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 106 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 seal 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 the STERRAD® CycleSure™ Biological Indicator and its validation. It does not contain information about an AI/ML powered device. Therefore, I will extract the information for the biological indicator.

Acceptance Criteria and Device Performance for STERRAD® CycleSure™ Biological Indicator

This document describes the validation of the STERRAD® CycleSure™ Biological Indicator (BI), a self-contained biological monitor for routine monitoring of STERRAD® Sterilization Processes. The studies primarily focused on the chemical indicator, spore population, D-value, incubation time, bacteriostasis, and growth media performance and stability.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Chemical Indicator
Color Change (STERRAD® 100)	Change from red to yellow when processed under maximum & minimum H2O2 exposure.	Successfully changes color from red to yellow.
No Color Change (Water Substitute)	No color change when water substituted for H2O2.	Chemical indicator did not change color.
Unprocessed Stability	Maintain red color for at least 24 months at 15°C to 25°C.	Maintained red color for at least 24 months.
Post-processing Stability	Indicator color stable for at least 7 months after processing.	Stable for at least 7 months after processing (real time aging).
Functionality after Aging	Successfully change color from red to yellow after aging (30°C/75% R.H. up to 24 mos).	Successfully changed color from red to yellow (aged up to 24 months).
Biological Indicator
Spore Population	Determined in accordance with ISO 11138-1	Determined using a BIER Vessel following ISO 11138-1.
D-value	Determined in accordance with ISO 11138-1	Determined using a BIER Vessel following ISO 11138-1.
Incubation Time	Defined minimal time for growth detection. (30-80% surviving samples)	Minimum incubation time determined to be 48 hours (at 55°-60°C).
Bacteriostasis (STERRAD® 100)	No bacteriostatic effects observed.	No bacteriostatic effects observed.
Bacteriostasis (STERRAD® 50)	No bacteriostatic effects observed.	No bacteriostatic effects observed.
Growth Media
Color Reversion	Yellow color stable for up to 7 days of total incubation.	Yellow color was stable for up to 7 days of total incubation.
Growth Promotion (real-time)	Promote growth.	Promoted growth.
Bacteriostasis (real-time)	Not bacteriostatic.	Not bacteriostatic.
Quality Characteristics (real-time)	Met specification (pH, color, appearance, stability).	Met specification. (Data for 12 months, ongoing).
Growth Promotion (accelerated aging)	Promote growth (after 36 months at 55°C).	Promoted growth.
Bacteriostasis (accelerated aging)	Not bacteriostatic (after 36 months at 55°C).	Not bacteriostatic.
Quality Characteristics (accelerated aging)	Met specification (pH, color, appearance, stability). (after 36 months at 55°C).	Met specification.
Performance Validation	Inactivation after half cycle with reduced 59% nominal H2O2.	Inactivation consistently obtained in STERRAD®100, 100S, and 50 Sterilizers.
Shelf-Life (Stability)	Within specifications for labeled storage conditions (2°C - 25°C).	Stable for at least 18 months, within specifications. (Data up to 18 mos.
		ongoing up to 24 mos).

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

Chemical Indicator Validation: The specific number of samples for each condition (simulated heavy load, no load, plasma presence, H2O2 absence) is not explicitly stated, but it was "evaluated by observing the color."
Incubation Time Determination: Three different lots of BIs, each consisting of one hundred samples, were tested.
Bacteriostasis (STERRAD® 100 & STERRAD® 50): For each sterilizer, twenty STERRAD® CycleSure™ Biological Indicator samples prepared with uninoculated glass fiber discs (10 test, 10 negative controls) and ten additional samples prepared without glass fiber discs (positive controls) were used.
Growth Media Validation: Media lots were prepared, and testing was conducted, but specific sample sizes for each test are not provided.
Performance Validation: Not explicitly stated, but performed "using three different spore crops."
Shelf-Life (Stability) Validation: Three different manufacturing lots of BIs were used, with portions of each lot placed into different storage conditions. Samples were periodically removed and tested.

Data Provenance: The studies were conducted by Advanced Sterilization Products, a division of Ethicon, Inc., based in Irvine, California. Implied to be prospective in nature as the studies were conducted to validate a new device prior to commercialization. The origin is the USA.

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

Not applicable. The ground truth for this biological indicator is based on quantifiable biological and chemical responses (e.g., spore inactivation, color change, growth promotion) rather than subjective expert assessment. The testing standards (ISO 11138-1, CDRH Guidance Document) dictate the methodology.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and observations (e.g., color change, microbial growth/no growth, D-value calculation) that do not require an adjudication process by multiple reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This product is a biological indicator, not an AI/ML powered device that would involve human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device operates "standalone" in the sense that it functions without continuous human intervention during sterilization and incubation, this is not an AI/ML algorithm. Its "performance" refers to its physical and biological function as described.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

Biological Activity: The viability and inactivation of Bacillus stearothermophilus spores.
Chemical Reactions: The color change of the chemical indicator in response to hydrogen peroxide.
Standardized Methods: Adherence to established industry standards like ISO 11138-1 and CDRH Guidance Documents for biological indicator evaluation.
Laboratory Testing: Direct measurement of pH, growth promotion, bacteriostasis, and stability in controlled laboratory environments.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device, so there is no "training set" in the context of machine learning. The studies described are validation and performance tests of a physical product.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply.

Summary

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K 994055

ADVANCED STERILIZATION PRODUCTS® a Johnnon Johnson company REGULATORY AFFAIRS DEPARTMENT

FEB 1 3 2002

510(k) Summary

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

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

Contact Person

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

Submission Date

February 6, 2002

Trade Name

STERRAD® CycleSure™ Biological Indicator

Common Name

Biological Indicator

Classification Name

Class II

Legally Marketed Equivalent Device Name(s)

3MTM Attest™ Biological Indicator STERRAD® BI Test Pack

DIVISION OF ETHICON, INC. • 33 TECHNOLOGY DRIVE • IRVINE, CA 92618 • (949) 581-5799 • FAX (949) 789-3900

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Description of Device

Statement of Intended Use

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

Summary of Nonclinical Tests

Chemical Indicator Validation

Effects of a simulated heavy load, no load, presence of plasma, and absence of hydrogen peroxide on the performance of the chemical indicator component of the STERRAD® CycleSure™ Biological Indicator were evaluated by observing the color of the chemical indicators before and after processing in the STERRAD® Sterilization System.

The results of these performance studies indicate that the chemical indicator component of the STERRAD® CycleSure™ Biological Indicator successfully changes color from red to yellow when processed in the STERRAD® 100 Sterilization System under maximum and minimum exposure to hydrogen peroxide.

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Additionally, the chemical indicator did not change color when water was substituted for hydrogen peroxide in the injection phase of the cycle. This demonstrates that the color change of the chemical indicator is due to the chemical reaction between the dye and hydrogen peroxide molecules during the diffusion phase and not due to the plasma phase of the STERRAD® 100 Sterilization Process.

Chemical Indicator Stability Validation

Color stability of the chemical indicator component of the STERRAD® CycleSure™ Color stabling of has evaluated before and after processing in the STERRAD® Sterilization System. The results of stability studies indicate that the unprocessed chemical indicators maintain their red color for at least 24 months when stored at the storage temperatures specified in the product labeling (15°C to 25°C).

Post-processing color stability of the chemical indicator was also evaluated after processing in the STERRAD® Sterilization System. Stability results, based upon real time aging, demonstrate that the indicator color is stable for at least 7 months after processing in a STERRAD® Sterilizer.

In addition to the stability studies, functionality studies were conducted to evaluate the ability of the chemical indicator, following aging at 30°C/75% R.H., to change color when processed in the STERRAD® Sterilization Systems. Chemical indicators from three different lots, aged up to 24 months, successfully changed color from red to yellow upon processing.

Population and Performance Characteristics Determination

The spore population and performance characteristics of the STERRAD® CycleSure™ Biological Indicators were determined using a Biological Indicator Evaluation Resistometer (BIER Vessel) following the in accordance with ISO 11138-1.

Incubation Time Determination

Testing was conducted using CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986). Three different lots of STERRAD® CycleSure™ Biological Indicator (each using a different spore crop and media lot), each consisting of one hundred samples, were tested to determine the required incubation time. The sterilization cycle parameters were reduced in order to obtain 30-80% surviving samples for each lot tested. Processed STERRAD® CycleSure™ Biological Indicators were incubated for 7 days at 55-60° C. Samples were observed and the results were recorded on a daily basis. Based on the results from this testing, the minimum incubation time required for the STERRAD® CycleSure™ Biological Indicator was determined to be 48 hours.

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Bacteriostasis

Bacteriostasis testing was performed in the STERRAD® 100 Sterilizer to represent the minimum hydrogen peroxide exposure conditions (6 mg/L injected) and in the STERRAD® 50 Sterilizer to represent the maximum hydrogen peroxide exposure conditions (two injections at 14.3 mg/L injected).

STERRAD® 100 Sterilizer

Twenty STERRAD® CycleSure™ Biological Indicator samples were prepared with uninoculated glass fiber discs. Ten samples were processed in the STERRAD®100 Sterilization System as test samples and ten were unprocessed as negative controls. Ten additional STERRAD® CycleSure™ Biological Indicator samples were prepared without the glass fiber discs for positive controls, this sample set also remained unprocessed. All samples were inoculated with <10 Bacillus stearothermophilus spores/10uL. Growth of the test organism was observed in all samples when incubated at 55°-60°C. No bacteriostatic effects due to the materials of the STERRAD® CycleSure™ Biological Indicator and the STERRAD® 100 Sterilization process were observed.

STERRAD® 50 Sterilizer

Twenty STERRAD® CycleSure™ Biological Indicator samples were prepared with uninoculated glass fiber discs. Ten samples were processed in the STERRAD®50 Sterilization System as test samples and ten were unprocessed as negative controls. Ten additional STERRAD® CycleSure™ Biological Indicator samples were prepared without the glass fiber discs for positive controls, this sample set also remained unprocessed. All samples were inoculated with <10 Bacillus stearothermophilus spores/10uL. Growth of the test organism was observed in all samples when incubated at 55° - 60°C. No bacteriostatic effects due to the materials of the STERRAD® CycleSure™ Biological Indicator and the STERRAD® 50 Sterilization process were observed.

Growth Media Validation

The growth media was tested for color reversion after growth and it was determined that the yellow color was stable for up to 7 days of total incubation.

Studies were conducted to confirm the performance and quality characteristics of the growth medium and to evaluate the suitability of the media for use in the STERRAD® CycleSure™ Biological Indicator. The performance characteristics of the media to be evaluated include: growth promotion and bacteriostasis of the pH indicator. The quality characteristics of the media to be evaluated include: pH, color, appearance, and stability.

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Media lots were prepared and aged at room temperature (20-25° C). ASP currently has data for 12 months real-time aging and the testing is ongoing.

The aged media was shown to promote growth, was not bacteriostatic and the evaluated quality characteristics met specification.

Additional studies, conducted on media ampuls stored at at 55° C accelerated aging conditions, were conducted to determine the performance and quality characteristics of the growth media and to evaluate the end of shelf-life suitability of the media for use in the STERRAD® CycleSure™ Biological Indicator. The performance characteristics of the media to be evaluated include: growth promotion and bacteriostasis of the pH indicator. The quality characteristics of the media to be evaluated include: pH, color, appearance, and stability. Media lots were prepared and aged at elevated temperature (55° C). ASP has data for 36 months shelf-life based on these accelerated aging studies.

The accelerated aged media was shown to promote growth, was not bacteriostatic and the evaluated quality characteristics met specification.

Performance Validation

The STERRAD® CycleSure™ Biological Indicator samples made with three different spore crops were used to evaluate the effect of varying concentrations of hydrogen peroxide on the STERRAD® CycleSure™ Biological Indicator performance at half cycle conditions in the STERRAD®100, 100S, and 50 Sterilizers.

The results indicated that the inactivation of the STERRAD® CycleSure™ Biological Indicator was consistently obtained after processing through a half cycle with a reduced injection volume of 59% nominal hydrogen peroxide in each of the STERRAD® Sterilizers. All the chemical indicators from STERRAD® CycleSure™ Biological Indicator changed color from red to yellow, indicating exposure to hydrogen peroxide.

STERRAD® CycleSure™ Biological Indicator Shelf-Life (Stability) Validation

An ongoing product stability testing program is currently underway. Three different manufacturing lots of STERRAD® CycleSure™ Biological Indicators (each made with a different spore crop, a different growth media lot and a different chemical indicator lot) were used. A portion of each lot was placed into the following storage conditions:

1 group from each lot at 2°C (+/- 2° C) refrigerated. .
1 group from each lot at 25°C/50%RH (+/-3° C & +/-5%RH) .

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Samples from each storage condition are periodically removed from storage and tested for spore population, D-value (fraction negative method), and chemical indicator functionality. Testing will continue up to 24 months.

ASP currently has completed testing for up to 4 months. All lots have shown to be within specifications for the labeled storage conditions (2° C - 25° C) when tested through 18 months of storage. These data demonstrate that the STERRAD® CycleSure™ Biological Indicator is stable for a shelf-life of up to 18 months. ASP will continue to collect data as part of ongoing stability studies and may extend the labeled shelf-life of the product based upon the same acceptance criteria used here.

Overall Performance Conclusions

The nonclinical studies demonstrate that the STERRAD® CycleSure™ Biological Indicator is safe and effective for the routine monitoring of the STERRAD® Sterilization Systems and establish equivalence to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

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

Re: K994055

Trade/Device Name: STERRAD® CycleSure™ Biological Indicator Regulation Number: 880.2800 Regulation Name: Biological Indicator Regulatory Class: II Product Code: FRC Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Corrigan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your booker or economined 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 Interstate conmisive prior to that have been reclassified in accordance with the provisions of Amendinens, of to devices that inst o Act (Act) that do not require approval of a premarket the rederal Pood, Drug, and Comment , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Feat - Feb - Feb Janual manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classinod (So are additional controls. Existing major regulations affecting (1 MF), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of round the rannouncements concerning your device in the Federal Register.

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 moan that I DA nas made a statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Corrigan

You must comply with all the Act's requirements, including, but not limited to: registration r ou inust comply war a807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CF read 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.

This letter will allow you to begin marketing your device as described in your Section 11ths teller will and w you've cogne FDA finding of substantial equivalence of your device to 9 rotty promanted 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 If you desire specific as now as a rear 809.10 for in vitro diagnostic devices), please contact the and additionally 21 OF N 7 an 1 694-4618. Additionally, for questions on the promotion and Office of Compania of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital 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

K994055 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
e and the states that the considered to articles eveles The STERRAD "CycleSure" "Diological martines in and of the Sterilizer cycles.
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)

Division Sign Off

Tivision Sign-Off Consion of Dental, Infection Contro · Ceneral Hospital Devices ്‍:: Number __

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).