The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in the solutions listed below, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD)

Device Description

The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a chemical indicator strip consisting of an indicator pad attached to a polymer substrate which serves as a handle. The test strip has been developed to monitor the concentration of glutaraldehyde in Micro-Cide" 28 HLD working solution. The indicator pad is impregnated with an indicator solution that changes color from vellow to purple if the concentration of the germicide exceeds the minimum effective concentration (MEC) of the solution.

The paper pad on an unused indicator strip is yellow in color. After an immersion time (dip time) of two seconds in a Micro-Cide™ 28 HLD solution, it is read at 120 seconds to verify the glutaraldehyde concentration of >1.8%. At 120 seconds the indicator strip will exhibit a stable uniform purple color if the concentration of glutaraldehyde is >2.1%. The strip will appear yellow or patchy yellow/purple if the solution has ≤1.8% glutaraldehyde, signaling to the customer that the solution must be replaced.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device, the Micro-MEC 1.8% Glutaraldehyde Monitor Strip, meets these criteria.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Performance	• Minimum 80% pass results when tested with 2.1% glutaraldehyde Micro-Cide™ 28 HLD solution • 100% fail results with 1.8% glutaraldehyde Micro-Cide™ 28 HLD solution	Pass
Specificity	Incomplete color change when exposed to tap water only	Pass
Contaminants	Meets performance specifications in the presence of organic and inorganic contaminants in the test solution	Pass
Exposure to aggressive chemicals	Meets performance specifications after exposure to aggressive chemicals.	Pass
Blind study testing	Meets performance specifications with inexperienced users	Pass
Shelf life	Meets performance specifications at each time point after storage in different environments	Pass
In-use (open bottle)	Meets performance specifications at each time point after storage in different environments	Pass
Functional stability	Meets performance specifications at each time point after storage outside bottle	Pass

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

The document does not explicitly state the specific sample sizes for each test in the "Performance Test Summary" (Table 5-2). It only indicates "Pass" for each criterion. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts to establish ground truth for any of the performance tests. For the "Blind study testing," it mentions performance specifications being met "with inexperienced users," implying that a human element was involved in observing results but not necessarily in establishing a ground truth by expert consensus.

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

The document does not describe any specific adjudication method for the test set.

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

An MRMC comparative effectiveness study was not conducted. This is a chemical indicator device, not an AI-powered diagnostic tool involving human readers.

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

This question is not applicable in the context of this device. The device is a chemical indicator strip, which inherently produces a physical color change that is interpreted by a human user. It is not an algorithm that functions purely in a standalone digital environment. The "Blind study testing" indicates human interpretation is part of the intended use.

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

The ground truth used for the performance evaluation appears to be the known glutaraldehyde concentrations of the Micro-Cide™ 28 HLD solutions (specifically 2.1% and 1.8%). For other tests like specificity, contaminants, and aggressive chemicals, the ground truth would be the known presence or absence of these factors and their expected impact on the indicator's performance.

8. The sample size for the training set

This concept is not applicable to a chemical indicator strip. The device operates based on a chemical reaction, not a machine learning algorithm that requires a "training set."

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

As there is no training set for this type of device, this question is not applicable.

Summary

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November 17, 2017

STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor. Ohio 44060

Re: K172472

Trade/Device Name: Micro-MEC 1.8% Glutaraldehyde Monitor Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 30, 2017 Received: September 1, 2017

Dear Jennifer Nalepka:

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.

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

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801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tara A. Ryan -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172472

Device Name

Micro-MEC 1.8% Glutaraldehyde Monitor Strip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary For Micro-MEC 1.8% Glutaraldehyde Monitor Strip

Sponsor:

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Manufacturer:

Albert Browne, Ltd. Chancery House 190 Waterside Rd. Hamilton Industrial Park Leicester United Kingdom LE5 1QZ

Contact:

Jennifer Nalepka Senior Regulatory Affairs Specialist Telephone: (440) 392-7458 Fax No: (440) 357-9198 E-mail: Jennifer_Nalepka@steris.com

Summary Date: November 15, 2017

Premarket Notification Number: K172472

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	Micro-MEC 1.8% Glutaraldehyde Monitor Strip
Common/usual Name:	Chemical Indicator
Device Classification:	Class II
Classification Name:	Physical/chemical sterilization process indicator(21 CFR 880.2800 (b), Product Code JOJ)

2. Predicate Device

K012335	MetriTest 1.8 Glutaraldehyde Concentration Monitor - the predicate is identical to the proposed device.
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3. Description of Device

The glutaraldehyde concentration of the neat, unused Micro-Cide™ 28 HLD solution is 3%. To ensure an adequate margin of safety over the MEC of the germicide, the indicator was formulated to undergo a complete color change at glutaraldehyde concentrations of 2.1% in at least 80% of the tests conducted. The concentration of glutaraldehyde that will induce a color change is sufficiently higher than the MEC for the Micro-Cide " 28 HLD solution to ensure that the indicator (test strip) will not indicate a PASS in solutions with glutaraldehyde at or below the MEC of 1.8%. However, due to the kinetics of the chemical reaction that produces the color change, a test conducted on a Micro-Cide™ 28 HLD solution

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with a glutaraldehyde concentration of 1.83-2.10% may indicate a PASS or a FAIL result.

The proposed test strip is used in the same way and performs the same as the predicate device to indicate the presence of the same glutaraldehyde concentration, >1.8%.

4. Intended Use

The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD).

5. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use chemical indicator strips that monitor the MEC of glutaraldehyde-containing germicide solutions.

Table 5-1 summarizes the comparison between the proposed device, Micro-MEC 1.8% Glutaraldehyde Monitor Strip, and the predicate.

	Proposed K172472Micro-MEC 1.8%Glutaraldehyde MonitorStrip	Predicate K012335MetriTest 1.8GlutaraldehydeConcentration Monitor	Comparison
Intended Use	The Micro-MEC 1.8%Glutaraldehyde MonitorStrip is a semi-quantitative chemicalindicator for use indetermining whether theconcentration ofglutaraldehyde, the activeingredient, is above orbelow the minimumeffective concentration(MEC) of 1.8%glutaraldehydeestablished for Micro-Cide™ 28 High LevelDisinfectant (Micro-Cide™ 28 HLD)	The MetriTest 1.8GlutaraldehydeConcentration Monitor isa glutaraldehydeconcentration monitor foruse in glutaraldehyde-containing germicidesolutions with an MEC of1.8% glutaraldehyde.The MetriTest 1.8GlutaraldehydeConcentration Monitor isdedicated for use withMetricide 28 andMetricide Plus 30Solutions.	Both indicatorsmonitor theconcentrationgreater than 1.8%glutaraldehydegermicide.
Substrate	Absorbent Paper	Absorbent Paper	Same

Table 5-1. Technological Comparison to Predicate

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Micro-MEC 1.8% Glutaraldehyde Monitor Strip

Indicator /reaction	Colorimetric sodiumsulfite pH-based reaction	Colorimetric sodiumsulfite pH-based reaction	Same
Backing	Polypropylene	Polypropylene	Same
Color change	Yellow to purple	Yellow to purple	Same
Detection	Greater than 1.8%glutaraldehyde	Greater than 1.8%glutaraldehyde	Same
Viewing	Paper on front of strip	Paper on front of strip	Same
Shelf-life,unopened	Current testing supports 8months	24 months	Target of 24 monthsfor proposed strip
Shelf-life.opened	90 days	90 days	Same
Dip andRead Times	Dip time = 2 secondRead time at 120 seconds	Dip time = 1 secondsRead time at 60 seconds	Both dip and readtimes optimized foreach glutaraldehydesolution.

Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Micro-MEC 1.8% Glutaraldehyde Monitor Strip is substantially equivalent to the claimed predicate device when used according to its instructions for use. The product effectively determines whether or not the concentration of the use solution of Micro-Cide 28 HLD solution is greater than 1.8% glutaraldehyde. These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended use.

Table 5-2 Performance Test Summary
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Test	Acceptance Criteria	Result
Performance	• Minimum 80% pass results when tested with 2.1%glutaraldehyde Micro-Cide™ 28 HLD solution• 100% fail results with 1.8% glutaraldehyde Micro-Cide™28 HLD solution	Pass
Specificity	Incomplete color change when exposed to tap water only	Pass
Contaminants	Meets performance specifications in the presence oforganic and inorganic contaminants in the test solution	Pass
Exposure to aggressivechemicals	Meets performance specifications after exposure toaggressive chemicals.	Pass
Blind study testing	Meets performance specifications with inexperienced users	Pass
Shelf life	Meets performance specifications at each time point afterstorage in different environments	Pass
In-use (open bottle)	Meets performance specifications at each time point afterstorage in different environments	Pass
Functional stability	Meets performance specifications at each time point afterstorage outside bottle	Pass

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6. Conclusion

The Micro-MEC 1.8% Glutaraldehyde Monitor Strip intended for use with Micro-Cide™ 28 HLD solution is substantially equivalent to the predicate device, MetriTest 1.8 Glutaraldehyde Concentration Monitor. Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, K012335, MetriTest 1.8 Glutaraldehyde Concentration Monitor (21 CFR 880.2800 (b), Product code JOJ).

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).