STERIGAGE MODEL 1243RA, 1243RB, 1243RE

K101249 · 3M Company · JOJ · Sep 8, 2010 · General Hospital

Device Facts

• Record ID: K101249
• Device Name: STERIGAGE MODEL 1243RA, 1243RB, 1243RE
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles. Cycle Type Temperature Exposure Time Gravity 250 °F/121 °C ≥ 30 minutes Gravity 270 °F/132 °C ≥ 3 minutes Vacuum-assisted (prevacuum) 270 °F/132 °C ≥ 4 minutes (wrapped) ≥ 3 minutes (unwrapped) Vacuum-assisted (prevacuum) 273 °F/134 °C ≥ 4 minutes (wrapped) ≥ 3.5 minutes (unwrapped) Vacuum-assisted (prevacuum) 275 °F/135 °C ≥ 3 minutes

Device Story

Single-use chemical indicator for steam sterilization monitoring; consists of paper wick and steam/temperature-sensitive chemical pellet in paper/film/foil laminate. Pellet melts and migrates as dark color along wick; migration extent depends on steam, time, and temperature. User observes migration through window marked ACCEPT or REJECT. Used in clinical settings to verify sterilization cycle parameters; provides immediate visual confirmation of sterilization conditions. Benefits patient by ensuring medical instruments are properly processed.

Clinical Evidence

Bench testing only. Performance verified using resistometer compliant with ANSI/AAMI/ISO 18472:2006. Testing confirmed stated values, dry heat response, correlation with biological indicators, and endpoint stability after 6 months storage.

Technological Characteristics

Chemical integrator; paper wick and steam/temperature-sensitive chemical pellet; paper/film/foil laminate housing. Class 5 chemical indicator per ANSI/AAMI/ISO 11140-1:2005. Rectangular form factor.

Indications for Use

Indicated for pack control monitoring of steam sterilization cycles (gravity and vacuum-assisted) at temperatures ranging from 121°C to 135°C.

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

• 3M™ Comply™ SteriGage™ Chemical Integrator (K771080)

Submission Summary (Full Text)

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### 510(k) Summary

K101249

SEP 0 8 2010

# SM

## Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person:

Phone Number:

FAX Number:

Suzanne Leung Regulatory Affairs [phone] [phone]

Date of Summary:

August 16, 2010

#### Device Name and Classification:

| Common or Usual Name: | Sterilization Process Indicators for Steam |
|------------------------|----------------------------------------------------------------------------------------|
| Proprietary Name: | 3MTM ComplyTM SteriGageTM 1243RA, 1243RB, and<br>1243RE Chemical Integrators for Steam |
| Classification Name: | Indicator, Physical/Chemical Sterilization Process<br>(21 CFR § 880.2800(b)) |
| Performance Standards: | There are no mandatory performance standards |

#### Predicate Device:

3M™ Comply™ SteriGage™ Chemical Integrator (formerly InfoChem SteriGage™ Chemical Integrator)

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#### Description of Device:

3M Comply SteriGage 1243RA, 1243RB, and 1243RE Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or REJECT; the extent of migration depends on steam, time, and temperature.

#### Indications for Use:

The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.

| Cycle Type | Temperature | Exposure Time |
|-----------------------------|---------------|----------------------------------------------------|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped)<br>≥ 3 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped)<br>≥ 3.5 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |

The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.

#### Minimum Stated Values for SteriGage

| 250° F | 270° F | 273° F | 275° F |
|---------|---------|---------|--------|
| 121° C | 132° C | 134° C | 135°C |
| 16.5 | 2.0 | 1.4 | 1.1 |
| minutes | minutes | minutes | minute |

#### Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Testing on multiple lots confirmed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam complies with the chemical integrator performance requirements of FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005 Sterilization of health care products - Chemical indicators, Part 1: General Requirements (for Class 5). Stated values were obtained

3M Confidential

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using a test vessel compliant to ANSVAAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment.

| Test | Acceptance Criteria | Results |
|----------------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Stated Values in<br>Resistometer | See Minimum Stated Values | Passed |
| Dry Heat | Shows 'Reject' at<br>137 – 138 °C, 30 min | Passed |
| Comparison to BI | Shows 'Reject' at conditions<br>where BI fails,<br>Shows 'Accept' only at<br>conditions where BI passes | Passed |
| Endpoint Stability | An 'Accept' result or a 'Reject'<br>result does not change after<br>storage for 6 months | Passed |

#### Summary of Nonclinical Testing

The testing summarized above showed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam is substantially equivalent to the predicate device, the current 3MTM ComplyTM SteriGage™ Chemical Integrator, cleared under K 771080 in terms of design, intended use, indications for use, composition, physical properties and technological characteristics. The only difference between the predicate and the new integrators is the change in the shape of the product from trapezoidal to rectangular. There are no new questions of safety or effectiveness.

.

Page 15 of 15

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Suzanne Leung, Ph.D Regulatory Affairs 3M Company 3M Center, Building 275-05-W-06 Saint Paul, Minnesota 55144-1000

SEP 0 g 2010

Re: K101249

Trade/Device Name: 3M™ Comply" SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 30, 2010 Received: August 31, 2010

Dear Dr. Leung:

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. 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.

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Page 2- Dr. Leung

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or àt its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh foc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### . Indications for Use

SEP 0 g 2010

#### 510(k) Number (if known): K101249

Device Name:

3MTM ComplyTM SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam

#### Indications For Use:

The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.

| Cycle Type | Temperature | Exposure Time |
|-----------------------------|---------------|----------------------------------------------------|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped)<br>≥ 3 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped)<br>≥ 3.5 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |

The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.

#### Minimum Stated Values for SteriGage

| 250° F<br>121° C | 270° F<br>132° C | 273° F<br>134° C | 275° F<br>135° C |
|------------------|------------------|------------------|------------------|
| 16.5<br>minutes | 2.0<br>minutes | 1.4<br>minutes | 1.1<br>minute |

Prescription Use (Part 21 CFR 801 Subpart D) -

AND/OR

Over-The-Counter Use · X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K101249