(122 days)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The STERIS Corporation VERIFY Assert Self-Contained Biological Indicator (SCBI) is a Class II device (21 CFR 880.2800, Product code FRC) intended for monitoring steam sterilization processes.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose of the Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Reduced Incubation Time (RIT) Testing | Validate the labeled incubation time of the SCBI | Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days*, ‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Viable spore population | Enumerate the number of viable spores per SCBI | 1.0 - 4.0 x 10^6 spore/SCBI**, ‡ | 2.7 - 3.7 x 10^6 spore/SCBI | PASS |
| Resistance | Determine the resistance of the SCBI to steam | D121 ≥ 1.5 min *D132 ≥ 10 s *D135 ≥ 8 s * | D121 ≥ 2.13 minD132 ≥ 42 sD135 ≥ 31 s | PASS |
| Signal Generation | Validate that the SCBI will produce signal in its reader | All unexposed SCBI show positive growth signal in reader within 40 minutes of incubation‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Hold Time | Demonstrate that performance of the SCBI is not affected by delaying incubation up to 72 hours | Performance not affected if incubated within 72 hours of exposure to steam sterilization‡ | Not explicitly quantified in this section, but stated to "PASS" | PASS |
| Simulated Use | Demonstrate SCBI performance in a steam sterilizer with the AAMI reference load (16 towel pack) | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle‡ | Abbreviated cycle – growthFull cycle – no growth | PASS |
Notes on Acceptance Criteria:
*: Based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions**: Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions‡: Based on specifications of the reference device, VERIFY Assert Self-Contained BI
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., number of SCBIs tested for RIT, viable spore population, etc.). It only provides the acceptance criteria and the conclusion (PASS) or the measured performance range.
The data provenance is from non-clinical testing conducted by STERIS Corporation for their VERIFY Assert Self-Contained Biological Indicator. This would inherently be prospective data collection as it's part of a device validation study. The country of origin of the data is not specified, but the applicant (STERIS Corporation) is based in Mentor, Ohio, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a biological indicator for sterilization processes. The "ground truth" for its performance is established through laboratory testing against well-defined, standardized sterilization parameters and biological growth assessment, rather than expert human interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of results (like in a medical imaging AI study) does not directly apply here. The "experts" involved would be the microbiologists and engineers who designed, executed, and analyzed the validation studies, ensuring adherence to standards like those outlined in FDA guidance documents and AAMI. Their qualifications would typically involve expertise in microbiology, sterilization science, and quality assurance for medical devices.
4. Adjudication method for the test set
Not applicable. As explained above, the "ground truth" is determined by objective biological and physical measurements and adherence to established scientific and regulatory standards for sterilization indicators, not by a panel of human adjudicators.
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 biological indicator, not an AI-powered diagnostic tool requiring human interpretation. Its function is to provide an objective fluorescent signal detected by a reader to indicate sterilization success or failure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The performance testing described is essentially a "standalone" assessment of the device's ability to accurately indicate sterilization conditions. The VERIFY Assert SCBI, when used with its proprietary reader, provides a fluorescent result within 40 minutes. This means the device itself, in conjunction with its automated reader, generates the result without human interpretation of a complex output. The human role is to observe the positive or negative signal from the reader. The tests confirm the device's intrinsic biological resistance and signal generation properties under various sterilization conditions and incubation parameters.
7. The type of ground truth used
The ground truth used for this device is based on:
- Microbiological Growth Assessment: Direct observation of bacterial growth (or lack thereof) after exposure to sterilization cycles, often confirmed by conventional incubation methods (e.g., 7 days of incubation) to establish true viability.
- Physical and Biological Standards: Adherence to established performance metrics ($D_{value}$, spore population) defined by regulatory guidance (FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions) and industry consensus standards (e.g., AAMI for sterilization processes).
- Controlled Sterilization Cycles: Exposure to precisely controlled steam sterilization cycles (e.g., abbreviated cycles to show growth, full cycles to show kill) to challenge the BI.
8. The sample size for the training set
Not applicable. This device is a biological indicator and does not employ machine learning or AI algorithms that would require a "training set." Its biological and chemical principles of operation are deterministic, based on the survival and metabolic activity of a target microorganism.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 22, 2020
STERIS Corporation Anthony Piotrkowski Regulatory Affairs Director 5960 Heisley Road Mentor, Ohio 44060
Re: K200126
Trade/Device Name: VERIFY Assert Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: April 23, 2020 Received: April 24, 2020
Dear Anthony Piotrkowski:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
For CAPT Elizabeth Claverie, M.S. 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)
K200126
Device Name
VERIFY Assert Self-Contained Biological Indicator
Indications for Use (Describe)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
| 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}------------------------------------------------
510(k) Summary For VERIFY Assert Self-Contained Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Contact: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
{4}------------------------------------------------
1. Device Name
| Trade Name: | VERIFY Assert Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Biological Sterilization Process Indicator(21 CFR 880.2800. FRC) |
2. Predicate Device
Celerity 20 Steam Biological Indicator, K173634, as modified under K181686. (21 CFR 880.2800. FRC)
3. Reference Device
VERIFY Assert Self-Contained Biological Indicator. K162701, as modified under K181422. (21 CFR 880.2805, OWP)
4. Description of Device
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
5. Intended Use/ Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
{5}------------------------------------------------
When used in conjunction with the VERIFY Incubator for Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
Summary of Technical Characteristics 6.
Table 5-1.Comparison of SCBI Physical Description and Technological Properties to Reference
| VERIFY Assert SCBI | VERIFY Assert SCBI | ||
|---|---|---|---|
| Feature | (modified) | Reference (K162701) | Comparison |
| Intended Use | The VERIFY Assert Self-Contained BiologicalIndicator (SCBI) is forroutine monitoring,qualification testing, loadmonitoring and producttesting of the followingsteam sterilizationprocesses:270F, 4-minute dynamicair removal; 275F, 3-minute dynamic airremoval; 250 F, 30-minute gravity; 270, 15-minutes gravity.When used in conjunctionwith the VERIFYIncubator for Assert Self-Contained BiologicalIndicator, the VERIFYAssert Self-ContainedIndicator provides afluorescent result within40 minutes. | The VERIFY Assert Self-Contained BiologicalIndicator (SCBI) is forroutine monitoring,qualification testing andproduct testing of thefollowing steamsterilization processes:270F, 4-minute dynamicair removal; 275F, 3-minute dynamic airremoval; 250 F, 30-minute gravity; 270, 15-minutes gravity.When used in conjunctionwith the VERIFYIncubator for Assert Self-Contained BiologicalIndicator, the VERIFYAssert Self-ContainedIndicator provides afluorescent result within40 minutes. | Added load monitoringto the indications foruse |
| Indicatororganism | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | Identical |
| Mechanismof action | An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substratewithin the defined nutrientmedia to produce afluorescent moiety. | An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substratewithin the defined nutrientmedia to produce afluorescent moiety. | Identical |
| Accessories | Automated incubator /reader | Automated incubator /reader | Identical |
| Viable sporepopulation | 1.0 - 4.0 x 106 spore/BI | 1.0 - 4.0 x 106 spore/BI | Identical |
| Resistancecharacteristics | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | Identical |
| CultureConditions | 55- 59 °C, media includedin SCBI, 40-minuteincubation time. | 55- 59 °C, media includedin SCBI, 40-minuteincubation time. | Identical |
| Feature | VERIFY Assert SCBI(modified) | VERIFY Assert SCBIPredicate (K162701) | Comparison |
| PrimaryPackaging | Direct inoculum on plasticvial, cap with recoverymedia. | Direct inoculum on plasticvial, cap with recoverymedia. | Identical |
| Processindicator | STERIS STEAM Π(K112256) | STERIS STEAM Π(K112256) | Identical |
| Label | Single-ply on cap edge | Two-ply on top of cap | This modification wascleared under K181442 |
| Shelf-life | 13 months | 13 months | Identical |
| ExogenousDNA | None | plasmid pSTERIS-Q1 | Plasmid has beenremoved |
{6}------------------------------------------------
Table 5-2. Comparison of SCBI Physical Description and Technological Properties to Predicate Device
| Feature | VERIFY Assert SCBI(modified) | Celerity 20 Steam SCBIPredicate (K173634) | Comparison |
|---|---|---|---|
| IntendedUse | The VERIFY Assert Self-Contained Biological Indicator(SCBI) is for routine monitoring,qualification testing, loadmonitoring and product testingof the following steamsterilization processes:• 270F, 4-minute dynamic airremoval;• 275F, 3- minute dynamic airremoval;• 250 F, 30-minute gravity;• 270, 15- minutes gravity.When used in conjunction withthe VERIFY Incubator for AssertSelf- Contained BiologicalIndicator, the VERIFY AssertSelf-Contained Indicatorprovides a fluorescent resultwithin 40 minutes. | The Celerity 20 SteamBiological Indicator is used forroutine monitoring,qualification testing, loadmonitoring and product testingof the following steamsterilization cycles:• Dynamic Air Removal270°F (132°C) 4 minutes• Dynamic Air Removal275°F (135°C) 3 minutes• Gravity 250°F (121°C) 30minutes• Gravity 270°F (132°C) 15minutes.When used in conjunctionwith the Celerity™ SteamIncubator, the Incubatorprovides a fluorescent resultwithin 20 minutes. | Predicate includesan indication forload monitoringThe onlydifferences areproduct name, readtime and incubator |
| Indicatororganism | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | > 90% similarity to ATCC7953 Geobacillusstearothermophilus | Identical |
| Mechanismof action | An enzyme, which isproduced by the indicatororganism, reacts with afluorogenic substrate withinthe defined nutrient media toproduce a fluorescent moiety. | An enzyme, which is producedby the indicator organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety | Identical |
| Accessories | Automated incubator / reader | Automated incubator / reader | Identical |
| Viable sporepopulation | 1.0 – 4.0 x 106 spore/BI | 1.0 - 4.0 x 106 spore/SCBI | Identical |
| Resistance | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | D121 ≥ 1.5 minD132 ≥ 10 sD135 ≥ 8 s | Identical |
{7}------------------------------------------------
| Feature | VERIFY Assert SCBI(modified) | Celerity 20 Steam SCBIPredicate (K173634) | Comparison |
|---|---|---|---|
| CultureConditions | 55- 59 °C, media included inSCBI, 40-minute incubationtime. | 55- 59 °C, media included inSCBI, 20-minute incubationtime. | Reference devicehas a shorter readtime |
| PrimaryPackaging | Direct inoculum on plastic vial,cap with recovery media. | Direct inoculum on plasticvial, cap with recovery media. | Identical |
| Processindicator | STERIS STEAM Π (K112256) | STERIS STEAM Π (K112256) | Identical |
| Label | Single-ply on cap edge | Two-ply on top of cap | This modificationwas cleared underK181442 |
| Shelf-life | 13 months | 13 months | Identical |
| ExogenousDNA | None | None | Identical |
The modifications that have triggered this premarket notification include a change to remove the GMO component (plasmid pSTERIS-Q1) from the biological indicator spore and to revise the indications for use to include load monitoring.
7. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
Table 5-3. Summary of Non-clinical Testing
| Test | Purpose of the Test | Acceptance Criteria | Conclusion |
|---|---|---|---|
| ReducedIncubationTime (RIT)Testing | Validate the labeledincubation time of theSCBI | Meets FDA's requirement of >97% alignment of the 40-minuteresults with the conventionalincubation time of 7 days*, ‡ | PASS |
| Viable sporepopulation | Enumerate the numberof viable spores perSCBI | $1.0 - 4.0 x 10^6 spore/SCBI**, ‡$ | $2.7 - 3.7 x 10^6$spore/SCBI |
| Resistance | Determine theresistance of the SCBIto steam | $D_{121} ≥ 1.5 min *$$D_{132} ≥ 10 s *$$D_{135} ≥ 8 s *$ | $D_{121} ≥ 2.13 min$$D_{132} ≥ 42 s$$D_{135} ≥ 31 s$ |
| SignalGeneration | Validate that the SCBIwill produce signal inits reader | All unexposed SCBI showpositive growth signal in readerwithin 40 minutes of incubation‡ | PASS |
| Hold Time | Demonstrate thatperformance of theSCBI is not affected bydelaying incubation upto 72 hours | Performance not affected ifincubated within 72 hours ofexposure to steam sterilization‡ | PASS |
{8}------------------------------------------------
| Test | Purpose of the Test | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Simulated Use | Demonstrate SCBI performance in a steam sterilizer with the AAMI reference load (16 towel pack) | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle‡ | Abbreviated cycle – growthFull cycle – no growth |
*Acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
** Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
- Acceptance criteria based on specifications of the reference device, VERIFY Assert Self-Contained BI
8. Conclusion
The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device, K173634 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).