Instant 20s Indicator

K210481 · True Indicating, LLC · MTC · Dec 14, 2021 · General Hospital

Device Facts

• Record ID: K210481
• Device Name: Instant 20s Indicator
• Applicant: True Indicating, LLC
• Product Code: MTC · General Hospital
• Decision Date: Dec 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121℃, 30 minutes (Gravity) 132°C, 4 minutes (Pre-Vacuum) 135°C, 3 minutes (Pre-Vacuum)

Device Story

The Instant 20s Indicator is a biological enzyme indicator used to monitor saturated steam sterilization efficacy. The device consists of a polycarbonate vial, polypropylene cap, silicone vented base, vinyl sealant, and a biological tablet containing enzymes from Geobacillus stearothermophilus. The user places the indicator in the most difficult area to sterilize within a load. Following the sterilization cycle, the user detaches the base and applies an included Indicator Solution dropwise to the tablet. The device relies on a biochemical reaction between the tablet's enzymes and the solution's co-enzymes. The user observes the tablet for 20 seconds; a color shift from off-white to red indicates an ineffective sterilization cycle, while the absence of color change indicates an effective cycle. The device provides immediate visual feedback to healthcare personnel, allowing for rapid verification of sterilization efficacy before equipment use, thereby reducing the risk of using improperly sterilized instruments.

Clinical Evidence

Bench testing only. Testing included resistance characteristic studies (D-value, z-value, survival/kill windows per ISO 11138-1/3), hold time assessment (72 hours), simulated use (full, half, and abbreviated cycles), chemical indicator performance (ISO 11140-1), and in vitro cytotoxicity (ISO 10993-5). All tests met acceptance criteria, confirming the device's ability to monitor sterilization efficacy across the claimed temperature and time parameters.

Technological Characteristics

Polycarbonate vial, polypropylene cap, silicone vented cap, vinyl sealant, and biological tablet (Geobacillus stearothermophilus ATCC 7953). Operates via enzymatic reaction with co-enzyme solution. Complies with ISO 11138-1, ISO 11138-3, and ISO 11140-1 standards. Standalone, non-electronic, visual indicator.

Indications for Use

Indicated for monitoring saturated steam sterilization processes (121°C gravity, 132°C/135°C pre-vacuum) in healthcare settings. No specific patient population age or gender restrictions.

Regulatory Classification

Identification

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

Predicate Devices

• Sportrol Rapid Sterility Indicator (K962649)

Submission Summary (Full Text)

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December 14, 2021

True Indicating LLC Thomas Riha CSO 946 Kane St Toledo, Ohio 43612

Re: K210481

Trade/Device Name: Instant 20s Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: MTC Dated: November 8, 2021 Received: November 8, 2021

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K210481

Device Name Instant 20s Indicator

Indications for Use (Describe)

The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at:

121℃, 30 minutes (Gravity) 132°C, 4 minutes (Pre-Vacuum) 135°C, 3 minutes (Pre-Vacuum)

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submitter: | True Indicating LLC<br>946 Kane Street<br>Suite A<br>Toledo, OH 43612<br>P: 419 476 7119<br>F: 419 470 8899<br>E: [e-mail] |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Tom Riha<br>Chief Scientific Officer<br>P: 248 982 6492<br>F: 419 470 8899<br>E: [e-mail]<br>Julie Wheeler<br>President and Chief Operations Officer<br>P:419 304 6535<br>F: 419 470 8899<br>[e-mail] |
| Prepared on: | December 13, 2021 |
| Device Name: | Instant 20s Indicator |
| Classification: | Class II Medical Device, FDA Product Code MTC, General Hospital |
| Predicate Devices:<br>(Legally Marketed) | Sportrol Rapid Sterility Indicator, K962649 |
| Description of Device: | The True Indicating Instant 20s Indicator consists of a polycarbonate vial,<br>polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant,<br>and a biological tablet produced using cellulose, and enzymes from Geobacillus<br>stearothermophilus ATCC® 7953. |
| Indications for Use: | The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme<br>indicator, is used for monitoring saturated steam sterilization processes operating<br>at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3<br>minutes (Pre-Vacuum). |
| Operational<br>Principles: | Place an Instant 20s Indicator in the most difficult area to sterilize in a load.<br>When the cycle is complete, the Instant 20s Indicator is removed and the base is<br>detached to gain access to the biological tablet. The Indicator Solution supplied<br>with the Instant 20s Indicator is applied dropwise onto the biological tablet to<br>activate.<br><br>The activated Instant 20s Indicator should be immediately viewed for a minimum<br>of 20 seconds to determine the efficacy of the sterilization cycle. Ineffective<br>cycles are indicated by a color shift of the biological tablet from off-white to a<br>shade of red. The absence of a red color change indicates the cycle was<br>effective. After 20 seconds, verify the color of the activated biological tablet and<br>immediately discard the tablet. |

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## Technological Characteristic Comparison Table

| Feature | Subject Device<br>Instant 20s Indicator<br>(K210481) | Predicate<br>Sportrol Rapid Sterility<br>Indicator (K962649) | Comparison |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use:<br>Method of<br>Sterilization | 121°C, 30 minutes (Gravity)<br>132°C, 4 minutes (Pre-Vac)<br>135°C, 3 minutes (Pre-Vac) | 121°C (Gravity) no stated time<br>132°C (Pre-Vac) no stated time<br>134°C (Pre-Vac) no stated time | Similar |
| Product Code | MTC | MTC | Same |
| FDA<br>Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for<br>Use (IFU) | The True Indicating Instant 20s<br>Indicator, a multiple, interactive,<br>bacterial enzyme indicator, is<br>used for monitoring saturated<br>steam sterilization processes<br>operating at: 121°C, 30 minutes<br>(Gravity), 132°C, 4 minutes (Pre-<br>Vacuum), 135°C, 3 minutes<br>(Pre-Vacuum) | The RSI Rapid Indicator, a<br>multiple, interactive, bacterial<br>enzyme indicator, is used for<br>monitoring saturated steam<br>sterilization processes<br>operating at 121°C gravity,<br>132°C vacuum assisted, 134°C<br>vacuum assisted cycles. | Similar |
| Mechanism of<br>Action | Enzymes, from Geobacillus<br>stearothermophilus, react with<br>Indicator Solution which consist<br>of co-enzymes. The co-enzymes<br>react with viable enzymes<br>present in the tablet to produce a<br>visual color change | Enzymes, from Geobacillus<br>stearothermophilus, react with<br>Indicator Solution which consist<br>of co-enzymes. The co-<br>enzymes can react with viable<br>enzymes present in the tablet to<br>produce a visual color change | Same |
| Modified<br>Survival Time | 121°C for 5 minutes 132°C for<br>20 seconds<br>Calculated = 121°C, ≥ 5.1 min<br>Calculated = 132°C, ≥ 1.0 min<br>Calculated = 135°C, ≥ 40 sec | 121°C for 5 minutes<br>132°C for 20 seconds<br>Calculated = Not Applicable | Similar |
| Feature | Subject Device<br>Instant 20s Indicator for Steam<br>(K210481) | Predicate<br>Sportrol Rapid Sterility<br>Indicator (K962649) | Comparison |
| Modified<br>Kill Time | 121°C for 15 minutes 132°C for<br>3 minutes<br><br>Calculated = 121°C, $<$ 15.3 min<br>Calculated = 132°C, $<$ 1.8 min<br>Calculated = 135°C, $<$ 1.35 min<br><br>Color change of Tablet was<br>observed in response to<br>enzymatic activity following the<br>provided time points at the<br>indicated temperatures | 121°C for 15 minutes<br>132°C for 3 minutes<br><br>Calculated = Not Applicable | Similar |
| Vial Label | Film label with Lot Number and<br>Expiration Date | Paper label with Lot Number<br>and expiration date and<br>chemical indicator that<br>transitions from Violet to Green | Similar |
| Shelf Life | Tablet = 13 Months Indicator<br>Solution = 13 months | Tablet = 12 Months<br>Indicator Solution = 12 Months | Similar |
| End Point<br>Stability of<br>Positive<br>Result Color | 7 Days | Not Applicable | Similar |
| End Point<br>Stability of<br>Negative<br>Result Color | 30 minutes | Not Applicable | Similar |

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#### Summary of Nonclinical Tests:

Per FDA recognized consensus standards and guidance documents, testingwas performed for steam sterilization processes using multiple lots of True Indicating Instant 20s Indicator over the range of the shelf life:

- Resistance Characteristic Studies were conducted including D value per ISO 11138-1 Annex D and ISO 11138-3 Annex A z value per ISO 11138-3 Annex B, and Survival/Kill Windows per ISO 11138-1 Annex E
- . Hold Time Assessment was evaluated for a period of 72-hours per Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions Section 7.D. Holding Time Assessment and True Indicating Protocol
- Simulated Use Full, Half, and Abbreviated Exposure Cycles were . tested per Guidance for Industry and FDA Staff Biological Indicator(BI) Premarket Notification [510(k)] Submissions Section 7 and True Indicating Protocols
- . Chemical Indicator Performance per ISO 11140-1:2014 and FDA Staff Chemical Indicator (CI) Premarket Notification [510(k)]Submissions
- . Biocompatibility (in Vitro Cytotoxicity) per ISO 10993-5:2009

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## K210481

## Summary of Nonclinical Testing - Instant 20s Indicator

Testing was conducted on the Instant 20s Indicator following the FDA quidance and standards below:

- Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification(510(k)] . Submissions, October 4, 2007
- . Guidance for Industry and FDA Staff, Premarket Notification [510(k)] Submissions for Chemical indicators, December 19, 2003
- . ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General requirements
- . ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3:Biological indicators for moist heat sterilization processes
- United Sates Pharmacopeia, <55> Biological Indicators Resistance Performance Tests ●
- . ISO 11140-1:2014 Sterilization of healthcare products – Chemical indicators - Part 1: General requirements
- . ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

## Summary of Nonclinical Testing Table

| Name of Test | Purpose and Guidance<br>Document/Standard | Acceptance Criteria | Subject Device Result |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| D value<br>Based on<br>Enzymatic<br>Activity | Determine the resistance<br>of the Instant 20s Indicator<br>following ISO<br>11138-1 and 11138-3 | D121 ≥ 1.5 min<br>D132 ≥ 10 s D135 ≥ 8 s | PASS<br>D121 ≥ 1.7 min<br>D132 ≥ 12 s<br>D135 ≥ 12 s |
| z value<br>Based on<br>Enzymatic<br>Activity | Determine the z-value of<br>the Instant 20s Indicator<br>per ISO 11138-1 and<br>11138-3 | ≥10 | PASS<br>≥13.6 |
| Survival Time<br>Based on<br>Enzymatic<br>Activity | Determine the exposure<br>time for all Instant 20s<br>Indicator to retain viable<br>spores (Survival Time) per<br>ISO 11138-1, 11138-3 and<br>Guidance for Industry and<br>Staff - Biological Indicator<br>(BI) Premarket Notification<br>[510(k)] Submission | Meets the longer of<br>FDA and ISO 11138-3<br>requirements | PASS<br>121°C ≥ 5.1 min<br>132°C ≥ 1.0 min<br>135°C ≥ 40 sec |
| Kill Time<br>Based on<br>Enzymatic<br>Activity | Determine the exposure<br>time for all Instant 20s<br>Indicator to inactivate all<br>spores (Kill Time) per ISO<br>11138-1,11138-3 and<br>Guidance for Industry and<br>Staff - Biological Indicator<br>(BI) Premarket Notification<br>[510(k)] Submission | Meets the shorter of<br>FDA and ISO 11138-3<br>requirements | PASS<br>121°C ≤ 15.3 min<br>132°C ≤ 1.8 min<br>135°C ≤ 1.8 min |
| Hold Time | Determine the length of<br>time that an exposed<br>Instant 20s Indicator can<br>be held before incubation<br>(Hold Time) per Guidance<br>for Industry and Staff –<br>Biological Indicator (BI)<br>Premarket Notification<br>[510(k)] Submission | Performance not<br>affected if used within<br>72 hours of exposure to<br>steam sterilization | PASS |
| Growth<br>Inhibition | Determine if positive result<br>is achieved when primary<br>packaging is subject to<br>worst case steam<br>exposure per Guidance for<br>Industry and Staff –<br>Biological Indicator (BI)<br>Premarket Notification<br>[510(k)] Submission | 100% Positive Results | Pass |
| Shelf Life | Resistance and<br>Survival/Kill must meet<br>above criteria at each<br>stability time point per ISO<br>11138-1, 11138-3 and<br>Guidance for Industry and<br>Staff - Biological Indicator<br>(BI) Premarket Notification<br>[510(k)] Submission | D value = see above<br>Survival = see above<br>Kill = see above | PASS |
| Chemical<br>Indicator<br>Performance | Determine the pass/fail<br>criteria for each critical<br>cycle parameter and<br>provide the pass/fail<br>results to show how the<br>chemical indicator reacts<br>to all the critical<br>parameters in the<br>sterilization cycle for which<br>it is intended according to<br>ANSI/AAMI/ISO<br>11140-1:2014 Sterilization | Pass result at Stated<br>Value for each<br>temperature claimed:<br><br>121°C, 30 minutes<br>(Gravity)<br>132°C, 3 minutes<br>(Pre-Vac)<br>135°C, 3 minutes<br>(Pre-Vac) | PASS |
| | of health care products -<br>Chemical indicators - Part<br>1: General requirements<br>and Guidance for Industry<br>and FDA Staff - Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators | Fail Result at 15% less<br>time and -1°C of Stated<br>Value | PASS |
| Endpoint<br>Stability of<br>Positive<br>Result Color | Determine the endpoint<br>stability of developed color<br>due to a positive result<br>(failure) per Guidance for<br>Industry and FDA Staff -<br>Premarket Notification<br>[510(k)] Submissions for<br>Chemical Indicators | 7 Days | PASS |
| | | | |
| Endpoint<br>Stability of<br>Negative<br>Result Color | Determine the endpoint<br>stability of color due to a<br>negative result (pass) per<br>Guidance for Industry and<br>FDA Staff - Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators | 30 Minutes | PASS |
| Simulated<br>Use | Determine the simulated<br>use of the Instant 20s<br>Indicator in a sterilizer per<br>Guidance for Industry and<br>FDA Staff - Biological<br>Indicator (BI) Premarket<br>Notification [510(k)]<br>Submission | Demonstrates a survival<br>(positive) result when<br>exposed to abbreviated<br>cycle, and all kill<br>(negative) in full and<br>half cycles | PASS<br>Abbreviated cycles -<br>positive<br>Half cycles - negative<br>Full cycles - negative |

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| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------|
| Biocompatibility<br>(In Vitro<br>Cytotoxicity) | To determine if the<br>device is cytotoxic to<br>mammalian cells in<br>vitro | Under conditions of<br>the study, did not<br>show potential<br>toxicity to L-929<br>cells. | PASS |

## Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210481, Instant 20s Indicator, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K962649.