(264 days)
Not Found
No
The device is a simple chemical indicator that changes color based on exposure to hydrogen peroxide. There is no mention of any computational analysis, learning, or adaptive capabilities.
No
The device is a chemical indicator used to monitor a high-level disinfection process, not to provide therapy to a patient.
No
The device is a chemical indicator used to monitor the high-level disinfection process of other medical devices, not to diagnose a patient's condition.
No
The device is a physical chemical indicator that changes color based on exposure to hydrogen peroxide, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor a disinfection process for medical devices (ultrasound probes) within a specific chamber (Nanosonics trophon®). It is not used to diagnose a disease, condition, or state of health in a human being.
- Mechanism: The device works by reacting to the presence and concentration of hydrogen peroxide, the active ingredient in the disinfectant. This is a chemical indicator for a process, not a biological or chemical test performed on a human sample.
- Device Description: The description confirms it's a chemical indicator with ink that changes color based on exposure to hydrogen peroxide.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a medical condition, or providing information about a patient's health status.
Therefore, the Ultraphon Chemical Indicator is a process indicator used to verify the effectiveness of a disinfection cycle, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing – Chemical Indicator:
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.
Summary of Nonclinical Testing Table:
- Performance Testing: Determine if the chemical indicators reach specified endpoint color of yellow and a fail color when exposed to the MEC when combined with a HLD load and exposed to the cycle for which it is intended.
- Acceptance Criteria: 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.
- Subject Device Result: PASS
- End Point Stability: Determine the length of time that an exposed Chemical Indicator for hydrogen peroxide retains its post-exposure signal color.
- Acceptance Criteria: 1 month
- Subject Device Result: PASS
- Offset/Transference: Demonstrate the chemical indicators do not bleed or offset to substrate which it's applied.
- Acceptance Criteria: 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.
- Subject Device Result: PASS
- Chemical Indicator Performance Testing in the Presence of Contaminated Ultrasound Probes: Determine exposure color results for product codes TRO-T and TRO-B Chemical Indicators in the presence of contaminated ultrasound probes, when using a Nanosonics trophon® EPR or trophon®2 High Level Disinfection unit.
- Acceptance Criteria:
- Hydrogen Peroxide 31.5% (1.8g): More yellow than MEC
- Hydrogen Peroxide 31.5% (1.0g): Equal to MEC or more red
- Subject Device Result: PASS
- Acceptance Criteria:
- Color Analysis (X-Rite Spectrophotometer): Determine the color of Chemical Indicators when detecting H2O2 used in Nanosonics trophon® EPR and trophon®2 High Level Disinfection (HLD) exposure cycles by using a spectrophotometer for Pass and Fail compared to MEC.
- Acceptance Criteria:
- 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
- Subject Device Result: PASS
- Acceptance Criteria:
- Sensitivity, Specificity, Accuracy, and Precision of Performance Data: Performance testing data analysis according to the characteristics of Comparative Sensitivity, Analytic Sensitivity, Comparative Sensitivity, Analytic Specificity, Accuracy, and Precision for Chemical Indicators.
- Subject Device Result: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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:
§ 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).
0
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"
1
(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
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
| Submitter: | True Indicating LLC
946 Kane Street
Suite A
Toledo, OH 43612
P: 419 476 7119
F: 419 470 8899
E: info@trueindicating.com |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Tom Riha
Chief Scientific Officer
P: 248 982 6492
F: 419 470 8899
E: 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 Hospital
Regulation 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 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. |
| Indications for Use: | 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. |
| Operational Principles: | The Ultraphon Chemical Indicator is intended for use within trophon® EPR and
trophon2® HLD systems when processing a single ultrasound probe to
demonstrate that the probe has been exposed to a hydrogen peroxide high
level disinfection cycle and to distinguish between processed and unprocessed
cycles. |
| | 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 to
hydrogen peroxide at a fixed time and temperature within trophon® EPR and
trophon2® HLD equipment. |
5
| Feature | Subject Device | Predicate Device
(K103126) | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Chemical indicator for trophon®
EPR and trophon® 2 High Level
Disinfection | Chemical indicator for trophon®
EPR and trophon® 2 High Level
Disinfection | Same |
| Product Code | JOJ | JOJ | Same |
| FDA
Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for
Use (IFU) | 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. | The Trophon Chemical Indicator
is used exclusively for monitoring
the High Level Disinfection
process when placed within the
Trophon EPR chamber. The color
of the Trophon Chemical
Indicator changes from red to
yellow when exposed to
hydrogen peroxide, the active
ingredient in Trophon EPR-C40
disinfectant. This occurs above
the minimum effective
concentration (MEC) established
for this solution. | Similar |
| Device Design | Product Code TRO-T: Tyvek®
(26 mm circle) printed with pH
reacting chemical indicator ink
Product Code TRO-B: Biaxially
Oriented Polypropylene (BOPP)
26 mm circle printed with pH
reacting chemical indicator ink | Tyvek® 26 mm circle printed with
pH reacting chemical indicator ink | Similar |
| Indicator
Agent | pH reacting chemical and
background dye | pH reacting chemical and
background dye | Same |
| Endpoint
Specification | Yellow | Yellow | Same |
| MEC | 1.0 gram of 31.5% hydrogen
peroxide | 1.0 gram of 31.5% hydrogen
peroxide | Same |
| End Point
Stability | 1 Month | Not Supplied | Similar |
| Shelf Life | 58 Months | 16 Months | Similar |
Technological Characteristic Comparison Table
6
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
Device
Result |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Performance Testing | Determine if the chemical
indicators reach specified
endpoint color of yellow and a fail
color when exposed to the MEC
when combined with a HLD load
and exposed to the cycle for
which it is intended according to
Premarket Notification [510(k)]
Submissions for Chemical
Indicators - Guidance for Industry
and FDA Staff and Content and
Format of Premarket Notification
[510(k)] Submissions for Liquid
Chemical Sterilants/High Level
Disinfectants, 2000 | 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 | Determine the length of time that
an exposed Chemical Indicator
for hydrogen peroxide retains its
post-exposure signal color per
Guidance for Industry and Staff -
Chemical Indicator (CI) Premarket
Notification [510(k)] Submission | 1 month | PASS |
| Offset/Transference | Demonstrate the chemical
indicators do not bleed or offset to
substrate which it's applied
according to ANSI/AAMI/ISO
11140-1:2014 Sterilization of
health care products - Chemical
indicators - Part 1: General
requirements. | 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 | Determine exposure color results
for product codes TRO-T and
TRO-B Chemical Indicators in the
presence of contaminated
ultrasound probes, when using a
Nanosonics trophon® EPR or
trophon®2 High Level
Disinfection unit per Content and
Format of Premarket Notification
[510(k)] Submissions for Liquid
Chemical Sterilants/High Level
Disinfectants, 2000 | 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) | Determine the color of Chemical
Indicators when detecting H2O2
used in Nanosonics trophon®
EPR and trophon®2 High Level
Disinfection (HLD) exposure
cycles by using a
spectrophotometer for Pass and
Fail compared to MEC per
Content and Format of Premarket
Notification [510(k)] Submissions
for Liquid Chemical
Sterilants/High Level
Disinfectants, 2000 | 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 | Performance testing data
analysis according to the
characteristics of Comparative
Sensitivity, Analytic Sensitivity,
Comparative Sensitivity, Analytic
Specificity, Accuracy, and
Precision for Chemical Indicators
| 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: