure to hydrogen peroxide above the minimum effective concentration (MEC) and distinguish processed from unprocessed cycles.

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

• Trophon Chemical Indicator (K103126)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2024

True Indicating LLC Thomas Riha Cso 946 Kane St Suite A Toledo, Ohio 43612

Re: K233413

Trade/Device Name: Ultraphon Chemical Indicator (TRO-T and TRO-B) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 6, 2024 Received: June 6, 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.

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"

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(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 OS 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.

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 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.

# Allan G

For Katie Segars, Ph.D., RAC, PMP, CQA Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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) K233413

Device Name Ultraphon Chemical Indicator (TRO-T and TRO-B)

Indications for Use (Describe)

The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

| 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] |
| Prepared on: | June 26, 2024 |
| Device Name: | Ultraphon Chemical Indicator (TRO-T and TRO-B) |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital<br>Regulation 21 CFR 880.2800 |
| Predicate Devices:<br>(Legally Marketed) | Trophon Chemical Indicator (K103126) |
| Description of Device: | The device is a qualitative, single use, disc (26 mm in diameter) that has a<br>hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate<br>(Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The<br>hydrogen peroxide sensitive chemical indicating ink has been designed to<br>transition from an initial red color to a signal yellow color when subjected to<br>sources of hydrogen peroxide. |
| Indications for Use: | The Ultraphon Chemical Indicator is used exclusively for monitoring the High<br>Level Disinfection process when placed within the Nanosonics trophon® EPR<br>and trophon® 2 chambers. The color of the Ultraphon Chemical Indicator<br>changes from red to yellow when exposed to hydrogen peroxide, the active<br>ingredient used in trophon® EPR and trophon® 2 disinfectant. This occurs<br>above the minimum effective concentration (MEC) established for this<br>solution. |
| Operational Principles: | The Ultraphon Chemical Indicator is intended for use within trophon® EPR and<br>trophon2® HLD systems when processing a single ultrasound probe to<br>demonstrate that the probe has been exposed to a hydrogen peroxide high<br>level disinfection cycle and to distinguish between processed and unprocessed<br>cycles. |
| | The Ultraphon Chemical Indicator will transition from an initial color of red<br>(product codes TRO-T and TRO-B) to a yellow signal color when exposed to<br>hydrogen peroxide at a fixed time and temperature within trophon® EPR and<br>trophon2® HLD equipment. |

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| Feature | Subject Device | Predicate Device<br>(K103126) | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Chemical indicator for trophon®<br>EPR and trophon® 2 High Level<br>Disinfection | Chemical indicator for trophon®<br>EPR and trophon® 2 High Level<br>Disinfection | Same |
| Product Code | JOJ | JOJ | Same |
| FDA<br>Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for<br>Use (IFU) | The Ultraphon Chemical<br>Indicator is used exclusively for<br>monitoring the High Level<br>Disinfection process when<br>placed within the Nanosonics<br>trophon® EPR and trophon® 2<br>chambers. The color of the<br>Ultraphon Chemical Indicator<br>changes from red to yellow<br>when exposed to hydrogen<br>peroxide, the active ingredient<br>used in trophon® EPR and<br>trophon® 2 disinfectant. This<br>occurs above the minimum<br>effective concentration (MEC)<br>established for this solution. | The Trophon Chemical Indicator<br>is used exclusively for monitoring<br>the High Level Disinfection<br>process when placed within the<br>Trophon EPR chamber. The color<br>of the Trophon Chemical<br>Indicator changes from red to<br>yellow when exposed to<br>hydrogen peroxide, the active<br>ingredient in Trophon EPR-C40<br>disinfectant. This occurs above<br>the minimum effective<br>concentration (MEC) established<br>for this solution. | Similar |
| Device Design | Product Code TRO-T: Tyvek®<br>(26 mm circle) printed with pH<br>reacting chemical indicator ink<br>Product Code TRO-B: Biaxially<br>Oriented Polypropylene (BOPP)<br>26 mm circle printed with pH<br>reacting chemical indicator ink | Tyvek® 26 mm circle printed with<br>pH reacting chemical indicator ink | Similar |
| Indicator<br>Agent | pH reacting chemical and<br>background dye | pH reacting chemical and<br>background dye | Same |
| Endpoint<br>Specification | Yellow | Yellow | Same |
| MEC | 1.0 gram of 31.5% hydrogen<br>peroxide | 1.0 gram of 31.5% hydrogen<br>peroxide | Same |
| End Point<br>Stability | 1 Month | Not Supplied | Similar |
| Shelf Life | 58 Months | 16 Months | Similar |

## Technological Characteristic Comparison Table

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## Summary of Nonclinical Testing – Chemical Indicator

Per FDA recognized consensus standards and guidance documents, testing was performed on multiple lots of the subject devices (TRO-T and TRO-B chemical indicators) over their range of shelf life using Nanosonics trophon® EPR and trophon® 2 HLD processes.

- Performance testing was performed per: Guidance for Industry and FDA Reviewers Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/ High Level Disinfectants https://www.fda.gov/media/72097/download.
- End Point Stability of the achieved signal color was evaluated for a period of 30 days (1 month) per:

Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification (510(k)] Submissions https://www.fda.gov/media/72010/download.

- Offset-Transference testing was conducted per ISO 11140-1 ●
#### Summary of Nonclinical Testing Table

| Name of Test | Purpose | Acceptance Criteria | Subject<br>Device<br>Result |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Performance Testing | Determine if the chemical<br>indicators reach specified<br>endpoint color of yellow and a fail<br>color when exposed to the MEC<br>when combined with a HLD load<br>and exposed to the cycle for<br>which it is intended according to<br>Premarket Notification [510(k)]<br>Submissions for Chemical<br>Indicators - Guidance for Industry<br>and FDA Staff and Content and<br>Format of Premarket Notification<br>[510(k)] Submissions for Liquid<br>Chemical Sterilants/High Level<br>Disinfectants, 2000 | Pass result when hydrogen peroxide<br>solution is above the MEC (signal color<br>achieved for all product codes) and fail<br>color when hydrogen peroxide solution<br>is at MEC achieved when exposed to<br>the HLD cycle in combination of a<br>worst-case load:<br>trophon® EPR and trophon® 2 HLD<br>Systems | PASS |
| End Point Stability | Determine the length of time that<br>an exposed Chemical Indicator<br>for hydrogen peroxide retains its<br>post-exposure signal color per<br>Guidance for Industry and Staff -<br>Chemical Indicator (CI) Premarket<br>Notification [510(k)] Submission | 1 month | PASS |
| Offset/Transference | Demonstrate the chemical<br>indicators do not bleed or offset to<br>substrate which it's applied<br>according to ANSI/AAMI/ISO<br>11140-1:2014 Sterilization of<br>health care products - Chemical<br>indicators - Part 1: General<br>requirements. | The chemical indicators shall not offset<br>or bleed, penetrate the substrate to<br>which it is applied, or materials in which<br>it is in contact before, during or after the<br>sterilization cycles for which it is<br>designed. | PASS |
| Chemical Indicator<br>Performance Testing in<br>the Presence of<br>Contaminated<br>Ultrasound Probes | Determine exposure color results<br>for product codes TRO-T and<br>TRO-B Chemical Indicators in the<br>presence of contaminated<br>ultrasound probes, when using a<br>Nanosonics trophon® EPR or<br>trophon®2 High Level<br>Disinfection unit per Content and<br>Format of Premarket Notification<br>[510(k)] Submissions for Liquid<br>Chemical Sterilants/High Level<br>Disinfectants, 2000 | Hydrogen Peroxide<br>31.5% (1.8g)<br>More yellow than MEC<br><br>Hydrogen Peroxide<br>31.5% (1.0g)<br>Equal to MEC or more red | PASS |
| Color Analysis (X-Rite<br>Spectrophotometer) | Determine the color of Chemical<br>Indicators when detecting H2O2<br>used in Nanosonics trophon®<br>EPR and trophon®2 High Level<br>Disinfection (HLD) exposure<br>cycles by using a<br>spectrophotometer for Pass and<br>Fail compared to MEC per<br>Content and Format of Premarket<br>Notification [510(k)] Submissions<br>for Liquid Chemical<br>Sterilants/High Level<br>Disinfectants, 2000 | More yellow than the MEC<br>using 31.5%, 1.8 grams Equal to or more red than<br>MEC using 31.5%, 1.0 gram More red than MEC using<br>31.5%, 0.8 grams More Yellow than MEC using<br>31.5%, 1.2 grams | PASS |
| Sensitivity, Specificity,<br>Accuracy, and Precision<br>of Performance Data | Performance testing data<br>analysis according to the<br>characteristics of Comparative<br>Sensitivity, Analytic Sensitivity,<br>Comparative Sensitivity, Analytic<br>Specificity, Accuracy, and<br>Precision for Chemical Indicators<br> | Comparative Sensitivity: > 0.95<br><br>Analytic Sensitivity (31.5% H2O2):<br>1.8 g H2O2 solution: 0.56 - 0.58 g H2O2<br>1.2 g H2O2 solution: 0.37 - 0.39 g H2O2<br>1.0 g H2O2 solution: 0.31 – 0.33 g H2O2<br>0.8 g H2O2 solution: 0.25 - 0.27 g H2O2<br><br>Comparative Specificity: > 0.95<br><br>Accuracy: > 0.95<br><br>Precision: < 1 ΔΕ using X-Rite<br>spectrophotometer<br><br>Analytic Specificity<br>Exposure to Bleach Wipe - Yellow<br><br>Exposure to Lysol - Yellow<br><br>Exposure to IPA (70%) - Yellow<br><br>Dry Heat Exposure 100°C, 15 min -<br>Red<br><br>UV Exposure - 2 hours - Light Red<br><br>Ethylene Oxide Exposure 20 min. 54°<br>C 600 ppm, 60%RH - Red | PASS |

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## 510(k) Summary – K233413

### Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the Ultraphon Chemical Indicator (TRO-T and TRO-B) is as safe, as effective, and performs as well as or better than the legally marketed predicate, Nanosonics Ltd., Trophon Chemical Indicator (K103126).