(200 days)
Not Found
No
The device is a chemical indicator test strip that changes color based on the concentration of a disinfectant. There is no mention of AI/ML, image processing, or any computational analysis of data.
No
The device is a test strip used to confirm the concentration of a disinfectant, not to directly treat a medical condition or provide therapy.
No
This device is used to test the concentration of a disinfectant solution, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "Test Strip," which is a physical, chemical indicator, not software.
Based on the provided information, the Rapicide PA High-Level Disinfectant Test Strips are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to test the concentration of a disinfectant solution, not to diagnose a disease or condition in a human or animal.
- Device Description: The device measures the concentration of a chemical (peracetic acid) in a solution.
- Anatomical Site/Patient Information: There is no mention of an anatomical site or patient information, which are key characteristics of IVD devices.
- Performance Studies: The performance studies focus on the accuracy and reliability of the test strips in measuring the disinfectant concentration, not on clinical performance related to patient diagnosis.
- Predicate Devices: The predicate devices are also test strips for measuring disinfectant concentration, not IVD devices.
IVD devices are used to examine specimens derived from the human body (or animal body) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device tests a chemical solution used for disinfection, which is a different purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
JOJ
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.
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 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.
| Study | Result |
|---|---|
| Dynamic Range | Met Acceptance Criteria: Negative response at concentrations at or below MRC, 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 at higher concentration |
| Analytic Specificity - Other Germicides | Met Acceptance Criteria: Negative response to other germicides |
| Shelf Life | Met Acceptance Criteria: Met specifications after storage for labeled shelf life of 12 months (unopened). |
| In-Use (Open Bottle) Stability | Met Acceptance Criteria: Met specifications after storage for labeled open bottle shelf life of one month. |
Key Metrics
Comparative Sensitivity and Specificity of 1
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
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
1
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
2
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)
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.
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)
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
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 North |
| Minneapolis, MN 55447 USA | |
| (800) 328-3345 | |
| Date: | March 11, 2016 |
| Official Contact: | Megan Dickey |
| Regulatory Affairs Specialist, Medivators Inc. | |
| Telephone: 763-553-3327 | |
| Fax No.: 763-551-2653 | |
| Email: 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:
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.
5
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:
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.
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.
| Device
Parameters | Subject Device – RAPICIDE
PA High-Level Disinfectant
Test Strips | Predicate –
Rapicide PA Test Strips
(K082988/K964264) | Predicate -
Endpoint 500 Peracetic Acid Test
Indicators
(K931935) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | RAPICIDE PA High-Level
Disinfectant Test Strips | Rapicide PA Test Strips | Endpoint 500 Peracetic Acid Test
Indicators |
| Regulation
Number | 880.2800 | 876.8520 | 878.4400 |
| Device Class | Class II | Class II | Class II |
| Certification
Panel | General Hospital | Gastroenterology/Urology | General Hospital |
| Product Code | JOJ | FKP/LIF | JOS |
| Single Use | Yes | Yes | Yes |
| Supplied sterile | No | No | No |
| Direct/Indirect
Patient Contact | No | No | No |
| Active
Ingredient
Measured | Peracetic Acid | Peracetic Acid | Peracetic Acid |
| Indication for
Use | 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
(850 ppm peracetic acid); this
ensures the disinfectant was
above MRC during the entire
disinfection cycle. | RAPICIDE PA Test Strips are
used after the disinfection cycle to
ensure that the Rapicide PA
disinfectant is above the
minimum recommended
concentration (850 ppm peracetic
acid): this ensures that the
disinfectant was above MRC
during the entire cycle. | Endpoint 500 Peracetic Acid Test
Indicators are used in determining
effective levels of peracetic acid
(greater than 500ppm) in dialyzer
reprocessing. Concentrations of
PAA 500 ppm and greater test
positive and concentrations of less
than 500 ppm test negative. This
ensures the disinfectant was above
MRC. |
| "PASS"
Indication | Solid Black > 850ppm PAA | Dark Brown/Black > 850ppm
PAA | Blue/Gray or Blue/Black> 500ppm
PAA |
6
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 the
test is based on the oxidation of
iodide to iodine by peracetic
acid. A dark complex is
obtained in the presence of
starch. | The chemical principle of the test
is based on the oxidation of iodide
to iodine by peracetic acid. A dark
complex is obtained in the
presence of starch. | The chemical principle of the test is
based on the oxidation of iodide to
iodine by peracetic acid. A dark
complex is obtained in the presence
of 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 below | |
| MRC, 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 at | |
| higher 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 life | |
| of 12 months (unopened). | |
| In-Use (Open Bottle) Stability | Met Acceptance Criteria: |
| Met specifications after storage for labeled open | |
| bottle 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.