(271 days)
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
Not Found
This document is a 510(k) premarket notification acceptance letter from the FDA for a STERILIZATION PROCESS INDICATOR, specifically the STERRAD® CYCLESURE® 24 PLUS Biological Indicator. This device is used to monitor the effectiveness of sterilization processes in healthcare facilities.
The document does not contain the acceptance criteria or device performance data for this type of device in the way it would for a software-based medical device (e.g., an AI algorithm for image analysis). The "acceptance criteria" for a biological indicator refer to its ability to reliably indicate whether a sterilization cycle has been successful by killing a defined population of microorganisms. The testing for such a device typically involves challenging the indicator with a specific sterilization process and then culturing the indicator to see if growth occurs.
Therefore, I cannot extract the specific information requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, effect size of human improvement with AI, etc.) because these concepts are not applicable to the type of device described in this FDA letter. This document is a regulatory approval letter, not a detailed study report for an AI-powered diagnostic device.
The information provided in the document is limited to:
- Device Name: STERRAD® CYCLESURE® 24 PLUS Biological Indicator
- Regulation Number: 21 CFR 880.2800(a) (Sterilization Process Indicator)
- Regulatory Class: II
- Product Code: FRC
- Intended Use: Used as a standard method for frequent monitoring of specified STERRAD® Sterilizer Systems.
To answer your specific questions, one would need to refer to the actual testing protocols and results submitted by Mesa Laboratories Incorporated to the FDA for their 510(k) submission K140589, which are not detailed in this public letter. These would typically include:
- Acceptance Criteria for a Biological Indicator:
- Expected performance: Growth (positive result) if not sterilized.
- Expected performance: No growth (negative result) if adequately sterilized.
- Specific D-value (decimal reduction time) or other resistance parameters demonstrating adequate challenge to the sterilization process.
- Population of microorganisms (e.g., Geobacillus stearothermophilus) used.
- Proof of device meets criteria:
- Results from laboratory testing demonstrating the indicator's resistance to the specified sterilization processes and its ability to consistently show no growth after successful cycles and growth after failed cycles.
Without the specific study details from the 510(k) submission, direct answers to your numbered points are not possible from the provided 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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).