3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR

K013228 · Minnesota Mining and Mfg. Co. · JOJ · Jan 18, 2002 · General Hospital

Device Facts

• Record ID: K013228
• Device Name: 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
• Applicant: Minnesota Mining and Mfg. Co.
• Product Code: JOJ · General Hospital
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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.

Device Story

3M Comply 1248 Gas Plasma Chemical Indicator is a physical/chemical sterilization process indicator; consists of blue chemical indicator ink bar printed on white plastic strip with comparison color match. Used as internal pack indicator to verify exposure to vapor hydrogen peroxide in STERRAD 100, 100S, and 50 sterilization cycles. Upon exposure to vapor hydrogen peroxide, ink bar changes color from blue to pink. Used by healthcare personnel in clinical settings to confirm sterilization cycle exposure for medical instruments. Provides visual confirmation of process exposure; aids in quality control of sterilization packs.

Clinical Evidence

Bench testing only. Verified color change from blue to pink in STERRAD 100, 100S, and 50 cycles. Minimum time to 'pass' color match: 10-15 mins (STERRAD 100), 4-8 mins (STERRAD 100S), 0.25-2.0 mins (STERRAD 50). Stability testing confirmed performance after 4 weeks of fluorescent light exposure and in open-pouch conditions. Device showed no color change in absence of hydrogen peroxide; unaffected by ethylene oxide; deformed by steam; sensitive to basic environments.

Technological Characteristics

Chemical indicator ink bar on white plastic strip. Sensing principle: chemical color change (blue to pink) upon exposure to vapor hydrogen peroxide. Dimensions/form factor: strip. Connectivity: none. Sterilization method: N/A (used to monitor sterilization).

Indications for Use

Indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in STERRAD 100, 100S, and 50 sterilization processes.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• STERRAD® Gas Plasma Chemical Indicator Strip (K921910)

Submission Summary (Full Text)

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| Premarket Notification (510 (k)) Summary<br>APPENDIX G: | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K013228 | |
| Manufacturer: | 3M Company<br>3M Medical-Surgical Division<br>3M Center, Bldg. 275-5W-06<br>St. Paul, MN 55144-1000 |
| Regulatory Affairs<br>Contact: | Gretchen Keenan, RAC<br>Product Regulation Manager<br>3M Company<br>Tel: [phone] |
| 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<br>[21CFR 880.2800(b)] |
| Device Description: | The 3M Comply 1248 Gas Plasma Chemical Indicator is a sterilization<br>process indicator and is comprised of a blue chemical indicator ink bar<br>printed on a white plastic strip. A comparison color match is also<br>printed on the plastic strip, below the blue indicator ink bar. The<br>chemical indicator changes color from blue to pink upon exposure to<br>vapor hydrogen peroxide in the STERRAD®100, STERRAD®100S<br>and the STERRAD®50 Sterilization processes. |
| Intended Use: | The 3M Comply 1248 Gas Plasma Chemical Indicator is indicated for<br>use as an internal pack process indicator to indicate exposure to vapor<br>hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and<br>STERRAD® 50 Sterilization processes. |
| Substantial Equivalence: | The 3M Comply 1248 Gas Plasma Chemical Indicator Strip is<br>substantially equivalent to the Advanced Sterilization Products (ASP)<br>STERRAD® Gas Plasma Chemical Indicator Strip (K921910). The 3M<br>Comply 1248 Gas Plasma Chemical Indicator and the predicate<br>device share the same intended use of internal pack sterilization<br>process indicators to indicate exposure to vapor hydrogen peroxide in<br>the STERRAD 100, STERRAD 100S, and the STERRAD 50<br>sterilization processes. In addition, the 3M Comply 1248 Gas Plasma<br>Chemical Indicator and the predicate device share similar design and<br>appearance. |
| Testing Summary: | |
| TEST: | RESULT: |
| Cycle Conditions<br>Required for Color<br>Change in a STERRAD<br>100 Sterilizer | Testing verified that the Comply™ 1248 Gas Plasma Chemical<br>Indicators turned from blue to pink when exposed to the STERRAD<br>100 Sterilization cycle and the minimum time required for all indicators<br>to 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 _