3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM

K101528 · 3M Company · JOJ · Oct 1, 2010 · General Hospital

Device Facts

• Record ID: K101528
• Device Name: 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Oct 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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, Comply 41360 Steam Test Pack, 3M Attest™ 1276 Steam Test Pack, 3M Attest™ 1296 Steam Test Pack, 3M Attest™ 41382 Steam-Plus Test Pack, 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 parameters omitted for brevity].

Device Story

Device consists of chemical indicator ink applied to paper substrates (crepe paper, cardstock, labelstock) to provide immediate visual identification of steam sterilization exposure. Ink formulation is lead-free. Used in clinical settings to secure or label sterilization test packs, record cards, and autoclave tape. Healthcare personnel apply indicators to items prior to sterilization; visual color change confirms exposure to steam process. Benefits include immediate verification of processing status, reducing risk of using unsterilized equipment.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI/ISO 11140-1:2005 standards for chemical indicators and FDA guidance for Premarket Notification [510(k)] Submissions for Chemical Indicators.

Technological Characteristics

Chemical sterilization process indicator; lead-free ink chemistry; substrates include adhesive-coated crepe paper, cardstock, and adhesive-coated labelstock. Sensing principle: chemical reaction to steam exposure resulting in visual color change. Complies with ANSI/AAMI/ISO 11140-1:2005.

Indications for Use

Indicated for use in healthcare facilities to provide visual confirmation of exposure to steam sterilization processes for medical units or loads, distinguishing processed from unprocessed items.

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™ Autoclave Tape (K932129)

Submission Summary (Full Text)

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K10/528

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Premarket Notification (510(k)) Summary

## 【DCT.1】 2010

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| Sponsor Information: | 3M Health Care<br>3M Center, Bldg. 275-5W-06<br>St. Paul, MN 55144-1000 | |
|---------------------------------|-------------------------------------------------------------------------|--|
| Contact Person: | Suzanne Leung, Ph.D.<br>Regulatory Affairs | |
| Phone Number: | [phone] | |
| FAX Number: | [phone] | |
| 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<br>(21 CFR § 880.2800(b)) |

### Predicate Device:

3M™ Comply™ Autoclave Tape

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#### Description of Device:

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.

#### 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

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

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.

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#### 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.

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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 (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 [phone] or [phone] 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

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#### Indications for Use

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

#### Indications for Use:

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™ 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)<br>≥ 15 minutes (wrapped) |
| Gravity | 275 °F/135 °C | ≥ 3 minutes (unwrapped)<br>≥ 10 minutes (wrapped) |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 3 minutes (unwrapped)<br>≥ 4 minutes (wrapped) |
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 3.5 minutes (unwrapped)<br>≥ 4 minutes (wrapped) |
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes (wrapped or<br>unwrapped) |

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