(139 days)
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is designed to determine whether the peractic acid concentration in the high-level disinfection (HLD) phase of the chosen reprocessing cycle of the enspire 300 Series AER employing Peracetic Acid (Revital-Ox PAA High Level Disinfectant) is above the minimum effective concentration (MEC) of 850 mg/L.
Revital-Ox PAA High Level Disinfectant Chemical Indicator is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed in a patch at one end. A clear, germicide-permeable laminate is applied over the reactive patch to protect the strip from damage during handling and to prevent the ink from leaching from the substrate.
One strip is used with each Cleaning and High-Level Disinfection (HLD) and HLD only cycle by placing the strip within the enspire 300 Series Automated Endoscope Reprocessor. At the end of the cycle, if the reactive patch has turned from the starting blue color to grey/tan, it was exposed to > 850 mg/L PAA min. which indicates an effective peracetic acid dose, i.e. 'Pass'.
This document describes the Revital-Ox PAA High Level Disinfectant Chemical Indicator and its performance testing to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity Study | Not explicitly stated in the provided text, but implied to demonstrate correct response to PAA levels. | PASS |
| Post-Processing Stability Study – Outside Processor | Not explicitly stated, but implied to show stability after processing. | PASS |
| Post-Processing Stability Study – Inside Processor | Not explicitly stated, but implied to show stability after processing. | PASS |
| Blind Reader | Not explicitly stated, but implied to demonstrate consistent and accurate interpretation by different readers. | PASS |
| Effects of Contaminants | Not explicitly stated, but implied to demonstrate resistance to common contaminants. | PASS |
| Exposure to Temperature Extremes | Not explicitly stated, but implied to demonstrate performance within expected temperature ranges. | PASS |
| Shelf Life for 16 months | Indicator remains effective for 16 months. (Study "ongoing" for extension). | PASS |
| Open Bottle Stability for 90 days | Indicator remains effective for 90 days after opening. | PASS |
2. Sample Size and Data Provenance
The provided text does not specify the sample sizes used for each test set within the "Performance Testing" section. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications
The document mentions a "Blind Reader" study, which implies human interpretation. However, it does not specify the number of experts used, their qualifications, or their role in establishing ground truth for the device's color change interpretation.
4. Adjudication Method
The document does not describe any specific adjudication method used for the test set interpretation, such as 2+1 or 3+1 concensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device. This device is a chemical indicator that changes color to signify a concentration level, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
The performance testing described, particularly the "Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity Study," implicitly represents a standalone (algorithm only, though in this case, a chemical reaction and visual change) performance evaluation of the chemical indicator's ability to respond to peracetic acid concentrations. The "Blind Reader" study then assesses the human interpretation of this standalone performance.
7. Type of Ground Truth Used
The ground truth for this device's performance would primarily be the measured concentration of peracetic acid (PAA) in the liquid. The chemical indicator is designed to change color when the PAA concentration is above 850 mg/L. Therefore, the ground truth is established by chemical analysis of the PAA concentration in the test solutions or in the effluent from the AER.
8. Sample Size for Training Set
The concept of a "training set" is not applicable to this device. Chemical indicators function based on chemical reactions, not machine learning algorithms that require training data.
9. How Ground Truth for Training Set Was Established
As stated above, a "training set" is not applicable. The device's color change mechanism is an inherent chemical property, not something that is "trained." The ground truth for evaluating its performance is based on precisely controlled and measured concentrations of peracetic acid.
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July 17, 2023
STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5976 Heisley Road Mentor, Ohio 44060
Re: K230558
Trade/Device Name: Revital-Ox PAA High Level Disinfectant Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 13, 2023 Received: June 13, 2023
Dear Gregory Land:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Paulo Laranjeira -S 2023.07.17 15:08:44 -04'00'
for Clarence Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230558
Device Name
Revital-Ox PAA High Level Disinfectant Chemical Indicator
Indications for Use (Describe)
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is designed to determine whether the peractic acid concentration in the high-level disinfection (HLD) phase of the chosen reprocessing cycle of the enspire 300 Series AER employing Peracetic Acid (Revital-Ox PAA High Level Disinfectant) is above the minimum effective concentration (MEC) of 850 mg/L.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is in a bold, serif font. Below the word is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual representation of water or waves.
510(k) Summary For Revital-Ox PAA High Level Disinfectant Chemical Indicator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
| Contact: | Gregory LandLead Regulatory Affairs Specialist |
|---|---|
| Telephone: | (440) 392-7424 |
| Fax No: | (440) 357-9198 |
June 13, 2023 Submission Date:
Submission #: K230558
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Revital-Ox PAA High Level Disinfectant Chemical Indicator |
|---|---|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator |
| Classification | 21 CFR 880.2800 |
| Product Code | JOJ |
2. Predicate Device
VERIFY® Chemical Indicator for SYSTEM 1E Processor (K102217, as modified by K173428)
3. Device Description
Revital-Ox PAA High Level Disinfectant Chemical Indicator is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed in a patch at one end. A clear, germicide-permeable laminate is applied over the reactive patch to protect the strip from damage during handling and to prevent the ink from leaching from the substrate.
One strip is used with each Cleaning and High-Level Disinfection (HLD) and HLD only cycle by placing the strip within the enspire 300 Series Automated Endoscope Reprocessor. At the end of the cycle, if the reactive patch has turned from the starting blue color to grey/tan, it was exposed to > 850 mg/L PAA min. which indicates an effective peracetic acid dose, i.e. 'Pass'.
4. Indications for Use:
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is designed to determine whether the peracetic acid concentration in the high-level disinfection (HLD) phase of the chosen reprocessing cycle of the enspire™ 300 Series AER employing Peracetic Acid (Revital-Ox™ PAA High Level Disinfectant) is above the minimum effective concentration (MEC) of 850 mg/L.
న్. Comparison to Legally Marketed Predicate Device:
The proposed and predicate devices are single use chemical indicators for use in monitoring peracetic acid concentration in reprocessing cycles. The differences between the proposed and predicate devices are limited to the processor the chemical indicator is used for, the peracetic acid concentration for color change, the endpoint color and shelf life. Table 5-1 contains a comparison of the technological characteristics and specifications of the proposed Revital-Ox PAA High Level
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Revital-Ox PAA High Level Disinfectant Test Strip
Disinfectant Chemical Indicator and the predicate VERIFY Chemical Indicator for SYSTEM 1E Processor.
| Feature | ProposedRevital-Ox PAA HighLevel DisinfectantChemical Indicator | PredicateVERIFY Chemical Indicatorfor SYSTEM 1E Processor | Comparison |
|---|---|---|---|
| Intended use | The Revital-Ox PAA HighLevel Disinfectant ChemicalIndicator is designed todetermine whether theperacetic acid concentration inthe high-level disinfection(HLD) phase of the chosenreprocessing cycle of theenspire™ 300 Series AERemploying Peracetic Acid(Revital-Ox™ PAA HighLevel Disinfectant) is abovethe minimum effectiveconcentration (MEC) of 850mg/L. | The VERIFY SYSTEM 1EChemical Indicator (SYSTEM 1EChemical Indicator) is a peraceticacid concentration indicator forroutine monitoring of theSYSTEM 1E Liquid ChemicalSterilant Processing Systememploying S40 SterilantConcentrate.The unprocessed Verify®SYSTEM 1E Chemical Indicatoris blue. When exposed to aconcentration of >1820 ppm(mg/L) peracetic acid found in theS40 use dilution, the indicatorchanges color from blue throughan intermediate beige and then tothe endpoint color pink. Theindicator may become more pinkwhen exposed to higher peraceticacid concentrations in S40 usedilution. | Similar — bothare intended todetect MEC ofPeracetic Acidin processors |
| Devicedesign -components | Printed indicator ink printedonto polypropylene overlaidwith a clear, permeablelaminate | Printed indicator ink printed ontopolypropylene overlaid with aclear, permeable laminate | Identical |
| Indicatoragent | Proprietary formulation | Proprietary formulation | Identical |
| Cycles | Used in a high leveldisinfection processing systememploying Revital-Ox PAAHigh Level Disinfectant toform a use dilutionconcentration of ≥850 ppm(mg/L) peracetic acid andprovide 3 minutes exposure at50 - 55°C. | Used in a liquid chemical sterilantprocessing system employing S40Sterilant Concentrate to form a usedilution concentration of ≥1820ppm (mg/L) peracetic acid andprovide 6 minutes exposure at 45.5- 60°C. | Similar - bothdetect aminimumconcentrationof Peraceticacid in aprocessorthrough anindicator colorchange |
| Mechanismof action | Bleaching of proprietary activeingredient as a result of | Bleaching of proprietary activeingredient as a result of oxidation | Identical |
| Feature | ProposedRevital-Ox PAA HighLevel DisinfectantChemical Indicator | PredicateVERIFY Chemical Indicatorfor SYSTEM 1E Processor | Comparison |
| oxidation, resulting in blue togrey/tan color change. | resulting in blue to beige/pinkcolor change. | ||
| Peraceticacid concen-tration forthe endpointcolor change | > 850 mg/L PAA | > 1820 mg/L PAA | Similar - thesubject devicedetects alowerconcentrationof PAA |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 16 months | 24 months | Similar - thesubject deviceshelf-lifestudy isongoing andthe shelf lifewill beextended asdata becomesavailable |
| Open bottleshelf life | 90 days | 6 months | Similar - thesubject devicehas a shorteropen bottleshelf life |
Table 5-1. Device Comparison Table
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Revital-Ox PAA High Level Disinfectant Test Strip
Performance Testing 6.
The following table summarizes the non-clinical performance testing.
The performance of the proposed device is summarized below:
| Testing | Results |
|---|---|
| Comparative Sensitivity, Comparative Specificity,Analytic Sensitivity and Analytic Specificity Study | PASS |
| Post-Processing Stability Study – Outside Processor | PASS |
| Post-Processing Stability Study – Inside Processor | PASS |
| Blind Reader | PASS |
| Effects of Contaminants | PASS |
| Exposure to Temperature Extremes | PASS |
| Shelf Life for 16 months | PASS |
| Open Bottle Stability for 90 days | PASS |
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7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the Revital-Ox PAA High Level Disinfectant Chemical Indicator is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K102217 as modified by K173428), Class II (CFR 880.2800), product code JOJ.
§ 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).