(119 days)
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.
The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).
The provided document describes the acceptance criteria and study results for the True Indicating Type 5 Integrating Indicator for Steam (CSPN-15). This device is a chemical indicator designed to monitor steam sterilization cycles.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Acceptance Criteria | Subject Device Result |
|---|---|---|
| Steam Resistometer Testing | Pass result (end signal color achieved for all product codes) at the value for each temperature claimed:121°C for 16.5 minutes132°C for 2.0 minutes134°C for 1.4 minutes135°C for 1.2 minutesFail result (end signal color not achieved) at the value for each temperature claimed:120°C for 14.025 minutes131°C for 1.7 minutes133°C for 1.19 minutes134°C for 1.02 minutesIntegrator temperature coefficient: 10 - 27 °CCorrelation coefficient: ≥ 0.9 | PASS |
| Hospital Steam Sterilizer Testing | Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load: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. | PASS |
| Dry Heat Testing | Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | 6 Months | PASS |
| Side-by-Side Testing with a Biological Indicator | Chemical Integrator does not reach endpoint before BIs are inactivated. | 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 |
2. Sample size used for the test set and the data provenance
The document states that "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". Specific numerical sample sizes for each test are not explicitly provided in this summary. The data provenance is derived from nonclinical tests conducted by or for True Indicating, LLC, following FDA and ISO guidelines. The context suggests prospective testing specific to the device's development and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for chemical indicators is established by objective physical and chemical measurements (e.g., specific temperatures, times, and presence/absence of steam for sterilization cycles, and color change observation). There is no mention of human experts being used to establish ground truth for this type of device.
4. Adjudication method for the test set
Not applicable. This device is a chemical indicator, and its performance is assessed by objective chemical/physical reactions and visual color changes, rather than subjective interpretation requiring adjudication.
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
Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The testing performed on the chemical indicator (Type 5 Integrating Indicator for Steam CSPN-15) is a standalone evaluation of its performance without human-in-the-loop interaction for interpretation, except for visual confirmation of the color change. The indicator itself is designed to provide a direct visual output.
7. The type of ground truth used
The ground truth used for this chemical indicator is based on:
- Physical and Chemical Parameters: Precisely controlled steam sterilization conditions (temperature, time, and steam presence) established in resistometers and hospital sterilizers.
- Biological Indicator Inactivation: For the "Side-by-Side Testing with a Biological Indicator," the ground truth for successful sterilization is the inactivation of biological indicators (BIs), which contain a known population of resistant bacterial spores. The chemical indicator's performance is compared against this biological standard.
- Color Change: The specific, objectively defined color change from pink to dark brown/black that indicates successful exposure to sterilization parameters.
8. The sample size for the training set
Not applicable. This is a chemical indicator, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not utilize a training set in the way an AI model would.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 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: | 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:(Legally Marketed) | Terragene Integron® IT26-1YS (K191021) |
| Device Description: | The True Indicating Chemical Indicator for Steam CSPN-15 consists of a whitepolyester substrate with acrylic adhesive married to a paper substrate. Thepaper substrate (with acrylic adhesive) has True Indicating water-based steamindicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed.After printing, the top layer of the Type 5 Integrating Indicator strip is coveredwith a clear colorless polyester laminate with acrylic adhesive. The IntegratingIndicators have been designed for Steam sterilization processes, ensuring theeffectiveness of sterilization by monitoring all critical process variables (time,temperature and steam). The pink indicating ink was developed to turn to darkand conceal the word "NOT" when a theoretical spore population reaches its killtime, indicating integration condition has been reached. This condition iscalibrated with the kill time of a 105 Geobacillus stearothermophilus sporepopulation, calculated in BIER (Biological Indicator Evaluator Resistometer). |
| Indications for Use: | The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designedto chemically react over time with the critical parameters of steam sterilizationcycle within a specified tolerance. The integrating indicator strip is intended to beplaced in each pack, pouch, container, tray or other containment device tofunction as an independent monitor of critical parameters for the followingsterilization cycles: |
| Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; | |
| Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3minutes. | |
| 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 |
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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 DeviceTrue Indicating Type 5 IntegratingIndicator for Steam CSPN-15 | Predicate DeviceTerragene Integron® IT26-1YS(K191021) | Comparison |
|---|---|---|---|
| Intended Use | Integrating indicator for steamsterilization | Integrating indicator for steamsterilization | Identical |
| Product Code | JOJ | JOJ | Identical |
| FDARegulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Identical |
| Indications forUse (IFU) | The True Indicating Type 5 IntegratingIndicator for Steam CSPN-15 isdesigned to chemicallyreact over time with the criticalparameters of steam sterilization cyclewithin a specified tolerance. Theintegrating indicator strip is intended tobe placed in each pack, pouch,container, tray or othercontainment device to function as anindependent monitor of criticalparameters for the followingsterilization cycles:Gravity Displacement: 121° C for 30minutes, 132° C for 15 minutes, 132°C for 25 minutes, 132° C for 3minutes, 132° C for 10 minutes;Dynamic Air Removal (VacuumAssist): 132° C for 4 minutes, 135° Cfor 3 minutes.Minimum Stated Values as determinedin a resistometer:SV121°C/16.5 min., SV132°C/2.0min,SV134°C/1.4 min. SV135°C/1.2 min. | The integrator Terragene Integron®IT26-1YS is designed to chemicallyreact over time with the criticalparameters of steam sterilization cyclewithin a specified tolerance. Theintegrating indicator strip is intended tobe placed in each pack, pouch,container, tray or other containmentdevice to function as an independentmonitor of critical parameters for thefollowing sterilization cycles:Gravity Displacement: 121° C for 30minutes, 132° C for 15 minutes, 132° Cfor 25 minutes, 135° C for 10 minutes;Dynamic Air Removal (Vacuum Assist):132° C for 4 minutes, 135° C for 3minutes.SV121° C/16.5 min. SV132° C/2.0 min,SV135° C/1.2 min. | Similar |
| Device Design | Paper Strip printed with pinkchemical indicator ink with polyesteroverlaminate applied over the top ofthe indicating ink strip | Paper strip printed with yellowchemical indicator ink with polyesteroverlaminate applied over the top ofthe indicating ink strip | Similar |
| IndicatorAgent | Sulfide based chemical to yieldcolor transition | Sulfide based chemical to yieldcolor transition | Similar |
| EndpointSpecification | Dark brown/black color change | Dark brown/black color change | Identical |
| End PointStability | 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 | SubjectDeviceResult |
|---|---|---|---|
| SteamResistometerTesting | To identify and test thepass/fail criteria for eachcritical parameter andprovide the pass/fail resultsto show how the Type 5Integrating Indicator reactsto the critical parameters inthe sterilization cycle forwhich it is intendedaccording to ANSI/AAMI/ISO11140-1:2014 Sterilizationof health care products -Chemical indicators - Part 1:General requirements andPremarket Notification[510(k)] Submissions forChemical Indicators -Guidance for Industry andFDA Staff. Integratortemperature coefficient andcorrelation coefficient arecalculated to confirmalignment to biologicalindicator performance. | Pass result (end signal colorachieved for all productcodes) at the value for eachtemperature claimed:121°C for 16.5 minutes132°C for 2.0 minutes134°C for 1.4 minutes135°C for 1.2 minutesFail result (end signal colornot achieved) at the valuefor each temperatureclaimed:120°C for 14.025 minutes131°C for 1.7 minutes133°C for 1.19 minutes134°C for 1.02 minutesIntegrator temperaturecoefficient | PASS |
| 10 - 27 °CCorrelation coefficient$\geq$ 0.9 | PASS | ||
| Hospital SteamSterilizer Testing | Determine if the Type 5Integrating indicator reachspecified endpoint color ofdark brown/black whencombined with a sterilizationload and exposed to thesterilization cycle for which itis intended according toPremarket Notification[510(k)] Submissions forChemical Indicators -Guidance for Industry andFDA Staff. | Pass result (signal color achievedfor all product codes) at the valuefor each temperature claimed incombination of a sterilization load:Gravity Displacement: 121° C for30 minutes, 132° C for 15minutes, 132° C for 25 minutes,132° C for 3 minutes, 135° C for10 minutes;Dynamic Air Removal (VacuumAssist): 132° C for 4 minutes,135° C for 3 minutes. | PASS |
| Dry Heat Testing | Demonstrate that theChemical Indicator for Steamdoes not change colorfollowing a dry heat cycleaccording to ANSI/AAMI/ISO11140-1:2014 Sterilization ofhealth care products -Chemical indicators - Part 1:General requirements andPremarket Notification [510(k)]Submissions for ChemicalIndicators - Guidance forIndustry and FDA Staff | Fail result when exposed to dryheat alone for 30 minutes (±1minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of timethat an exposed ChemicalIndicator for Steam retainsits post-exposure signalcolor per Guidance forIndustry and Staff -Chemical Indicator (CI)Premarket Notification[510(k)] Submission | 6 Months | PASS |
| Side-by-Side Testingwith a BiologicalIndicator | Confirm Integrators areparallel (or more robust) inperformance to biologicalindicators (BI). | Chemical Integrator does notreach endpoint before Bls areinactivated | PASS |
| Offset/Transference | Demonstrate the chemicalindicators do not bleed oroffset to substrate which it'sapplied according toANSI/AAMI/ISO 11140-1:2014 Sterilization of healthcare products - Chemicalindicators - Part 1: Generalrequirements. | The chemical indicators shallnot offset or bleed, penetratethe substrate to which it isapplied, or materials in which itis in contact before, during orafter the sterilization cycles forwhich 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.
§ 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).