(139 days)
No
The device is a simple chemical indicator that changes color based on chemical concentration, with no mention of AI or ML in the description or performance studies.
No.
The device is a chemical indicator used to verify the concentration of a disinfectant for reprocessing medical devices, not for diagnosing, treating, or preventing disease in patients.
No
The device is a chemical indicator used to determine whether the peracetic acid concentration in a high-level disinfectant is above a minimum effective concentration. It does not diagnose a medical condition in a patient.
No
The device description clearly states it is a physical strip with indicator ink and laminate, which are hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is designed to determine the concentration of a disinfectant (peracetic acid) within an automated endoscope reprocessor. It's assessing the effectiveness of a reprocessing cycle, not analyzing a biological sample from a patient to diagnose a disease or condition.
- Device Description: It's a chemical indicator strip that changes color based on exposure to a chemical concentration. This is a quality control tool for a medical device (the reprocessor), not a diagnostic test performed on a patient sample.
- Lack of Biological Sample Analysis: IVDs are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. This device does not interact with any biological samples.
Therefore, the Revital-Ox PAA High Level Disinfectant Chemical Indicator falls under the category of a sterilization/disinfection process indicator, which is a different regulatory classification than an IVD.
N/A
Intended Use / Indications for 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.
Product codes
JOJ
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'.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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
2
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 Land
Lead 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
4
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
5
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
Revital-Ox PAA High
Level Disinfectant
Chemical Indicator | Predicate
VERIFY Chemical Indicator
for SYSTEM 1E Processor | Comparison |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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. | The VERIFY SYSTEM 1E
Chemical Indicator (SYSTEM 1E
Chemical Indicator) is a peracetic
acid concentration indicator for
routine monitoring of the
SYSTEM 1E Liquid Chemical
Sterilant Processing System
employing S40 Sterilant
Concentrate.
The unprocessed Verify®
SYSTEM 1E Chemical Indicator
is blue. When exposed to a
concentration of >1820 ppm
(mg/L) peracetic acid found in the
S40 use dilution, the indicator
changes color from blue through
an intermediate beige and then to
the endpoint color pink. The
indicator may become more pink
when exposed to higher peracetic
acid concentrations in S40 use
dilution. | Similar — both
are intended to
detect MEC of
Peracetic Acid
in processors |
| Device
design -
components | Printed indicator ink printed
onto polypropylene overlaid
with a clear, permeable
laminate | Printed indicator ink printed onto
polypropylene overlaid with a
clear, permeable laminate | Identical |
| Indicator
agent | Proprietary formulation | Proprietary formulation | Identical |
| Cycles | Used in a high level
disinfection processing system
employing Revital-Ox PAA
High Level Disinfectant to
form a use dilution
concentration of ≥850 ppm
(mg/L) peracetic acid and
provide 3 minutes exposure at
50 - 55°C. | Used in a liquid chemical sterilant
processing system employing S40
Sterilant Concentrate to form a use
dilution concentration of ≥1820
ppm (mg/L) peracetic acid and
provide 6 minutes exposure at 45.5
- 60°C. | Similar - both
detect a
minimum
concentration
of Peracetic
acid in a
processor
through an
indicator color
change |
| Mechanism
of action | Bleaching of proprietary active
ingredient as a result of | Bleaching of proprietary active
ingredient as a result of oxidation | Identical |
| Feature | Proposed
Revital-Ox PAA High
Level Disinfectant
Chemical Indicator | Predicate
VERIFY Chemical Indicator
for SYSTEM 1E Processor | Comparison |
| | oxidation, resulting in blue to
grey/tan color change. | resulting in blue to beige/pink
color change. | |
| Peracetic
acid concen-
tration for
the endpoint
color change | > 850 mg/L PAA | > 1820 mg/L PAA | Similar - the
subject device
detects a
lower
concentration
of PAA |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 16 months | 24 months | Similar - the
subject device
shelf-life
study is
ongoing and
the shelf life
will be
extended as
data becomes
available |
| Open bottle
shelf life | 90 days | 6 months | Similar - the
subject device
has a shorter
open bottle
shelf life |
Table 5-1. Device Comparison Table
6
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.