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.

The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® EPR and 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® EPR and trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

Device Description

The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate (Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.

AI/ML Overview

The provided text describes the acceptance criteria and a summary of non-clinical testing for the Ultraphon Chemical Indicator (TRO-T and TRO-B). Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Name of Test	Acceptance Criteria	Subject Device Result
Performance Testing	Pass result when hydrogen peroxide solution is above the MEC (signal color achieved for all product codes) and fail color when hydrogen peroxide solution is at MEC achieved when exposed to the HLD cycle in combination of a worst-case load: trophon® EPR and trophon® 2 HLD Systems	PASS
End Point Stability	1 month	PASS
Offset/Transference	The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed.	PASS
Chemical Indicator Performance Testing in the Presence of Contaminated Ultrasound Probes	Hydrogen Peroxide 31.5% (1.8g): More yellow than MEC Hydrogen Peroxide 31.5% (1.0g): Equal to MEC or more red	PASS
Color Analysis (X-Rite Spectrophotometer)	More yellow than the MEC using 31.5%, 1.8 grams Equal to or more red than MEC using 31.5%, 1.0 gram More red than MEC using 31.5%, 0.8 grams More Yellow than MEC using 31.5%, 1.2 grams	PASS
Sensitivity, Specificity, Accuracy, and Precision of Performance Data	Comparative Sensitivity: > 0.95 Analytic Sensitivity (31.5% H2O2): 1.8 g H2O2 solution: 0.56 - 0.58 g H2O2 1.2 g H2O2 solution: 0.37 - 0.39 g H2O2 1.0 g H2O2 solution: 0.31 – 0.33 g H2O2 0.8 g H2O2 solution: 0.25 - 0.27 g H2O2 Comparative Specificity: > 0.95 Accuracy: > 0.95 Precision: < 1 ΔΕ using X-Rite spectrophotometer Analytic Specificity Exposure to Bleach Wipe - Yellow Exposure to Lysol - Yellow Exposure to IPA (70%) - Yellow Dry Heat Exposure 100°C, 15 min - Red UV Exposure - 2 hours - Light Red Ethylene Oxide Exposure 20 min. 54° C 600 ppm, 60%RH - Red	PASS

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "multiple lots of the subject devices (TRO-T and TRO-B chemical indicators)" were used for testing, but does not specify the exact sample size for the test set. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a chemical indicator, not an AI or imaging device requiring human interpretation for ground truth. Therefore, no
experts were used in this context. The "ground truth" is determined by the chemical reaction and concentration of hydrogen peroxide.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since this is a chemical indicator, the ground truth is based on the chemical reaction and color change, not human interpretation. Therefore, no adjudication method was used for a test set in the traditional sense of expert consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a chemical indicator, not intended to assist human readers in interpreting medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This product is a standalone chemical indicator. Its performance is evaluated based on its color change in response to hydrogen peroxide without human interpretation being part of its core function or acceptance criteria.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device is based on chemical reactions and concentrations of hydrogen peroxide. Specifically, the "minimum effective concentration (MEC)" of hydrogen peroxide (1.0 gram of 31.5% hydrogen peroxide) is the key reference point for expected color change.

8. The sample size for the training set

The document does not specify a training set sample size. As a chemical indicator, it likely does not involve machine learning or traditional "training sets" in the same way an AI algorithm would. Its performance is based on the inherent chemical properties and manufacturing consistency.

9. How the ground truth for the training set was established

Since there is no mention of a training set for machine learning, the establishment of ground truth in that context is not applicable. The underlying "ground truth" for the device's function is the known chemical reaction between the indicator ink and hydrogen peroxide at specific concentrations.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 LLC946 Kane StreetSuite AToledo, OH 43612P: 419 476 7119F: 419 470 8899E: info@trueindicating.com
Contacts:	Tom RihaChief Scientific OfficerP: 248 982 6492F: 419 470 8899E: tom.riha@trueindicating.com
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 HospitalRegulation 21 CFR 880.2800
Predicate Devices:(Legally Marketed)	Trophon Chemical Indicator (K103126)
Description of Device:	The device is a qualitative, single use, disc (26 mm in diameter) that has ahydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate(Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). Thehydrogen peroxide sensitive chemical indicating ink has been designed totransition from an initial red color to a signal yellow color when subjected tosources of hydrogen peroxide.
Indications for Use:	The Ultraphon Chemical Indicator is used exclusively for monitoring the HighLevel Disinfection process when placed within the Nanosonics trophon® EPRand trophon® 2 chambers. The color of the Ultraphon Chemical Indicatorchanges from red to yellow when exposed to hydrogen peroxide, the activeingredient used in trophon® EPR and trophon® 2 disinfectant. This occursabove the minimum effective concentration (MEC) established for thissolution.
Operational Principles:	The Ultraphon Chemical Indicator is intended for use within trophon® EPR andtrophon2® HLD systems when processing a single ultrasound probe todemonstrate that the probe has been exposed to a hydrogen peroxide highlevel disinfection cycle and to distinguish between processed and unprocessedcycles.
	The Ultraphon Chemical Indicator will transition from an initial color of red(product codes TRO-T and TRO-B) to a yellow signal color when exposed tohydrogen peroxide at a fixed time and temperature within trophon® EPR andtrophon2® HLD equipment.

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Feature	Subject Device	Predicate Device(K103126)	Comparison
Intended Use	Chemical indicator for trophon®EPR and trophon® 2 High LevelDisinfection	Chemical indicator for trophon®EPR and trophon® 2 High LevelDisinfection	Same
Product Code	JOJ	JOJ	Same
FDARegulation	21 CFR§ 880.2800	21 CFR§ 880.2800	Same
Indications forUse (IFU)	The Ultraphon ChemicalIndicator is used exclusively formonitoring the High LevelDisinfection process whenplaced within the Nanosonicstrophon® EPR and trophon® 2chambers. The color of theUltraphon Chemical Indicatorchanges from red to yellowwhen exposed to hydrogenperoxide, the active ingredientused in trophon® EPR andtrophon® 2 disinfectant. Thisoccurs above the minimumeffective concentration (MEC)established for this solution.	The Trophon Chemical Indicatoris used exclusively for monitoringthe High Level Disinfectionprocess when placed within theTrophon EPR chamber. The colorof the Trophon ChemicalIndicator changes from red toyellow when exposed tohydrogen peroxide, the activeingredient in Trophon EPR-C40disinfectant. This occurs abovethe minimum effectiveconcentration (MEC) establishedfor this solution.	Similar
Device Design	Product Code TRO-T: Tyvek®(26 mm circle) printed with pHreacting chemical indicator inkProduct Code TRO-B: BiaxiallyOriented Polypropylene (BOPP)26 mm circle printed with pHreacting chemical indicator ink	Tyvek® 26 mm circle printed withpH reacting chemical indicator ink	Similar
IndicatorAgent	pH reacting chemical andbackground dye	pH reacting chemical andbackground dye	Same
EndpointSpecification	Yellow	Yellow	Same
MEC	1.0 gram of 31.5% hydrogenperoxide	1.0 gram of 31.5% hydrogenperoxide	Same
End PointStability	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	SubjectDeviceResult
Performance Testing	Determine if the chemicalindicators reach specifiedendpoint color of yellow and a failcolor when exposed to the MECwhen combined with a HLD loadand exposed to the cycle forwhich it is intended according toPremarket Notification [510(k)]Submissions for ChemicalIndicators - Guidance for Industryand FDA Staff and Content andFormat of Premarket Notification[510(k)] Submissions for LiquidChemical Sterilants/High LevelDisinfectants, 2000	Pass result when hydrogen peroxidesolution is above the MEC (signal colorachieved for all product codes) and failcolor when hydrogen peroxide solutionis at MEC achieved when exposed tothe HLD cycle in combination of aworst-case load:trophon® EPR and trophon® 2 HLDSystems	PASS
End Point Stability	Determine the length of time thatan exposed Chemical Indicatorfor hydrogen peroxide retains itspost-exposure signal color perGuidance for Industry and Staff -Chemical Indicator (CI) PremarketNotification [510(k)] Submission	1 month	PASS
Offset/Transference	Demonstrate the chemicalindicators do not bleed or offset tosubstrate which it's appliedaccording to ANSI/AAMI/ISO11140-1:2014 Sterilization ofhealth care products - Chemicalindicators - Part 1: Generalrequirements.	The chemical indicators shall not offsetor bleed, penetrate the substrate towhich it is applied, or materials in whichit is in contact before, during or after thesterilization cycles for which it isdesigned.	PASS
Chemical IndicatorPerformance Testing inthe Presence ofContaminatedUltrasound Probes	Determine exposure color resultsfor product codes TRO-T andTRO-B Chemical Indicators in thepresence of contaminatedultrasound probes, when using aNanosonics trophon® EPR ortrophon®2 High LevelDisinfection unit per Content andFormat of Premarket Notification[510(k)] Submissions for LiquidChemical Sterilants/High LevelDisinfectants, 2000	Hydrogen Peroxide31.5% (1.8g)More yellow than MECHydrogen Peroxide31.5% (1.0g)Equal to MEC or more red	PASS
Color Analysis (X-RiteSpectrophotometer)	Determine the color of ChemicalIndicators when detecting H2O2used in Nanosonics trophon®EPR and trophon®2 High LevelDisinfection (HLD) exposurecycles by using aspectrophotometer for Pass andFail compared to MEC perContent and Format of PremarketNotification [510(k)] Submissionsfor Liquid ChemicalSterilants/High LevelDisinfectants, 2000	More yellow than the MECusing 31.5%, 1.8 grams Equal to or more red thanMEC using 31.5%, 1.0 gram More red than MEC using31.5%, 0.8 grams More Yellow than MEC using31.5%, 1.2 grams	PASS
Sensitivity, Specificity,Accuracy, and Precisionof Performance Data	Performance testing dataanalysis according to thecharacteristics of ComparativeSensitivity, Analytic Sensitivity,Comparative Sensitivity, AnalyticSpecificity, Accuracy, andPrecision for Chemical Indicators	Comparative Sensitivity: > 0.95Analytic Sensitivity (31.5% H2O2):1.8 g H2O2 solution: 0.56 - 0.58 g H2O21.2 g H2O2 solution: 0.37 - 0.39 g H2O21.0 g H2O2 solution: 0.31 – 0.33 g H2O20.8 g H2O2 solution: 0.25 - 0.27 g H2O2Comparative Specificity: > 0.95Accuracy: > 0.95Precision: < 1 ΔΕ using X-RitespectrophotometerAnalytic SpecificityExposure to Bleach Wipe - YellowExposure to Lysol - YellowExposure to IPA (70%) - YellowDry Heat Exposure 100°C, 15 min -RedUV Exposure - 2 hours - Light RedEthylene Oxide Exposure 20 min. 54°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).

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).