(298 days)
The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).
The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.
The provided text describes the nonclinical tests conducted for the "Instant 20s Indicator" device (K210481), a sterilization process indicator. The information pertains to the device's performance in laboratory settings to ensure it meets the required safety and effectiveness standards for its intended use.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Name of Test | Purpose and Guidance Document/Standard | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| D value Based on Enzymatic Activity | Determine the resistance of the Instant 20s Indicator following ISO 11138-1 and 11138-3 | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | PASSD121 ≥ 1.7 minD132 ≥ 12 sD135 ≥ 12 s |
| z value Based on Enzymatic Activity | Determine the z-value of the Instant 20s Indicator per ISO 11138-1 and 11138-3 | ≥10 | PASS≥13.6 |
| Survival Time Based on Enzymatic Activity | Determine the exposure time for all Instant 20s Indicator 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 | PASS121°C ≥ 5.1 min132°C ≥ 1.0 min135°C ≥ 40 sec |
| Kill Time Based on Enzymatic Activity | Determine the exposure time for all Instant 20s Indicator 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 | PASS121°C ≤ 15.3 min132°C ≤ 1.8 min135°C ≤ 1.8 min |
| Hold Time | Determine the length of time that an exposed Instant 20s Indicator 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 used within 72 hours of exposure to steam sterilization | PASS |
| Growth Inhibition | Determine if positive result is achieved when primary packaging is subject to worst case steam exposure per Guidance for Industry and Staff – Biological Indicator (BI) Premarket Notification [510(k)] Submission | 100% Positive Results | Pass |
| Shelf Life | Resistance and Survival/Kill must meet above criteria at each stability time point per ISO 11138-1, 11138-3 and Guidance for Industry and Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | D value = see aboveSurvival = see aboveKill = see above | PASS |
| Chemical Indicator Performance | Determine the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical indicator reacts to all the critical parameters in the sterilization cycle for which it is intended according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements and Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | Pass result at Stated Value for each temperature claimed:121°C, 30 minutes (Gravity)132°C, 3 minutes (Pre-Vac)135°C, 3 minutes (Pre-Vac)Fail Result at 15% less time and -1°C of Stated Value | PASS |
| Endpoint Stability of Positive Result Color | Determine the endpoint stability of developed color due to a positive result (failure) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 7 Days | PASS |
| Endpoint Stability of Negative Result Color | Determine the endpoint stability of color due to a negative result (pass) per Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators | 30 Minutes | PASS |
| Simulated Use | Determine the simulated use of the Instant 20s Indicator in a sterilizer per Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submission | Demonstrates a survival (positive) result when exposed to abbreviated cycle, and all kill (negative) in full and half cycles | PASSAbbreviated cycles - positiveHalf cycles - negativeFull cycles - negative |
| Biocompatibility (In Vitro Cytotoxicity) | To determine if the device is cytotoxic to mammalian cells in vitro | Under conditions of the study, did not show potential toxicity to L-929 cells. | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is a 510(k) submission for a non-clinical device (sterilization indicator). The testing described is not related to patient data or clinical studies in the traditional sense of medical imaging or diagnostic devices. Instead, it involves laboratory verification of the physical and biological characteristics of the "Instant 20s Indicator."
- Sample Size: The document does not specify exact numerical sample sizes (e.g., number of indicators tested for each criterion). It mentions "multiple lots of True Indicating Instant 20s Indicator over the range of the shelf life" were used for testing on page 5.
- Data Provenance: The data is generated from nonclinical laboratory tests of the device itself.
- Country of Origin: Not explicitly stated, but the company (True Indicating LLC) is based in Toledo, Ohio, USA, which implies the testing was likely conducted in the US or by US-affiliated labs.
- Retrospective or Prospective: Not applicable in the context of clinical studies. These are prospective laboratory tests conducted specifically for the 510(k) submission to demonstrate compliance with standards and guidance documents.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device and study. The "Instant 20s Indicator" is a physical product designed to provide a direct, observable biological or chemical reaction (color change) based on exposure to a sterilization process. Ground truth is established by:
- Objective physical measurements: Temperature, time, and steam conditions in the sterilization chambers used for testing.
- Biological viability (spores): Growth or inhibition of "Geobacillus stearothermophilus ATCC® 7953" enzymes. This "ground truth" is determined by established microbiological methods and is not subject to expert consensus in the way a medical image diagnosis would be.
- Chemical reaction: The color change observed.
There are no human "experts" establishing a subjective ground truth, as would be the case in image interpretation studies. The process is objective and measurable against established physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication process. The results are based on objective laboratory measurements and observations (e.g., color change, growth/no growth, D-value calculation).
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 device is a sterilization indicator, not an AI-powered diagnostic tool. There are no human "readers" or AI assistance involved in its function or the testing described. Its output is a direct, observable color change or a measurable biological/chemical response, not an interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device. The device itself performs its function (indicating sterilization efficacy) in a "standalone" manner in that it is placed in the sterilizer and then removed and activated to provide a result. There is no human required during the sterilization process for the device to function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on:
- Physical Parameters: Precisely controlled and measured temperature, time, and steam conditions in the sterilization test chambers. These parameters are rigorously defined by international standards (e.g., ISO 11138 series).
- Microbiological Viability: The known resistance characteristics of the Geobacillus stearothermophilus spores/enzymes used in the indicator. The "kill" or "survival" of these biological entities under defined conditions constitutes the ground truth.
- Chemical Reaction: The expected color change of the indicator solution when it reacts with viable or inviable enzymes, as per the device's design.
Essentially, the "ground truth" is the known effect of specific sterilization conditions on the indicator's biological and chemical components, established through adherence to recognized consensus standards and guidance documents.
8. The sample size for the training set
Not applicable. As a physical sterilization indicator, this device does not use machine learning or require a "training set" in the computational sense. Its function is based on inherent biological and chemical properties, not learned patterns from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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 WheelerPresident and Chief Operations OfficerP:419 304 6535F: 419 470 8899julie.wheeler@trueindicating.com |
| Prepared on: | December 13, 2021 |
| Device Name: | Instant 20s Indicator |
| Classification: | Class II Medical Device, FDA Product Code MTC, General Hospital |
| Predicate Devices:(Legally Marketed) | Sportrol Rapid Sterility Indicator, K962649 |
| Description of Device: | The True Indicating Instant 20s Indicator consists of a polycarbonate vial,polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant,and a biological tablet produced using cellulose, and enzymes from Geobacillusstearothermophilus ATCC® 7953. |
| Indications for Use: | The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzymeindicator, is used for monitoring saturated steam sterilization processes operatingat: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3minutes (Pre-Vacuum). |
| OperationalPrinciples: | Place an Instant 20s Indicator in the most difficult area to sterilize in a load.When the cycle is complete, the Instant 20s Indicator is removed and the base isdetached to gain access to the biological tablet. The Indicator Solution suppliedwith the Instant 20s Indicator is applied dropwise onto the biological tablet toactivate.The activated Instant 20s Indicator should be immediately viewed for a minimumof 20 seconds to determine the efficacy of the sterilization cycle. Ineffectivecycles are indicated by a color shift of the biological tablet from off-white to ashade of red. The absence of a red color change indicates the cycle waseffective. After 20 seconds, verify the color of the activated biological tablet andimmediately discard the tablet. |
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Technological Characteristic Comparison Table
| Feature | Subject DeviceInstant 20s Indicator(K210481) | PredicateSportrol Rapid SterilityIndicator (K962649) | Comparison |
|---|---|---|---|
| Intended Use:Method ofSterilization | 121°C, 30 minutes (Gravity)132°C, 4 minutes (Pre-Vac)135°C, 3 minutes (Pre-Vac) | 121°C (Gravity) no stated time132°C (Pre-Vac) no stated time134°C (Pre-Vac) no stated time | Similar |
| Product Code | MTC | MTC | Same |
| FDARegulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications forUse (IFU) | The True Indicating Instant 20sIndicator, a multiple, interactive,bacterial enzyme indicator, isused for monitoring saturatedsteam sterilization processesoperating at: 121°C, 30 minutes(Gravity), 132°C, 4 minutes (Pre-Vacuum), 135°C, 3 minutes(Pre-Vacuum) | The RSI Rapid Indicator, amultiple, interactive, bacterialenzyme indicator, is used formonitoring saturated steamsterilization processesoperating at 121°C gravity,132°C vacuum assisted, 134°Cvacuum assisted cycles. | Similar |
| Mechanism ofAction | Enzymes, from Geobacillusstearothermophilus, react withIndicator Solution which consistof co-enzymes. The co-enzymesreact with viable enzymespresent in the tablet to produce avisual color change | Enzymes, from Geobacillusstearothermophilus, react withIndicator Solution which consistof co-enzymes. The co-enzymes can react with viableenzymes present in the tablet toproduce a visual color change | Same |
| ModifiedSurvival Time | 121°C for 5 minutes 132°C for20 secondsCalculated = 121°C, ≥ 5.1 minCalculated = 132°C, ≥ 1.0 minCalculated = 135°C, ≥ 40 sec | 121°C for 5 minutes132°C for 20 secondsCalculated = Not Applicable | Similar |
| Feature | Subject DeviceInstant 20s Indicator for Steam(K210481) | PredicateSportrol Rapid SterilityIndicator (K962649) | Comparison |
| ModifiedKill Time | 121°C for 15 minutes 132°C for3 minutesCalculated = 121°C, $<$ 15.3 minCalculated = 132°C, $<$ 1.8 minCalculated = 135°C, $<$ 1.35 minColor change of Tablet wasobserved in response toenzymatic activity following theprovided time points at theindicated temperatures | 121°C for 15 minutes132°C for 3 minutesCalculated = Not Applicable | Similar |
| Vial Label | Film label with Lot Number andExpiration Date | Paper label with Lot Numberand expiration date andchemical indicator thattransitions from Violet to Green | Similar |
| Shelf Life | Tablet = 13 Months IndicatorSolution = 13 months | Tablet = 12 MonthsIndicator Solution = 12 Months | Similar |
| End PointStability ofPositiveResult Color | 7 Days | Not Applicable | Similar |
| End PointStability ofNegativeResult 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 GuidanceDocument/Standard | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| D valueBased onEnzymaticActivity | Determine the resistanceof the Instant 20s Indicatorfollowing ISO11138-1 and 11138-3 | D121 ≥ 1.5 minD132 ≥ 10 s D135 ≥ 8 s | PASSD121 ≥ 1.7 minD132 ≥ 12 sD135 ≥ 12 s |
| z valueBased onEnzymaticActivity | Determine the z-value ofthe Instant 20s Indicatorper ISO 11138-1 and11138-3 | ≥10 | PASS≥13.6 |
| Survival TimeBased onEnzymaticActivity | Determine the exposuretime for all Instant 20sIndicator to retain viablespores (Survival Time) perISO 11138-1, 11138-3 andGuidance for Industry andStaff - Biological Indicator(BI) Premarket Notification[510(k)] Submission | Meets the longer ofFDA and ISO 11138-3requirements | PASS121°C ≥ 5.1 min132°C ≥ 1.0 min135°C ≥ 40 sec |
| Kill TimeBased onEnzymaticActivity | Determine the exposuretime for all Instant 20sIndicator to inactivate allspores (Kill Time) per ISO11138-1,11138-3 andGuidance for Industry andStaff - Biological Indicator(BI) Premarket Notification[510(k)] Submission | Meets the shorter ofFDA and ISO 11138-3requirements | PASS121°C ≤ 15.3 min132°C ≤ 1.8 min135°C ≤ 1.8 min |
| Hold Time | Determine the length oftime that an exposedInstant 20s Indicator canbe held before incubation(Hold Time) per Guidancefor Industry and Staff –Biological Indicator (BI)Premarket Notification[510(k)] Submission | Performance notaffected if used within72 hours of exposure tosteam sterilization | PASS |
| GrowthInhibition | Determine if positive resultis achieved when primarypackaging is subject toworst case steamexposure per Guidance forIndustry and Staff –Biological Indicator (BI)Premarket Notification[510(k)] Submission | 100% Positive Results | Pass |
| Shelf Life | Resistance andSurvival/Kill must meetabove criteria at eachstability time point per ISO11138-1, 11138-3 andGuidance for Industry andStaff - Biological Indicator(BI) Premarket Notification[510(k)] Submission | D value = see aboveSurvival = see aboveKill = see above | PASS |
| ChemicalIndicatorPerformance | Determine the pass/failcriteria for each criticalcycle parameter andprovide the pass/failresults to show how thechemical indicator reactsto all the criticalparameters in thesterilization cycle for whichit is intended according toANSI/AAMI/ISO11140-1:2014 Sterilization | Pass result at StatedValue for eachtemperature claimed:121°C, 30 minutes(Gravity)132°C, 3 minutes(Pre-Vac)135°C, 3 minutes(Pre-Vac) | PASS |
| of health care products -Chemical indicators - Part1: General requirementsand Guidance for Industryand FDA Staff - PremarketNotification [510(k)]Submissions for ChemicalIndicators | Fail Result at 15% lesstime and -1°C of StatedValue | PASS | |
| EndpointStability ofPositiveResult Color | Determine the endpointstability of developed colordue to a positive result(failure) per Guidance forIndustry and FDA Staff -Premarket Notification[510(k)] Submissions forChemical Indicators | 7 Days | PASS |
| EndpointStability ofNegativeResult Color | Determine the endpointstability of color due to anegative result (pass) perGuidance for Industry andFDA Staff - PremarketNotification [510(k)]Submissions for ChemicalIndicators | 30 Minutes | PASS |
| SimulatedUse | Determine the simulateduse of the Instant 20sIndicator in a sterilizer perGuidance for Industry andFDA Staff - BiologicalIndicator (BI) PremarketNotification [510(k)]Submission | Demonstrates a survival(positive) result whenexposed to abbreviatedcycle, and all kill(negative) in full andhalf cycles | PASSAbbreviated cycles -positiveHalf cycles - negativeFull cycles - negative |
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| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| Biocompatibility(In VitroCytotoxicity) | To determine if thedevice is cytotoxic tomammalian cells invitro | Under conditions ofthe study, did notshow potentialtoxicity to L-929cells. | 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.
§ 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).