STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR

K140589 · Mesa Laboratories, Inc. · FRC · Dec 3, 2014 · General Hospital

Device Facts

• Record ID: K140589
• Device Name: STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
• Applicant: Mesa Laboratories, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® CYCLESURE® 24 PLUS Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilizer Systems used in Healthcare facilities: - STERRAD® 50 - STERRAD® 100S - STERRAD® 200 - STERRAD® NX Standard Cycle - STERRAD® NX Advanced Cycle - STERRAD® 100NX STANDARD Cycle - STERRAD® 100NX FLEX Cycle - STERRAD® 100NX DUO Cycle - STERRAD® 100NX EXPRESS Cycle

Device Story

Biological indicator used to monitor sterilization cycles in STERRAD® hydrogen peroxide gas plasma sterilizers. Device contains biological spores; placed in sterilizer to verify lethality of sterilization process. After cycle, indicator is incubated; growth or lack thereof indicates sterilization success or failure. Used by healthcare personnel in clinical settings to ensure instrument sterility. Provides objective verification of sterilization process; helps prevent use of non-sterile instruments; improves patient safety by reducing risk of healthcare-associated infections.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Biological indicator containing bacterial spores. Designed for use with STERRAD® hydrogen peroxide gas plasma sterilization systems. Standalone monitoring device; no software or electronic components.

Indications for Use

Indicated for monitoring sterilization efficacy in STERRAD® Sterilizer Systems (50, 100S, 200, NX, 100NX) within healthcare facilities. No specific patient population or contraindications defined as it is a process monitoring device.

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.

Submission Summary (Full Text)

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

December 3,2014

Mesa Laboratories Incorporated Mr. Kurt McCauley Director of Quality Assurance & Regulatory Affairs 8607 Park Drive Omaha, NE 68127

Re: K140589

Trade/Device Name: STERRAD® CYCLESURE® 24 PLUS Biological Indicator Regulation Number: 21 CFR 880.2800(a) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: November 4, 2014 Received: November 5, 2014

Dear Mr. McCauley:

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 - Mr. McCauley

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K140589

Device Name STERRAD® CYCLESURE® 24 PLUS Biological Indicator

Indications for Use (Describe) The STERRAD® CYCLESURE® 24 PLUS Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilizer Systems used in Healthcare facilities:

- · STERRAD® 50
- · STERRAD® 100S
- · STERRAD® 200
- · STERRAD® NX Standard Cycle
- · STERRAD® NX Advanced Cycle
- · STERRAD® 100NX STANDARD Cycle
- · STERRAD® 100NX FLEX Cycle
- · STERRAD® 100NX DUO Cycle
- · STERRAD® 100NX EXPRESS Cycle

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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