Revital-Ox PAA High Level Disinfectant Chemical Indicator

K230558 · STERIS Corporation · JOJ · Jul 17, 2023 · General Hospital

Device Facts

• Record ID: K230558
• Device Name: Revital-Ox PAA High Level Disinfectant Chemical Indicator
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Jul 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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.

Device Story

Single-use chemical indicator strip; polypropylene substrate with reactive indicator ink patch; protected by clear, germicide-permeable laminate. Used in enspire 300 Series AER during high-level disinfection cycles. Operator places strip in processor; chemical reaction (oxidation) occurs upon exposure to peracetic acid. Visual color change from blue to grey/tan indicates peracetic acid concentration > 850 mg/L (Pass). Provides immediate visual confirmation of disinfectant efficacy for healthcare personnel; ensures proper reprocessing of endoscopes; reduces risk of inadequate disinfection.

Clinical Evidence

Bench testing only. Performance validated through comparative sensitivity/specificity studies, analytic sensitivity/specificity, post-processing stability (inside/outside processor), blind reader studies, contaminant effects, temperature extremes, and shelf-life/open-bottle stability testing. All tests passed.

Technological Characteristics

Polypropylene strip with proprietary indicator ink; clear, germicide-permeable laminate overlay. Mechanism: chemical oxidation resulting in color change. Dimensions/form factor: strip. Standalone device; no energy source or connectivity. Shelf life: 16 months; open bottle stability: 90 days.

Indications for Use

Indicated for use in the enspire 300 Series Automated Endoscope Reprocessor (AER) to verify that the peracetic acid concentration during the high-level disinfection phase meets the minimum effective concentration (MEC) of 850 mg/L.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• VERIFY Chemical Indicator for SYSTEM 1E Processor (K102217, as modified by K173428)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax No: [phone]

| Contact: | Gregory Land<br>Lead Regulatory Affairs Specialist |
|------------|----------------------------------------------------|
| | |
| Telephone: | [phone] |
| Fax No: | [phone] |

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 | Proposed<br>Revital-Ox PAA High<br>Level Disinfectant<br>Chemical Indicator | Predicate<br>VERIFY Chemical Indicator<br>for SYSTEM 1E Processor | Comparison |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Revital-Ox PAA High<br>Level Disinfectant Chemical<br>Indicator is designed to<br>determine whether the<br>peracetic acid concentration in<br>the high-level disinfection<br>(HLD) phase of the chosen<br>reprocessing cycle of the<br>enspire™ 300 Series AER<br>employing Peracetic Acid<br>(Revital-Ox™ PAA High<br>Level Disinfectant) is above<br>the minimum effective<br>concentration (MEC) of 850<br>mg/L. | The VERIFY SYSTEM 1E<br>Chemical Indicator (SYSTEM 1E<br>Chemical Indicator) is a peracetic<br>acid concentration indicator for<br>routine monitoring of the<br>SYSTEM 1E Liquid Chemical<br>Sterilant Processing System<br>employing S40 Sterilant<br>Concentrate.<br>The unprocessed Verify®<br>SYSTEM 1E Chemical Indicator<br>is blue. When exposed to a<br>concentration of >1820 ppm<br>(mg/L) peracetic acid found in the<br>S40 use dilution, the indicator<br>changes color from blue through<br>an intermediate beige and then to<br>the endpoint color pink. The<br>indicator may become more pink<br>when exposed to higher peracetic<br>acid concentrations in S40 use<br>dilution. | Similar — both<br>are intended to<br>detect MEC of<br>Peracetic Acid<br>in processors |
| Device<br>design -<br>components | Printed indicator ink printed<br>onto polypropylene overlaid<br>with a clear, permeable<br>laminate | Printed indicator ink printed onto<br>polypropylene overlaid with a<br>clear, permeable laminate | Identical |
| Indicator<br>agent | Proprietary formulation | Proprietary formulation | Identical |
| Cycles | Used in a high level<br>disinfection processing system<br>employing Revital-Ox PAA<br>High Level Disinfectant to<br>form a use dilution<br>concentration of ≥850 ppm<br>(mg/L) peracetic acid and<br>provide 3 minutes exposure at<br>50 - 55°C. | Used in a liquid chemical sterilant<br>processing system employing S40<br>Sterilant Concentrate to form a use<br>dilution concentration of ≥1820<br>ppm (mg/L) peracetic acid and<br>provide 6 minutes exposure at 45.5<br>- 60°C. | Similar - both<br>detect a<br>minimum<br>concentration<br>of Peracetic<br>acid in a<br>processor<br>through an<br>indicator color<br>change |
| Mechanism<br>of action | Bleaching of proprietary active<br>ingredient as a result of | Bleaching of proprietary active<br>ingredient as a result of oxidation | Identical |
| Feature | Proposed<br>Revital-Ox PAA High<br>Level Disinfectant<br>Chemical Indicator | Predicate<br>VERIFY Chemical Indicator<br>for SYSTEM 1E Processor | Comparison |
| | oxidation, resulting in blue to<br>grey/tan color change. | resulting in blue to beige/pink<br>color change. | |
| Peracetic<br>acid concen-<br>tration for<br>the endpoint<br>color change | > 850 mg/L PAA | > 1820 mg/L PAA | Similar - the<br>subject device<br>detects a<br>lower<br>concentration<br>of PAA |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 16 months | 24 months | Similar - the<br>subject device<br>shelf-life<br>study is<br>ongoing and<br>the shelf life<br>will be<br>extended as<br>data becomes<br>available |
| Open bottle<br>shelf life | 90 days | 6 months | Similar - the<br>subject device<br>has a shorter<br>open bottle<br>shelf 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,<br>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.