(180 days)
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%.
The Verify Chemical Monitoring Strip for Resert Solutions Version 2 is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals that is adhesively bonded to one end of a polymer film. The Verify Chemical Monitoring Strip for Resert Solutions Version 2 has been developed to monitor the Resert 11 XL HLD High-Level Disinfectant that has a minimum recommended concentration (MRC) of 1.5%.
The provided document describes the K102296 510(k) submission for the "Verify® Chemical Monitoring Strip for Resert Solutions Version 2". This is a chemical indicator device, not an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, human reader improvement, and training set details) are not applicable.
Below is a description of the acceptance criteria and study information that can be extracted from the provided text for this specific device type.
Device Name: Verify® Chemical Monitoring Strip for Resert Solutions Version 2
Description: A chemical indicator strip designed to monitor the concentration of Resert XL HLD High-Level Disinfectant to determine if it is above the minimum recommended concentration (MRC) of 1.5%.
1. Table of Acceptance Criteria and Reported Device Performance
| Test of 3 Lots | Acceptance Criteria @ 20° and 24°C | Reported Device Performance (Result) |
|---|---|---|
| Performance Testing | FAIL @ 1.5%, PASS @ 1.8% | Pass |
| Blind Study Testing | 100% | Pass |
| Simulated Use (Contaminants) Testing | ≥ 50% | Pass |
| Test Strip Life Outside the Bottle | 100% | Pass |
| Aggressive Chemical Stability Testing | ≥ 50% | Pass |
| Specificity Testing for hydrogen peroxide | 100% | Pass |
| Stability Testing in three storage environments through labeled shelf life | ≥ 50% | Pass |
| In-Use Stability Testing in three storage environments through labeled opened bottle shelf life | 100% | Pass |
| ≥ 50% |
Note on Performance Testing Acceptance Criteria: The row for "Performance Testing" includes two criteria: "FAIL @ 1.5%" and "PASS @ 1.8%". This implies that the device should indicate a "fail" when the concentration is at the MRC (1.5%) and a "pass" when it is above the MRC (1.8%), demonstrating its ability to distinguish between concentrations at or below the MRC and those above it. The "Result" for this test is simply "Pass", indicating that these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document states that a "Test of 3 Lots" was performed for all listed verification activities. This implies that the testing was conducted on samples from three different manufacturing lots of the device.
- Sample Size (Test Set): Samples from 3 lots. Specific number of strips per lot is not provided.
- Data Provenance: Not explicitly stated, but based on the device type (chemical indicator) and the nature of the tests (laboratory testing of chemical reactions and stability), this would be considered prospective data generated in a controlled laboratory environment. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a chemical indicator device, and its performance is determined by its chemical reaction to a specific concentration of a disinfectant solution. The "ground truth" is the known chemical concentration of the solution, not an expert assessment.
4. Adjudication Method for the Test Set
Not applicable. The performance is based on the chemical reaction of the strip, not on subjective human interpretation that would require adjudication. The "Blind Study Testing" mentioned in the table suggests that the evaluators were blinded to the expected outcome, which is a form of control, but not an adjudication method for ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement
Not applicable. This is not an AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While this is a "standalone" device in the sense that it doesn't integrate with an algorithm, the term "standalone performance" typically refers to the performance of an AI algorithm without human input. This device's performance is intrinsically linked to its intended use by a human visually interpreting the result. Therefore, the concept of standalone algorithm performance does not apply. The performance testing described is the standalone performance of the device as a chemical indicator.
7. The Type of Ground Truth Used
The ground truth for this device is the known chemical concentration of the Resert XL HLD High-Level Disinfectant solutions. For example, for the "Performance Testing," the ground truth was solutions at 1.5% (expected FAIL) and 1.8% (expected PASS).
8. The Sample Size for the Training Set
Not applicable. This is a chemical indicator; its design is based on chemical principles and formulation, not on a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set as described for AI/ML devices.
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K102296
510(k) Summary For Verify® Chemical Monitoring Strip for Resert Solution Version 2
STERIS Corporation 5960 Heisley Road Mentor OH 44060-1834
Contact:
".
Robert Sullivan Senior Director Regulatory Affairs Telephone: (440) 392-7695 Fax No:
November 5, 2010 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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K 102296
Device Name 1.
| Trade Name: | Verify® Chemical Monitoring Strip for Resert™Solutions Version 2 |
|---|---|
| Common/usual Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator(21 CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Device
- K081600 Verify Chemical Monitoring Strip for Resert Solution . (cleared as STERIS Resert XL Test Strip)
3. Description of Device
The Verify Chemical Monitoring Strip for Resert Solutions Version 2 is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals that is adhesively bonded to one end of a polymer film. The Verify Chemical Monitoring Strip for Resert Solutions Version 2 has been developed to monitor the Resert 11 XL HLD High-Level Disinfectant that has a minimum recommended concentration (MRC) of 1.5%.
4. Intended Use
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 Solution 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%.
The Verify Chemical Monitoring Strip for Resert Solutions Version 2 only indicates hydrogen peroxide concentration and does not confirm disinfection.
Description of Safety and Substantial Equivalence ട.
The proposed and predicate devices are both single use chemical indicators used to monitor the hydrogen peroxide concentration in Resert XL HLD solutions. The difference between the proposed and predicate devices is limited to the relative concentrations of components in the formulation, and statements in the Instructions for Use that clarify the device's effective ambient use temperature range of 20 -24°C. These differences raise no new issues of safety and effectiveness.
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The following table summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Verify Chemical Monitoring Strip for Resert Solutions Version 2 is safe and effective. These studies confirm that .the device's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
| Test of 3 Lots | Acceptance Criteria @ 20° and 24°C | Result | |
|---|---|---|---|
| FAIL @ 1.5% | PASS @ 1.8% | ||
| Performance Testing | 100% | ≥ 50% | Pass |
| Blind Study Testing | 100% | ≥ 50% | Pass |
| Simulated Use(Contaminants) Testing | 100% | ≥ 50% | Pass |
| Test Strip LifeOutside the Bottle | 100% | ≥ 50% | Pass |
| Aggressive ChemicalStability Testing | 100% | ≥ 50% | Pass |
| Specificity Testingfor hydrogen peroxide | 100% | ≥ 50% | Pass |
| Stability Testing in threestorage environmentsthrough labeled shelf life | 100% | ≥ 50% | Pass |
| In-Use Stability Testing inthree storage environmentsthrough labeled openedbottle shelf life | 100% | ≥ 50% | Pass |
The Verify Chemical Monitoring Strip for Resert Solutions Version 2 is substantially equivalent to its predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 9 2011
Mr. Robert Sullivan Senior Director STERIS Corporation 5960 Heisley Road Mentor. Ohio 44060-1834
Re: K102296
Trade/Device Name: Verify® Chemical Monitoring Strip for Resert Solutions Version 2 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process indicator Regulatory Class: II Product Code: JOJ Dated: February 1, 2011 Received: February 2, 2011
Dear Mr. Sullivan:
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.
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Page 2- Mr. Sullivan
Enclosure
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
:
Anthony D. Watson, B.S., M.S.. M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K102296
Device Name:
Verify® Chemical Monitoring Strip for Resert Solutions Version 2
Indications for Use:
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%.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Edith D. Clemmer Webb
(Division Sign-Off) (Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K102296
Page 1 of 1
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November 5, 2010
Appendix 2: Page 2 of 2
§ 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).