EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132 C , 134 C and 135 C.

Device Description

The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EZTest® - Steam biological indicator, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (USP XXIII)	Reported Device Performance (as listed in 510(k) summary)
Spore Population	0.5 x 10^5 to 5.0 x 10^5 spores for a 10^5 BI	"between 0.5 x 10^5 and 5 x 10^5" (Matches USP guideline)
D-value at 121°C	Not explicitly stated in the summary, but implied by USP XXIII.	"D values at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Survival/Kill Time	Not explicitly stated in the summary, but implied by USP XXIII.	"Survival/Kill times at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
D-value at 132°C	Not explicitly stated in the summary, but implied by USP XXIII.	"D values at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Survival/Kill Time	Not explicitly stated in the summary, but implied by USP XXIII.	"Survival/Kill times at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
D-value at 134°C	Not explicitly stated in the summary, but implied by USP XXIII.	"D values at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Survival/Kill Time	Not explicitly stated in the summary, but implied by USP XXIII.	"Survival/Kill times at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
D-value at 135°C	Not explicitly stated in the summary, but implied by USP XXIII.	"D values at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Survival/Kill Time	Not explicitly stated in the summary, but implied by USP XXIII.	"Survival/Kill times at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Z-value	Not explicitly stated in the summary, but implied by USP XXIII.	"Z values", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided)
Spore Species	Bacillus stearothermophilus, ATCC 7953 or equivalent.	Bacillus stearothermophilus, ATCC 7953 or equivalent. (Meets criteria)
Sample Purity	Not explicitly stated as an acceptance criterion.	Evaluated as part of performance. (Details not provided)
Incubation Readout Time	Implied by CDRH guideline (48 hours).	Validation of 48 hours incubation read out time following the CDRH guideline. (Meets guideline)
Shelf Life Stability	Not explicitly stated as an acceptance criterion.	Stability of the product over the eighteen (18) month shelf life claim. (Reported as evaluated)
Post-Exposure Recovery	Not explicitly stated as an acceptance criterion.	Evaluation of the effect of holding time after exposure to sterilant until incubation, upon recovery of injured spores. (Reported as evaluated)
pH Indicator Effect	Not explicitly stated as an acceptance criterion.	Evaluation of the effect of the pH indicator upon the recovery of injured spores. (Reported as evaluated)
Media Support Growth	Not explicitly stated as an acceptance criterion.	Validation of the effect of the sterilization process on the ability of the media to support the growth of injured spores. (Reported as evaluated)

Note: The summary states that "A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII." and that "Such compliance is required on each lot prior to release." This implies that the specific numeric acceptance criteria for D-values, survival/kill times, and Z-values, although not explicitly listed in the 510(k) summary, are derived from USP XXIII and are met by the device. The summary provides a list of evaluated characteristics rather than specific quantitative performance values.

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

Sample Size: The summary states that "Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots." This indicates a minimum of three distinct lots were used for testing resistance characteristics. The exact number of individual biological indicators tested within each lot is not specified.
Data Provenance: The data is generated internally by SGM Biotech, Inc., as part of their "in-process quality control system" and "quality assurance specification." The summary does not provide information on the country of origin of the data or whether it was retrospective or prospective, but it implies a prospective testing approach as part of a release process for each lot.

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

This type of information is not applicable to this device. The ground truth for a biological indicator is inherent to its design and function: the presence or absence of viable spores after a sterilization cycle. The "ground truth" is established by direct microbiological methods (observing growth/color change), not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the output of a biological indicator (color change, turbidity) is a direct, objective observation of microbial growth or lack thereof, rather than something requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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-based diagnostic tool. It does not involve human readers interpreting data or AI assistance.

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

This is not applicable. This device is a biological indicator for monitoring sterilization, not an algorithm. Its "standalone" performance is its ability to accurately reflect sterilization efficacy based on spore survival.

7. The Type of Ground Truth Used

The ground truth used is based on microbiological growth/viability, specifically the survival and subsequent growth of Bacillus stearothermophilus spores. The change in the pH indicator (bromcresol purple changing from purple to yellow) is a direct, observable proxy for this microbiological activity. This is akin to a pathology/microbiology outcome.

8. The Sample Size for the Training Set

This is not applicable. As a biological indicator, the device does not employ a training set in the typical machine learning sense. Its performance is based on the inherent biological resistance of the spores and the chemical properties of the culture medium.

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

This is not applicable for the same reasons as point 8. The "ground truth" for its operation is the established science of microbial heat resistance and culture medium efficacy, which is a foundational scientific principle rather than a dataset requiring ground truth establishment.

Summary

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K963841

"510(k) Summary"

[as required by Section 807.92(c)]

FEB 25 1997

510(k) Notification

EZTest® - Steam biological indicator monitor for steam sterilizers

Submitted by:

SGM Biotech, Inc. 10 Evergreen Drive, Suite E Bozeman, MT 59715

Contact:

John R. Gillis, Ph.D. President Phone: (406) 585-9535 FAX: (406) 585-9219

This summary was prepared on September 18, 1996 Amended on January 8, 1997 [as required by Section 807.92(a)(1)]

DEVICE:

Trade name: EZTest® - Steam biological indicator Common name: Self-contained biological indicator for steam [as required by Section 807.92(a)(2)]

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SUBSTANTIALLY EQUIVALENT TO THE FOLLOWING LEGALLY MARKETED DEVICES:

EZTest® - SGM Biotech, Inc. (K930682)

ATITEST® - PyMaH Corp. (K902344)

ATTEST® - 3M Co. (pre 1976 device)

PROOF® - AMSCO (K801109)

[as required by Section 807.92(a)(3)]

DESCRIPTION OF DEVICE: EZTest® - Steam

[as required by Section 807.92(a)(4)]

Spores

Bacterial endospores of Bacillus stearothermophilus, ATCC 7953 or equivalent, are inoculated onto a 591 Schleicher & Schuell. Inc. filter paper carrier* cut into strips of a convenient size to be placed inside the plastic body of the device. The population of spores on each individual piece of paper will be between 0.5 x 10 00 and 5 x 10 00

The spore concentration will be labeled as a 105 concentration. The guideline in the general section on sterilization, USP XXI, p. 121. indicates that the population of spores for a 10° biological indicator should be between 0.5 x 10° and 5.0 x 10°. This is also the SGM Biotech. Inc. specification.

The population data is based on the heat shock population assay. The heat shock procedure is 95°C to 100°C for 15 minutes as outlined in USP XXIII official monographs. P. 205.

- reference USP XXIII p. 204

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Culture Tube

The culture tube is made of a polypropylene. The plastic culture tube is a) 1.75" in length and 0.34" in OD. The 0.02" wall allows the culture tube to be flexible so that the culture media glass ampule can be broken to activate the test.

Culture Medium

The culture medium, consisting of a formulated soybean casein digest base, is filled into ampules of Type III pharmaceutical grade glass, flame sealed and sterilized. The sealed ampules are of convenient size to be placed into the plastic body with the spore paper. Following filling, the ampules are exposed to a steam processing cycle to render them sterile. The ampule is a thin wall glass which allows it to be easily crushed when the plastic body is compressed. This provides the spores with nutrient medium for growth.

The culture medium has a pH indicator (bromcresol purple) added to it which appears as a purple color prior to crushing for incubation. When the spores grow, they produce acid and alter the pH. This causes the medium to change to a yellow color. If the medium changes to yellow, viable spores are present and the sterilization process is not acceptable, If the medium remains purple, the spores did not grow, which means they are not viable.

Filter Paper Vent

The plastic body is closed with a ½" disc filter vent material that allows the exchange of gases from the sterilizer or from the environment.

Cap

A polypropylene plastic cap is used to hold the vent material in place. This cap has three small holes in it to allow steam and air to freely move in and out of the body.

These materials are all compatible with steam sterilization. These materials have no effect on the resistance of the biological indicator. They are similar to those used in the 3M Attest®.

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INTENDED USE OF DEVICE:

fas required by Section807.92(a)(5)]

The operational principles of the device are as follows. The EZTest® -Steam indicator is placed into a sterilizer load and an appropriate sterilization cycle is run. As sterilization conditions are met, the bacterial spores are destroyed by logarithmic thermal death principles. Following the sterilization cycle, the Bl is removed from the load, the operator activates the self-contained ampule by mechanically flexing the side wall of the plastic vial or by using the plastic crusher provided to break the glass ampule containing the culture medium. The activated EZTest® -Steam Bl is then placed in an incubator which will provide temperatures 55°C to 60°C which is conducive for growth of any bacterial spores which might have survived the sterilization cycle. Microbial growth of the indicator organisms will produce acid in the microbiological culture medium containing bromcresol purple, thus lowering the pH of the solution and invoking a yellow and/or cloudy color change of the media components. If all spores have been killed the media will remain clear and purple.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF EZTest® -Steam COMPARED TO THE CHARACTERISTICES OF THE PREDICTATE DEVICE:

[as required by Section 807.92(a)(6)]

EZTest® - Steam, being similar in type to other products presently in the marketplace whose useful intent is the monitoring of sterilizer efficacy. has been determined to be safe and effective.

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Active components of the indicator have been in routine use more than 20 years. They predate the medical device amendment of the Food and Drug Cosmetic Act and are recognized by the United States Pharmacopoeia XXIII.

Spores of Bacillus stearothermophilys are the microorganisms of choice for the evaluation of steam sterilization processes because of their high degree of resistance to this type of processes. The USP XXIII specifically indicates that this species of microorganism be used to monitor steam sterilization process. Numerous biological indicators on the marketplace, such as Proof®, Attest®, and ATITest®, use these microorganisms and have proved to be both safe and efficacious.

EZTest® - Steam biological indicators are produced under a manufacturing in-process quality control system to specifications defining exacting parameters for production to assure a consistent product and good manufacturing procedures. Upon completion of production, each lot is inspected and tested to a quality assurance specification to affirm functional conformance to product specifications. A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII. Such compliance is required on each lot prior to release.

DETERMINATION OF SUBSTANTIALLY EQUIVALENT BASED ON PHYSICAL CHARACTERISTICS:

[as required by Section 807.92(b)(1)]

A comparison is provided of the EZTest® - Steam to the legally marketed predicate device describing similarities and differences such as technology and other important characteristics.

A. EZTest® - Steam (K930682):

Is manufactured in precisely the same manner as this device. The difference is the extension of the label claims for use in high temperature saturated steam processes of 132°C. 134°C and 135°C.

B. ATITest® PyMaH/ATI (K902344):
This device is exactly the same as the PyMaH ATITest® disclosed in 510(k) notification K902344. The ATITest® was developed by

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SGM Biotech for private label to PyMaH/ATI.

C. Attest® 3M - Pre '76 Product:
This device is virtually identical is size and shape to the 3M Attest®. It has virtually the same carrier material for the spores with the same concentration of Bacillus stearothermophilus spores (10°). The volume of culture medium in the crushable glass ampule is similar. The pH indicator is bromcresol purple in the Attest®, as well as the EZTest®. Therefore, when viable spores grow, the color changes from purple to vellow.

The glass of the crushable glass ampule in Attest® is virtually the same as that used in the EZTest®.

The culture medium in the 3M Attest® is a sovbean casein digest derived culture medium. EZTest® uses a soybean casein digest derived culture medium. The specific formulation of the SGM Biotech medium is considered proprietary and confidential.

Activation of the 3M Attest® biological indicator devices are performed by compressing the flexible sides of the plastic culture tubes to break the crushable glass ampule containing the culture medium. This is exactly the way EZTest® -Steam is activated.

D. PROOF® - AMSCO (K801109):
The EZTest® - Steam is similar to the AMSCO PROOF® in that:
1. similar concentration B. stearothermophilus spores are used, i.e. 10°.
1. spores are carried on chromatography grade pure cotton derived filter paper.
1. culture medium is contained in crushable glass ampule.
1. culture medium is a soybean casein digest derived medium.
1. spore growth is detected by lowering the pH of the culture medium. This shift in pH is detected by the addition of a pH indicator to the medium.

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DETERMINATION OF SUBSTANTIALLY EQUIVALENCE BASED ON IN USE PERFORMANCE:

[as required by Section 807.92(b)(2)]

The performance of EZTest® - Steam was evaluated for the following characteristics (Certificate of Performance - attached):

a. Bacterial spore species
b. Bacterial spore concentration
c. Sample purity
d. Resistance characteristics including:
- 1. D values at 121°C, 132°C, 134°C and 135°C.
- 1. Survival/Kill times at 121°C, 132°C, 134°C and 135°C.
- 1. Z values
e. Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots.
Resistance characteristics were evaluated to determine the ﻧﮯ effect of holding time after the exposure to the sterilant until incubation, upon the recovery of injured spores.
g. Validation of 48 hours incubation read out time following the CDRH guideline.
h. Evaluation of the effect of the pH indicator upon the recovery of iniured spores.
Validation of the effect of the sterilization process on the ability i. of the media to support the growth of injured spores.
Stability of the product over the eighteen (18) month shelf life j. claim.

CONCLUSION:

[as required by Section 807.92(b)(3)]

EZTest® - Steam is appropriate for monitoring steam sterilization processes of 121°C, 132°C, 134°C and 135°C and EZTest® - Steam meets the USP XXIII requirements.

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).