The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.

Device Description

Rapicide PA High-Level Disinfectant Test Strips have the ability to measure the disinfectant use solution concentration above 850ppm PAA. This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black color.

AI/ML Overview

The Medivators Rapicide PA High-Level Disinfectant Test Strips are designed to ensure that the Rapicide PA High-Level Disinfectant Solution is above its minimum recommended concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning a solid black color when the solution is above 850ppm PAA, while a "fail" is indicated by the pad turning dark grey, violet grey, light grey, or white (no color change) if the solution is at or below the MRC.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Study	Acceptance Criteria	Reported Device Performance
Dynamic Range	Negative response at concentrations at or below MRC, positive response at higher concentrations.	Met Acceptance Criteria: Negative response at concentrations at or below MRC, positive response at higher concentrations.
Comparative Sensitivity and Specificity	Comparative sensitivity and specificity of 1 (implicitly, indicating perfect agreement with a reference method or ideal performance).	Met Acceptance Criteria: Comparative sensitivity and specificity of 1.
Analytic Specificity – Contaminants	Negative response at MRC (for contaminants), positive response at higher concentration (for the active ingredient). (This implies the device should not give a false positive due to contaminants at MRC, and correctly identify the active ingredient above MRC).	Met Acceptance Criteria: Negative response at MRC, positive response at higher concentration.
Analytic Specificity - Other Germicides	Negative response to other germicides. (Ensuring the device is specific to peracetic acid and does not react with other common germicides).	Met Acceptance Criteria: Negative response to other germicides.
Shelf Life	Met specifications after storage for a labeled shelf life of 12 months (unopened).	Met Acceptance Criteria: Met specifications after storage for labeled shelf life of 12 months (unopened).
In-Use (Open Bottle) Stability	Met specifications after storage for a labeled open bottle shelf life of one month.	Met Acceptance Criteria: Met specifications after storage for labeled open bottle shelf life of one month.

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

The document does not explicitly state the sample sizes used for each of the tests (Dynamic Range, Comparative Sensitivity and Specificity, Analytic Specificity – Contaminants, Analytic Specificity - Other Germicides, Shelf Life, In-Use Stability). It only indicates that "non-clinical tests" were performed.

The data provenance is from Medivators Inc., a company based in Minneapolis, MN, USA. The data is retrospective as it was generated prior to the 510(k) submission.

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

This information is not provided in the document. For a chemical indicator, the ground truth would likely be established by a laboratory assay (e.g., titration or spectrophotometry) to precisely determine the peracetic acid concentration, rather than by human experts interpreting the results.

4. Adjudication method for the test set:

This information is not applicable as the test strips are chemical indicators with a direct visual output (color change). The outcome is determined by the specific chemical reaction embedded in the strip, not by expert adjudication.

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:

This is not applicable. The device is a chemical test strip, not an AI-powered diagnostic tool requiring human interpretation with or without AI assistance.

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

This information is not applicable as the device is a chemical test strip, not an algorithm. The "standalone" performance is the inherent chemical reaction on the strip.

7. The type of ground truth used:

The ground truth used for these chemical test strips would be the actual concentration of peracetic acid in the disinfectant solution, determined by a precise analytical method (e.g., chemical titration, spectrophotometry, or a validated reference standard). The document implies this by referring to "concentrations at or below MRC" and "higher concentrations."

8. The sample size for the training set:

This information is not provided as chemical test strips do not typically involve a "training set" in the context of machine learning or AI. The performance of the test strip is a result of its chemical formulation and manufacturing process, optimized through R&D and verified through testing.

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

This is not applicable as there isn't a "training set" in the traditional sense for these chemical test strips. The chemical composition is designed to react at specific concentrations, and the ground truth for validating this design (during R&D and manufacturing quality control) would be established using precise analytical methods to determine peracetic acid concentrations in control solutions.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

March 11, 2016

Medivators Inc. Mr. Brent Geiger, M.S., RAC Director of Regulatory Compliance 14605 28th Ave North Minneapolis, MN 55447

Re: K152394

Trade/Device Name: Rapicide PA High-Level Disinfectant Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 10, 2016 Received: February 11, 2016

Dear Mr. Geiger,

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

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152394

Device Name RAPICIDE PA High-Level Disinfectant Test Strips

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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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, block letters. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue. The circular graphic appears to be a stylized representation of a globe or sphere with curved lines.

510(k) Summary RAPICIDE® PA High-Level Disinfectant Test Strips

Manufacturer:	Medivators Inc., A Cantel Medical Company
Address:	14605 28th Avenue NorthMinneapolis, MN 55447 USA(800) 328-3345
Date:	March 11, 2016
Official Contact:	Megan DickeyRegulatory Affairs Specialist, Medivators Inc.Telephone: 763-553-3327Fax No.: 763-551-2653Email: mdickey@medivators.com

Medivators Inc. has supplied the following information to support substantial equivalence of the Rapicide PA High-Level Disinfectant Test Strips to other test strips currently cleared for sale in the United States of America.

1. Submission Device Information:

Trade Name:	Rapicide PA High-Level Disinfectant Test Strips
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 Information:

K082988/K964264 - Rapicide PA Test Strips K931935 - Endpoint 500 Peracetic Acid Test Indicators

3.Intended Use:

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Image /page/5/Picture/0 description: The image contains the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic with several curved lines inside, followed by the word "MEDIVATORS" in large, bold, blue letters. Below the company name is the text "A Cantel Medical Company" in a smaller, lighter blue font.

4. Description of Device:

5. Comparison to Other Devices in Commercial Distribution Within the United States:

Rapicide PA High-Level Disinfectant Test Strips, the subject device, are substantially equivalent in function, intended use and scientific technology to its predicate devices - predicate Rapicide PA Test Strips cleared under 510(k) -K082988/K964264 and Endpoint 500 Peracetic Acid Test Indicators cleared under 510(k) - K931935.

DeviceParameters	Subject Device – RAPICIDEPA High-Level DisinfectantTest Strips	Predicate –Rapicide PA Test Strips(K082988/K964264)	Predicate -Endpoint 500 Peracetic Acid TestIndicators(K931935)
Trade Name	RAPICIDE PA High-LevelDisinfectant Test Strips	Rapicide PA Test Strips	Endpoint 500 Peracetic Acid TestIndicators
RegulationNumber	880.2800	876.8520	878.4400
Device Class	Class II	Class II	Class II
CertificationPanel	General Hospital	Gastroenterology/Urology	General Hospital
Product Code	JOJ	FKP/LIF	JOS
Single Use	Yes	Yes	Yes
Supplied sterile	No	No	No
Direct/IndirectPatient Contact	No	No	No
ActiveIngredientMeasured	Peracetic Acid	Peracetic Acid	Peracetic Acid
Indication forUse	RAPICIDE PA High-LevelDisinfectant Test Strips areused as a chemical indicatorafter the disinfection cycle toensure that the Rapicide PAHigh-Level DisinfectantSolution is above minimumrecommended concentration(850 ppm peracetic acid); thisensures the disinfectant wasabove MRC during the entiredisinfection cycle.	RAPICIDE PA Test Strips areused after the disinfection cycle toensure that the Rapicide PAdisinfectant is above theminimum recommendedconcentration (850 ppm peraceticacid): this ensures that thedisinfectant was above MRCduring the entire cycle.	Endpoint 500 Peracetic Acid TestIndicators are used in determiningeffective levels of peracetic acid(greater than 500ppm) in dialyzerreprocessing. Concentrations ofPAA 500 ppm and greater testpositive and concentrations of lessthan 500 ppm test negative. Thisensures the disinfectant was aboveMRC.
"PASS"Indication	Solid Black > 850ppm PAA	Dark Brown/Black > 850ppmPAA	Blue/Gray or Blue/Black> 500ppmPAA

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Image /page/6/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, block letters. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, lighter blue font. The circular graphic appears to be a stylized representation of a globe or sphere, with several curved lines running across it.

Chemistry	The chemical principle of thetest is based on the oxidation ofiodide to iodine by peraceticacid. A dark complex isobtained in the presence ofstarch.	The chemical principle of the testis based on the oxidation of iodideto iodine by peracetic acid. A darkcomplex is obtained in thepresence of starch.	The chemical principle of the test isbased on the oxidation of iodide toiodine by peracetic acid. A darkcomplex is obtained in the presenceof starch.
	Packaging	Aluminum Vial - 100 Strips	Aluminum Vial - 100 Strips	Aluminum Vial - 100 Strips

6. Technological Comparison:

The chemical properties of the test strip chemical indicator pad in the predicates' design and the subject device's design is based on the oxidation of iodine by peracetic acid which creates a reaction of a dark color complex to indicate that recommended concentration of the disinfectant usesolution has been met. Same as the subject device, the Endpoint 500 strip threshold reactivity is modulated to give a qualitative, Pass/Fail, reading. The Endpoint 500 strip will turn blue/black, Pass indication, when Renalin concentration is 500ppm or greater. In comparison, the predicate Rapicide PA Test strips, a coupler is used where the strip reactivity is modulated to provide a continuous reaction range for disinfectant PA solutions from 100 to 1500ppm. In the Advantage Plus and Rapicide PA HLD 510(k) - K082988, the predicate Rapicide PA Test Strips are used as a quantitative indication of PA concentration where a darker color reaction indicates a higher PA concentration. The quantitative indication, different than the subject device qualitative indication, does not pose any additional risk because both types of strips indicate whether an acceptable PA concentration for the HLD use solution has been achieved.

7. Summary of Non-Clinical Performance Data

The performance of the Rapicide PA High-Level Disinfectant Test Strips were evaluated in Rapicide PA High-Level Disinfectant solutions at MRC and above in the following non-clinical tests. These results demonstrated that the Rapicide PA High-Level Disinfectant Test Strips are reliable and meet the guidance performance requirements similar to that of the predicate devices.

The following table summarizes the non-clinical testing performed by Medivators to demonstrate safety and effectiveness of Rapicide PA High-Level Disinfectant Test Strips in monitoring the concentration of Rapicide PA High-Level Disinfectant solution-

Study	Result
Dynamic Range	Met Acceptance Criteria:Negative response at concentrations at or belowMRC, positive response at higher concentrations
Comparative Sensitivity and Specificity	Met Acceptance Criteria:Comparative sensitivity and specificity of 1
Analytic Specificity – Contaminants	Met Acceptance Criteria:Negative response at MRC, positive response athigher concentration
Analytic Specificity - Other Germicides	Met Acceptance Criteria:

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Image /page/7/Picture/0 description: The image shows the logo for "MEDIVATORS A Cantel Medical Company". The logo consists of a blue circular graphic with several horizontal lines inside, followed by the company name in blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue.

	Negative response to other germicides
Shelf Life	Met Acceptance Criteria:Met specifications after storage for labeled shelf lifeof 12 months (unopened).
In-Use (Open Bottle) Stability	Met Acceptance Criteria:Met specifications after storage for labeled openbottle shelf life of one month.

8. Conclusion:

Rapicide PA High-Level Disinfectant Test Strips are intended for use with Rapicide PA High-Level Disinfectant Solution and are substantially equivalent to the predicate devices, Rapicide PA Test Strips cleared under 510(k) -K082988/K964264 and Endpoint 500 Peracetic Acid Test Indicators cleared under 510(k) - K931935. Based on the intended use, technological characteristics, performance data, and nonclinical tests performed the subject Rapicide PA High-Level Disinfectant Test Strip is substantially equivalent and is as safe and as effective as the legally marketed predicate device.

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).