CIDEX* OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of active ingredient in CIDEX* OPA Solution is above or below the minimum effective concentration of 0.3% OPA. CIDEX* OPA Solution Test Strips cannot be used to validate the sterilization or disinfection process.

Device Description

The CIDEX® OPA Solution Test Strips consist of a 0.2-inch reagent-containing pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains a color-forming reagent. It also contains an inhibiting compound that prevents visible reaction when the OPA concentration is at or below the MEC. When the OPA level is in sufficient excess of the MEC, the surplus reacts with the color-forming reagent. The sample is placed in a 12 x 75-mm glass test tube. The indicator pad is immersed in the sample for 30 seconds, removed and allowed to react for an additional two and one-half minutes at which time it is compared to a color standard. If the color of the entire pad is equal to or darker than the color standard, the concentration of ortho-phthalaldehyde (OPA) in CIDEX® OPA Solution is above the minimum effective concentration (MEC). If any part of the pad is lighter than the color standard, the CIDEX® OPA Solution should not be used.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for CIDEX® OPA Solution Test Strips.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specificity (no false PASS results) at MEC (0.30% OPA)	1.00 (All 324 results were FAIL at 0.30% OPA, correctly indicating the solution is below the effective concentration)
Ability to detect OPA concentrations above MEC (0.40% OPA)	322 out of 324 results were PASS (99.38% sensitivity)
Ability to detect OPA concentrations above MEC (0.45% OPA)	324 out of 324 results were PASS (100% sensitivity)

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

Test Set Sample Size: A total of 324 results were obtained with each standard (0.30% OPA, 0.40% OPA, and 0.45% OPA). This implies the test set comprised multiple samples (standards) evaluated multiple times. The document states "324 results were obtained with each standard," suggesting 324 individual tests for each OPA concentration.
Data Provenance: The document does not explicitly state the country of origin. The study was conducted as "blind studies" using "CIDEX® OPA Solution standards." This suggests a controlled laboratory setting rather than data derived from real-world clinical use. The study is prospective as it involves controlled testing of the device.

3. Number of Experts and Qualifications

Number of Readers: Eight individuals.
Qualifications: "Three of the readers were inexperienced in laboratory techniques." The qualifications of the other five readers are not specified.

4. Adjudication Method

The document implies that each of the eight individuals independently read the test strips, and their individual results were collected. It does not describe an adjudication method like 2+1 or 3+1 (where multiple experts independently interpret and then a tie-breaker or consensus is used). The results are presented as aggregated counts (e.g., "324 results were FAIL").

5. MRMC Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a chemical indicator test strip, not an AI-powered diagnostic tool.

6. Standalone Performance

Yes, a standalone performance study was done. The study evaluated the performance of the CIDEX® OPA Solution Test Strips (the device itself) in detecting OPA concentrations in solution. There is no human-in-the-loop component beyond the visual interpretation of the color change on the strip, which is an inherent part of the device's function.

7. Type of Ground Truth Used

Known Concentration Standards: The ground truth was established using "CIDEX® OPA Solution standards" with known concentrations of OPA (0.30%, 0.40%, and 0.45%). This is an objective ground truth based on chemically prepared solutions.

8. Sample Size for the Training Set

The document describes performance testing for regulatory submission, not a machine learning model. Therefore, there is no explicit training set sample size as typically understood in AI/ML contexts. The description focuses solely on the validation/test phase of the device.

9. How Ground Truth for the Training Set was Established

As concluded in point 8, there is no explicit training set for this device in the context of AI/ML. The device's mechanism is based on chemical reactions, and its design and formulation would have been developed through R&D, likely using internal experiments and optimization, rather than a formal "training set" with established ground truth as in supervised learning.

Summary

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NOV 2 3 1999

K992341 page 1 of 2

Image /page/0/Picture/2 description: The image shows the logo for Serim Research Corp. The logo is black and white and features the word "Serim" in a large, bold font. Below the word "Serim" is the text "RESEARCH CORP" in a smaller font. The letters in "Serim" are connected, and there is a small "TM" symbol in the upper right corner of the logo.

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

510(k) SUMMARY

CIDEX® OPA Solution Test Strips

SUBMITTED BY

James E. Christner Serim Research Corporation P.O. Box 4002 23565 Reedy Dr. Elkhart, IN 46514

Phone:	(219) 264-3440
Fax:	(219) 266-6222
E-mail:	jchristner@serim.com
Contact Person:	James E. Christner
Date Prepared:	July 7, 1999

DEVICE NAME

Trade Name:	CIDEX® OPA Solution Test Strips
Common Name:	Test Strips for ortho-Phthalaldehyde (OPA) in CIDEX® OPASolution
Classification Name:	Chemical Sterilization Process Indicator

PREDICATE DEVICE

Cidex® Solution Test Strips (K915170)

DESCRIPTION OF THE CIDEX® OPA SOLUTION TEST STRIP

The sample is placed in a 12 x 75-mm glass test tube. The indicator pad is immersed in the sample for 30 seconds, removed and allowed to react for an additional two and one-half

1 ® Advanced Sterilization Products, a Johnson company, Division of Ethicon, Inc., Irvine, CA.

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K992341
Page 2 of 2

minutes at which time it is compared to a color standard. If the color of the entire pad is equal to or darker than the color standard, the concentration of ortho-phthalaldehyde (OPA) in CIDEX® OPA Solution is above the minimum effective concentration (MEC). If any part of the pad is lighter than the color standard, the CIDEX® OPA Solution should not be used.

INTENDED USE

CIDEX® OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of OPA in CIDEX® OPA Solution is above or below the MEC. CIDEX® OPA Solution Test Strips cannot be used to validate the disinfection process.

TECHNOLOGICAL COMPARISON TO THE PREDICATE DEVICE

CIDEX® OPA Solution Test Strips are used for determining OPA in CIDEX® OPA Solution whereas the CIDEX® Solution Test Strips are used for determining glutaraldehyde levels in CIDEX® Activated Dialdehyde Solution. Both tests have dry, reagent-containing paper indicator pads attached to plastic handles. Both pads contain an inhibitor that prevents reaction with an indicator at ineffective active ingredient concentrations.

The reaction pad of the CIDEX® OPA Solution Test Strips is observed three minutes after the strip is immersed in the solution while that of CIDEX® Solution Test Strips is read between five and eight minutes after immersion. For interpretation of the indicator pad of the CIDEX® OPA Solution Test Strip is compared with a standard color block. The CIDEX® Solution Test Strips use a visual standard for interpretation of the result.

STATEMENT OF SUBSTANTIAL EQUIVALENCE

Eight individuals used CIDEX® OPA Solution Test Strips from three trial production lots in blind studies to test CIDEX® OPA Solution standards. Three of the readers were inexperienced in laboratory techniques. A total of 324 results were obtained with each standard.

At the MEC (0.30% OPA), 324 results were FAIL giving a specificity (lack of false PASS results) of 1.00. At 0.40% and 0.45% OPA, 322 and 324 results, respectively, were PASS. These results show that the CIDEX® OPA Solution Test Strips effectively indicate when the OPA concentration in CIDEX® OPA Solution is at the MEC of 0.3%.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the feathers.

Public Health Service

NOV 2 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James E. Christner Vice President, Research & Development Serim Research Corporation P.O. Box 4002 23565 Reedy Drive Elkhart, Indiana 46514

Re : K992341 CIDEX® OPA Solution Test Strips Trade Name: Requlatory Class: II Product Code: JOJ October 22, 1999 Dated: Received: October 26, 1999

Dear Mr. Christner:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Christner

obligation you might have under sections 531 through 542 of obligation you might have aha Electronic Product Radiation the Act for devices ander one Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis leccer will arrow your can be and fication. The FDA described in your from premation of your device to a legally Finding of Subscancear equired in a classification for your marketed predicate device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpos Part 801 and additionally 809.10 for in regulacion (si c devices), please contact the Office of VILID draghobere at (301) 594-4692. Additionally, for questions on Compriance at (501) sectising of your device, please contact che promocion and adversional (301) 594-4639. Also, please note the Orice Of Comprising wo entitled, "Misbranding by reference to the regulation chercred, "Microlaria" (21 CFR 807.97) der Other general information on your responsibilities under the Act may be Information on your ropportion of Small Manufacturers Assistance obcation from choman (800) 638-2041 or (301) 443-6597 or at at its corr free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992341 510(k) Number (if known): __

Device Name: CIDEX* OPA Solution Test Strips

Indications For Use:

CIDEX* OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of active ingredient in CIDEX* OPA Solution is above or below the minimum CIDEX* OPA Solution Test effective concentration of 0.3% OPA. Strips cannot be used to validate the sterilization or disinfection process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ાવ

Over-The-Counter Use

(Optional Format 1-2-96)

sion Sign-Off

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devices 510(k) Number J

P.2

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).