(259 days)
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).
The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.
The provided document is a 510(k) premarket notification for a medical device: the True Indicating Self-Contained Biological Indicator. This device is a biological indicator used to monitor the efficacy of steam sterilization processes. The document outlines the device's characteristics, intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
It's crucial to understand that this document describes the validation of a physical, in-vitro biological indicator, not an AI-powered diagnostic device or software. Therefore, many of the requested fields related to AI/MRMC studies, number of experts for ground truth establishment, data provenance for test/training sets, and adjudication methods are not applicable to this type of device and its validation.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, with explicit notes where information is not applicable:
Acceptance Criteria and Device Performance for True Indicating Self-Contained Biological Indicator
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| Viable Spore Population | Determine the spore population per the manufacturer's procedure following ISO 11138-1 | ≥10^5 or greater | PASS: 1.0 - 4.8 x 10^5 Spore/SCB |
| D value | Determine the resistance of the BI following ISO 11138-1 and 11138-3 | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | PASS: D121 ≥ 1.7 minD132 ≥ 18 sD135 ≥ 12 s |
| z value | Determine the z-value of the BI per ISO 11138-1 and 11138-3 | ≥10 | PASS: ≥11.6 |
| Survival Time | Determine the exposure time for all BI's to retain viable spores (Survival Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the longer of FDA and ISO 11138-3 requirements | PASS: 121°C ≥ 5.9 min132°C ≥ 1.1 min135°C ≥ 42 sec |
| Kill Time | Determine the exposure time for all BI's to inactivate all spores (Kill Time) per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets the shorter of FDA and ISO 11138-3 requirements | PASS: 121°C ≤ 28.0 min132°C ≤ 2.8 min135°C ≤ 1.8 min |
| Reduced Incubation Time (RIT) | Determine the Reduced Incubation Time outlined in Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Meets FDA's requirement of > 97% alignment of the 10 hour results with the conventional incubation time of 7 days | PASS: Minimum of 10 Hours |
| Carrier growth inhibition / media growth promotion | Determine the carrier growth inhibition/media growth promotion per ISO 11138-1 and 11138-3 | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure | PASS |
| Hold Time | Determine the length of time that an exposed BI can be held before incubation (Hold Time) per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Performance not affected if incubated within 72 hours of exposure to steam sterilization | PASS |
| Simulated Use | Determine the simulated use of the BI in a sterilizer per Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrate growth when exposed to abbreviated cycle, all kill in a full cycle and a half cycle. All cycles utilized full loads using porous, non-porous, and mixed load material | PASS: Abbreviated cycle - growthHalf cycle - no growthFull cycle - no growth |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes (e.g., number of BIs tested) for each test. Instead, it refers to conducting tests "using multiple lots of True Indicating SCBI for Steam over the range of the shelf life." This implies a sufficient number of units were tested to meet the requirements of the referenced ISO standards (ISO 11138-1:2017, ISO 11138-3:2017) and FDA guidance for BI submissions.
- Data Provenance: The data is generated from non-clinical laboratory testing of the physical medical device. The document does not specify country of origin for the testing itself, but the submission is to the U.S. FDA, and tested against international (ISO) and U.S. (FDA) standards. This is not retrospective or prospective in the sense of clinical study data; it's product performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a non-clinical device that relies on a physical, chemical, and biological reaction (spore inactivation and subsequent growth/no-growth). The ground truth is objective and established by the physical and biological properties of the system (e.g., spore count, thermal resistance characteristics, visual color change indicating growth) under controlled experimental conditions according to recognized international and national standards. There are no human "experts" establishing a "ground truth" through interpretation in the way there would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this involves objective, quantifiable laboratory measurements of a physical device's performance, judicial adjudication methods are not relevant. The results are determined by the specified test protocols and acceptance criteria.
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-powered device or a diagnostic device that involves human readers interpreting images or data. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical biological indicator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth is established through objective laboratory measurements and biological principles as defined by recognized standards (ISO 11138 series) and FDA guidance documents for biological indicators. For example:
- Viable Spore Population: Determined quantitatively by plating and counting colony-forming units.
- D-value and Z-value: Calculated from survival curves generated under controlled sterilization conditions.
- Survival/Kill Time: Demonstrated by whether spores survive or are inactivated after specific exposure times, verified by incubation and visible growth/no growth.
- Reduced Incubation Time: Verified by statistical alignment (greater than 97%) of 10-hour results with conventional 7-day incubation results, where growth (yellow media) indicates sterilization failure and no growth (purple media) indicates success.
- Simulated Use: Demonstrated by objective growth/no-growth results after exposure to specific sterilization cycles (abbreviated cycle = growth, half cycle = no growth, full cycle = no growth), ensuring the indicator performs as expected under varied challenge levels.
8. The sample size for the training set
- Not Applicable for this type of device. Training sets are relevant for machine learning algorithms. This device is a physical biological indicator validated through non-clinical performance testing.
9. How the ground truth for the training set was established
- Not Applicable for this type of device. See point 8.
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December 28, 2020
True Indicating LLC Thomas Riha CSO 946 Kane St Toledo, Ohio 43612
Re: K200970
Trade/Device Name: True Indicating Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 02, 2020 Received: December 02, 2020
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 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-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,
Clarence W. Murray III, Ph.D. Acting 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) K200970
Device Name
True Indicating Self-Contained Biological Indicator
Indications for Use (Describe)
The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
121°C, 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 LLC946 Kane StreetSuite AToledo, OH 43612P: 419 476 7119F: 419 470 8899E: info@trueindicating.com |
|---|---|
| Contacts: | Julie WheelerPresident and Chief Operations OfficerP:419 304 6535F: 419 470 8899julie.wheeler@trueindicating.com |
| Tom RihaChief Scientific OfficerP: 248-982-6492F: 419 470 8899E: tom.riha@trueindicating.com | |
| Prepared on: | December 28, 2020 |
| Device Name: | True Indicating Self-Contained Biological Indicator |
| Classification: | 21 CFR 880.2800, Class II Medical Device, FDA Product Code FRC,General Hospital |
| Predicate Devices:(Legally Marketed) | SporView® 10 Steam Self Contained Biological Indicator (K122024) |
| Device Description: | The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 -mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC®7953, at a minimum of 105 bacterial spores encased within a polypropylene cap,and a polypropylene vial which includes a glass ampule hermetically sealedcontaining a nutrient broth culture medium modified with a pH indicator,Bromocresol Purple. |
| Indications for Use: | The True Indicating Self Contained Biological Indicator is Intended formonitoringthe efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10hours and may be used in the following steam sterilization cycles: 121°C, 30minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum). |
| OperationalPrinciples: | Place an SCBI in the most difficult area to sterilize in a load. When the cycle iscomplete, the SCBI is retrieved and activated by crushing the growth mediumampule to engulf the disc within the bottom of the SCBI vial. |
| The activated SCBI should be incubated at 55-65°C for a minimum of 10 hours.The SCBI should be monitored for visible signs of growth. Growth is indicated bya visual shift in color of the growth medium from purple to yellow, and/or thepresence of turbidity. The absence of growth, resulting in growth mediumremaining purple in color and/or no turbidity being visually present, indicates thecycle was effective. |
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Subject Device Predicate Device True Indicating SCBI for SporView® 10 Steam Self Comparison Feature Contained Biological Indicator Steam (K200970) (K122024) Same Gravity 121°C 30 minutes Gravity 132°C 15 minutes Gravity 134°C 4 minutes Gravitv-Flash 132°C 3 minutes Intended Use: 121°C, 30 minutes (Gravity) Gravity-Flash 132°C 10 minutes 132°C, 4 minutes (Pre-Vac) Method of Dynamic Air 121°C 20 minutes Sterilization 135°C, 3 minutes (Pre-Vac) DynamicAir 121°C 30 minutes Dynamic Air 132°C 3 minutes Dynamic Air 132°C 4 minutes Dynamic Air 134°C 4 minutes Dynamic Air 135°C 3 minutes Product Code FRC FRC Same FDA Regulation 21 CFR§ 880.2800 21 CFR§ 880.2800 Same SporView® 10 Steam is a selfcontained biological indicator inoculated with viable Geobacillus Same stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam The True Indicating Self-Contained sterilization processes. Spor View® Biological Indicator is intended for 10 self-contained biological monitoring the efficacy of saturated indicators have a validated reduced steam sterilization processes. The incubation time of 10 hours and may True Indicating Self-Contained be used in the following steam Biological Indicator has a validated Indications for sterilization cycles: reduced incubation time of 10 Use (IFU) hours and may be used in the Gravity 121°C 30 minutes following steam sterilization cycles: Gravity 132°C 15 minutes Gravity 134°C 4 minutes 121°C, 30 minutes (Gravity) Gravity-Flash 132°C 3 minutes 132°C, 4 minutes (Pre-Vacuum) Gravity-Flash 132°C 10 minutes 135°C, 3 minutes (Pre-Vacuum) Dynamic Air 121°C 20 minutes DynamicAir 121°C 30 minutes Dynamic Air 132°C 3 minutes Dynamic Air 132°C 4 minutes Dynamic Air 134°C 4 minutes Dynamic Air 135°C 3 minutes Geobacillus stearothermophilus Geobacillus stearothermophilus Organism Same ATCC 7953 ATCC 7953 Biochemical activity of Biochemical activity of Geobacillus stearothermophilus Geobacillus stearothermophilus Mechanism of produces acid by-products that produces acid by-products that Same Action lower the pH of the media lower the pH of the media which changing its color from purple to changing its color from purple to yellow yellow
Technological Characteristic Comparison Table
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| Feature | Subject DeviceTrue Indicating SCBI forSteam | PredicateSporView® 10 Steam SelfContained Biological Indicator(K122024) | Comparison |
|---|---|---|---|
| Device Design | Inoculated paper disc and glassampule with growth mediacontained within a vial andenclosed with a cap with liner | Inoculated paper disc and glassampule with growth mediacontained within a vial andenclosed with a cap with liner | Same |
| Growth MediumColor Change | Purple to Yellow | Purple to Yellow | Same |
| Viable SporePopulation | ≥105 or greater | ≥105 or greater | Same |
| Carrier Material | Paper Filter Carrier | Paper Filter Carrier | Same |
| IncubationConditions | 55 - 65 °C | 55 - 60°C | Similar |
| SCBI Label | Film label with Lot Number andexpiration date | Film label with Lot Number andexpiration date and chemicalindicator that transitions fromblue to dark | Similar |
| D value | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | Same |
| ReducedIncubation Time | 10 hours | 10 hours | Same |
| Hold Time | 72 Hours | 48 Hours | Similar |
| z value | ≥ 10°C | ≥ 10°C | Same |
| Shelf Life | 24 Months | 24 Months | Same |
Summary of
Nonclinical Testing: Per FDA recognized consensus standards and guidance documents testing was performed for steam sterilization processes using multiple lots of True Indicating SCBI for Steam over the range of the shelf life:
- Total Viable Spore Count was evaluated per manufacturer's methodology and in compliance with ISO 11138-1 Annex A
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510(k) Summary K200970
- . 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
- Carrier and Primary Packaging Materials were evaluated per Annex B . and ISO 11138-3 7.1
- 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
- Reduced Incubation Time Studies were conducted per Guidance for . Industry and FDA Staff Biological Indicator (BI) Premarket Notification [51-(k)] Submissions Section 7.E. and Attachment II and True Indicating standard operating procedure
- . Simulated Use - Full, Half, and Abbreviated Exposure Cycles were tested per Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [51-(k)] Submissions Section 7 and True Indicating Protocols
Summary of Nonclinical Testing Table:
Testing was conducted on the Test Pack following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- 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
| Name of Test | Purpose | Acceptance Criterial | Subject Device Result |
|---|---|---|---|
| Viable SporePopulation | Determine the spore populationper the manufacturer'sprocedure following ISO 11138-1 | ≥105 or greater | PASS1.0 - 4.8 x 105 Spore/SCB |
| D value | Determine theresistance of theBI following ISO11138-1 and11138-3 | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | PASSD121 ≥ 1.7 minD132 ≥ 18 sD135 ≥ 12 s |
| z value | Determine the z-value of the Blper ISO 11138-1 and 11138-3 | ≥10 | PASS≥11.6 |
| Survival Time | Determine the exposure time for allBI's to retain viable spores(Survival Time) per ISO 11138-1,11138-3 and Guidance for Industryand Staff - Biological Indicator (BI)Premarket Notification [510(k)]Submission | Meets the longer of FDAand ISO 11138-3requirements | PASS121°C ≥ 5.9 min132°C ≥ 1.1 min135°C ≥ 42 sec |
| Kill Time | Determine the exposure time for allBI's to inactivate all spores (KillTime) per ISO 11138-1,11138-3and Guidance for Industry andStaff - Biological Indicator (BI)Premarket Notification [510(k)]Submission | Meets the shorter of FDAand ISO 11138-3requirements | PASS121°C ≤ 28.0 min132°C ≤ 2.8 min135°C ≤ 1.8 min |
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| Name of Test | Purpose | Acceptance Criterial | Subject Device Result |
|---|---|---|---|
| ReducedIncubationTime (RIT) | Determine the ReducedIncubation Time outlined inGuidance for Industry and Staff -Biological Indicator (BI)Premarket Notification [510(k)]Submission | Meets FDA's requirementof > 97% alignment of the10 hourresults with theconventional incubationtime of 7 days | PASSMinimum of 10 Hours |
| Carrier growthinhibition /media growthpromotion | Determine the carrier growthinhibition/media growthpromotion per ISO 11138-1and 11138-3 | Positive growth of lessthan 100 spores afterprimary packaging andmedia are subject toworst case steamexposure | PASS |
| Hold Time | Determine the length of timethat an exposed BI can be heldbefore incubation (Hold Time)per Guidance for Industry andStaff - Biological Indicator (BI)Premarket Notification [510(k)]Submission | Performance notaffected if incubatedwithin 72 hours ofexposure to steamsterilization | PASS |
| Simulated Use | Determine the simulated useof the BI in a sterilizer perGuidance for Industry andStaff - Biological Indicator (BI)Premarket Notification [510(k)]Submission | Demonstrate growth whenexposed to abbreviatedcycle, all kill in a full cycleand a half cycle. All cyclesutilized full loads usingporous, non-porous, and mixed loadmaterial | PASSAbbreviated cycle - growthHalf cycle - no growthFull cycle - no growth |
- Conclusion: Based on the non-clinical performance data, The True Indicating Self-Contained Biological Indicator is as safe, as effective, and performs as well as or better than the legally marketed predicate, SporView® 10 Steam Self Contained Biological Indicator cleared under K122024, Class II (21 CFR 880.2800), product code FRC.
§ 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).