(145 days)
Not Found
No
The device is a simple chemical indicator strip that changes color based on a chemical reaction, not AI/ML. The description focuses on chemical composition and performance studies related to chemical reactions and stability.
No
This device is a test strip designed to monitor the concentration of a high-level disinfectant solution, not to treat or diagnose a medical condition in a patient.
No
This device monitors the concentration of a high-level disinfectant solution, not a physiological condition or a disease in humans or animals.
No
The device is a physical chemical indicator strip, not a software application.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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%." This is a measurement or determination made in vitro (outside of the body) on a solution.
- Device Description: The device is a chemical indicator strip that reacts with the solution to provide a visual indication of the concentration. This is a common characteristic of IVD tests used for chemical analysis.
- Performance Studies: The performance studies focus on the device's ability to accurately determine the concentration (pass/fail conditions, specificity, contaminants), which is directly related to its diagnostic function for the disinfectant solution.
- Key Metrics: The mention of "Specificity" as a key metric further supports its classification as an IVD, as specificity is a crucial performance characteristic for diagnostic tests.
While it's not diagnosing a condition in a human, it is performing a diagnostic test on a solution to determine its suitability for a specific purpose (high-level disinfection). This falls under the scope of IVD devices, which are used to examine specimens from the human body or other materials to provide information for diagnostic, monitoring, or screening purposes. In this case, the "material" being examined is the disinfectant solution.
N/A
Intended Use / Indications for Use
The Revital-OxTM 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%.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Performance: Equivalent performance to the predicate in pass and fail conditions for simulated use. Result: 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. Result: 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. Result: Equivalent.
- Exposure to aggressive chemicals: Equivalent performance to the predicate in pass and fail conditions. Result: 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. Result: Equivalent.
- Shelf life: Meet performance specifications at each time point after storage in different environments. Result: 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. Result: Performance testing of the proposed device up to 11 days was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity (as described in the "Summary of Performance Studies")
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
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.
1
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)
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 recommentration (MRC) of 1.5%.
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)
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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
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.
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™ R60 | ||
| Solution Test Strip | Verify® Chemical Monitoring Strip | |
| for Resert Solutions Version 2 | ||
| 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%. | The Verify® Chemical Monitoring Strip | |
| for Resert Solutions Version 2 is a high | ||
| level disinfectant concentration | ||
| monitor dedicated for use with Resert® | ||
| XL HLD High-Level Disinfectant. The | ||
| purpose of the Verify® Chemical | ||
| Monitoring Strip for Resert Solutions | ||
| Version 2 is to determine whether the | ||
| concentration of a Resert® XL HLD | ||
| High-Level Disinfectant solution is | ||
| above the minimum recommended | ||
| concentration (MRC) of 1.5%. | Change in intended | |
| use is limited to a | ||
| name change to | ||
| reflect the | ||
| brand/name change | ||
| of Resert® XL | ||
| HLD High-Level | ||
| Disinfectant to | ||
| Revital-Ox™ | ||
| RESERT™ High | ||
| Level Disinfectant | ||
| and to specify that | ||
| the strips monitors | ||
| the active | ||
| ingredient in the | ||
| disinfectant | ||
| solution. |
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 sulfite | ||
| pH-based reaction | Colorimetric | ||
| starch/iodide reaction | The strip does not contact | ||
| patients. Impact of the | |||
| difference in reactive | |||
| chemistry on safety was | |||
| evaluated through literature | |||
| review. | |||
| Efficacy of the proposed | |||
| strip is summarized in | |||
| Table 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 testing |
| demonstrated proper | |||
| interpretation of strips. | |||
| Detection | greater than 1.5% | ||
| hydrogen peroxide | greater than 1.5% | ||
| hydrogen peroxide | Same | ||
| Use | |||
| temperature | |||
| range | 20 °C minimum | 20 -24 °C | Efficacy of the proposed |
| strip at or above 20 °C was | |||
| demonstrated through | |||
| testing under simulated | |||
| use, testing with | |||
| contaminants, testing after | |||
| exposure to aggressive | |||
| chemicals and blind | |||
| interpretation of exposed | |||
| strips. | |||
| Viewing | Viewing window, paper | ||
| on back of strip | Paper on front of strip | Blinded testing | |
| demonstrated proper | |||
| interpretation of strips. | |||
| Shelf-life, | |||
| unopened | 1 year | 6 months | Testing was performed to |
| support 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).