The 3M™ Comply™ Lead Free Process Indicators for Steam are designed to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads.

3M Comply Lead Free Process Indicators for Steam include:

Comply 68200 Lead Free Record Card .
Comply 1322 Lead Free Indicator Tape .
Lead Free Test Pack Labels to be used on test packs including the following -.
- Comply 41380 Steam-Plus Test Pack o
- Comply 41360 Steam Test Pack o
- 3M Attest™ 1276 Steam Test Pack 0
- 3M Attest™ 1296 Steam Test Pack O
- 3M Attest™ 41382 Steam-Plus Test Pack O
- Comply 1233LF, 00132LF, 00135LF Bowie Dick Test Packs

Use the 3M™ Comply™ Lead Free Process Indicators for Steam in steam sterilization processes described below.

Cycle Type	Temperature	Exposure Time
Gravity	250 °F/121 °C	≥ 30 minutes (wrapped)
Gravity	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 15 minutes (wrapped)
Gravity	275 °F/135 °C	≥ 3 minutes (unwrapped)≥ 10 minutes (wrapped)
Vacuum-assisted (prevacuum)	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	273 °F/134 °C	≥ 3.5 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	275 °F/135 °C	≥ 3 minutes (wrapped orunwrapped)

Device Description

The 3MTM ComplyTM Lead Free Process Indicators for Steam provides immediate identification of processed items. The chemical indicator ink does not contain lead as part of the reaction chemistry and can be printed onto suitable paper substrates. As an example, the ink is printed onto adhesive-coated crepe paper for autoclave tape, onto cardstock for record cards, and onto adhesive-coated labelstock for indicator labels on test packs.

The purpose of this submission is to:

Replace the lead ink in the current 3M™ Comply™ Autoclave Tape with Lead . Free Ink. The current Comply Autoclave Tape was cleared under K932129
Apply the Lead Free Ink to cardstock as a new 3M™ Comply™ Record Card .
Replace the lead ink in the process indicators on the labels currently used to . secure all 3M™ Comply™ test packs. The use of the Lead Free Ink in process indicators on labels securing the Lead Free Bowie Dick test pack was cleared under K093199. This filing will extend its use to other test packs for steam.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3M™ Comply™ Lead Free Process Indicators for Steam:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that the testing "met the process indicator 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."

Therefore, the acceptance criteria are implicitly the standards set forth in these regulatory guidance documents and international standards.

The reported device performance is that the device "met the process indicator requirements" of these standards. The document also states that the device is "substantially equivalent to the predicate device 3M™ Comply™ Autoclave Tape, cleared under K932129 in terms of intended use, performance, physical properties and technological characteristics." This implies that the new device performs at least as well as the predicate device, which would have previously met similar standards.

Acceptance Criteria (Implicit from referenced standards)	Reported Device Performance
Meets requirements of FDA 510(k) Guidance for Chemical Indicators (Dec 19, 2003)	Met
Meets requirements of ANSI/AAMI/ISO 11140-1:2005 (Sterilization Chemical Indicators Part 1)	Met
Substantially equivalent to predicate device (3M™ Comply™ Autoclave Tape K932129)	Substantially equivalent in intended use, performance, physical properties, and technological characteristics

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It mentions "testing that was conducted," but no specific number of units tested is provided.
Data Provenance: The data provenance is internal testing conducted by 3M Health Care for the purpose of seeking FDA clearance. It is inherently prospective as it was performed to evaluate the performance of the new lead-free indicators. The location of the testing is not specified, but it can be inferred to be within the US given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For chemical indicators, the "ground truth" is typically established by the physical and chemical properties of the indicator's reaction to sterilizing agents under controlled conditions, as defined by the referenced standards (e.g., color change at specific temperature/time/steam exposure). It's unlikely that human experts in the traditional sense (like radiologists reading images) were used for establishing ground truth for individual indicator performance, but rather the performance was judged against objective photometric or visual color change criteria defined within the standards.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the ground truth determination for chemical indicators relies on objective physical/chemical reactions rather than human interpretation requiring adjudication.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret patient cases. For a chemical indicator, the performance is assessed by its physical reaction to sterilization conditions, not by human interpretation of complex data that could be aided by AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The "device" in this context is the chemical indicator itself, which performs its function (color change) without human intervention during the sterilization process. The testing conducted to meet the FDA and ISO standards evaluated the indicator's performance independently.

7. The Type of Ground Truth Used

The ground truth used is based on objective physical and chemical reactions of the indicator to specific steam sterilization conditions, as defined and specified by the referenced regulatory guidance (FDA's 510(k) Guidance for Chemical Indicators) and the international standard (ANSI/AAMI/ISO 11140-1:2005). This involves precise control of temperature, time, and steam saturation, and then observing the indicator's color change against defined acceptable outcomes for "processed" and "unprocessed" states.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a passive chemical indicator, not an AI or machine learning algorithm that requires a "training set" in the computational sense. Its design and material composition are developed through chemical engineering and materials science, not through a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as in point 8.

Summary

{0}------------------------------------------------

K10/528

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Premarket Notification (510(k)) Summary

【DCT.1】 2010

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Sponsor Information:	3M Health Care3M Center, Bldg. 275-5W-06St. Paul, MN 55144-1000
Contact Person:	Suzanne Leung, Ph.D.Regulatory Affairs
Phone Number:	(651) 575-8052
FAX Number:	(651) 736-0897
Date of Summary:	September 28, 2010
Device Name and Classification:

Device Name and Classification:

Common or Usual Name:	Sterilization Process Indicators for Steam
Proprietary Name:	3M™ Comply™ Process Indicators for Steam
Classification Name:	Indicator, Physical/Chemical Sterilization Process(21 CFR § 880.2800(b))

Predicate Device:

3M™ Comply™ Autoclave Tape

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

Description of Device:

The purpose of this submission is to:

Replace the lead ink in the current 3M™ Comply™ Autoclave Tape with Lead . Free Ink. The current Comply Autoclave Tape was cleared under K932129
Apply the Lead Free Ink to cardstock as a new 3M™ Comply™ Record Card .
Replace the lead ink in the process indicators on the labels currently used to . secure all 3M™ Comply™ test packs. The use of the Lead Free Ink in process indicators on labels securing the Lead Free Bowie Dick test pack was cleared under K093199. This filing will extend its use to other test packs for steam.

Indications for Use:

The 3MTM ComplyTM Lead Free Process Indicators for Steam are designed to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads.

3M Comply Lead Free Process Indicators for Steam include:

Comply 68200 Lead Free Record Card .
Comply 1322 Lead Free Indicator Tape .
Lead Free Test Pack Labels to be used on test packs including the following -.
- Comply 41380 Steam-Plus Test Pack o
- Comply 41360 Steam Test Pack o
- 3M Attest™ 1276 Steam Test Pack 0
- 3M Attest™ 1296 Steam Test Pack O
- 3M Attest™ 41382 Steam-Plus Test Pack O
- Comply 1233LF, 00132LF, 00135LF Bowie Dick Test Packs

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

Cycle Type	Temperature	Exposure Time
Gravity	250 °F/121 °C	≥ 30 minutes (wrapped)
Gravity	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 15 minutes (wrapped)
Gravity	275 °F/135 °C	≥ 3 minutes (unwrapped)≥ 10 minutes (wrapped)
Vacuum-assisted (prevacuum)	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	273 °F/134 °C	≥ 3.5 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	275 °F/135 °C	≥ 3 minutes (wrapped orunwrapped)

Use the 3M™ Comply™ Lead Free Process Indicators for Steam in steam sterilization processes described below.

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

Results from testing that was conducted met the process indicator requirements of FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19. 2003 and ANSI/AAMI/1SO 11140-1:2005 Sterilization of health care products - Chemical indicators, Part 1: General Requirements. The 3M™ Comply™ Lead Free Process Indicators are substantially equivalent to the predicate device 3M™ Comply™ Autoclave Tape, cleared under K932129 in terms of intended use, performance, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

"OCT 1 2010

Re: K101528

Trade/Device Name: 3M™ Comply™ Lead Free Process Indicators for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: September 16, 2010 Received: September 20, 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.

{4}------------------------------------------------

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 (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.

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 at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony O. mutt

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

{5}------------------------------------------------

Indications for Use

510(k) Number: K101528 3M™ ComplyTM Lead Free Process Indicators for Steam Device Name:

Indications for Use:

3M™ ComplyTM Lead Free Process Indicators for Steam include:

Comply 68200 Lead Free Record Card .
Comply 1322 Lead Free Indicator Tape
Lead Free Test Pack Labels to be used on test packs including the following
- o ComplyTM 41380 Steam-Plus Test Pack
- ComplyTM 41360 Steam Test Pack O
- Attest™ 1276 Steam Test Pack 0
- Attest™ 1296 Steam Test Pack 0
- Attest™ 41382 Steam-Plus Test Pack O
- ComplyTM 1233LF, 00132LF, 00135LF Bowie Dick Test Packs 0

Use the 3M™ Comply™ Lead Free Process Indicators for Steam in steam sterilization processes described below.

Cycle Type	Temperature	Exposure Time
Gravity	250 °F/121 °C	≥ 30 minutes (wrapped)
Gravity	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 15 minutes (wrapped)
Gravity	275 °F/135 °C	≥ 3 minutes (unwrapped)≥ 10 minutes (wrapped)
Vacuum-assisted (prevacuum)	270 °F/132 °C	≥ 3 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	273 °F/134 °C	≥ 3.5 minutes (unwrapped)≥ 4 minutes (wrapped)
Vacuum-assisted (prevacuum)	275 °F/135 °C	≥ 3 minutes (wrapped orunwrapped)

Prescription Use . (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Elizabeth P. Claverie Wills

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

510(k) Number: K101528

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).