(75 days)
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 has an indicator ink bar printed on a white plastic strip. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. 3M™ Comply™ Hydrogen Peroxide Indicator 1248 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248. This device is a chemical indicator, not an AI/ML powered medical device, therefore, many of the requested bullet points regarding AI/ML studies are not applicable.
Here's the information extracted from the document:
1. Table of acceptance criteria and the reported device performance
The document presents a summary of non-clinical testing, which includes acceptance criteria and results.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| STERIZONE® VP4 Sterilizer (Cycle 1) Color Development | To demonstrate the color change of the device and determine the minimum exposure time for end point color change when used in the STERIZONE® VP4 Sterilizer (Cycle 1) | Complete Cycle: Color change from blue toward pink. 7 second exposure: Color change is not as pink (bluer) than color reference match. Determination of the minimum time for color to change from blue toward pink. | Pass |
| STERIZONE® VP4 Sterilizer (Cycle 1) End Point Color (Post-Sterilization) Light Stability | To demonstrate the end point color change stability of the device following exposure to STERIZONE® VP4 Sterilizer (Cycle 1) | No significant change in the endpoint color after exposure to light during storage. | Pass |
| ISO 11140-1:2014 Type 1 Absence of hydrogen peroxide | Verify device requires the presence of vaporized hydrogen peroxide to reach endpoint. | 45 Min at 50°C: Device does not reach endpoint color. | Pass |
| ISO 11140-1:2014 Type 1 Hydrogen peroxide | Confirm device meets the Type 1 process indicator for vaporized hydrogen peroxide requirements. | 7 Sec at 50°C and gas concentration of 2.3 mg/l: Device does not reach endpoint color. 6 Min at 50°C and gas concentration of 2.3 mg/l: Device reaches endpoint color. | Pass |
| ISO 11140-1:2014 Off-set/transference | Confirm device meets the Type 1 process indicator requirements. | After exposure to 6 Min at 50°C and gas concentration of 2.3 mg/l: Ink does not transfer to another surface. | Pass |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical testing was conducted to support the product performance. However, it does not explicitly state the specific sample size (e.g., number of indicators tested) for each test. The provenance of the data is implied to be from laboratory testing conducted by 3M, as indicated by "3M conducted nonclinical testing". The data would be prospective, directly generated from these tests. No country of origin for the data is specified beyond being conducted by 3M.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a chemical indicator, not an AI/ML-powered diagnostic device. Therefore, no human experts were used to establish "ground truth" in the way one would for diagnostic image interpretation. The ground truth for chemical indicators is established by objective physical and chemical changes in response to specific sterilization parameters and assessed against a predefined color reference.
4. Adjudication method for the test set
Not applicable. As this is a chemical indicator, there is no human adjudication process involved in interpreting results as there would be for an AI/ML diagnostic system. The results are based on objective chemical reactions and color changes.
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 a chemical indicator, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a chemical indicator. Its performance is inherent in its chemical reaction, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective physical/chemical changes in the indicator ink (color change from blue toward pink) in response to specific controlled exposure conditions of vaporized hydrogen peroxide, as defined by sterilization standards (e.g., ISO 11140-1:2014) and verified by manufacturer testing. It's a binary outcome (reacted/not reacted, or sufficient/insufficient change) compared to a known reference.
8. The sample size for the training set
Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.
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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.
November 1, 2022
3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K222508
Trade/Device Name: 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 17, 2022 Received: August 18, 2022
Dear Yumi Wackerfuss:
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
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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 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 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) K222508
Device Name
3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
Indications for Use (Describe)
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ |
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Image /page/3/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number 3 followed by the letter M. The logo is simple and recognizable.
510(k) Summary for 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 K222508
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Yumi Wackerfuss Senior Regulatory Affairs Associate Phone Number: (651) 733-3556 Fax Number: (651) 737-5320
Date of Preparation: Oct 20th, 2022
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PREMARKET NOTIFICATION [510(k)] 4 ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508
1. Device Name and Classification:
| Common Name: | Chemical Indicators |
|---|---|
| Proprietary Name: | 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR 880.2800(b) |
| Product Code: | JOJ |
2. Predicate Device:
K203458, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
3. Description of Device:
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 has an indicator ink bar printed on a white plastic strip. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. 3M™ Comply™ Hydrogen Peroxide Indicator 1248 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.
4. Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:
| STERRAD 100® Sterilization System |
|---|
| STERRAD 100S® Sterilization System |
| STERRAD NX® Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) |
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
STERIZONE® VP4 Sterilizer (Cycle 1)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
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3M
5. Technological Characteristic Comparison Table
| Feature | Submission Device (K222508):3M™ Comply™ Hydrogen Peroxide ChemicalIndicator 1248 | Predicate Device (K203458):3M™ Comply™ Hydrogen Peroxide ChemicalIndicator 1248 | Comparison |
|---|---|---|---|
| Indications for Use | Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:STERRAD® 100 Sterilization SystemSTERRAD® 100SSterilization SystemSTERRAD® NX Sterilization System(Standard and Advanced cycles)STERRAD® 100NX Sterilization System(Standard, Flex, Express, and Duo cycles)STERRAD® NX with ALLClear® TechnologySterilization System (Standard and Advanced cycles)STERRAD® 100NX with ALLClear®Technology Sterilization System (Standard,Flex, Express, and Duo cycles)V-PRO® 1 Low Temperature SterilizationSystem (Lumen cycle)V-PRO® 1 Plus Low Temperature SterilizationSystem (Lumen and Non Lumen cycles)V-PRO® maX Low Temperature SterilizationSystem (Lumen, Non Lumen, and Flexiblecycles)V-PRO® 60 Low Temperature SterilizationSystem (Lumen, Non Lumen, and Flexiblecycles)V-PRO® maX 2 Low Temperature SterilizationSystem (Lumen, Non Lumen, Flexible, andFast Non Lumen cycles) | Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:STERRAD® 100 Sterilization SystemSTERRAD® 100SSterilization SystemSTERRAD® NX Sterilization System(Standard and Advanced cycles)STERRAD® 100NX Sterilization System(Standard, Flex, Express, and Duo cycles)STERRAD® NX with ALLClear® TechnologySterilization System (Standard and Advanced cycles)STERRAD® 100NX with ALLClear®Technology Sterilization System (Standard,Flex, Express, and Duo cycles)V-PRO® 1 Low Temperature SterilizationSystem (Lumen cycle)V-PRO® 1 Plus Low Temperature SterilizationSystem (Lumen and Non Lumen cycles)V-PRO® maX Low Temperature SterilizationSystem (Lumen, Non Lumen, and Flexiblecycles)V-PRO® 60 Low Temperature SterilizationSystem (Lumen, Non Lumen, and Flexiblecycles)V-PRO® maX 2 Low Temperature SterilizationSystem (Lumen, Non Lumen, Flexible, andFast Non Lumen cycles) | Similar. The submissiondevice adds theSTERIZONE® VP4Sterilizer (Cycle 1) tothe Indications for Use. |
| Feature | Submission Device (K222508):3M™ Comply™ Hydrogen Peroxide ChemicalIndicator 1248 | Predicate Device (K203458):3M™ Comply™ Hydrogen Peroxide ChemicalIndicator 1248 | Comparison |
| V-PRO® s2 Low Temperature SterilizationSystem (Lumen, Non Lumen, Flexible, andFast cycles)STERIZONE® VP4 Sterilizer (Cycle 1)The chemical indicator bar turns from blue towardpink after exposure to vaporized hydrogenperoxide. | V-PRO® s2 Low Temperature SterilizationSystem (Lumen, Non Lumen, Flexible, andFast cycles)The chemical indicator bar turns from blue towardpink after exposure to vaporized hydrogenperoxide. | ||
| Substrate | Polyethylene | Polyethylene | Same |
| Biocompatibility | The exposure to health care professionals isminimal and well below any identified toxicthresholds for the compounds. | The exposure to health care professionals isminimal and well below any identified toxicthresholds for the compounds. | Same |
| Color Change | Blue toward pink | Blue toward pink | Same |
| Detection | Hydrogen Peroxide | Hydrogen Peroxide | Same |
| Stability of theendpoint reaction | At least one month(4 weeks) | At least one month(4 weeks) | Same |
| Shelf life | Two (2) years | Two (2) years | Same |
| Indicator Type | Type 1 Process Indicator | Not claimed | New claim for Type 1process indicator |
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Image /page/6/Picture/0 description: The image shows the title of a document, which is a premarket notification for a 3M product. The product is the 3M Comply Hydrogen Peroxide Chemical Indicator 1248. The document is a 510(k) summary with the identifier K222508.
The 3MM Comply ™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of same model number (predicate device: K203458) which is sold under the same tradename 3M™ Comply™ Hydrogen Peroxide Indicator 1248. No change has been made to the device materials, performance specifications, or fundamental technology.
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Image /page/7/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. The logo is bold and eye-catching.
PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508
6. Summary of Non-clinical Testing
3M conducted nonclinical testing to support the product performance in accordance with :
- FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for . Chemical Indicators, issued December 19, 2003
- . ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators-Part 1: General requirements for Type 1 (e1) Process Indicators.
Reference Table 6.1 for summary of nonclinical testing.
Reference Table 6.1 for testing completed in the used for STERIZONE® VP4 Sterilizer (Cycle 1) and Type 1 Process Indicator claim.
| Test | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| STERIZONE®VP4 Sterilizer(Cycle 1) ColorDevelopment | To demonstrate the colorchange of the device anddetermine the minimumexposure time for end pointcolor change when used in theSTERIZONE® VP4 Sterilizer(Cycle 1) | Complete Cycle: Color changefrom blue toward pink7 second exposure: Colorchange is not as pink (bluer)than color reference match.Determination of the minimumtime for color to change fromblue toward pink. | Pass | |
| STERIZONE®VP4 Sterilizer(Cycle 1) EndPoint Color(Post-Sterilization)Light Stability | To demonstrate the end pointcolor change stability of thedevice following exposure toSTERIZONE® VP4 Sterilizer(Cycle 1) | No significant change in theendpoint color after exposureto light during storage. | Pass | |
| ISO 11140-1:2014 Type 1Absence ofhydrogenperoxide | Verify device requires thepresence of vaporized hydrogenperoxide to reach endpoint. | 45 Min at50°C | Device doesnot reachendpointcolor. | Pass |
| ISO 11140-1:2014 Type 1Hydrogenperoxide | Confirm device meets the Type1 process indicator forvaporized hydrogen peroxiderequirements. | 7 Sec at 50°Cand gasconcentrationof 2.3 mg/l6 Min at 50°Cand gasconcentrationof 2.3 mg/l | Device doesnot reachendpointcolor.Devicereachesendpointcolor. | Pass |
| ISO 11140-1:2014 Off-set/transference | Confirm device meets the Type1 process indicatorrequirements. | Afterexposure to 6Min at 50°Cand gasconcentrationof 2.3 mg/l | Ink does nottransfer toanothersurface. | Pass |
Table 6.1 Summary of Nonclinical Testing
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Image /page/8/Picture/0 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The logo is simple and recognizable.
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508
7. Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the subject device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K203458, Class II (21 CFR 880.2800), product code JOJ.
§ 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).