(40 days)
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Metricide OPA Plus Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator designed to determine if the concentration of ortho-phthalaldehyde (OPA) in Metricide OPA Plus Solution is above or below its minimum effective concentration (MEC) of 0.3%.
Here's an analysis of the provided information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device, specifically the Metricide OPA Plus Solution Test Strip, by accurately indicating OPA concentration relative to the 0.3% MEC.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Reliable indication of OPA concentration above 0.3% MEC (green color formation). | The device reliably indicates if the OPA concentration is above or below the MEC level of 0.3% OPA. OPA levels above 0.3% react with a second chemical to form a colored compound, resulting in a green color. |
| Reliable indication of OPA concentration below 0.3% MEC (colorless product formation). | The device reliably indicates if the OPA concentration is above or below the MEC level of 0.3% OPA. A concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product (implying no green color if below MEC). |
| Performance substantially equivalent to the predicate device (Metricide OPA Plus Solution Test Strips). | The performance of the Serim DISINTEK OPA Test Strips was evaluated in split samples blind studies and compared to test results obtained with Metricide OPA Plus Solution Test Strips. The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Metricide OPA Plus Solution Test Strips. |
| Does not raise any new safety or effectiveness issues compared to the predicate device. | The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size used for the test set. It mentions "split samples blind studies" but provides no specific numbers for the samples tested.
- Data Provenance: Not explicitly stated. Given the context of a 510(k) submission to the US FDA, it is highly likely that the data was generated in the United States, but this is not explicitly confirmed. The studies appear to be prospective in nature, as they involve actively evaluating the performance of the new device in comparison to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The method for establishing ground truth for the test set is implied by the comparison to a predicate device and chemical reactions, rather than expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. The nature of a chemical indicator test, where the result is a color change based on a chemical reaction, typically does not involve human adjudication in the same way an imaging diagnostic might. The output is a direct chemical reading.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists in the reading process. The Serim® DISINTEK™ OPA Test Strip is a chemical indicator that produces a direct, objective result (color change), not a complex interpretation task for human readers.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Was it done? Yes, in essence, the performance evaluation described is a standalone study of the device. The "split samples blind studies" evaluated the performance of the Serim DISINTEK OPA Test Strips on their own merits and then compared the results directly to the predicate device. The device's mechanism is a chemical reaction leading to a direct color change, which is an inherent "algorithm" of the test strip itself. The outcome is not subject to human interpretation in the same way as an imaging algorithm might be reviewed by a human.
7. Type of Ground Truth Used
The ground truth used is based on chemical concentration levels of OPA relative to the 0.3% MEC. This is established by:
- The known chemical properties and reactions designed into the test strip.
- Comparison to the performance of an already legally marketed and accepted predicate device (Metricide OPA Plus Solution Test Strips) which also relies on chemical determination of OPA concentration.
- The chemical principle: "A chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color." This defines the objective ground truth against which the strip's response is measured.
8. Sample Size for the Training Set
This information is not provided. As this is a chemical indicator and not a machine learning or AI-driven device in the modern sense (which typically requires large training sets), the concept of a "training set" for an algorithm isn't directly applicable in the same way. The device's "training" would be through its chemical formulation and manufacturing tolerances, which are established through lab development and quality control, not typically a large data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of a "training set" for a traditional algorithm. The "ground truth" for the device's design and chemical formulation would have been established through:
- Understanding the specific chemical reactions of OPA.
- Titration or analytical chemistry methods to precisely determine OPA concentrations at and around the 0.3% MEC.
- Empirical testing during product development to refine the chemical composition of the test strip to achieve the desired sensitivity and specificity for the color change at the MEC threshold.
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SERIM Research Corporation 510(k) Premarket Notification
Serim® DISINTEK™ OPA Test Strip
SEP 2 5 2008
K082352
CONFIDENTIAL
P 1 of 2
510 (K) SUMMARY
| Prepared: | August 12, 2008 |
|---|---|
| Submitter: | Serim Research Corporation |
| Address | P.O. Box 4002Elkhart IN 46514 |
| Phone:Fax: | 574-264-3440574-266-6222 |
| Contact: | Patricia A. RupchockDirector of Regulatory Affairs |
| Device Trade Name: | Serim® DISINTEK™ OPA Test Strips |
| Common or Usual Name: | Indicator for ortho-phthalaldehyde (OPA) high leveldisinfectant |
| Device Classification Name: | Chemical Indicators for Liquid Chemical Germicide. (b)Class II (Physical/Chemical Sterilization ProcessIndicator). |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 21CFR 880.2800 |
| Substantial Equivalence: | The Serim DISINTEK OPA Test Strip is substantiallyequivalent to Metricide OPA Plus Solution Test Strip;K070419. |
| Device Description: | The device is a qualitative, single use, reagent test stripmade up of a 0.40 inch square test pad that has beenchemically treated to detect OPA in Metricide OPA PlusSolution. The pad is affixed to one end of a 3.25 inch by0.40 inch white opaque polystyrene strip. |
| Intended Use: | The Serim® DISINTEK™ OPA Test Strip is a chemicalindicator for use in determining whether the concentrationof ortho-phthalaldehyde, the active ingredient in MetricideOPA Plus Solution, is above or below the minimumeffective concentration (MEC) established for MetricideOPA Plus Solution. |
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SERIM Research Corporation 510(k) Premarket Notification Serim® DISINTEK™ OPA Test Strip
CONFIDENTIAL
p. 2/2
Technological Characteristics: The Serim DISINTEK OPA Test Strips contains two reacting chemicals, a stabilizer, and other non-reacting ingredients. The reaction process involved with the test strip is based on a two step reaction. The first step involves a reaction in which a chemical at a concentration equivalcnt to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color. The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color. The device will reliably indicate if the OPA concentration is above or below the MEC level of 0.3% OPA.
- Performance: The performance of the Serim DISINTEK OPA Test Strips was evaluated in split samples blind studies and compared to test results obtained with Metricide OPA Plus Solution Test Strips. The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Metricide OPA Plus Solution Test Strips.
- Conclusion: The Serim DISINTEK OPA Test Strips have the same intended use as the predicate device. Both test strips measure the potency of OPA in Metricide OPA Plus Solution, above or below the Minimum Effective Concentration of 0.3%. The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
SEP 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia A. Rupchock Director of Regulatory Affairs Serim Rescarch Corporation 3506 Reedy Drive P.O. Box 4002 Elkhart, Indiana 46514
Re: K082352
Trade/Device Name: Scrim® DISINTEK™ OPA Test Strips Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 12, 2008 Received: August 16, 2008
Dear Ms. Rupchock:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Rupchock
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Survcillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clas
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO82352 510(k) Number (if known):
Serim® DISINTEK™ OPA Test Strips Device Name:
Indications For Use: The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.
Prescription Use AND / OR Over-The-Counter Use ﮯ (Part 21 CFR 801 Subpart D) (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)
Division Sign-Off)
Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number. K082352
§ 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).