The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Device Description

The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 10° Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.

The narrow opening and channels leading to the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.

The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the STERRAD® BI Test Pack, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on the modification of an existing device (STERRAD® BI Test Pack) to include performance characteristics for new sterilizer models (STERRAD® 50 and STERRAD® 100S). The core acceptance criteria revolve around the "Survival and Kill characteristics" of the biological indicator within these new sterilization processes. While explicit numeric acceptance criteria are not detailed in the provided text, the overall performance goal is to demonstrate that the STERRAD® BI Test Pack accurately reflects the sterilization process in these new models, as it did in the original STERRAD 100 Sterilizer.

Acceptance Criteria (Implied)	Reported Device Performance
Survival Characteristics: The biological indicator (BI) should accurately demonstrate survival when exposed to conditions that do not achieve sterilization in the STERRAD® 50 and STERRAD® 100S Sterilizers.	The study generated new "Survival characteristics" for the STERRAD® BI Test Pack in the STERRAD® 50 and STERRAD® 100S sterilizers. The results were found to be "accurate and reproducible." The intent is that these new characteristics allow the pack to function as a reliable biological sterilization process indicator for these sterilizers.
Kill Characteristics: The BI should accurately demonstrate kill when exposed to conditions that achieve sterilization in the STERRAD® 50 and STERRAD® 100S Sterilizers.	The study generated new "Kill characteristics" for the STERRAD® BI Test Pack in the STERRAD® 50 and STERRAD® 100S sterilizers. The results were found to be "accurate and reproducible." The intent is that these new characteristics allow the pack to function as a reliable biological sterilization process indicator for these sterilizers.
Reproducibility: The Survival and Kill data should be consistent across different manufacturing lots of the STERRAD® BI Test Packs.	Testing was conducted to show that the Survival and Kill Performance Data was "accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs."
Chemical Indicator Functionality: The chemical process indicator within the test pack should change color appropriately upon exposure to the STERRAD® 50 and STERRAD® 100S Sterilizer cycles.	The text states, "Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow." While specifically mentioning STERRAD® Sterilizer (singular), the context implies this functionality extends to the new models if the pack is to be effective with them. No specific performance data for the chemical indicator in the new models is explicitly presented as being newly tested in this submission, but its consistent function is assumed for the overall test pack to be effective.

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The text states that "three different manufacturing lots of STERRAD BI Test Packs" were used. The exact number of individual BI Test Packs or sterilization cycles tested per lot is not specified.
- Data Provenance: The study appears to be prospective, as it was conducted specifically to generate "new performance data" for the STERRAD 50 and STERRAD 100S sterilizers. No country of origin for the data is explicitly mentioned, but the applicant (Advanced Sterilization Products) is located in Irvine, California, USA, implying the studies were likely conducted in the US or under US regulatory standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a study of a biological and chemical indicator, not an algorithm or diagnostic device that requires human interpretation of complex images or data. The "ground truth" for a biological indicator is typically established by microbiological methods (e.g., culturing the spore strips to determine viability after a sterilization cycle) and chemical reaction observation (color change). Therefore, the concept of "experts" to establish ground truth in the typical clinical sense (like radiologists interpreting images) is not applicable here. The "experts" would be microbiologists and technicians performing the tests. No specific number or qualifications are mentioned.
Adjudication method for the test set:
- Not applicable in the sense of human adjudicators for subjective interpretations. The outputs (sterilization/non-sterilization, color change) are objective and determined by standard laboratory protocols.
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:
- No. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this is a standalone performance study of a device. The biological indicator and chemical indicator are designed to provide an objective output (spore growth/no growth, color change) without human intervention in the interpretation process (beyond observing the result). The "algorithm" here is the biological and chemical reaction and spore death kinetics under sterilization conditions. The study confirms the performance of this "algorithm" in new sterilizer models.
The type of ground truth used:
- Microbiological viability (absence/presence of Bacillus subtilis var. niger growth) for the biological indicator.
- Chemical reaction/color change for the chemical indicator.
- The ultimate ground truth is whether the sterilization process itself was effective at killing microorganisms. The BI is a direct measurement of this biological efficacy, and the chemical indicator is a process indicator.
The sample size for the training set:
- This is not an AI/machine learning device; therefore, there is no "training set." The performance evaluation is based on experimental testing of the physical device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.

Summary

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Advanced Sterilization Products

ADVANCED STERILIZATION PRODUCTS®

a Johnson Johnson company REGULATORY AFFAIRS DEPARTMENT

993775
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

November 5, 1999

Trade Name

STERRAD® BI Test Pack

Common Name

Biological Indicator (Challenge Pack)

Classification Name Class II

Legally Marketed Equivalent Device Name(s)

STERRAD® BI Test Pack, K921909, October 1, 1993 as modified in K991675, June 15, 1999.

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

Description of Modification

The modification to the STERRAD® BI Test Pack involves labeling only.

With the continued evolution of the STERRAD Sterilization System, new models of the sterilizer have been developed. The STERRAD BI Test Pack was originally cleared for use in the STERRAD 100 Sterilizer. In January of 1999, ASP received marketing clearance (K981625) for the STERRAD 50 Sterilizer and ASP currently has a 510(k) notification pending for another new sterilizer model, the STERRAD 100S Sterilizer. These two new sterilizers utilize a modification of the original STERRAD process. Consequently, new performance data (Survival and Kill characteristics) were needed for the STERRAD BI Test Pack in these new sterilizers.

This premarket notification modifies the Performance Certification of the STERRAD BI Test Pack to add the performance characteristics of the test pack in the STERRAD 50 and STERRAD 100S Sterilizers.

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Summary of Nonclinical Tests

Testing was conducted to show that the Survival and Kill Performance Data generated for the STERRAD 50 and STERRAD 100S Sterilizers was accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines, possibly representing movement or progress. The logo is presented in black and white.

JUN - 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kevin Corrigan, R.A.C. Director, Regulatory Affairs Advanced Sterilization Products Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

K993775 Re : STERRAD® BI Test Pack Trade Name: Regulatory Class: II FRC Product Code: Dated: March 10, 2000 Received: March 13, 2000

Dear Mr. Corrigan:

We have reviewed your Section 510(k) notification of intent to we have reviewed freferenced above and we have determined the market the device ially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been Medical Device imendance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Intras, 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back us your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with SubbeanClarly Squaring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (UP) / regarions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif bac. abbamasy action. In addition. In addition, FDA regaration may ther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any premazion you might have under sections 531 through 542 of

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Page 2 - Mr. Corrigan

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510 m, providence of your device to a legally rinding of bubbandedice results in a classification for your marketed predication wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Jourision of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, Suzar unner

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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ED STERILIZATION PRODUCTS® ADVANC

1031400111001 como REGULATORY AFFAIRS DEPARTMENT

Indications for Use

To Be Assigned 510(k) Number:

STERRAD®BI Test Pack Device Name

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

(Optional Format 1-2-96)

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

Lain S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev

510(k) Number K993275

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).