(260 days)
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to dark), all turn a permanent dark brown/black color when exposed to high temperature steam.
Paper Strip printed with Bismuth based chemical indicator ink with polyester overlaminate applied over the entire indicating ink strip
The provided text describes the acceptance criteria and the results of nonclinical tests for a chemical indicator for steam sterilization, not an AI/ML-based device. Therefore, many of the requested points, such as MRMC studies, number of expert readers, adjudication methods, and training set information, are not applicable.
Here's an analysis of the provided information concerning the acceptance criteria and performance of the Chemical Indicator for Steam (K220778):
Device: Chemical Indicator for Steam (K220778)
Type: Chemical Indicator
Purpose: To demonstrate that individual materials (pouches, packs, trays) have been exposed to a steam sterilization process, distinguishing between processed and unprocessed goods.
1. A table of acceptance criteria and the reported device performance:
| Name of Test | Purpose | Acceptance Criteria | Reported Device Performance (Subject Device Result) |
|---|---|---|---|
| Steam Resistometer Testing | To test the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical indicator reacts to the critical parameters in the sterilization cycle for which it is intended. | Pass result (signal color achieved for all product codes) at the value for each temperature claimed:- 121°C for 10 minutes- 134°C for 2 minutes- 135°C for 2 minutesFail result (signal color not achieved for all product codes) at the value for each temperature claimed:- 121°C for 2 minutes- 134°C for 0.3 minutes- 135°C for 0.3 minutes | PASS |
| Hospital Steam Sterilizer Testing | Determine if the chemical indicators reach specified endpoint color of dark brown/black when combined with a sterilization load and exposed to the sterilization cycle for which it is intended. | Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load:- Gravity: 121°C/250 F - 30 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 132°C/270 F - 3 minutes (unwrapped/nonporous)- Vacuum assisted (prevacuum): 132°C/270 F - 4 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 134°C/273 F - 4 minutes (wrapped/porous)- Vacuum assisted (prevacuum): 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load) | PASS |
| Dry Heat Testing | Demonstrate that the Chemical Indicator for Steam does not change color following a dry heat cycle. | Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of time that an exposed Chemical Indicator for Steam retains its post-exposure signal color. | 1 Month | PASS |
| Offset/Transference | Demonstrate the chemical indicators do not bleed or offset to the substrate to which it's applied. | 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 using "multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life."
- Specific numerical sample sizes for each test (e.g., number of indicators per lot, number of cycles) are not provided in the given text.
- The data provenance is from nonclinical laboratory testing following FDA guidance and relevant ISO standards (ISO 11140-1:2014) for the performance of chemical indicators. It is not patient data; rather, it is performance data of the physical device under controlled laboratory conditions simulating sterilization processes. The location of the testing is not explicitly stated as a country but is likely within the US given the FDA submission. The nature of the testing is experimental/prospective, as it involves putting the indicators through specific sterilization cycles and observing their color change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a chemical indicator that undergoes a physical color change (yellow/pink/blue to dark brown/black) in response to steam exposure. The ground truth (whether the indicator changed color correctly) is determined by direct observation of the physical chemical reaction, not by expert interpretation of complex medical images or data. No human experts are involved in establishing the ground truth for the performance of the chemical indicator itself. The "experts" would be the laboratory technicians or scientists conducting the tests according to the defined protocols and visually confirming the color change.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are relevant for human interpretation tasks, especially in medical imaging where inter-reader variability exists. For a chemical indicator, the color change is a physical phenomenon intended to be unambiguous. The "ground truth" is the presence or absence of the expected color change based on exposure to the specified steam conditions.
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:
- This question is not applicable. An MRMC study is relevant for AI/ML-based devices assisting human readers in diagnostic tasks. This device is a passive chemical indicator, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a chemical indicator, not an algorithm. Its performance is inherent to its chemical composition and design, observed directly as a color change.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth is established by the physical and chemical properties of the indicator and the controlled steam sterilization conditions to which it is exposed.
- For "pass" criteria, the ground truth is that the indicator was exposed to the required steam conditions (temperature, time) and should show the signal color change.
- For "fail" criteria (e.g., inadequate exposure, dry heat), the ground truth is that the indicator was not exposed to the required conditions to trigger a full color change (or was exposed to conditions it should not react to) and should not show the signal color.
- The "ground truth" for End Point Stability and Offset/Transference is the observable physical property of the indicator maintaining its color and not bleeding.
8. The sample size for the training set:
- This question is not applicable. This is a physical chemical indicator, not a machine learning model; therefore, it does not have "training data" in the sense of an AI algorithm. Its performance is based on its intrinsic chemical formulation and manufacturing quality.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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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.
December 2, 2022
True Indicating LLC Thomas Riha Chief Scientific Officer 946 Kane St Toledo, Ohio 43612
Re: K220778
Trade/Device Name: Chemical Indicator for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 12, 2022 Received: November 1, 2022
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Christopher K. Dugard -S
for Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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
510(k) Number (if known) K220778
Device Name Chemical Indicator for Steam
Indications for Use (Describe)
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
| 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.comJulie WheelerPresidentP:419 304 6535F: 419 470 8899julie.wheeler@trueindicating.com |
| Prepared on: | November 28, 2022 |
| Device Name: | Chemical Indicator for Steam |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital |
| Predicate Devices:(Legally Marketed) | Lead-free Chemical Indicators for Steam Sterilization (K181788) |
| Description of Device: | The True Indicating Lead-Free Chemical Indicator for Steam product codesCSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue todark), all turn a permanent dark brown/black color when exposed to hightemperature steam. |
| Indications for Use: | The Chemical Indicator for Steam is intended for use with individual materials(i.e. pouches, packs, trays) to demonstrate the material has been exposed to asteam sterilization process to distinguish between processed and unprocessedgoods.The Chemical Indicator for Steam can transition from an initial color of yellow andturn to a dark brown/black color for Product Code: CSYN-US, pink to a darkbrown/black color for Product Code: CSPN-US, and blue to a dark brown/blackcolor for Product Code: CSBN-US when exposed to high temperature steam atthe following time and temperature intervals as process indicators:Gravity: 121°C/250 F - 30 minutes (wrapped/porous)Pre-vacuum: 132°C/270 F - 3 minutes (unwrapped/nonporous)Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)Pre-vacuum: 134°C/273 F - 4 minutes (wrapped/porous)Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load) |
| OperationalPrinciples: | The Chemical Indicator for Steam is intended for use with individual units, (e.g.packs, containers) to demonstrate that the goods have been exposed to a steamsterilization process and to distinguish between processed and unprocessedgoods |
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Technological Characteristic Comparison Table
| Feature | Subject Device(K220778) | Predicate Device(K181788) | Comparison |
|---|---|---|---|
| Intended Use | Process indicator for steamsterilization | Process indicator for steamsterilization | Same |
| Product Code | JOJ | JOJ | Same |
| Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications forUse (IFU) | The Chemical Indicator forSteam is intended for use withindividual materials (i.e.pouches, packs, trays) todemonstrate the material hasbeen exposed to a steamsterilization process todistinguish between processedand unprocessed goods.The Chemical Indicator forSteam can transition from aninitial color of yellow and turn toa dark brown/black color forProduct Code: CSYN-US, pinkto a dark brown/black color forProduct Code: CSPN-US, andblue to a dark brown/black colorfor Product Code: CSBN-USwhen exposed to hightemperature steam at thefollowing time and temperatureintervals as process indicators:Gravity: 121°C/250 F - 30minutes (wrapped/porous)Pre-vacuum: 132°C/270 F -3 minutes (unwrapped/nonporous)Prevacuum: 132°C/270 F -4 minutes (wrapped/porous)Prevacuum: 134°C/273 F -4 minutes (wrapped/porous)Prevacuum: 135°C/275 F -3 minutes (wrapped/porous andunwrapped/nonporous, mixedload) | The Kem Medical Lead-freeChemical Indicators for SteamSterilization are designed for useby a health care provider todemonstrate that the unit or loadhas been exposed to a steamsterilization process, and todistinguish between processedand unprocessed units or loads.Use the Kem Medical Lead-freeChemical Indicators for SteamSterilization in the validatedsteam sterilization processesdescribed below:Gravity: 121°C/250 F - 30 minutes(wrapped/porous)Gravity: 132°C/270 F - 3 minutes(unwrapped/nonporous)Gravity: 132°C/270 F - 15 minutes(wrapped/porous)Gravity: 135°C/275 F - 3 minutes(unwrapped/nonporous)Gravity: 135°C/275 F - 10 minutes(wrapped/porous orunwrapped/nonporous, mixedload) Vacuum assisted(prevacuum): 132°C/270 F - 3minutes (unwrapped/nonporous)Vacuum assisted (prevacuum):132°C/270 F - 4 minutes(wrapped/porous)Vacuum assisted (prevacuum):134°C/273 F - 4 minutes(wrapped/porous)Vacuum assisted (prevacuum):135°C/275 F - 3 minutes(wrapped/porous orunwrapped/nonporous, mixedload) | Similar |
| Device Design | Paper Strip printed withBismuth based chemicalindicator ink with polyesteroverlaminate applied overthe entire indicating ink strip | Paper dot/strip/card printedwith bismuth sulfide basedchemical indicator ink | Similar |
| Feature | Subject Device(K220778) | Predicate Device(K181788) | Comparison |
| IndicatorAgent | Bismuth based chemical to yieldcolor transition | Bismuth based chemical to yieldcolor transition | Same |
| EndpointSpecification | Dark brown/black color change | Dark brown/black color change | Same |
| End PointStability | 1 Month | 6 Months | Similar |
| Shelf Life | 30 Months | 12 Months | Similar |
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Summary of Nonclinical Tests:
Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes usinq multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life:
- Performance Exposure Studies were conducted per ISO 11140-1
- . End Point Stability of the achieved signal color was evaluated for a period of days 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 utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
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Summary of Nonclinical Testing – Chemical Indicator for Steam
Testing was conducted on the Chemical Indicator for Steam following the FDA guidance 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
| Name of Test | Purpose | Acceptance Criteria | SubjectDeviceResult |
|---|---|---|---|
| SteamResistometerTesting | To test the pass/failcriteria for each criticalcycle parameter andprovide the pass/failresults to show how thechemical indicator reactsto the critical parametersin the sterilization cycle forwhich it is intendedaccording toANSI/AAMI/ISO 11140-1:2014 Sterilization ofhealth care products -Chemical indicators - Part1: General requirementsand Premarket Notification[510(k)] Submissions forChemical Indicators -Guidance for Industry andFDA Staff. | Pass result (signal colorachieved for all product codes)at the value for eachtemperature claimed:121°C for 10 minutes134°C for 2 minutes135°C for 2 minutesFail result (signal color notachieved for all product codes)at the value for eachtemperature claimed:121°C for 2 minutes134°C for 0.3 minutes135°C for 0.3 minutes | PASS |
| HospitalSteamSterilizerTesting | Determine if the chemicalindicators reach specifiedendpoint color of darkbrown/black whencombined with asterilization load andexposed to the sterilizationcycle for which it isintended according toPremarket Notification[510(k)] Submissions forChemical Indicators -Guidance for Industry andFDA Staff. | Pass result (signal color achieved forall product codes) at the value foreach temperature claimed incombination of a sterilization load:• Gravity: 121°C/250 F - 30 minutes(wrapped/porous)• Vacuum assisted(prevacuum): 132°C/270 F -3 minutes(unwrapped/nonporous)• Vacuum assisted(prevacuum): 132°C/270 F -4 minutes (wrapped/porous)• Vacuum assisted (prevacuum):134°C/273 F - 4 minutes(wrapped/porous)• Vacuum assisted (prevacuum):135°C/275 F - 3 minutes(wrapped/porous and | PASS |
| Name of Test | Purpose | Acceptance Criteria | SubjectDeviceResult |
| Dry Heat Testing | Demonstrate that theChemical Indicator forSteam does not changecolor following a dryheat cycle according toANSI/AAMI/ISO 11140-1:2014 Sterilization ofhealth care products -Chemical indicators -Part 1: Generalrequirements andPremarket Notification[510(k)] Submissionsfor Chemical Indicators -Guidance for Industryand FDA Staff | Fail result when exposed todry heat alone for 30 minutes(±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length oftime that an exposedChemical Indicator forSteam retains its post-exposure signal colorper Guidance forIndustry and Staff -Chemical Indicator (CI)Premarket Notification[510(k)] Submission | 1 Month | PASS |
| Offset/Transference | Demonstrate thechemical indicators donot bleed or offset tosubstrate which it'sapplied according toANSI/AAMI/ISO 11140-1:2014 Sterilization ofhealth care products -Chemical indicators -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 |
Summary of Nonclinical Testing Table
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Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K220778, the Chemical Indicator for Steam, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K181788.
§ 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).