(126 days)
The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
The device is a qualitative, single use, reagent test strip made up of a 0.40-inch square reagent pad that has been chemically treated to detect glutaraldehyde in CIDEXPLUS 28 Day solutions. The pad is affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the Serim® DISINTEK™ GTA 2.1%. Instead, it refers to performance in comparison to a predicate device. The core functionality is to indicate whether the glutaraldehyde concentration is above or below the Minimum Effective Concentration (MEC) of 2.1%. The description focuses on the qualitative visual response.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Reliable indication of glutaraldehyde concentration above MEC (2.1%) | When glutaraldehyde concentration is above 2.1% (MEC), enough base is produced to result in an irreversible and distinct purple color change on the indicator pad. Testing of freshly activated Cidex® Plus solutions always results in a solid purple color. |
| Reliable indication of glutaraldehyde concentration at or approaching MEC (2.1%) | When the glutaraldehyde concentration is at or approaching the MEC level, the base is neutralized by sodium bisulfite, and the indicator pad will display a distinctly blotched yellow and purplish appearance. |
| Reliable indication of glutaraldehyde concentration below MEC (approaching 1.5%) | As the glutaraldehyde concentration approaches 1.5%, the indicator pad will appear mostly yellow. The device will reliably indicate if the glutaraldehyde concentration is above or below the MEC level of 2.1%. |
| Substantial equivalence to predicate device | The performance of the Serim Disintek GTA 2.1% Test Strips was evaluated in split samples blind studies and compared to test results obtained with CIDEXPLUS Solution Test Strips. The performance is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "The performance of the Serim Disintek GTA 2.1% Test Strips was evaluated in split samples blind studies..."
- Sample Size: The exact sample size for the test set is not specified in the provided text.
- Data Provenance: The text does not specify the country of origin of the data. The study was a "blind study," which implies it was conducted to objectively assess the device's performance. It is a prospective study, as it's an evaluation of the device's performance under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the "split samples blind studies". The ground truth appears to be based on the actual glutaraldehyde concentration (e.g., above 2.1%, at/approaching 2.1%, approaching 1.5%) rather than expert interpretation of the test strips.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (like 2+1, 3+1, none) for the test set. Given the nature of the device (a chemical indicator with a visual color change), the "ground truth" seems to be determined by the objective chemical concentration rather than requiring expert adjudication of reader interpretations, although visual interpretation is involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
- Was an MRMC study done? No, not in the sense of comparing human readers' performance with and without AI assistance. This device is a manual chemical indicator, not an AI-assisted diagnostic tool for Human-in-the-Loop scenarios. The study compared the new device's performance against a predicate device.
- Effect Size: Not applicable as it's not an AI-assisted MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable to the device as presented. The device is a "qualitative, single use, reagent test strip" that relies on a visual interpretation by a human observer. There is no "algorithm only" performance because the device itself is a passive chemical indicator that requires human observation for its intended use. The performance evaluation would inherently include the human interpretation component, or at least a comparison against a known chemical concentration.
7. The Type of Ground Truth Used
The ground truth used for the study appears to be the actual glutaraldehyde concentration in the CIDEXPLUS 28 Day solutions. The device is designed to indicate whether this concentration is "above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution." This implies that the solutions used in the "split samples blind studies" had known glutaraldehyde concentrations.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. Therefore, a sample size for a training set is not applicable. The device relies on chemical reactions, not on data-driven models that require training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this chemical indicator device, this question is not applicable.
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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
۰۰ ۰۰۰ ۰
CONFIDENTIAL
510 (K) SUMMARY
MAR 1 6 2009
| Prepared: | November 6, 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™ GTA 2.1% |
| Common or Usual Name: | Indicator for CIDEXPLUS glutaraldehyde disinfectantsolutions. |
| Device Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 21CFR 880.2800 |
| Substantial Equivalence: | The Serim® DISINTEK™ GTA 2.1% is substantiallyequivalent to CIDEXPLUS Solution test strips ; K981054 |
| Device Description: | The device is a qualitative, single use, reagent test stripmade up of a 0.40-inch square reagent pad that has beenchemically treated to detect glutaraldehyde inCIDEXPLUS 28 Day solutions. The pad is affixed to oneend of a 3.25 inch by 0.40-inch white opaque polystyrenestrip. |
| Intended Use: | The Serim® Disintek GTA 2.1% Test Strip is a chemicalindicator for use in determining whether the concentrationof glutaraldehyde the active ingredient in CIDEXPLUS28 Day Solution, is above or below the minimumeffective concentration (MEC) established forCIDEXPLUS 28 Day Solution |
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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
The Serim® Disintek GTA 2.1% Test Strips contain three Technological Characteristics: reacting chemicals, and a background dye. The visual response given by the indicator pad of the test strip is based on the following chemical reactions. Glutaraldehyde reacts with sodium sulfite to form a colorless addition product and a base. The base then reacts with a pH indicator producing a purple color. The indicator pad also contains sodium bisulfite, which reacts with both glutaraldehyde and with the base. When glutaraldehyde concentration is above the 2.1% level (MEC), enough base is produced to result in an irreversible and distinct color change of the indicator pad. Testing of freshly activated Cidex® Plus solutions always results in a solid purple color on the indicator pad. When the glutaraldehyde concentration is at or approaching the MEC level, the base is neutralized by the sodium bisulfite and the indicator pad will display a distinctly blotched yellow and purple appearance. The test pad size of 0.4" x 0.4" and a color block showing a representative color change for the MEC level allows for easy interpretation of the change in color. As the glutaraldehyde concentration approaches 1.5%, the indicator pad will appear mostly yellow. The device will reliably indicate if the glutaraldehyde concentration is above or below the MEC level of 2.1% in CIDEXPLUS 28 Day solutions. The performance of the Serim Disintek GTA 2.1% Test Performance: Strips was evaluated in split samples blind studies and compared to test results obtained with CIDEXPLUS Solution Test Strips. The performance of the Serim Disintek GTA 2.1% Test Strips is substantially equivalent to the predicate device, CIDEXPLUS Solution Test Strips. Conclusion: The Serim Disintek GTA 2.1% Test Strips have the same intended use as the predicate device. Both test strips measure the potency of GTA in CIDEXPLUS 28 Day Solution, above or below the Minimum Effective Concentration of 2.1%. The Serim Disintek GTA 2.1% 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 seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized eagle with three overlapping wings, representing health, services, and people. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
MAR 1 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Drive Elkhart, Indiana 46514
Re: K083295
Trade/Device Name: Scrim® DISINTEK™ GTA 2.1% Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 23, 2009 Received: February 26, 2009
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 Surveillance 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 vours.
Sutte y. Michael Davis.
Ginette Y. Michaud, M.D. Acting 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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SERIM Research Corporation 510(k) Premarket Notification Serim DISINTEK GTA 2.1%
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Serim® DISINTEK™ GTA 2.1%
Indications For Use: The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
K
Prescription Use Over-The-Counter Use AND / OR (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)
Shala A Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083245
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§ 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).