The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

STERRAD® 100S
STERRAD® 50
STERRAD® 200
STERRAD® NX®
STERRAD® 100NX® (Standard, Flex and Express Cycles)
For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

Device Description

The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x10^6 Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion. There are no changes to the STERRAD® CYCLESURE® 24 Biological Indicator from the device cleared in K102884. The change is to the labeling to add the STERRRAD® 100NX® DUO Cycle to the CYCLESURE® 24 Biological Indicator Indications for Use Statement.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the STERRAD® CYCLESURE® 24 Biological Indicator:

1. Table of Acceptance Criteria and Reported Device Performance

The summary states that the device "meets the same performance criteria as the predicate devices." While specific numerical acceptance criteria for each test (e.g., specific thresholds for reduction, growth rates, etc.) are not explicitly detailed in the provided text, the categories of performance criteria tested are:

Acceptance Criteria Category	Reported Device Performance
Evaporation	Passed
Verification of Positive BI Color	Passed
Bacteriostasis	Passed
BI Validation in the STERRAD® Sterilization Systems (Dose Response)	Passed

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

The summary does not provide specific sample sizes for the test set for each of the studies listed. It states: "Therefore, only following performance data related to the DUO Cycle are included in this submission." This implies that the tests were conducted specifically for the DUO Cycle.

Sample Size: Not specified.
Data Provenance: The document implies the data was generated specifically for this submission to support the new DUO Cycle, so it would be prospective data, likely collected in a laboratory setting at Advanced Sterilization Products. The country of origin of the data is not explicitly stated, but given the applicant's address, it's highly probable to be United States.

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

This type of device (a biological indicator for sterilization) does not typically involve human expert interpretation in the same way as medical imaging devices. The "ground truth" for a biological indicator is based on microbiological culturing results (i.e., presence or absence of Geobacillus stearothermophilus growth), which is an objective outcome rather than a subjective interpretation. Therefore, the concept of "experts establishing ground truth" as it applies to subjective assessments is not relevant here.

4. Adjudication Method for the Test Set

As the "ground truth" for a biological indicator is objective microbiological growth, there is no adjudication method (like 2+1 or 3+1 consensus) required for the test set. The outcome is determined by scientific observation of bacterial growth.

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

No. This is a biological indicator for monitoring sterilization processes, not a diagnostic imaging device that involves human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable or performed for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense. The "device" itself (the biological indicator) is a standalone entity that provides an objective output (color change in the chemical indicator and potential microbiological growth). The performance studies evaluate the indicator's ability to accurately reflect sterilization efficacy without human intervention during the "reading" of the growth. The "algorithm" here is the biological process itself, not a computer algorithm.

7. Type of Ground Truth Used

The ground truth used for evaluating the performance of a biological indicator is microbiological growth/non-growth.

For the "BI Validation in the STERRAD® Sterilization Systems (Dose Response)" test, the ground truth would be the known efficacy of the sterilization parameters (e.g., specific hydrogen peroxide exposure levels, time, temperature) to kill bacterial spores, and the subsequent observation of whether the Geobacillus stearothermophilus spores in the BI were killed or survived. This is essentially outcomes data in a controlled experimental setting.
For "Verification of Positive BI Color" and "Bacteriostasis," the ground truth would be the expected visual change or lack of inhibitory effect on growth based on standard microbiological techniques.

8. Sample Size for the Training Set

The concept of a "training set" is not relevant for this device. Biological indicators do not use machine learning or AI algorithms that require training data. Their function is based on established biological principles of spore resistance and growth in response to sterilization, which are inherently fixed properties, not learned ones.

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

Since there is no "training set" for this biological indicator, this question is not applicable. The device's performance relies on its inherent biological properties and manufacturing consistency, not on an algorithm trained on data.

Summary

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510(k) Summary

SEP 14 2012

Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products, Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Nancy Chu Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900

Summary Date: September 10, 2012

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Common/Usual Name: Product Classification: Classification Regulation: Proprietary Name:

Biological Sterilization Process Indicator Biological Indicator II 21 CFR 880.2200

STERRAD® CYCLESURE® 24 Biological indicator

2. PREDICATE DEVICES

STERRAD® CYCLESURE® 24 Biological Indicator, K102884, 1/28/2011 .
STERRAD® CYCLESURE® 24 Biological Indicator for use in STERRAD® EXPRESS Cycle, K103222, 2/25/2011

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3. INDICATIONS FOR USE

The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

STERRAD® 100S .
STERRAD® 50 .
STERRAD® 200 .
STERRAD® NX® .
STERRAD® 100NX® (Standard, Flex and Express Cycles) .
- o For STERRAD® 100NX® DUO Cycle. the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

4. DESCRIPTION OF DEVICE

The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of lx10° Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion. There are no changes to the STERRAD® CYCLESURE® 24 Biological Indicator from the device cleared in K102884. The change is to the labeling to add the STERRRAD® 100NX® DUO Cycle to the CYCLESURE® 24 Biological Indicator Indications for Use Statement.

5. SUMMARY OF NONCLINICAL TESTS

Testing conducted for this submission is to confirm that STERRAD® CYCLESURE® 24 Biological Indicator performs as its intended use in a newly developed STERRAD® 100NX® DUO Cycle.

The STERRAD® CYCLESURE® 24 Biological Indicator, the subject device of this submission, remains the same since receiving clearance on January 28, 2011 (K102884). A subsequent submission (K103222) added the STERRAD® 100NX® EXPRESS Cycle to the Indications for Use statement. The only change to the predicate devices is a newly developed STERRAD® 100NX® DUO Cycle added to the Indications for Use statement.

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Recently cleared predicate devices (K102884 and K103222) and the subject device of this submission, have the same intended use, the same technological characteristics, the same operating principles, and utilize the same sterilant (hydrogen peroxide).

This submission is intended to support the DUO Cycle for use in the STERRAD® 100NX® Sterilizer. Therefore, only following performance data related to the DUO Cycle are included in this submission.

Studies Performed	Results
Evaporation	Passed
Verification of Positive BI Color	Passed
Bacteriostasis	Passed
BI Validation in the STERRAD® Sterilization Systems(Dose Response)	Passed

6. DESCRIPTION OF CHANGE

A newly developed STERRAD® 100NX® DUO Cycle is added to the Indications for Use statement.

7. OVERALL PERFORMANCE CONCLUSIONS

The performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX® DUO Cycle by meeting the same performance criteria as the predicate devices.

The STERRAD® CYCLESURE® 24 Biological Indicator is substantially equivalent to predicate devices (K102884 and K103222) because they have the same intended use, the same technological characteristics, the same operating principles and use the same sterilant (Hydrogen Peroxide).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

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

SEP 14 2012

Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: Ki11375

Trade/Device Name: Sterrad® Cyclesure® 24 Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: September 10, 2012 Received: September 12, 2012

Dear Ms. Chu:

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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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 yours,

F. Roodman

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 (if known): K111375

STERRAD® CYCLESURE® 24 Biological Indicator Device Name:

Indication for Use:

The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

STERRAD® 100S .
STERRAD® 50
STERRAD® 200 .
STERRAD® NX®
STERRAD® 100NX® (Standard, Flex and Express Cycles) .
- o For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

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)

Ropiy Gangulim

sion Sign-Orr)
Ion of Anestheslology, General Hospital
Ion of Anestheslology, General Infection Control,

510(k) Number: K111375

Page 1 of 1

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).