The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.

Device Description

The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square indicator pad that has been chemically treated to detect GTA. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Serim® D-CIDE GTA 1.5% Test Strip, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.	The performance of the Serim D-CIDE GTA 1.5% Test Strips was evaluated in split samples blind studies and compared to test results obtained with 3M Comply Cold Sterilog 1.5% GTA Test Strips. The performance of the Serim D-CIDE GTA 1.5% Test Strips is substantially equivalent to the predicate device, 3M Comply Cold Sterilog 1.5% GTA Test Strips, for determining if glutaraldehyde concentration is above or at/below the MEC of 1.5%. Specifically, when glutaraldehyde concentration is above 1.5% (MEC), enough base is produced to result in an irreversible and distinct purple color change on the indicator pad. When glutaraldehyde concentration is at or approaching the MEC level, the indicator pad will display distinct white areas.

Acceptance Criteria

Reported Device Performance

The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.

The performance of the Serim D-CIDE GTA 1.5% Test Strips was evaluated in split samples blind studies and compared to test results obtained with 3M Comply Cold Sterilog 1.5% GTA Test Strips. The performance of the Serim D-CIDE GTA 1.5% Test Strips is substantially equivalent to the predicate device, 3M Comply Cold Sterilog 1.5% GTA Test Strips, for determining if glutaraldehyde concentration is above or at/below the MEC of 1.5%. Specifically, when glutaraldehyde concentration is above 1.5% (MEC), enough base is produced to result in an irreversible and distinct purple color change on the indicator pad. When glutaraldehyde concentration is at or approaching the MEC level, the indicator pad will display distinct white areas.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in the provided document. The document mentions "split samples blind studies" but does not give a numeric count of samples.
Data Provenance: Not explicitly stated. There's no mention of country of origin or whether the data was retrospective or prospective.

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 of establishing ground truth relies on the chemical reaction and visual color change of the test strip, and comparison to a predicate device, rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set:

This information is not provided as the ground truth appears to be based on the chemical reaction and visual color change, not on subjective assessment that would require adjudication. The study involved "blind studies" and comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool. Its performance is based on a chemical reaction producing a visual color change, not on human interpretation that could be augmented by AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Yes, in essence, a standalone performance was done. The device itself, a chemical test strip, operates independently to produce a visual result based on the glutaraldehyde concentration. The "performance" described is the inherent function of the test strip (a chemical reaction) and its visual output, without a human "in the loop" for interpretation beyond simply observing the color change.

7. The Type of Ground Truth Used:

The ground truth is established by the chemical concentration of glutaraldehyde in the solutions being tested. The device is designed to visually indicate whether this concentration is above or at/below the MEC of 1.5%, based on a specific chemical reaction. The validation relies on comparing this visual indication against the known concentration of glutaraldehyde and against the performance of a predicate device.

8. The Sample Size for the Training Set:

This information is not provided in the document. The device is a chemical indicator, not a machine learning algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided. As mentioned, the device is a chemical indicator. Its development and validation likely involved chemical formulations and testing to ensure the desired color change reaction at specific glutaraldehyde concentrations, rather than a "training set" with established ground truth as understood in AI/machine learning contexts.

Summary

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CONFIDENTIAL

SERIM Research Corporation 510(k) Premarket Notification
Serim® D-CIDE GTA 1.5% Test Strip

K092346

510 (K) SUMMARY

JAN - 7 2010

Prepared:	January 4, 2010
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® D-CIDE GTA 1.5% Test Strips
Common or Usual Name:	Indicator for glutaraldehyde (GTA) high level disinfectant
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 D-CIDE GTA 1.5% Test Strip is substantiallyequivalent to 3M Comply Cold Sterilog 1.5% GTA TestStrips, 3M Health Care, P/N 3983MM; K915170.
Device Description:	The device is a qualitative, single use, reagent test stripmade up of a 0.20 inch square indicator pad that has beenchemically treated to detect GTA. The pad is affixed to oneend of a 3.25 inch by 0.20 inch white opaque polystyrenestrip.
Intended Use:	The Serim® D-CIDE GTA 1.5% Test Strip is achemical indicator for use in determining whether theconcentration of glutaraldehyde, the active ingredientin Rapicide HLD and Sterilant (MedivatorsReprocessing Systems), is above or at/below theminimum effective concentration (MEC) of 1.5%

・ :

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GTA established for this solution.

The Serim® D-CIDE GTA 1.5% 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 1.5% level (MEC), enough base is produced to result in an irreversible and distinct color change of the indicator pad. Testing of glutaraldehyde solutions well above the MEC level of 1.5% 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 distinct white areas.

Performance: The performance of the Serim D-CIDE GTA 1.5% Test Strips was evaluated in split samples blind studies and compared to test results obtained with 3M Comply Cold Sterilog 1.5% GTA Test Strips. The performance of the Serim D-CIDE GTA 1.5% Test Strips is substantially equivalent to the predicate device, 3M Comply Cold Sterilog 1.5% GTA Test Strips.

Conclusion: The proposed and predicate devices are all single use indicators used to monitor the glutaraldehyde concentration in specific solutions. The Serim D-CIDE GTA 1.5% Test Strip does not raise any new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation P.O.Box 4002 Elkhart, Indiana 46514

JAN - 7 2010

Re: K092346

Trade/Device Name: Serim®D-CIDE GTA 1.5% Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: December 8, 2009 Received: December 10, 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 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); 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,

Susan Quires

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K092346

Device Name: Serim® D-CIDE GTA 1.5% Test Strips

Indications For Use: The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or af/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.

Prescription Use AND / OR (Part 21 CFR 801 Subpart D)

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)

Elizabeth C. Clamin-Wills

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 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).