Self-Contained Biological Indicator

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 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: info@trueindicating.com | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contacts: | Julie Wheeler<br>President and Chief Operations Officer<br>P:419 304 6535<br>F: 419 470 8899<br>julie.wheeler@trueindicating.com | | | Tom Riha<br>Chief Scientific Officer<br>P: 248-982-6492<br>F: 419 470 8899<br>E: 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,<br>General Hospital | | Predicate Devices:<br>(Legally Marketed) | SporView® 10 Steam Self Contained Biological Indicator (K122024) | | Device Description: | The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 -<br>mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC®<br>7953, at a minimum of 105 bacterial spores encased within a polypropylene cap,<br>and a polypropylene vial which includes a glass ampule hermetically sealed<br>containing a nutrient broth culture medium modified with a pH indicator,<br>Bromocresol Purple. | | Indications for Use: | The True Indicating Self Contained Biological Indicator is Intended formonitoring<br>the efficacy of saturated steam sterilization processes. The True Indicating Self-<br>Contained Biological Indicator has a validated reduced incubation time of 10<br>hours and may be used in the following steam sterilization cycles: 121°C, 30<br>minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-<br>Vacuum). | | Operational<br>Principles: | Place an SCBI in the most difficult area to sterilize in a load. When the cycle is<br>complete, the SCBI is retrieved and activated by crushing the growth medium<br>ampule 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.<br>The SCBI should be monitored for visible signs of growth. Growth is indicated by<br>a visual shift in color of the growth medium from purple to yellow, and/or the<br>presence of turbidity. The absence of growth, resulting in growth medium<br>remaining purple in color and/or no turbidity being visually present, indicates the<br>cycle was effective. | {4}------------------------------------------------ #### 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 {5}------------------------------------------------ | Feature | Subject Device<br>True Indicating SCBI for<br>Steam | Predicate<br>SporView® 10 Steam Self<br>Contained Biological Indicator<br>(K122024) | Comparison | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------| | Device Design | Inoculated paper disc and glass<br>ampule with growth media<br>contained within a vial and<br>enclosed with a cap with liner | Inoculated paper disc and glass<br>ampule with growth media<br>contained within a vial and<br>enclosed with a cap with liner | Same | | Growth Medium<br>Color Change | Purple to Yellow | Purple to Yellow | Same | | Viable Spore<br>Population | ≥105 or greater | ≥105 or greater | Same | | Carrier Material | Paper Filter Carrier | Paper Filter Carrier | Same | | Incubation<br>Conditions | 55 - 65 °C | 55 - 60°C | Similar | | SCBI Label | Film label with Lot Number and<br>expiration date | Film label with Lot Number and<br>expiration date and chemical<br>indicator that transitions from<br>blue to dark | Similar | | D value | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | Same | | Reduced<br>Incubation 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 {6}------------------------------------------------ ### 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 Spore<br>Population | Determine the spore population<br>per the manufacturer's<br>procedure following ISO 11138-1 | ≥105 or greater | PASS<br>1.0 - 4.8 x 105 Spore/SCB | | D value | Determine the<br>resistance of the<br>BI following ISO<br>11138-1 and<br>11138-3 | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D135 ≥ 8 s | PASS<br>D121 ≥ 1.7 min<br>D132 ≥ 18 s<br>D135 ≥ 12 s | | z value | Determine the z-value of the Bl<br>per ISO 11138-1 and 11138-3 | ≥10 | PASS<br>≥11.6 | | Survival Time | Determine the exposure time for all<br>BI's to retain viable spores<br>(Survival Time) per ISO 11138-1,<br>11138-3 and Guidance for Industry<br>and Staff - Biological Indicator (BI)<br>Premarket Notification [510(k)]<br>Submission | Meets the longer of FDA<br>and ISO 11138-3<br>requirements | PASS<br>121°C ≥ 5.9 min<br>132°C ≥ 1.1 min<br>135°C ≥ 42 sec | | Kill Time | Determine the exposure time for all<br>BI's to inactivate all spores (Kill<br>Time) per ISO 11138-1,11138-3<br>and Guidance for Industry and<br>Staff - Biological Indicator (BI)<br>Premarket Notification [510(k)]<br>Submission | Meets the shorter of FDA<br>and ISO 11138-3<br>requirements | PASS<br>121°C ≤ 28.0 min<br>132°C ≤ 2.8 min<br>135°C ≤ 1.8 min | {7}------------------------------------------------ | Name of Test | Purpose | Acceptance Criterial | Subject Device Result | |-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Reduced<br>Incubation<br>Time (RIT) | Determine the Reduced<br>Incubation Time outlined in<br>Guidance for Industry and Staff -<br>Biological Indicator (BI)<br>Premarket Notification [510(k)]<br>Submission | Meets FDA's requirement<br>of > 97% alignment of the<br>10 hour<br>results with the<br>conventional incubation<br>time of 7 days | PASS<br>Minimum of 10 Hours | | Carrier growth<br>inhibition /<br>media growth<br>promotion | Determine the carrier growth<br>inhibition/media growth<br>promotion per ISO 11138-1<br>and 11138-3 | Positive growth of less<br>than 100 spores after<br>primary packaging and<br>media are subject to<br>worst case steam<br>exposure | PASS | | Hold Time | Determine the length of time<br>that an exposed BI can be held<br>before incubation (Hold Time)<br>per Guidance for Industry and<br>Staff - Biological Indicator (BI)<br>Premarket Notification [510(k)]<br>Submission | Performance not<br>affected if incubated<br>within 72 hours of<br>exposure to steam<br>sterilization | PASS | | Simulated Use | Determine the simulated use<br>of the BI in a sterilizer per<br>Guidance for Industry and<br>Staff - Biological Indicator (BI)<br>Premarket Notification [510(k)]<br>Submission | Demonstrate growth when<br>exposed to abbreviated<br>cycle, all kill in a full cycle<br>and a half cycle. All cycles<br>utilized full loads using<br>porous, non-<br>porous, and mixed load<br>material | PASS<br>Abbreviated cycle - growth<br>Half cycle - no growth<br>Full 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.