(94 days)
Not Found
No
The device is a simple chemical indicator strip that changes color based on a chemical reaction, not through computational analysis or learning.
No.
This device is a chemical indicator strip used to monitor the concentration of glutaraldehyde in a high-level disinfectant solution, not for medical treatment or diagnosis.
No.
Explanation: The device is a "Glutaraldehyde Monitor Strip" used to determine the concentration of a disinfectant solution, not to diagnose a medical condition in a patient.
No
The device is a physical chemical indicator strip with an indicator pad and polymer substrate, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the concentration of glutaraldehyde in a high-level disinfectant solution (Micro-Cide™ 28 HLD). This is a test performed on a chemical solution, not on a biological sample from a human or animal.
- Device Description: The device is a chemical indicator strip that reacts with the glutaraldehyde in the disinfectant solution. It does not interact with or analyze any biological material.
- Lack of Biological Sample: There is no mention of the device being used with blood, urine, tissue, or any other biological specimen.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is to assess the efficacy of a disinfectant solution, which is a quality control measure for a chemical product, not a diagnostic test for a patient.
N/A
Intended Use / Indications for Use
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in the solutions listed below, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD)
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a chemical indicator strip consisting of an indicator pad attached to a polymer substrate which serves as a handle. The test strip has been developed to monitor the concentration of glutaraldehyde in Micro-Cide" 28 HLD working solution. The indicator pad is impregnated with an indicator solution that changes color from vellow to purple if the concentration of the germicide exceeds the minimum effective concentration (MEC) of the solution.
The paper pad on an unused indicator strip is yellow in color. After an immersion time (dip time) of two seconds in a Micro-Cide™ 28 HLD solution, it is read at 120 seconds to verify the glutaraldehyde concentration of >1.8%. At 120 seconds the indicator strip will exhibit a stable uniform purple color if the concentration of glutaraldehyde is >2.1%. The strip will appear yellow or patchy yellow/purple if the solution has ≤1.8% glutaraldehyde, signaling to the customer that the solution must be replaced.
The glutaraldehyde concentration of the neat, unused Micro-Cide™ 28 HLD solution is 3%. To ensure an adequate margin of safety over the MEC of the germicide, the indicator was formulated to undergo a complete color change at glutaraldehyde concentrations of 2.1% in at least 80% of the tests conducted. The concentration of glutaraldehyde that will induce a color change is sufficiently higher than the MEC for the Micro-Cide " 28 HLD solution to ensure that the indicator (test strip) will not indicate a PASS in solutions with glutaraldehyde at or below the MEC of 1.8%. However, due to the kinetics of the chemical reaction that produces the color change, a test conducted on a Micro-Cide™ 28 HLD solution with a glutaraldehyde concentration of 1.83-2.10% may indicate a PASS or a FAIL result.
The proposed test strip is used in the same way and performs the same as the predicate device to indicate the presence of the same glutaraldehyde concentration, >1.8%.
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)
The following verification activities were performed:
- Performance: Minimum 80% pass results when tested with 2.1% glutaraldehyde Micro-Cide™ 28 HLD solution; 100% fail results with 1.8% glutaraldehyde Micro-Cide™ 28 HLD solution. Result: Pass.
- Specificity: Incomplete color change when exposed to tap water only. Result: Pass.
- Contaminants: Meets performance specifications in the presence of organic and inorganic contaminants in the test solution. Result: Pass.
- Exposure to aggressive chemicals: Meets performance specifications after exposure to aggressive chemicals. Result: Pass.
- Blind study testing: Meets performance specifications with inexperienced users. Result: Pass.
- Shelf life: Meets performance specifications at each time point after storage in different environments. Result: Pass.
- In-use (open bottle): Meets performance specifications at each time point after storage in different environments. Result: Pass.
- Functional stability: Meets performance specifications at each time point after storage outside bottle. Result: Pass.
These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
November 17, 2017
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor. Ohio 44060
Re: K172472
Trade/Device Name: Micro-MEC 1.8% Glutaraldehyde Monitor Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 30, 2017 Received: September 1, 2017
Dear Jennifer Nalepka:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tara A. Ryan -S
for
Tina Kiang, Ph.D. Acting 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)
K172472
Device Name
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
Indications for Use (Describe)
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in the solutions listed below, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD)
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in large, bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word "STERIS" is a graphic of several horizontal, wavy lines in blue, resembling water waves.
510(k) Summary For Micro-MEC 1.8% Glutaraldehyde Monitor Strip
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:
Jennifer Nalepka Senior Regulatory Affairs Specialist Telephone: (440) 392-7458 Fax No: (440) 357-9198 E-mail: Jennifer_Nalepka@steris.com
Summary Date: November 15, 2017
Premarket Notification Number: K172472
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | Micro-MEC 1.8% Glutaraldehyde Monitor Strip |
|---|---|
| Common/usual Name: | Chemical Indicator |
| Device Classification: | Class II |
| Classification Name: | Physical/chemical sterilization process indicator |
| (21 CFR 880.2800 (b), Product Code JOJ) |
2. Predicate Device
| K012335 | MetriTest 1.8 Glutaraldehyde Concentration Monitor - the predicate is identical to the proposed device. |
|---|---|
| --------- | --------------------------------------------------------------------------------------------------------- |
3. Description of Device
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a chemical indicator strip consisting of an indicator pad attached to a polymer substrate which serves as a handle. The test strip has been developed to monitor the concentration of glutaraldehyde in Micro-Cide" 28 HLD working solution. The indicator pad is impregnated with an indicator solution that changes color from vellow to purple if the concentration of the germicide exceeds the minimum effective concentration (MEC) of the solution.
The paper pad on an unused indicator strip is yellow in color. After an immersion time (dip time) of two seconds in a Micro-Cide™ 28 HLD solution, it is read at 120 seconds to verify the glutaraldehyde concentration of >1.8%. At 120 seconds the indicator strip will exhibit a stable uniform purple color if the concentration of glutaraldehyde is >2.1%. The strip will appear yellow or patchy yellow/purple if the solution has ≤1.8% glutaraldehyde, signaling to the customer that the solution must be replaced.
The glutaraldehyde concentration of the neat, unused Micro-Cide™ 28 HLD solution is 3%. To ensure an adequate margin of safety over the MEC of the germicide, the indicator was formulated to undergo a complete color change at glutaraldehyde concentrations of 2.1% in at least 80% of the tests conducted. The concentration of glutaraldehyde that will induce a color change is sufficiently higher than the MEC for the Micro-Cide " 28 HLD solution to ensure that the indicator (test strip) will not indicate a PASS in solutions with glutaraldehyde at or below the MEC of 1.8%. However, due to the kinetics of the chemical reaction that produces the color change, a test conducted on a Micro-Cide™ 28 HLD solution
5
with a glutaraldehyde concentration of 1.83-2.10% may indicate a PASS or a FAIL result.
The proposed test strip is used in the same way and performs the same as the predicate device to indicate the presence of the same glutaraldehyde concentration, >1.8%.
4. Intended Use
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a semi-quantitative chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient, is greater than the minimum effective concentration (MEC) of 1.8% glutaraldehyde established for Micro-Cide™ 28 High Level Disinfectant (Micro-Cide™ 28 HLD).
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are single use chemical indicator strips that monitor the MEC of glutaraldehyde-containing germicide solutions.
Table 5-1 summarizes the comparison between the proposed device, Micro-MEC 1.8% Glutaraldehyde Monitor Strip, and the predicate.
| | Proposed K172472
Micro-MEC 1.8%
Glutaraldehyde Monitor
Strip | Predicate K012335
MetriTest 1.8
Glutaraldehyde
Concentration Monitor | Comparison |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | The Micro-MEC 1.8%
Glutaraldehyde Monitor
Strip is a semi-
quantitative chemical
indicator for use in
determining whether the
concentration of
glutaraldehyde, the active
ingredient, is above or
below the minimum
effective concentration
(MEC) of 1.8%
glutaraldehyde
established for Micro-
Cide™ 28 High Level
Disinfectant (Micro-
Cide™ 28 HLD) | The MetriTest 1.8
Glutaraldehyde
Concentration Monitor is
a glutaraldehyde
concentration monitor for
use in glutaraldehyde-
containing germicide
solutions with an MEC of
1.8% glutaraldehyde.
The MetriTest 1.8
Glutaraldehyde
Concentration Monitor is
dedicated for use with
Metricide 28 and
Metricide Plus 30
Solutions. | Both indicators
monitor the
concentration
greater than 1.8%
glutaraldehyde
germicide. |
| Substrate | Absorbent Paper | Absorbent Paper | Same |
Table 5-1. Technological Comparison to Predicate
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Micro-MEC 1.8% Glutaraldehyde Monitor Strip
| Indicator /
reaction | Colorimetric sodium
sulfite pH-based reaction | Colorimetric sodium
sulfite pH-based reaction | Same |
|-------------------------|--------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------|
| Backing | Polypropylene | Polypropylene | Same |
| Color change | Yellow to purple | Yellow to purple | Same |
| Detection | Greater than 1.8%
glutaraldehyde | Greater than 1.8%
glutaraldehyde | Same |
| Viewing | Paper on front of strip | Paper on front of strip | Same |
| Shelf-life,
unopened | Current testing supports 8
months | 24 months | Target of 24 months
for proposed strip |
| Shelf-life.
opened | 90 days | 90 days | Same |
| Dip and
Read Times | Dip time = 2 second
Read time at 120 seconds | Dip time = 1 seconds
Read time at 60 seconds | Both dip and read
times optimized for
each glutaraldehyde
solution. |
Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Micro-MEC 1.8% Glutaraldehyde Monitor 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 Micro-Cide 28 HLD solution is greater than 1.8% glutaraldehyde. These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended use.
| Table 5-2 Performance Test Summary | |
|---|---|
| ------------------------------------ | -- |
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance | • Minimum 80% pass results when tested with 2.1% | |
| glutaraldehyde Micro-Cide™ 28 HLD solution | ||
| • 100% fail results with 1.8% glutaraldehyde Micro-Cide™ | ||
| 28 HLD solution | Pass | |
| Specificity | Incomplete color change when exposed to tap water only | Pass |
| Contaminants | Meets performance specifications in the presence of | |
| organic and inorganic contaminants in the test solution | Pass | |
| Exposure to aggressive | ||
| chemicals | Meets performance specifications after exposure to | |
| aggressive chemicals. | Pass | |
| Blind study testing | Meets performance specifications with inexperienced users | Pass |
| Shelf life | Meets performance specifications at each time point after | |
| storage in different environments | Pass | |
| In-use (open bottle) | Meets performance specifications at each time point after | |
| storage in different environments | Pass | |
| Functional stability | Meets performance specifications at each time point after | |
| storage outside bottle | Pass |
7
6. Conclusion
The Micro-MEC 1.8% Glutaraldehyde Monitor Strip intended for use with Micro-Cide™ 28 HLD solution is substantially equivalent to the predicate device, MetriTest 1.8 Glutaraldehyde Concentration Monitor. Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device, K012335, MetriTest 1.8 Glutaraldehyde Concentration Monitor (21 CFR 880.2800 (b), Product code JOJ).