MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.

Device Description

The MetriCide™ OPA Plus Solution Test Strip is for use with MetriCide™ OPA Plus ortho-Phthaldehyde (OPA) High Level Disinfectant (HLD) solution which contains 0.6% MetriCide™ as the active ingredient. The test strip is an OPA concentration indicator that was developed for another OPA HLD solution. The test strip consists of an impregnated paper pad attached to a polymer substrate (which serves as the handle) - the test strip is evaluated by looking at the color of the pad at the stated read time. In essence, the test strip, following immersion in the test solution for a specified time period (1 second), will change from a start color to an endpoint color in a manner that is dependent on the concentration of the active (OPA); the test strip is read at a specified time interval (90 seconds).

AI/ML Overview

The MetriCide™ OPA Plus Solution Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA), the active ingredient in MetriCide™ OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3%.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Acceptance Criteria	Study Result
Performance Characterization	- Minimum 80% PASS results for strips tested with 0.45% MetriCide™ OPA Plus solution	Pass – All criteria met
Shelf Life	- 0% PASS results for strips tested with 0.3% MetriCide™ OPA Plus solution	Pass – All criteria met
Analytic Specificity	0% PASS results for strips exposed to tap water	Pass - Criterion met
Contaminants Testing	0% PASS results for strips tested with contaminated 0.3% MetriCide™ OPA solutions.	Pass - Criterion met

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

The document does not explicitly state the numerical sample size used for the test set for each specific test (Performance Characterization, Shelf Life, Analytic Specificity, Contaminants Testing). However, it implies that multiple strips were tested for each condition.

The data provenance is not specified regarding country of origin or whether the study was retrospective or prospective. It is implied that these are lab-based, controlled studies conducted by STERIS Corporation to verify the performance characteristics of the device.

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

This type of device (chemical indicator test strip) does not typically involve human experts to establish ground truth in the same way an image-based diagnostic AI device would. The "ground truth" for the test strip is the actual, known concentration of OPA in the solutions used for testing (e.g., 0.45% OPA, 0.3% OPA, tap water, contaminated 0.3% OPA). These concentrations would be established through laboratory analytical methods (e.g., spectrophotometry, titration) which are considered objective and do not rely on expert interpretation in the same manner as clinical imaging. Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by objective chemical analysis of the test solutions, not by expert interpretation requiring adjudication. The "reading" of the test strip is a visual color change which is then compared against a documented reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for human-in-the-loop AI systems where human readers interpret medical images or data. The MetriCide™ OPA Plus Solution Test Strip is a standalone chemical indicator that produces a visual color change for direct interpretation, not an AI system.

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

This device is fundamentally a "standalone" chemical indicator that provides a direct visual result. It is not an algorithm, nor does it involve human interpretation beyond reading the color change against a reference. The performance testing outlined in the document (Table 2) reflects the standalone performance of the test strip itself.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on:

Known chemical concentrations: Solutions with precisely defined OPA concentrations (e.g., 0.45% OPA, 0.3% OPA, 0% OPA for tap water) and contaminated OPA solutions. These concentrations are established through laboratory analytical methods.
Absence of contaminants: For the Contaminants Testing, the ground truth is that certain solutions were intentionally contaminated, while others (like the 0.45% OPA solution for performance characterization) are presumed to be uncontaminated.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not an AI/ML algorithm that requires a "training set" in the traditional sense. The test strip's design and chemical formulations are developed through research and development, but there isn't a "training set" of data used to "train" the device to perform its function.

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

Not applicable. As mentioned above, there is no "training set" for this type of device.

Summary

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June 11, 2024

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060

Re: K241344

Trade/Device Name: MetriCide™ OPA Plus Solution Test Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 13, 2024 Received: May 13, 2024

Dear Anthony Piotrkowski:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed by Stephen Stephen A. A. Anisko -S Anisko -S Date: 2024.06.11 13:22:36 -04'00 for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

Center for Devices and Radiological Health

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Enclosure

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Indications for Use

510(k) Number (if known) K241344

Device Name

MetriCide™ OPA Plus Solution Test Strip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K241344 510(k) Summary For MetriCide™ OPA Plus Solution Test Strip

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Manufacturing Facility

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com

May 13, 2024 Submission Date:

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

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1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

Browne OPA Test Strip Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K081427

2. Device Description

3. Indications for Use:

4. Technological Characteristics

There have been no physical modifications to the subject device K241344 compared to the predicated device K081427. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices the same visible color change.

Note that the predicate for K081427 was K991709 where K081427 had no physical modifications from K991709: and K081427 was submitted and cleared to support a 60 second read time for K081427 compared to the 90 second read time for K991709.

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Feature	Proposed: MetriCide™ OPA Plus SolutionTest Strip	Predicate: Browne OPA Test Strip(K081427)	Comparison
Intended Use /Indications forUse	MetriCide OPA Plus Solution Test Strips arechemical indicators for use in determiningwhether the concentration of ortho-phthalaldehyde, the active ingredient inMetriCide OPA Plus Solution, is above or belowthe Minimum Recommended Concentration(MRC) of 0. 3 % established forMetriCide OPA PlusSolution.	The Browne OPA Test Strip is a concentrationmonitor for use in ortho-phthalaldehydecontaining germicide solutions with aminimum effective concentration of 0.3%.The Browne OPA Test Strip is dedicated foruse with CidexTM OPA solution	Similar - bothproducts monitorOPA at an MEC orMRC of 0.3%
Dip and ReadTime	1 second, 90 seconds	1 second, 60 seconds	Similar
Device Design- components	Absorbent paper impregnated withindicator solution affixed to inertpolypropylene film	Absorbent paper impregnated withindicator solution affixed to inertpolypropylene film	Identical
Shelf Life	11 months	10 months	Similar
Color change	Light blue to purple	Light blue to purple	Identical

Table 1 Comparison of CI Physical Description and Technological Properties

The only changes to the subject device K241344 compared to the predicate device K081427 are the indication for use in another brand of OPA and the consequent labeling changes, and the difference in read times. Since the 90 second read time was established for the same physical product in K991709, and the testing to support subject device K241344 was performed with a 90 second read time, the 90 second read time is acceptable for the subject device. Although the indications are changing, the intended use, to monitor OPA at an MEC or MRC of 0.3%, remains the same.

న్. Performance Testing

Performance testing was completed using well established methods, i.e. those used to verify the predicate design.

Testing	Acceptance Criteria	Study Result
PerformanceCharacterization	- Minimum 80% PASS results for strips tested with 0.45%MetriCideTM OPA Plus solution	Pass – All criteria met
Shelf Life	- 0% PASS results for strips tested with 0.3% MetriCideTM OPAPlus solution	Pass – All criteria met
Analytic Specificity	0% PASS results for strips exposed to tap water	Pass - Criterion met
Contaminants Testing	0% PASS results for strips tested with contaminated 0.3%MetricideTM OPA solutions.	Pass - Criterion met

Table 2. Verification Results Summary

The results of the performed testing demonstrate that the MetriCide™ OPA Plus Solution Test Strip performs as intended.

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6. Conclusion

The conclusion drawn from the non-clinical testing demonstrates that the subject device, MetriCide™ OPA Plus Solution Test Strip, is as safe, as effective, and performs as well as the legally marketed predicate device, Browne OPA Test Strip, cleared under K081427.

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).