The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-Ox™ RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-Ox™ RESERT™ High Level Disinfectant, is above the minimum recommended concentration (MRC) of 1.5%.

Device Description

The Revital-Ox™ RESERT™ R60 Solution Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with reactive chemicals that is adhesively bonded to one end of a polymer film. The polymer strip has a window to facilitate viewing of the color change. The Revital-OxTM RESERT™ R60 Solution Test Strip has been developed to monitor Revital-Ox™ RESERT™ High Level Disinfectant solution (originally cleared as Resert XL HLD High Level Disinfectant) that has a minimum recommended concentration (MRC) of 1.5%. The Revital-Ox™ RESERTIM R60 Solution Test Strip is dipped into a working solution of Revital-Ox™ RESERT™ High Level Disinfectant and the resultant color reaction is viewed through the window to determine if the solution is above the MRC and thus still suitable for use.

AI/ML Overview

The provided text describes the acceptance criteria and a summary of performance testing for the Revital-Ox™ RESERT™ R60 Solution Test Strip. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Performance	Equivalent performance to the predicate in pass and fail conditions for simulated use.	Equivalent
Specificity	Incomplete color change when exposed to tap water only or to Revital-Ox™ RESERT™ High Level Disinfectant solution with peroxide below MRC or no peroxide	The proposed strip does not change when exposed to the active ingredient (hydrogen peroxide) alone as the predicate does. The proposed strip requires the active ingredient of the disinfectant to be in its final form thus demonstrating greater specificity to the disinfectant solution than the predicate. The proposed strip performs equivalently to the predicate in water alone or in disinfectant without the active ingredient.
Contaminants	Equivalent performance to the predicate in pass and fail conditions in the presence of organic and inorganic contaminants in the test solution	Equivalent
Exposure to aggressive chemicals	Equivalent performance to the predicate in pass and fail conditions	The proposed strip demonstrated failing results under pass conditions after exposure to aggressive chemicals. The product labeling includes a warning to store away from aggressive chemicals. This same warning is in the labeling of the predicate device.
Blind study testing	Equivalent performance to the predicate in pass and fail conditions	Equivalent
Shelf life	Meet performance specifications at each time point after storage in different environments	Performance testing of the proposed device out to one year was performed.
In-use (open bottle)	Meet performance specifications at each time point after storage in different environments	Performance testing of the proposed device up to 11 days was performed.

2. Sample size used for the test set and the data provenance:

The document summarizes "verification activities" and "performance testing" but does not explicitly state the sample sizes (e.g., number of test strips, number of solution samples) used for each test. It also does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer.

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

The document mentions "Blind study testing" and "Blind interpretation of exposed strips" but does not provide details on the number or qualifications of experts involved in establishing ground truth for these interpretations.

4. Adjudication method for the test set:

The document mentions "Blind study testing" and "Blind interpretation," but does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set results.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. This is a chemical indicator device, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

Yes, the performance tests described are standalone evaluations of the chemical indicator strip's ability to detect the hydrogen peroxide concentration. The device is a test strip, not an algorithm, and its performance is inherently standalone (without human-in-the-loop for its basic function of indicating concentration). Human interpretation is required to read the strip's color change, which is covered by the "blind study testing."

7. The type of ground truth used:

The ground truth for this device would be established by controlled chemical solutions with known concentrations of hydrogen peroxide, both above and below the Minimum Recommended Concentration (MRC) of 1.5%. For specificity, tap water and disinfectant solutions without the active ingredient would also serve as ground truth for negative controls.

8. The sample size for the training set:

Not applicable. This device is a chemical indicator strip, not a machine learning algorithm that requires a "training set." The development of the strip involves chemical formulation and optimization, not data-driven training.

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

Not applicable. See point 8.

Summary

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

April 14, 2015

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K143333

Trade/Device Name: Revital-OxTM RESERT™ R60 Solution Test Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator/Physical/Chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: March 16, 2015 Received: March 17, 2015

Dear Mr. 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 (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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Indications for Use

510(k) Number (if known) K143333

Device Name

Revital-Ox™ RESERT™ R60 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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STERIS®

510(k) Summary For Revital-Ox™ RESERT™ R60 Solution Test Strip K143333

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:

Anthony Piotrkowski Regulatory Affairs Manager Telephone: (440) 392-7473 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com

April 8, 2015 Summary Date:

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

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1. Device Name

Trade Name:	Revital-Ox™ RESERT™ R60 Solution Test Strip
Common/usual Name:	Chemical Indicator
Device Class:	Class II
Classification Name:	Physical/chemical sterilization process indicator(21 CFR 880.2800 (b), Product Code JOJ)

2. Predicate Device

K102296 Verify® Chemical Monitoring Strip for Resert™ Solution

This predicate has not been subject to a design-related recall. ●

3. Description of Device

4. Intended Use

The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-OxTM RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-OxTM RESERT™ High Level Disinfectant, is above the minimum recommended concentration (MRC) of 1.5%.

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Proposed	Predicate K102296	Comparison
Revital-Ox™ RESERT™ R60Solution Test Strip	Verify® Chemical Monitoring Stripfor Resert Solutions Version 2
The Revital-Ox™ RESERT™ R60Solution Test Strip is a high leveldisinfectant concentration monitordedicated for use with Revital-Ox™RESERT™ High Level Disinfectant.The purpose of the Revital-Ox™RESERT™ R60 Solution Test Strip is todetermine whether the concentrationof hydrogen peroxide, the activeingredient in Revital-Ox™ RESERT™High Level Disinfectant, is above theminimum recommendedconcentration (MRC) of 1.5%.	The Verify® Chemical Monitoring Stripfor Resert Solutions Version 2 is a highlevel disinfectant concentrationmonitor dedicated for use with Resert®XL HLD High-Level Disinfectant. Thepurpose of the Verify® ChemicalMonitoring Strip for Resert SolutionsVersion 2 is to determine whether theconcentration of a Resert® XL HLDHigh-Level Disinfectant solution isabove the minimum recommendedconcentration (MRC) of 1.5%.	Change in intendeduse is limited to aname change toreflect thebrand/name changeof Resert® XLHLD High-LevelDisinfectant toRevital-Ox™RESERT™ HighLevel Disinfectantand to specify thatthe strips monitorsthe activeingredient in thedisinfectantsolution.

Table 5-1. Indications for Use Comparison

Bolded text is identical between predicate and proposed devices

5. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use chemical indicator strips that monitor the hydrogen peroxide concentration in Revital-Ox™ RESERT™ High Level Disinfectant solution.

The purpose of this submission is to clear design changes to the Revital-OxTM RESERT™ R60 Solution Test Strip for ease of read and longer shelf life.

Table 5-2 summarizes the comparison between the proposed device, Revital-OxTM RESERT™ Solution Test Strip, and the predicate.

	Proposed	Predicate	Comparison
Substrate	Absorbent Paper	Absorbent Paper	Same
Indicator /reaction	Colorimetric sulfitepH-based reaction	Colorimetricstarch/iodide reaction	The strip does not contactpatients. Impact of thedifference in reactivechemistry on safety wasevaluated through literaturereview.Efficacy of the proposedstrip is summarized inTable 5.3 below
Backing	Polypropylene	Polypropylene	Same

Table 5-2. Technological Comparison to Predicate

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	Proposed	Predicate	Comparison
Color change	Yellow to blue/purple	Blue to black	Blinded testingdemonstrated properinterpretation of strips.
Detection	greater than 1.5%hydrogen peroxide	greater than 1.5%hydrogen peroxide	Same
Usetemperaturerange	20 °C minimum	20 -24 °C	Efficacy of the proposedstrip at or above 20 °C wasdemonstrated throughtesting under simulateduse, testing withcontaminants, testing afterexposure to aggressivechemicals and blindinterpretation of exposedstrips.
Viewing	Viewing window, paperon back of strip	Paper on front of strip	Blinded testingdemonstrated properinterpretation of strips.
Shelf-life,unopened	1 year	6 months	Testing was performed tosupport increased
Shelf-life,opened	11 days to date	180 days	unopened bottle shelf life.

Table 5-3 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Revital-OxTM RESERT™ R60 Solution Test 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 Revital-Ox™ RESERT™ High Level Disinfectant is greater than 1.5% hydrogen peroxide. These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended uses.

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Test	Acceptance Criteria	Comparision
Performance	Equivalent performance to the predicate in pass and fail conditions for simulated use.	Equivalent
Specificity	Incomplete color change when exposed to tap water only or to Revital-Ox™ RESERT™ High Level Disinfectant solution with peroxide below MRC or no peroxide	The proposed strip does not change when exposed to the active ingredient (hydrogen peroxide) alone as the predicate does. The proposed strip requires the active ingredient of the disinfectant to be in its final form thus demonstrating greater specificity to the disinfectant solution than the predicate. The proposed strip performs equivalently to the predicate in water alone or in disinfectant without the active ingredient.
Contaminants	Equivalent performance to the predicate in pass and fail conditions in the presence of organic and inorganic contaminants in the test solution	Equivalent
Exposure to aggressive chemicals	Equivalent performance to the predicate in pass and fail conditions	The proposed strip demonstrated failing results under pass conditions after exposure to aggressive chemicals. The product labeling includes a warning to store away from aggressive chemicals. This same warning is in the labeling of the predicate device.
Blind study testing	Equivalent performance to the predicate in pass and fail conditions	Equivalent
Shelf life	Meet performance specifications at each time point after storage in different environments	Performance testing of the proposed device out to one year was performed.
In-use (open bottle)	Meet performance specifications at each time point after storage in different environments	Performance testing of the proposed device up to 11 days was performed.

Table 5-3 Performance Test Summary

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6. Conclusion

The Revital-Ox™ RESERT™ R60 Solution Test Strip intended for use with Revital-Ox™ RESERT™ High Level Disinfectant is substantially equivalent to the predicate device, Verify® Chemical Monitoring Strip for Resert™ Solution. Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, 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).