Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:

Cycle Type	Cycle Temp	Cycle Exposure Time
Gravity	121°C	30 Minutes
Gravity	132°C	10 Minutes
Flash Gravity	132°C	3 Minutes*
Pre-Vac	132°C	4 Minutes
Pre-Vac	135°C	3 Minutes

*Unwrapped nonporous devices only

Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.

Device Description

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 incculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. Smart Read EZTest - Steam is intended for use in monitoring the efficacy of steam sterilization processes with minimum exposure times of 20 minutes at 121 ℃ gravity displacement, 10 minutes at 132°C gravity displacement and 3 minutes at 132°C flash gravity displacement cycles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Mesa Smart Read EZTest - Steam Biological Indicator, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Smart Read EZTest - Steam Biological Indicator are primarily based on its ability to demonstrate specific resistance characteristics (D-value, Z-value, Survival/Kill Window) and culture conditions for Geobacillus stearothermophilus ATCC #7953, matching those of its predicate devices. The performance is reported as meeting these criteria.

Acceptance Criteria Element	Description	Reported Device Performance (Smart Read EZTest - Steam, Subject Device)
Organism Type	Geobacillus stearothermophilus ATCC #7953	Geobacillus stearothermophilus ATCC #7953
Viable Spore Population	Minimum standard population 1.0 x 105	Minimum standard population 1.0 x 105
D-value @ 121°C	1.5 - 3.0 minutes	1.5 - 3.0 minutes
D-value @ 132°C	Not Less Than (NLT) 10 seconds	NLT 10 seconds
D-value @ 134°C	NLT 8 seconds	NLT 8 seconds
D-value @ 135°C	NLT 8 seconds	NLT 8 seconds
Z-value	Not Less Than 10°C	Not Less Than 10°C
Survival Time @ 121°C	NLT 5 minutes (Calculated per USP)	NLT 5 minutes (Calculated per USP)
Survival Time @ 132°C	NLT 1 minute (Calculated per USP)	NLT 1 minute (Calculated per USP)
Survival Time @ 134°C	NLT 40 seconds (Calculated per USP)	NLT 40 seconds (Calculated per USP)
Survival Time @ 135°C	NLT 40 seconds (Calculated per USP)	NLT 40 seconds (Calculated per USP)
Culture Conditions	60°C +/- 2°C for 10 hours (for reduced incubation time validation)	60°C +/- 2°C for 10 hours
Effectiveness Claim	Monitoring efficacy in various steam sterilization cycles (Expanded claims)	Demonstrated overall effectiveness in monitoring routine steam
		sterilization cycles, including the expanded 121°C gravity, 132°C
		gravity/flash gravity cycles.

Study Information

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: "Three separate lots of product manufactured from three different primary spore crops" were tested.
Data Provenance: Not explicitly stated, but based on the FDA submission, it would be considered US-based for regulatory purposes. The study appears to be prospective, specifically designed to validate the device's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a biological indicator, and its "ground truth" (i.e., whether sterilization was achieved or not) is determined by the growth or non-growth of Geobacillus stearothermophilus spores under controlled conditions, not by expert interpretation. The "truth" is an objective biological outcome based on the indicator's design and the sterilization process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The "adjudication" for a biological indicator is a direct observation of color change (purple to yellow) or turbidity indicating microbial growth (failure) or no change (success). This is an objective, binary outcome not requiring expert adjudication in the traditional sense of medical image interpretation.

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

Not applicable. This device is a self-contained biological indicator, not an AI-powered diagnostic tool for human readers. There is no human interpretation component in its fundamental operation that would necessitate an MRMC study.

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

Yes, in a conceptual sense. The performance of the biological indicator is its standalone performance, as it objectively indicates sterilization efficacy based on spore viability and growth. There is no "human-in-the-loop" influencing its output. The device itself provides the result (color change/turbidity).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth is the biological viability of Geobacillus stearothermophilus spores and their response to steam sterilization conditions. This is an objective biological outcome, determined by the presence or absence of growth (indicated by color change/turbidity) after incubation. This ground truth is established through standardized laboratory methods as per AAMI/ISO 11138-1:2006 and AAMI/ISO 11138-3:2006.

8. The sample size for the training set

Not applicable in the context of an AI/machine learning training set. This device is not an AI algorithm but a physical biological indicator. The concept of a "training set" for AI does not directly apply here. However, the manufacturing process and quality control for biological indicators involve extensive testing and characterization of spore crops and finished products to ensure consistent performance, which could be considered analogous to "training" to ensure the device performs as expected.

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

Not applicable for a biological indicator in the context of AI. For the development and validation of the biological indicator itself, the "ground truth" (i.e., the expected response of Geobacillus stearothermophilus spores to steam sterilization) is established through highly controlled laboratory experiments using standardized sterilization cycles and established methods for determining spore viability (e.g., direct plating, fractional experimentation) to derive D-values, Z-values, and survival/kill times. This ensures the spores in the BI have the known and consistent resistance characteristics necessary for monitoring sterilization.

Summary

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K112018

510(k) Summary

JAN 3 0 2012

510(k) Notification Smart-Read EZTest - Steam Biological Indicator

Sponsor information

Mesa Laboratories, Inc. - 12100 W. 6th Ave Lakewood, CO 80228

Contact:

Prepared on:

Device:

Manufacturing Facility:

Classification name:

Classification:

Predicate Device:

Wendy Rovalty Sr. Director, BI Ops Quality & Regulatory Affairs 8607 Park Drive Omaha, NE 68127

Phone: (402) 593-0781 Fax: (402) 593-0921 Email: wroyalty@mesalabs.com

July 11, 2011

Trade name: Smart Read EZTest - Steam Biological Indicator Common name: Self-contained Biological Indicator for Steam

10 Evergreen Drive Bozeman, MT 59715 FDA facility registration #: 3026231

Indicator, Biological Sterilization Process (21 CFR 880.2800(a))

Class II

ProTest Steam (K041386 & K082756), Smart-Read EZTest Steam (K093794)

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DESCRIPTION

INDICATIONS FOR USE

Cycle Type	Cycle Temp	Cycle Exposure Time
Gravity	121°C	30 Minutes
Gravity	132°C	10 Minutes
Flash Gravity*	132°C	3 Minutes
Pre-Vac	132°C	4 Minutes
Pre-Vac	135°C	3 Minutes

"Unwrapped nonporous devices only

Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.

OPERATIONAL PRINCIPALS

The Smart Read EZTest - Steam Biological Indicator is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The unit is then removed and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 60 +/- 2°C for 10 hours.

During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the provided nutrients waste products are released, increasing the acidity of the media which lowers the pH and causes a color change from purple to yellow.

Evidence of growth by color change and/or turbidity within 10 hours should be interpreted as a failure to meet the conditions necessary for sterilization, provided signs of growth are present in the control unit.

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STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE

The subject device Smart Read EZTest - Steam is identical in composition and function to the legally marketed predicate device ProTest - Steam (K041386 & K082786) and Smart Read EZTezt Steam (K093794). This submission is to expand the label claims for the device #K093794 to include 121°C gravity and 132°C gravity/flash gravity cycles.

ELEMENT	SMART READ EZTEST -STEAM(Subject Device)	PROTEST - STEAM(K041386 and K082756)(Predicate Device)	SMART READ EZTEST -STEAM(K-093794)(Predicate Device)
Intended Use:☐ Method ofsterilization	Steam	Steam	Steam
☐ ProcessParameters	121°C gravity - 30 minutes132°C gravity - 10 minutes132°C flash gravity - 3 minutes*132°C prevacuum - 4 minutes134°C prevacuum - 3 minutes	121°C gravity;121°C - 135°C prevacuum10 minute 132°C gravity and 3minute 132°C flash gravity	121°C - 135°C prevacuum
Organism:. SporeSpecies & Strain	Geobacillus stearothermophilusATCC#7953	Geobacillus stearothermophilusATCC#7953	GeobacillusstearothermophilusATCC#7953
Viable sporepopulation	Minimumstandard population 1.0 x 105	$1.0-4.0 x 10^{(x)}$standard population 105	Minimumstandard population 1.0 x 105
Resistancecharacteristics:
☐ D-value	1.5-3.0 minutes @ 121°CNLT 10 sec. @ 132°CNLT 8 sec. @ 134°CNLT 8 sec @ 135°C	1.5-3.0 minutes @ 121°CNLT 10 sec. @ 132°CNLT 8 sec. @ 134°CNLT 8 sec @ 135°C	1.5-3.0 minutes @ 121°CNLT 10 sec. @ 132°CNLT 8 sec. @ 134°CNLT 8 sec @ 135°C
☐ Z-value	Not Less than 10°C	Not Less than 10°C	Not Less than 10°C
☐ Survival/KillWindow	Calculated per USPSurvive time:@ 121°C NLT 5 min.@ 132°C NLT 1 min.@ 134°C NLT 40 sec.@ 135°C NLT 40 sec.	Calculated per USPSurvive time:@ 121°C NLT 5 min.@ 132°C NLT 1 min.@ 134°C NLT 40 sec.@ 135°C NLT 40 sec.	Calculated per USPSurvive time:@ 121°C NLT 5 min.@ 132°C NLT 1 min.@ 134°C NLT 40 sec.@ 135°C NLT 40 sec.
Culture Conditions	60°C +/-2°C for 10 hours	55-60°C for 24 hours	60°C +/-2°C for 10 hours
Storage Conditions	Room temperature	15-27°C, 30-70% RH	Room temperature
Shelf-life	24 months	18 months	24 months

*Unwrapped nonporous devices only

DESCRIPTION OF TESTING (NON-CLINICAL DATA)

Testing was performed in accordance with AAMI/ISO 11138-1:2006 and AAMI/ISO 11138-3:2006 to validate the labeled claims and performance characteristics of Smart Read EZTest - Steam.

Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, and effectiveness in gravity cycles. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.

STATEMENT OF SAFETY AND EFFECTIVENESS

Based on the similar claims, design and results from the above mentioned testing, the Smart Read EZTest - Steam Biological Indicator has been demonstrated to be substantially equivalent to and therefore, as safe and effect as, the legally marketed devices ProTest-Steam (K041386 and K082756) and Smart Read EZTest - Steam (K093794).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 3 0 2012

Mesa Laboratories Incorporated C/O Ms. Wendy Royalty Senior Director, BI Ops, Quality Assurance & Regulatory Affairs Bozeman Manufacturing Facility (SGM Biotech) 10 Evergreen Drive Bozeman, Montana 59715

Re: K112018

Trade/Device Name: Mesa Smart Read EZTest - Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 25, 2011 Received: January 26, 2011

Dear Ms. Royalty:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Royalty

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

G. for Andrew, D. Wilson.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112018

Indications for Use Statement

510(k) Number

Device Name

Mesa Smart Read EZTest - Steam

Indications for Use

Cycle Type	Cycle Temp	Cycle Exposure Time
Gravity	121°C	30 Minutes
Gravity	132°C	10 Minutes
Flash Gravity	132°C	3 Minutes*
Pre-Vac	132°C	4 Minutes
Pre-Vac	135°C	3 Minutes

*Unwrapped nonporous devices only

Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use . X (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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112018

Page 5

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).