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 1x10 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.

AI/ML Overview

This document describes a 510(k) premarket notification for a modified biological indicator, the STERRAD® CycleSure® Biological Indicator. The primary modification is a change in the culture media formulation to achieve a reduced incubation time of 24 hours. Given that this is a biological indicator for sterilization processes and not an AI/ML powered device, several of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample size for training set) are not applicable or cannot be extracted from the provided text.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Reported Device Performance
No color reversion after growth	Color did not revert and yellow (positive) color was stable for up to seven days of incubation time.
Not bacteriostatic	Growth media was not bacteriostatic.
Maintains enough volume for positive growth	Growth media maintained enough volume to support positive growth.
Meets 24-hour incubation time	Test data confirmed the 24 hours incubation time.
Consistently supports growth of Geobacillus stearothermophilus	Test data confirmed growth support of the indicator organism (Geobacillus stearothermophilus).
Initial shelf life	Test results support eighteen months of shelf life.

2. Sample size(s) used for the test set and the data provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., color reversion, bacteriostasis, fill volume, incubation time, growth support, stability). It broadly refers to "test data" and "studies" conducted.

Provenance: The studies were conducted by Advanced Sterilization Products, Inc. (ASP) to confirm the performance and quality characteristics of the modified culture media. The specific country of origin for the data is not mentioned, but ASP is based in Irvine, CA, USA, suggesting the studies were likely conducted in the US. The studies appear to be prospective as they were conducted to test the performance of the modified device.

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

This is not applicable for this type of device. The "ground truth" for a biological indicator is determined by objective microbiological and chemical tests (e.g., presence/absence of microbial growth, color change, pH measurements), not by human expert opinion or interpretation in the way it would be for an image-based diagnostic AI.

4. Adjudication method for the test set

This is not applicable. As described above, the ground truth is established through objective laboratory testing, not human expert adjudication.

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

This is not applicable. This device is a biological indicator, not an AI-powered diagnostic tool, and therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This is not applicable. This is a physical biological indicator, not an algorithm. Its "performance" is its ability to accurately indicate sterilization.

7. The type of ground truth used

The ground truth for this device's performance is based on objective laboratory measurements and microbiological assays. This includes:

Observing microbial growth (Geobacillus stearothermophilus).
Monitoring color changes (yellow for positive, stable for non-reversion).
Measuring pH.
Assessing fill volume.
Stability testing over time.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set. The term "training set" refers to data used to train a machine learning model.

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

This is not applicable as there is no training set for this type of device.

Summary

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K071014

Advanced Sterilization Products Confidential

510(K) Summary

STERRAD® CycleSure®Biological Indicator

1. Sponsor:

MAY 2 4 2007

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

Contact Person:

Yogi Shah Advanced Sterilization Products, Inc. 33. Technology Drive Irvine, CA. 92618 Phone: 949-789-8548 Fax: 949-789-3900 E: mail: yshah6@aspus.inj.com

Summary Date: March 27, 2007

2. Device Name

Proprietary Name: STERRAD® CycleSure® Biological Indicator a.
Device Common/Usual Name: Biological indicator b.
Device Classification Name: Biological Sterilization Process Indicators C.

3. Identification of Predicate Device:

STERRAD® CycleSure®Biological STERRAD® CycleSure® Biological Indicator, K031226, May 2, 2003 and Indicator, K994055, February 13, 2002

4. Device Description:

The STERRAD® CycleSure® Biological Indicator is identical in design (with exception of fill volume) and performance specifications (with exception of incubation time) to the predicate device.

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Indication For Use: 5.

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

The Indication For Use is identical for the predicate device and proposed device.

Description of Modification 6.

The culture media has been modified to achieve 24 hours incubation time (read out time) and the labeling for the device was modified to reflect the reduce incubation time of 24 hours. Additionally, growth media fill volume has been modified.

7. Performance Test Data

The studies were conducted to confirm the performance and quality characteristics of the modified culture media to evaluate suitability of the media for use in the STERRAD® CycleSure® Biological Indicator.

The growth media was tested for the color reversion after the growth and it was determined that color did not revert and yellow (positive) color was stable for up to seven days of incubation time. This test result confirms performance characteristic of the growth media.

The Bacteriostatis test was conducted to evaluate growth promotion and bactriostatic effect of pH indicator. Test data demonstrated that growth media was not bacteriostatic and met the specifications of performance characteristics.

The Fill Volume Determination study was conducted to determine if the growth media maintains enough volume to support positive growth and test data met the specifications.

The study was performed to determine the culture media reformulation can meet the reduced incubation time of 24 hours and test data confirms the 24 hours incubation time.

The design verification was done to confirm that the culture media consistently support growth of the Geobacillus stearothermophilus organism. Test data also confirms the growth support of the indicator organism.

The accelerated stability study was performed to evaluate the initial shelf life of the culture media to use in the STERRAD® CycleSure® Biological Indicator. The test result supports eighteen months of shelf life.

The performance and quality testing results of the media formulation has shown to promote growth, no color reversion, was not bacteriostatic and meet the 24 hours incubation time.

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Substantial Equivalence 8.

The modified STERRAD® CycleSure® Biological Indicator have the following similarities to the predicate device:

have the same indicated use
use same operating principles ■
incorporate same design (with exception of culture media formulation and fill volume) .
트 have the same shelf life
have same performance characteristics (with exception of incubation time) 트
. are packaged using the same materials and process

In addition, the test result indicates that proposed STERRAD® CycleSure® Biological Indicator is substantially equivalent to currently marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the symbol.

Public Health Service

MAY 2 4 2007

ood and Drug Administration 200 Corporate Boulevard ockville MD 20850

Mr. Yogi Shah Project Manager, Regulatory Affairs Advanced Sterilization Products, Incorporated 33 Technology Drive Irvine, California 92618

Re: K071014

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: May 8, 2007 Received: May 9, 2007

Dear Mr. Shah:

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 your 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. Shah

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 (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 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

HFZ-401 DMC

cc:

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ADVANCED STERILIZATION PRODUCTS®

common Johnson company

REGULATORY AFFAIRS DEPARTMENT

Indications for Use

510(k) Number: To be assigned

K171014

Device Name: STERRAD® CycleSure®Biological Indicator

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.

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)	Page 1 of 1
(Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices
410(k) Number	K071014

PAGE 3

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

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).