The STERRAD® CycleSure™ Biological Indicator is intended for use by healthcare providers for monitoring of the sterilization process in STERRAD® Sterilization Systems. STERRAD® CycleSure™ Biological indicator is designed to accompany medical devices placed in the sterilizer.

The STERRAD® CycleSure™ Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.

Device Description

The STERRAD® CycleSure™ Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 100 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, 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.

After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to close the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).

The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified STERRAD® CycleSure™ Biological Indicator. However, the document focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, ground truth methodologies, and expert qualifications are not explicitly available in the provided text.

Based on the information available:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document focuses on "consistency and appropriateness for the evaluation and release of CycleSure BIs" with new testing methods.	18 different lots of CycleSure BIs were tested using the new methods. The results obtained indicated that "the methods used were consistent and appropriate for the evaluation and release of CycleSure BIs."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: 18 different lots of CycleSure BIs were tested. The exact number of BIs within each lot tested is not specified.
Data Provenance: Not specified, but given it's a product from Advanced Sterilization Products, a Johnson & Johnson company based in Irvine, CA, the testing was likely conducted in the US or under their global quality system. The study is retrospective in the sense that it's a post-modification release test rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The determination of "consistent and appropriate" methods would likely involve internal testing and validation professionals.

4. Adjudication method for the test set:

Not specified. The document refers to "methods used to test the product for final release," implying standard laboratory testing protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device that relies on a biological response to determine sterilization effectiveness, not an algorithm. The "reading" is a visual color change observed by a human after incubation.

7. The type of ground truth used:

The ground truth for a biological indicator is typically established by comparing its response (growth/no growth) to known conditions of sterility (or lack thereof) in a controlled sterilization process, often verified by other established methods (e.g., physical/chemical indicators, or direct sterility testing of products). The document mentions "new methods" based upon a "BIER vessel," which is a Biological Indicator Evaluator Resistometer – a standard device for evaluating BI performance under controlled conditions. This suggests a controlled laboratory environment where the sterility challenge is precisely known and verified.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary of Device Modification and Study:

The core of this 510(k) submission is a modification to the methods used to test the product for final release. The device itself (the STERRAD® CycleSure™ Biological Indicator) remains largely the same as its predicate (same indicated use, operating principle, design, materials, shelf life, and packaging). The "study" described is a nonclinical test of 18 different lots of the modified BI, using these new release testing methods. The conclusion of this testing was that the new methods were deemed "consistent and appropriate for the evaluation and release of CycleSure BIs," implying that the device continued to meet its performance requirements when evaluated by the updated testing procedures.

Summary

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STERRAD® CycleSure™ Biological Indicator

ADVANCED STERILIZATION PRODUCTS®

Johnson company REGULATORY AFFAIRS DEPARTMENT

510(k) Summary

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

Advanced Sterilization Products A Division of Johnson & Johnson Medical, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Kevin Corrigan, R.A.C. Manager of Regulatory Affairs Tel: (949) 453-6410 Fax: (949) 789-3900

Submission Date April 17, 2003

Trade Name

STERRAD® CycleSure™ Biological Indicator

Common Name

Biological Indicator

Classification Name

Class II

Legally Marketed Equivalent Device Name(s)

STERRAD® CycleSure™ Biological Indicator, K994055, February 13, 2002.

DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • • IRVINE, CA 92618 • (949) 581-5799 • FAX (949) 789-3998

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Description of Device

The STERRAD® CycleSure™ Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization It consists of a glass fiber disc containing a minimum of 100 Bacillus Process. stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, 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.

Statement of Intended Use

Description of Modification

The modification is to the methods used to test the product for final release. Additionally, the labeling for the device was modified to reflect this release testing based upon the BIER vessel.

Summary of Nonclinical Tests

18 different lots of CycleSure BIs were tested using the new methods. Based upon the results obtained, the methods used were consistent and appropriate for the evaluation and release of CycleSure BIs.

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Substantial Equivalence

The modified STERRAD CycleSure Biological Indicators have the following similarities to those which previously received 510(k) clearance:

. have the same indicated use,
. use the same operating principle,
incorporate the same design, ●
incorporate the same materials, ●
have the same shelf life, and .
are packaged using the same materials and processes. .

In summary, the STERRAD CycleSure Biological Indicator described in this submission is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles merging into a single form, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Mr. Kevin Corrigan Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: K031226

Trade/Device Name: STERRAD® CycleSure™ Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 17, 2003 Received: April 21, 2003

Dear Mr. Corrigan:

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.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Corrigan

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Siser Runore

Susan Runner, DDS, MA Interim 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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ADVANCED STERILIZATION PRODUCTS® a Johnson Johnson company REGULATORY AFFAIRS DEPARTMENT

Indications for Use

510(k) Number:

STERRAD® CycleSure™ Biological Indicator Device Name

Indications For Use:

The STERRAD® CycleSure™ Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __

Over-the-Counter Use ____________

(Optional Format 1-2-96)

Qiu S. Lin

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

510(k) Number: K031226

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).