(113 days)
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to indicate exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes.
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.
The 3M Comply 1248 Gas Plasma Chemical Indicator is a sterilization process indicator and is comprised of a blue chemical indicator ink bar printed on a white plastic strip. A comparison color match is also printed on the plastic strip, below the blue indicator ink bar. The chemical indicator changes color from blue to pink upon exposure to vapor hydrogen peroxide in the STERRAD®100, STERRAD®100S and the STERRAD®50 Sterilization processes.
The provided text describes the acceptance criteria and study results for the 3M™ Comply™ 1248 Gas Plasma Chemical Indicator.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device should do) | Reported Device Performance (What the device did) |
|---|---|
| Cycle Conditions Required for Color Change (STERRAD 100): Indicator accurately changes color from blue to pink when exposed to the STERRAD 100 sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 100): All indicators turned from blue to pink and indicated a "pass" within 10 to 15 minutes of exposure to the STERRAD 100 cycle. |
| Cycle Conditions Required for Color Change (STERRAD 100S): Indicator accurately changes color from blue to pink when exposed to the STERRAD 100S sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 100S): All indicators turned from blue to pink and indicated a "pass" within 4 to 8 minutes of exposure to the STERRAD 100S cycle. |
| Cycle Conditions Required for Color Change (STERRAD 50): Indicator accurately changes color from blue to pink when exposed to the STERRAD 50 sterilization cycle within a specified minimum time. | Cycle Conditions Required for Color Change (STERRAD 50): All indicators turned from blue to pink and indicated a "pass" within 0.25 to 2.0 minutes of exposure to the STERRAD 50 cycle. |
| Two-Year Stability Study: Indicators maintain the ability to change color correctly after storage for two years (interim results for one month also monitored). | Two-Year Stability Study: One-month interim results verified all indicators turned from blue to pink when exposed to complete STERRAD 100S cycles and cancelled cycles (12-minute diffusion), confirming continued stability. (Two-year testing ongoing at the time of report). |
| Open-Pouch Stability Testing: Indicators maintain the ability to change color correctly after the package is opened (interim results for one month also monitored). | Open-Pouch Stability Testing: One-month interim results verified all indicators turned from blue to pink when exposed to complete STERRAD 100S cycles and cancelled cycles (12-minute diffusion), confirming continued stability after opening. (Eight-week testing ongoing at the time of report). |
| Light Stability Testing: Processed and unprocessed indicators retain their color after exposure to fluorescent light for a specified period. | Light Stability Testing: Processed and unprocessed indicators retained their color after four (4) weeks of exposure to fluorescent light. |
| Performance After Exposure to Light: Indicators perform correctly (change color) after exposure to fluorescent light. | Performance After Exposure to Light: All indicators continued to meet the color match criteria when exposed to complete STERRAD 100S cycles and 12-minute cancelled cycles, confirming stability after four (4) weeks of fluorescent light exposure. |
| Effect of the Absence of Hydrogen Peroxide on the Color Change: Indicators should not change color in the absence of hydrogen peroxide. | Effect of the Absence of Hydrogen Peroxide on the Color Change: Indicators did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide. |
| Effects of Steam and Ethylene Oxide Sterilization: Indicators should not indicate "pass" for steam or ethylene oxide, and their physical integrity should be understood. | Effects of Steam and Ethylene Oxide Sterilization: Indicators were unaffected by ethylene oxide (no color change). Indicators were grossly deformed but retained blue color in steam sterilization. (Instructions For Use to include precaution against using for steam/EO). |
| Effects of Acid and Base: Indicators' color change mechanism should not be unduly affected by acidic or basic environments, or specific precautions should be noted. | Effects of Acid and Base: Indicators were not sensitive to an acidic environment. Processed indicators were not sensitive to a basic environment. Unprocessed indicators were sensitive to a basic (alkaline) environment. (Instructions For Use to include precaution to store away from alkaline chemicals). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set (number of indicators tested in each condition). Instead, it uses phrases like "all indicators" or "the Comply™ 1248 Gas Plasma Chemical Indicators" without quantifying.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted by the manufacturer, 3M Company, based in St. Paul, MN, USA. The testing appears to be prospective, specifically designed to demonstrate the device's performance against defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of chemical indicator relies on a direct physical color change, which is then compared to a "comparison color match" printed on the indicator itself. The "ground truth" for the color change is the pre-defined comparison color. Therefore, there is no mention of human experts (like radiologists) being used to establish the ground truth for the color change interpretation in the provided text. The color change is an objective, visual comparison against a standard.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" typically refers to how discrepancies in human interpretation of results are resolved. Since the device's performance is based on an objective color change compared to a printed standard, and no human interpretation requiring adjudication is mentioned, this section is not relevant.
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 that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device itself is a "standalone" chemical indicator. Its performance is evaluated based on its physical properties (color change) in response to stimuli, without any "human-in-the-loop" interpretation beyond observing the color and comparing it to the reference. There is no algorithm involved.
7. The Type of Ground Truth Used
The ground truth used is an objective, pre-defined color standard (the "comparison color match" printed on the plastic strip) for evaluating the chemical indicator's color change. Additionally, the ground truth for "pass" or "fail" is tied to exposure to specific sterilization cycles (STERRAD 100, 100S, 50) and also includes conditions where a color change should not occur (absence of H2O2, steam, EO, acid/base sensitivity tests).
8. The Sample Size for the Training Set
Not applicable. This is a chemical indicator, not a machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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| Premarket Notification (510 (k)) SummaryAPPENDIX G: | |
|---|---|
| K013228 | |
| Manufacturer: | 3M Company3M Medical-Surgical Division3M Center, Bldg. 275-5W-06St. Paul, MN 55144-1000 |
| Regulatory AffairsContact: | Gretchen Keenan, RACProduct Regulation Manager3M CompanyTel: 651-733-7605 |
| Date Summary Prepared: | September 26, 2001 |
| Device Trade Name: | 3M™ Comply™ 1248 Gas Plasma Chemical Indicator |
| Common or Usual Name: | Chemical Indicator |
| Classification: | Physical/Chemical Sterilization Process Indicator[21CFR 880.2800(b)] |
| Device Description: | The 3M Comply 1248 Gas Plasma Chemical Indicator is a sterilizationprocess indicator and is comprised of a blue chemical indicator ink barprinted on a white plastic strip. A comparison color match is alsoprinted on the plastic strip, below the blue indicator ink bar. Thechemical indicator changes color from blue to pink upon exposure tovapor hydrogen peroxide in the STERRAD®100, STERRAD®100Sand the STERRAD®50 Sterilization processes. |
| Intended Use: | The 3M Comply 1248 Gas Plasma Chemical Indicator is indicated foruse as an internal pack process indicator to indicate exposure to vaporhydrogen peroxide in the STERRAD® 100, STERRAD® 100S, andSTERRAD® 50 Sterilization processes. |
| Substantial Equivalence: | The 3M Comply 1248 Gas Plasma Chemical Indicator Strip issubstantially equivalent to the Advanced Sterilization Products (ASP)STERRAD® Gas Plasma Chemical Indicator Strip (K921910). The 3MComply 1248 Gas Plasma Chemical Indicator and the predicatedevice share the same intended use of internal pack sterilizationprocess indicators to indicate exposure to vapor hydrogen peroxide inthe STERRAD 100, STERRAD 100S, and the STERRAD 50sterilization processes. In addition, the 3M Comply 1248 Gas PlasmaChemical Indicator and the predicate device share similar design andappearance. |
| Testing Summary: | |
| TEST: | RESULT: |
| Cycle ConditionsRequired for ColorChange in a STERRAD100 Sterilizer | Testing verified that the Comply™ 1248 Gas Plasma ChemicalIndicators turned from blue to pink when exposed to the STERRAD100 Sterilization cycle and the minimum time required for all indicatorsto indicate a "pass" in relation to the color match was found to be |
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between 10 and 15 minutes.
Testing verified that the Comply™ 1248 Gas Plasma Chemical Cycle Conditions Indicators turned from blue to pink when exposed to the STERRAD Required for Color 100S Sterilization cycle and the minimum time required for all Change Using the indicators to indicate a "pass" in relation to the color match was found STERRAD 100S Cycle to be between 4 and 8 minutes.
Testing verified that the Comply™ 1248 Gas Plasma Chemical Cycle Conditions Indicators turned from blue to pink when exposed to the STERRAD 50 Required for Color Sterilization cycle and the minimum time required for all indicators to Change in a STERRAD 50 indicate a "pass" in relation to the color match was found to be Sterilizer between 0.25 and 2.0 minutes.
One-month interim results verified that all indicators turned from blue Two-Year Stability Study to pink when exposed to the complete STERRAD 100S Sterilization cycles with a hydrogen peroxide diffusion time of 16 minutes as well as the cycles cancelled after 12-minutes of hydrogen peroxide diffusion, thereby confirming the continued stability of the Comply™ 1248 Gas Plasma Chemical Indicator to date. Two-year stability testing is ongoing.
One-month interim results verified that all indicators turned from blue Open-Pouch Stability to pink when exposed to the complete STERRAD 100S Sterilization Testing cycles with a hydrogen peroxide diffusion time of 16 minutes as well as the cycles cancelled after 12 minutes of hydrogen peroxide diffusion, thereby confirming the continued stability of the Comply™ 1248 Gas Plasma Chemical Indicator following opening the package, to date. Eight-week open-pouch stability testing is ongoing.
Testing verified that the processed and unprocessed 3M Comply 1248 Light Stability Testing Gas Plasma Chemical Indicators retained their color after four (4) weeks of exposure to fluorescent light.
Testing verified that all indicators continued to meet the color match Performance After when exposed to both the complete STERRAD 100S Sterilization Exposure to Light cycles with a hydrogen peroxide diffusion time of 16 minutes as well as the 12-minute cancelled cycles, thereby confirming the stability of the Comply™ 1248 Gas Plasma Chemical Indicator following four (4) weeks of exposure to fluorescent light.
Testing verified that the Comply 1248 Gas Plasma Chemical Effect of the Absence of Indicators did not exhibit any color change following exposure to a Hydrogen Peroxide on the cycle containing deionized water instead of hydrogen peroxide. Color Change
Testing verified that the Comply 1248 Gas Plasma Chemical Effects of Steam and Indicators were found to be unaffected by the ethylene oxide Ethylene Oxide sterilization process and were grossly deformed while retaining the Sterilization blue color of the indicator by the steam sterilization process. The Instructions For Use includes a Precaution not to use the indicators to monitor steam or ethylene oxide sterilization cycles.
Effects of Acid and Base Testing verified that the Comply 1248 Gas Plasma Chemical Indicators were not sensitive to the presence of an acidic environment. The processed indicators were not sensitive to a basic environment. The
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unprocessed color of the 3M Comply 1248 Gas Plasma Chemical Indicator was found to be sensitive to the presence of a basic (alkaline) environment. The Instructions For Use includes a Precaution to store the indicators away from alkaline chemicals.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2002
Minnesota Mining and Manufacturing Company C/O Ms. Tierney Norsted Vice President Regulatory & Clinical Research Institute, Inc 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416
Re: K013228
Trade/Device Name: 3M™ Comply™ 1248 Gas Plasma Chemical Indicator Regulation Number: 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: II Product Code: JOJ Dated: December 12, 2001 Received: December 13, 2001
Dear Ms. Norsted:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Norsted
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT APPENDIX C:
| 510(k) Number: | K013228 |
|---|---|
| Device Name: | 3M™ Comply™ 1248 Gas Plasma Chemical Indicator |
| Indications For Use: | The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes. |
Oan S. Lin
(Division Sign-Off) ﻪ Division of Dental, Infection Control, and General Hospital 510(lg Nornber _
§ 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).