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

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

Minimum Stated Values for SteriGage

250° F121° C	270° F132° C	273° F134° C	275° F135° C
16.5minutes	2.0minutes	1.4minutes	1.1minute

Device Description

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the 3M™ Comply™ SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam (K101249).

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Stated Values in Resistometer	See Minimum Stated Values (e.g., 250°F/121°C: 16.5 minutes; 270°F/132°C: 2.0 minutes; etc.)	Passed
Dry Heat	Shows 'Reject' at 137 – 138 °C, 30 min	Passed
Comparison to BI (Biological Indicator)	Shows 'Reject' at conditions where BI fails, Shows 'Accept' only at conditions where BI passes	Passed
Endpoint Stability	An 'Accept' result or a 'Reject' result does not change after storage for 6 months	Passed

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes for the test sets (number of integrators tested for each condition). It mentions "testing on multiple lots" which implies a sufficient number of devices were evaluated, but no specific quantity is given.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in that it's testing a finished product against established standards, but it's not data collected from real-world usage over time. It's a laboratory-based performance evaluation.

3. Number of Experts and Qualifications for Ground Truth

This type of device (chemical integrator for sterilization) does not typically rely on human expert interpretation for ground truth. The "ground truth" is based on objective physical/chemical reactions and comparison to a "biological indicator" (BI) which is a well-established standard for sterility assurance. Therefore, there are no "experts" in the radiological or medical sense establishing ground truth; rather, the process is validated against scientific standards.

4. Adjudication Method

Not applicable. The evaluation of chemical integrators is objective (visible migration to 'ACCEPT' or 'REJECT' window) and doesn't involve subjective human judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a standalone chemical indicator, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are standalone performance evaluations of the chemical integrator itself. There is no human-in-the-loop for the primary function of determining if sterilization conditions were met. The device's performance (showing Accept/Reject) is the standalone algorithm's output.

7. Type of Ground Truth Used

The ground truth used for this study is:

Established scientific standards for sterilization conditions: Demonstrated by "Minimum Stated Values" determined using a resistometer, which provides precise control over temperature and time.
Comparison to Biological Indicators (BI): Biological indicators contain resistant bacterial spores and are considered the gold standard for monitoring the effectiveness of sterilization processes. The chemical integrator's performance is compared directly to the BI's "fail" or "pass" conditions.
Physical/chemical properties: The dry heat and endpoint stability tests rely on the inherent physical and chemical properties of the integrator to behave consistently under specified conditions.

8. Sample Size for the Training Set

Not applicable. This device is a chemical integrator, not a machine learning model that requires a "training set." Its design and performance are based on chemical engineering principles, not data-driven learning.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a chemical integrator device.

Summary

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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 (651) 575-8052 (651) 736-0897

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, and1243RE Chemical Integrators for Steam
Classification Name:	Indicator, Physical/Chemical Sterilization Process(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)

{1}------------------------------------------------

Description of Device:

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)≥ 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

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

{2}------------------------------------------------

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 inResistometer	See Minimum Stated Values	Passed
Dry Heat	Shows 'Reject' at137 – 138 °C, 30 min	Passed
Comparison to BI	Shows 'Reject' at conditionswhere BI fails,Shows 'Accept' only atconditions where BI passes	Passed
Endpoint Stability	An 'Accept' result or a 'Reject'result does not change afterstorage 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 (800) 638-2041 or (301) 796-7100 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)≥ 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

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

Minimum Stated Values for SteriGage

250° F121° C	270° F132° C	273° F134° C	275° F135° C
16.5minutes	2.0minutes	1.4minutes	1.1minute

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

Regulation Number and Section

§ 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).