The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® 100 Sterilizer cycle*, It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.

See precautionary statement in Instructions For Use concerning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:

NOTE: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® 50 Sterilizer will be provided by ASP as soon as it is available.

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 106 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 interior of 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

The provided text describes a 510(k) submission for a modification to the STERRAD® BI Test Pack, primarily concerning a reduced incubation time for the biological indicator and the provision of a catalase reagent. The submission references a study to validate the reduced incubation time.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The core of the modification is the reduced incubation time for the STERRAD® BI Test Pack.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Success Metric)	Reported Device Performance
At least 97% growth of Bacillus subtilis var. niger spores (biological indicator) within 48 hours for valid tests after partial sterilization cycles.	All valid tests showed at least 97% growth in 48 hours.
Catalase concentration confirmed at the end of shelf-life.	Confirmed by stability study (4°C, 25°C, and 40°C).
Aseptic fill of catalase vials confirmed.	Confirmed by process validation.
Excess catalase does not affect spore growth.	Shown by a Bacteriostasis test.

Study Details

The study primarily focuses on validating the reduced incubation time of the biological indicator.

Sample Size used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions that "partial sterilization cycles were based on decrease in diffusion and plasma time." It also states, "Three different spore lots, from three different spore crops, were used for this validation. Each test was performed using a different lot of media."
- Data Provenance: Not explicitly stated, but given it's a submission to the FDA, it's implied that the testing was conducted by Advanced Sterilization Products (ASP), likely in the US, as part of their regulatory compliance. The study design followed the "CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986)," indicating adherence to US regulatory guidelines. The data is retrospective in the sense that the testing was completed prior to the submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable to this type of device. The "ground truth" for a biological indicator is determined by the growth or non-growth of spores, which is a microbiological outcome, not an expert visual interpretation.
Adjudication Method for the Test Set:
- Not applicable. The outcome (growth or no growth) is an objective, measurable biological phenomenon, not subject to human adjudication in the typical sense.
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 is a biological indicator device, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm. The performance is the inherent biological response of the indicator.
The type of ground truth used:
- Microbiological Outcome/Pathology: The ground truth is the actual viability (growth or no growth) of the Bacillus subtilis var. niger spores, determined through standard microbiological culture techniques after exposure to partial sterilization cycles. The 97% growth is the performance metric against this ground truth.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires "training data." The validation study uses a test set to confirm the performance of the biological indicator.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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JUN 1 5 1999

ADVANCED STERILIZATION PRODUCTS® a Johnson Johnson compan REGULATORY AFFAIRS DEPARTMENT

510(k) Summary -- K991675

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

May 14, 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.

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

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

{1}------------------------------------------------

AGG 1675

Description of Device

Statement of Intended Use

The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® 100 Sterilizer cycle*. It finctions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Catalase Reagent is added to the Tryptic Sov Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.

See precautionary statement in Instructions For Use concerning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:

PRECAUTION: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® S0 Sterilizer will be provided by ASP as soon as it is available.

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XGG1675

Description of Modification

The recommended incubation time for the STERRAD® BI Test Pack is being reduced to 48 hours based upon validation using The Center for Devices and Radiological Health, FDA Guide for Validation of Biological Indicator Incubation Time (1986).

For customer convenience, ASP now offers a catalase reagent for use with the STERRAD® BI Test Pack. Catalase has always been required for use with the STERRAD® BI Test pack. Previously, instructions were included for the user to make a catalase reagent. The reagent is supplied in single use dropper vials. The catalase reagent is sold in boxes of 50 vials.

Summary of Nonclinical Tests

Testing was conducted using the CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986). Partial sterilization cycles were based on decrease in diffusion and plasma time. Three different spore lots, from three different spore crops, were used for this validation. Each test was performed using a different lot of media. All valid tests showed at least 97% growth in 48 hours,

Catalase concentration was confirmed at end of shelf life by a stability study conducted at 4°C, 25°C and 40°C.

Aseptic fill of the catalase vials was confirmed by process validation.

Excess catalase was shown to not effect the growth of spores by a Bacteriostasis test.

Substantial Equivalence

The modified STERRAD® BI Test Packs 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® BI Test Pack described in this submission is substantially equivalent to the predicate device

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 1999

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

K991675 Re : Modification of: STERRAD® BI Test Pack Trade Name: Requlatory Class: II Product Code: FRC Dated: May 14, 1999 Received: May 17, 1999

Dear Mr. Corrigan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially 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 reclassified in accordance 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 devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Corrigan

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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

Timothy A. Ulatowski

Directbr 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 John on company REGULATORY AFFAIR5 DEPARTMENT

Indications for Use

510(k) Number:	K991675 - Special 510(k) - Device Modification
Device Name	STERRAD® BI Test Pack

Indications For Use:

Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.

See precautionary statement in Instructions For Use concerning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Prescription Use	OR	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
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	K991675
---------------	---------

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).