SPOROX® Test Strips provide a rapid, convenient, semi-quantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX™ Sterilizing and Disinfecting Solution. The SPOROX® Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.

Device Description

The SPOROX™ Test Strips consist of a 0.2 x 0.2 inch reagentcontaining pad attached to one end of a 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed in the sample. The strip is rotated to a vertical position for five seconds with the pad up to allow excess sample to drain by gravity and then is covered with a chamber to prevent sample evaporation. The reagent pad is observed 15 minutes after immersion. If the pad is completely brown/black, the SPOROX™ Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0% (the minimum effective concentration or MEC). If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad. The reagent pad contains iodide and starch plus a reducing compound that prevents visible reaction when the hydrogen peroxide concentration is at or below the MEC. When the peroxide level is in sufficient excess of the MEC, the surplus oxidizes the iodide to iodine which in turn forms a dark-colored complex with the starch.

AI/ML Overview

Here's an analysis of the provided text regarding the SPOROX® Test Strips, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Specificity: No false PASS results at hydrogen peroxide concentrations at or below the Minimum Effective Concentration (MEC) of 6.0%. (Implied: 100% specificity at 6.05% H2O2 as a critical threshold implying below 6.0% should also be 100% specific)	At 6.05% hydrogen peroxide, 0 out of 168 results were PASS, giving a test specificity (lack of false PASS results) of 1.00 (100%). This confirms that at concentrations just above the MEC threshold, the device correctly indicates a failure to pass (i.e. not effective concentration), which fulfills the requirement of not giving false PASS results when the concentration is at or below 6.0%.
Sensitivity/Accuracy for Effective Concentrations: Ability to indicate "PASS" when hydrogen peroxide concentration is effectively above the MEC (e.g., 6.58% and 7.00%).	At 6.58% hydrogen peroxide, 41 out of 84 results were PASS (48.8%). At 7.00% hydrogen peroxide, 165 out of 168 results were PASS (98.2%).
Mechanism of Indication: Distinct white area forms in the center of the pad when hydrogen peroxide concentration is 6.0% or less.	"If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad." The study implicitly validates this by demonstrating 0 PASS results at 6.05%, suggesting correct visual indication of "FAIL" (white area).
Mechanism of Indication: Pad is completely brown/black when hydrogen peroxide concentration is greater than 6.0%.	"If the pad is completely brown/black, the SPOROX™ Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0%." The study implicitly validates this by the high rate of "PASS" (brown/black) results at 7.00%.

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

Test Set Sample Size:
- For 6.05% hydrogen peroxide: 168 results
- For 6.58% hydrogen peroxide: 84 results
- For 7.00% hydrogen peroxide: 168 results
- Total individual tests/readings: 168 + 84 + 168 = 420 results.
- The study used SPOROX™ Test Strips from three trial production lots.
Data Provenance: The document does not explicitly state the country of origin. It describes a "blind study" involving "seven participants" testing "SPOROX™ standards assayed by a titrimetric procedure." This suggests a controlled laboratory setting, likely in the US where Serim Research Corporation is based. The study is prospective in the sense that the experiment was designed and executed to test the performance of the strips under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Ground Truth Establishment: The ground truth was established by "SPOROX™ standards assayed by a titrimetric procedure." This is an objective chemical assay/measurement.
Number of Experts: Zero experts were used to establish the ground truth for the test set, as it was based on a direct chemical measurement (titrimetric procedure) rather than expert opinion.
Qualifications of Experts: Not applicable, as expert consensus was not the ground truth method.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple human readers. Instead, the study involved "seven participants in blind studies" using the test strips and reporting their results against the known concentrations (ground truth) established by the titrimetric procedure. It implies individual participants' readings were compared directly to the titrimetric ground truth. There is no mention of a process to adjudicate disagreements among the seven participants if they read the same strip differently (though this is less likely for a clear pass/fail strip).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, a formal MRMC comparative effectiveness study as typically understood in medical imaging (comparing AI-assisted human readers to non-AI-assisted human readers) was not performed.
Effect Size: Not applicable, as no MRMC study was conducted. The study evaluated the performance of the device itself, not the impact of AI assistance on human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, in a way. The device (SPOROX® Test Strip) is the "algorithm" in this context. Its "performance" is its ability to chemically react and display a visual result (brown/black or white spot) based on the hydrogen peroxide concentration. The "seven participants" are effectively the "readers" of this visual output. The study measures the accuracy of this device's visual output against a known chemical standard. While humans interpret the final visual output, the core performance being evaluated is the chemical reaction and visual change of the strip itself, independent of complex human interpretation or AI.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used was "SPOROX™ standards assayed by a titrimetric procedure." This represents an objective chemical measurement or reference standard.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not explicitly mention a separate "training set" or a sample size for one. The study described appears to be a verification/validation study used to demonstrate the device's performance, not a study involving iterative training of an algorithm.

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

Ground Truth for Training Set: Not applicable, as no separate training set or associated ground truth establishment process is described. The device operates based on a fundamental chemical reaction, not a machine learning algorithm requiring a separate training phase with labeled data in the context of this submission.

Summary

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Image /page/0/Picture/1 description: The image shows a logo for "Serim RESEARCH CORP". The word "Serim" is in a large, bold, sans-serif font, with the "i" replaced by a stylized image that resembles a flame or a drop. Above the right side of "Serim" is the trademark symbol "TM". Below "Serim" in a smaller, sans-serif font is the text "RESEARCH CORP".

P.O. Box 4002, Elkhart, IN 46514-0002 • (219) 264-3440 • FAX (219) 266-6222

AUG 2 9 1997

510(k) SUMMARY

SPOROX® Test Strips

SUBMITTED BY:

James E. Christner Serim Research Corporation P.O. Box 4002 Elkhart, IN 46514

(219) 264-3440 Phone : (219) 266-6222 Fax :

James E. Christner Contact Person:

May 29, 1997 Date Prepared:

James E. Christner
May 29, 1997

DEVICE NAME:

SPOROX™ Test Strips Trade Name: Test Strips for Hydrogen Peroxide in SPOROX™ Common Name: Sterilizing and Disinfecting Solution Classification Chemical Sterilization Process Indicator Name :

LEGALLY MARKETED EQUIVALENT DEVICE

This product is similar in design, composition, and function to the Peracetic Acid Reagent Strips manufactured by Serim Research Corporation which was the subject of Premarket Notification The product is similar in utility to a titrimetric #K910320A. Supportive data for substantial equivalence to the assay. latter was obtained.

DESCRIPTION OF THE SPOROX™ TEST STRIP:

The SPOROX™ Test Strips consist of a 0.2 x 0.2 inch reagentcontaining pad attached to one end of a 0.2 x 3.25 inch The reagent pad is immersed in the sample polystyrene handle. The strip is rotated to a vertical position for five seconds. with the pad up to allow excess sample to drain by gravity and then is covered with a chamber to prevent sample evaporation. The reagent pad is observed 15 minutes after immersion. If the pad is completely brown/black, the SPOROX™ Sterilizing and

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K972035

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Disinfecting Solution contains hydrogen peroxide at concentrations greater than 6.0% (the minimum effective concentration or MEC). If the SPOROX® Sterilizing and Disinfecting Solution contains hydrogen peroxide at concentrations of 6.0% or less, a distinct white area forms in the center of the pad.

The reagent pad contains iodide and starch plus a reducing compound that prevents visible reaction when the hydrogen peroxide concentration is at or below the MEC. When the peroxide level is in sufficient excess of the MEC, the surplus oxidizes the iodide to iodine which in turn forms a dark-colored complex with the starch.

INTENDED USE:

SPOROX® Test Strips provide a rapid, convenient, semiquantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX™ Sterilizing and Disinfecting Solution. The SPOROX® Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:

SPOROX® Test Strips are used for determining hydrogen peroxide levels in SPOROX® Disinfecting and Sterilizing Solution whereas the Serim Peracetic Acid Reagent Strips are used for determining peracetic acid levels in disinfectants employed in hemodialyzer Both tests consist of dry reagent-containing reprocessing. paper pads attached to plastic handles. Both contain a reducing compound which prevents visible reaction at ineffective concentrations of active ingredient and a starch/iodide Both give PASS/FAIL results. Completely colored indicator. reagent pads indicate effective levels of germicide. When the disinfectant solutions are at or below their MEC values, white areas are visible on the reagent pads.

STATEMENT OF SUBSTANTIAL EQUIVALENCE:

SPOROX™ Test Strips from three trial production lots were used by seven participants in blind studies to test SPOROX™ standards assayed by a titrimetric procedure. At 6.05% hydrogen peroxide, 0 out of 168 results were PASS, giving a test specificity (lack of false PASS results) of 1.00. At hydrogen peroxide concentrations of 6.58% and 7.00% respectively, 41 out of 84 and 165 out of 168 results were PASS. These results show that the SPOROX® Test Strips effectively indicate when the hydrogen peroxide concentration in SPOROX™ Disinfecting and Sterilizing Solution is at or below its MEC of 6.0%.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert C. Boguslaski, Ph.D. President Serim Research Corporation P.O. Box 4002 46514-0002 Elkhart, Indiana

AUG 29 1997

K972035 Re : Sporox Test Strips Trade Name: Regulatory Class: II Product Code: JOJ Dated: May 29, 1997 Received: June 2, 1997

Dear Dr. Boguslaski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Dr. Boguslaski

this response to your premarket notification submission does chis response or light have under sections 531 not arrect any obligation for devices under the Electronic Chrough J42 Or the net rol sovisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 marketed predicate with your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth y A. ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_

SPOROX™ Test Strips Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(Per 21 CFR 801.109)

SPOROX® Test Strips provide a rapid, convenient semi-quantitative means of indicating whether effective concentrations of hydrogen means of Indicating whocher ore Sterilizing and Disinfecting e present in bst Strips indicate concentrations of Solution. Sofulion. The Brokon 1155 Confirm disinfection or sterilization.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ర్

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number	K972035
Prescription Use	OR
	Over-The-Counter Use X

(Optional Format 1-2-96)

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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).