(29 days)
No
The device description and performance studies indicate a chemical indicator test strip that relies on a color change reaction, not AI/ML. There is no mention of AI, ML, or image processing.
No
The device is a chemical indicator used to test the concentration of a disinfectant solution, not to treat a medical condition or disease.
No
The device is a chemical indicator used to determine the concentration of a disinfectant solution, not to diagnose a medical condition in a patient.
No
The device description clearly states the device is a physical test strip consisting of an impregnated paper pad attached to a polymer substrate, which is a hardware component.
Based on the provided information, the MetriCide OPA Plus Solution Test Strips are an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to determine the concentration of an active ingredient in a solution (MetriCide OPA Plus Solution). This solution is a high-level disinfectant used for medical devices. While the test strip itself isn't directly testing a patient sample, it's providing information about a product used in a healthcare setting to ensure its efficacy for disinfecting medical devices that will come into contact with patients. This falls under the scope of IVDs, which are used to examine specimens derived from the human body or to provide information about a physiological state, a state of health or disease, or a congenital abnormality. In this case, the test strip is providing information about the quality of a product used to prepare medical devices for use on patients, which directly impacts patient health and safety.
- Device Description: The description details a chemical indicator designed to react with a specific substance (ortho-phthalaldehyde) in a solution to provide a visual result (color change) that indicates the concentration of that substance. This is a classic description of an in vitro diagnostic test.
- Predicate Device: The predicate device listed (K081427 Browne OPA Test Strip) is also an OPA test strip, which are generally classified as IVDs.
While the test strip isn't directly analyzing a human sample, its function is to ensure the proper concentration of a disinfectant used on medical devices that will be used on humans. This is a critical step in preventing the spread of infection and is considered a diagnostic function in the broader sense of ensuring the safety and efficacy of medical procedures.
N/A
Intended Use / Indications for Use
MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The MetriCide™ OPA Plus Solution Test Strip is for use with MetriCide™ OPA Plus ortho-Phthaldehyde (OPA) High Level Disinfectant (HLD) solution which contains 0.6% MetriCide™ as the active ingredient. The test strip is an OPA concentration indicator that was developed for another OPA HLD solution. The test strip consists of an impregnated paper pad attached to a polymer substrate (which serves as the handle) - the test strip is evaluated by looking at the color of the pad at the stated read time. In essence, the test strip, following immersion in the test solution for a specified time period (1 second), will change from a start color to an endpoint color in a manner that is dependent on the concentration of the active (OPA); the test strip is read at a specified time interval (90 seconds).
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 Testing was completed using well established methods, i.e. those used to verify the predicate design.
Testing: Performance Characterization. Acceptance Criteria: Minimum 80% PASS results for strips tested with 0.45% MetriCide OPA Plus solution. Study Result: Pass – All criteria met.
Testing: Shelf Life. Acceptance Criteria: 0% PASS results for strips tested with 0.3% MetriCide OPA Plus solution. Study Result: Pass – All criteria met.
Testing: Analytic Specificity. Acceptance Criteria: 0% PASS results for strips exposed to tap water. Study Result: Pass - Criterion met.
Testing: Contaminants Testing. Acceptance Criteria: 0% PASS results for strips tested with contaminated 0.3% Metricide OPA solutions. Study Result: Pass - Criterion met.
The results of the performed testing demonstrate that the MetriCide™ OPA Plus Solution Test Strip performs as intended.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 11, 2024
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060
Re: K241344
Trade/Device Name: MetriCide™ OPA Plus Solution Test Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 13, 2024 Received: May 13, 2024
Dear Anthony 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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, Digitally signed by Stephen Stephen A. A. Anisko -S Anisko -S Date: 2024.06.11 13:22:36 -04'00 for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K241344
Device Name
MetriCide™ OPA Plus Solution Test Strip
Indications for Use (Describe)
MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K241344 510(k) Summary For MetriCide™ OPA Plus Solution Test Strip
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Manufacturing Facility
Contact:
Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com
May 13, 2024 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Predicate Device
Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:
Browne OPA Test Strip Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K081427
2. Device Description
The MetriCide™ OPA Plus Solution Test Strip is for use with MetriCide™ OPA Plus ortho-Phthaldehyde (OPA) High Level Disinfectant (HLD) solution which contains 0.6% MetriCide™ as the active ingredient. The test strip is an OPA concentration indicator that was developed for another OPA HLD solution. The test strip consists of an impregnated paper pad attached to a polymer substrate (which serves as the handle) - the test strip is evaluated by looking at the color of the pad at the stated read time. In essence, the test strip, following immersion in the test solution for a specified time period (1 second), will change from a start color to an endpoint color in a manner that is dependent on the concentration of the active (OPA); the test strip is read at a specified time interval (90 seconds).
3. Indications for Use:
MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.
4. Technological Characteristics
There have been no physical modifications to the subject device K241344 compared to the predicated device K081427. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices the same visible color change.
Note that the predicate for K081427 was K991709 where K081427 had no physical modifications from K991709: and K081427 was submitted and cleared to support a 60 second read time for K081427 compared to the 90 second read time for K991709.
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| Feature | Proposed: MetriCide™ OPA Plus Solution
Test Strip | Predicate: Browne OPA Test Strip
(K081427) | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use /
Indications for
Use | MetriCide OPA Plus Solution Test Strips are
chemical indicators for use in determining
whether the concentration of ortho-
phthalaldehyde, the active ingredient in
MetriCide OPA Plus Solution, is above or below
the Minimum Recommended Concentration
(MRC) of 0. 3 % established for
MetriCide OPA Plus
Solution. | The Browne OPA Test Strip is a concentration
monitor for use in ortho-phthalaldehyde
containing germicide solutions with a
minimum effective concentration of 0.3%.
The Browne OPA Test Strip is dedicated for
use with CidexTM OPA solution | Similar - both
products monitor
OPA at an MEC or
MRC of 0.3% |
| Dip and Read
Time | 1 second, 90 seconds | 1 second, 60 seconds | Similar |
| Device Design
- components | Absorbent paper impregnated with
indicator solution affixed to inert
polypropylene film | Absorbent paper impregnated with
indicator solution affixed to inert
polypropylene film | Identical |
| Shelf Life | 11 months | 10 months | Similar |
| Color change | Light blue to purple | Light blue to purple | Identical |
Table 1 Comparison of CI Physical Description and Technological Properties
The only changes to the subject device K241344 compared to the predicate device K081427 are the indication for use in another brand of OPA and the consequent labeling changes, and the difference in read times. Since the 90 second read time was established for the same physical product in K991709, and the testing to support subject device K241344 was performed with a 90 second read time, the 90 second read time is acceptable for the subject device. Although the indications are changing, the intended use, to monitor OPA at an MEC or MRC of 0.3%, remains the same.
న్. Performance Testing
Performance testing was completed using well established methods, i.e. those used to verify the predicate design.
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Performance | ||
| Characterization | - Minimum 80% PASS results for strips tested with 0.45% | |
| MetriCideTM OPA Plus solution | Pass – All criteria met | |
| Shelf Life | - 0% PASS results for strips tested with 0.3% MetriCideTM OPA | |
| Plus solution | Pass – All criteria met | |
| Analytic Specificity | 0% PASS results for strips exposed to tap water | Pass - Criterion met |
| Contaminants Testing | 0% PASS results for strips tested with contaminated 0.3% | |
| MetricideTM OPA solutions. | Pass - Criterion met |
Table 2. Verification Results Summary
The results of the performed testing demonstrate that the MetriCide™ OPA Plus Solution Test Strip performs as intended.
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6. Conclusion
The conclusion drawn from the non-clinical testing demonstrates that the subject device, MetriCide™ OPA Plus Solution Test Strip, is as safe, as effective, and performs as well as the legally marketed predicate device, Browne OPA Test Strip, cleared under K081427.