The Verify® SYSTEM IE Chemical Indicator is a single-use chemical indicator consisting of a polymeric strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevents the indicator ink from leaching from the substrate. The indicator was developed to monitor the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in a SYSTEM IE Liquid Chemical Sterilant Processing System during a processing cycle.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them:

Device: Verify® SYSTEM 1E Chemical Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's function and provides a summary of performance testing with "PASS" results for each. While explicit numerical acceptance criteria are not always stated, the intent is clear from the description of each test.

Test Category	Acceptance Criteria (Implied/Explicit)	Reported Device Performance
Comparative Sensitivity and Specificity	The device can correctly differentiate between "PASS" and "FAIL" conditions for Peracetic Acid (PAA) concentrations in the SYSTEM 1E Liquid Chemical Sterilant Processing System. (Implied: High accuracy in detecting PAA above/below the threshold).	PASS
Color Read Time	The observed color of the indicator must be stable for at least 30 minutes following completion of the processor cycle to allow for evaluation.	PASS
Analytic Specificity	Under normal storage and use conditions as per labeling, any observed color change must exclusively be due to the presence of PAA in the processor use dilution (i.e., no false positives from other factors).	PASS
Blind Reader	Blind readers must correctly evaluate a high percentage (ideally all) of processed indicators.	PASS
Simulated Use Testing	The addition of a medical device to the processing chamber should not negatively affect the performance of the chemical indicator.	PASS
UV Study	The shipping and storage bottle must adequately protect unprocessed indicator strips from the degrading effects of UV light.	PASS
Shelf Life	The indicator must maintain its appropriate characteristics after 15 months of storage.	PASS
Effects of Aggressive Chemicals	The shipping and storage bottle must protect unprocessed indicator strips from aggressive chemicals.	PASS
Effects of Contaminants	The presence of potential contaminants (from inadequate cleaning/rinsing of medical devices) should not affect the expected color change of processed indicators.	PASS
Open Bottle Stability	The indicator must demonstrate appropriate FAIL results (presumably when PAA concentration is below the threshold) after 13 months of the bottle being opened. (This criterion is less clearly defined in its "PASS" statement, but implies maintaining functionality for a certain period post-opening).	PASS

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

Sample Size for Blind Reader Test: 179 randomly displayed processed Verify SYSTEM 1E Chemical Indicators.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a submission to the FDA in the USA, implying studies were conducted to support this submission, likely by STERIS Corporation. The nature of the tests (e.g., "Simulated Use Testing," "Open Bottle Stability") suggests prospective experimental studies.

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

The document refers to "Blind Readers" in the "Blind Reader" test, who "correctly evaluated 179 of 179 randomly displayed processed Verify SYSTEM 1E Chemical Indicators."
Number of Experts: The number of "Blind Readers" is not specified. It is simply pluralized.
Qualifications of Experts: The qualifications of these "Blind Readers" are not provided. They are implied to be personnel trained in interpreting the chemical indicator's color change.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1. For the "Blind Reader" test, it states that "Blind Readers correctly evaluated 179 of 179," suggesting a clear Pass/Fail determination based on the indicator's state, rather than a reconciliation process among multiple independent observers for ground truth determination. The "ground truth" for the indicators themselves (i.e., whether they should be a "PASS" or "FAIL" condition) was likely established by the controlled PAA concentrations they were exposed to, which is not an adjudication process but a direct experimental setup.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is described in the provided text. The "Blind Reader" test assesses the ability of readers to interpret the indicator, but it does not compare human readers with and without AI assistance. The device is the indicator, not an AI system assisting human interpretation of something else.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Since this device is a chemical indicator that relies on visual color change for interpretation, it is inherently a "human-in-the-loop" device in its intended use. There is no "algorithm only" component that would operate without human interpretation. Therefore, a standalone algorithm-only performance study would not be applicable or described for this type of product. The "Blind Reader" test explicitly assesses the human interpretation aspect.

7. Type of Ground Truth Used:

The ground truth for the performance tests, particularly for "Comparative Sensitivity and Specificity," "Analytic Specificity," and the color change behavior, appears to be based on controlled experimental conditions with known concentrations of peracetic acid (PAA) at or above the threshold of >1820 ppm.
- For example, if an indicator was exposed to >1820 ppm PAA, the ground truth for that specific indicator would be "PASS" (should change to pink). If exposed to <1820 ppm, the ground truth would be "FAIL" (should remain blue or not change fully).
For the "Blind Reader" test, the "correct evaluation" of the 179 indicators implies that the ground truth for each of those indicators (whether it should show a pass or fail color) was independently established by their exposure during processing.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" sample size. Chemical indicators are typically developed through empirical laboratory testing, formulation adjustments, and validation, rather than machine learning training sets in the computational sense. The "performance testing" described covers the validation of the final product.

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

As there is no explicitly mentioned "training set" in the context of machine learning, the establishment of its ground truth is not applicable. The development of the indicator itself would involve extensive R&D and quality control testing, where the "ground truth" for chemical reactivity and color change would be linked to measured PAA concentrations under various controlled conditions.

Summary

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K102217 p.104 STERIS®

NOV 2 2 2010

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510(k) Summary For Verify® SYSTEM 1E Chemical Indicator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Robert F. Sullivan Senior Director, FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198

Submission Date:

November 17, 2010

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

November 17, 2010

Appendix B: Page 2 of 5

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K102217

K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator

1. Device Name

Trade Name:	Verify® SYSTEM IE Chemical Indicator
Models:	N/A
Common Name:	Chemical Indicator
Classification Name:	Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ)

2. Predicate Devices

Verify Chemical Monitoring Strip for Resert Solutions (K081600) cleared as Resert XL Test Strip

Reliance CI Process Indicator (K063285)

3. Device Description

Intended Use: 4.

The unprocessed Verify® SYSTEM 1E Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.

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K102217

K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator

p 3.

· 5. Description of Safety and Substantial Equivalence

The proposed device and the Reliance CI Process Indicator predicate device both consist of a printed indicator spot on an inert polymeric substrate. The Resert XL Test Strip predicate device consists of a paper pad impregnated with indicator ink attached to an inert polymeric substrate. The active ingredients of the inks used for the proposed and predicate devices are dyes/salts that change color upon oxidation by the active (peracetic acid or hydrogen peroxide).

The proposed device, like the predicates, indicates exposure to a targeted effective concentration or dose of active by a color change to the designated end point. The proposed device changes from blue to pink when exposed to concentrations of peracetic acid greater than 1820 ppm; the predicate devices also each indicate exposure to the effective concentration or dose of the active germicide by a color change as described in their respective labeling.

Therefore, the differences between the proposed and predicate oxidative chemistry concentration monitors are limited to differences in the indicator ink composition, in the active being detected and device materials (for one predicate device) and/or the concentration range being monitored. These differences in technological characteristics do not raise any new issues of safety and effectiveness.

6. Performance Testing

Performance testing was conducted to determine that the Verify® SYSTEM 1E Chemical Indicator is an effective monitor for the peracetic acid concentration of the use dilution of the SYSTEM 1E Liquid Chemical Sterilant Processing Cycle.

The following table summarizes the non-clinical testing performed to demonstrate that the Verify® SYSTEM 1E Chemical Indicator is safe and effective. The performance testing has demonstrated that the Verify SYSTEM 1E Chemical Indicator is substantially equivalent to its predicates and raises no new questions of safety or effectiveness.

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K102217
$P^{4}fy$

K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator

Testing	Results
ComparativeSensitivity andSpecificity	PASSThe Verify SYSTEM 1E Chemical Indicator can correctly identify PASSor FAIL conditions for PAA concentrations in the SYSTEM 1E LiquidChemical Sterilant Processing System.
Color Read Time	PASSThe observed color of Verify SYSTEM 1E Chemical Indicators has beenshown to be stable for 30 minutes following completion of the processorcycle. However, it is recommended that the PASS/FAIL evaluation bemade immediately after the CI strip is removed from the processor.
Analytic Specificity	PASSUnder conditions of normal storage and use, as indicated in the labeling,any color change observed in a processed Verify SYSTEM 1E ChemicalIndicator will be the result of the presence of PAA in the processor usedilution.
Blind Reader	PASSBlind Readers correctly evaluated 179 of 179 randomly displayedprocessed Verify SYSTEM 1E Chemical Indicators.
Simulated UseTesting	PASSThe addition of a medical device to the processing chamber does not affectthe performance of the Verify SYSTEM 1E Chemical Indicator.
UV Study	PASSThe bottle used to ship and store the Verify SYSTEM 1E ChemicalIndicators protects the unprocessed strips from the effects of UV light.
Shelf Life	PASSThe Verify SYSTEM 1E Chemical Indicator maintains appropriateindicator characteristics after 15 months of storage.
Effects ofAggressiveChemicals	PASSThe bottle used to ship and store the Verify SYSTEM 1E ChemicalIndicator protects the unprocessed strips from the effects of aggressivechemicals.
Effects ofContaminants	PASSThe presence of possible contaminants from inadequate cleaning or rinsingof the medical devices does not affect the expected color change ofprocessed Verify SYSTEM 1E Chemical Indicators.
Open Bottle Stability	PASSAt the 13 month time point, The Verify SYSTEM 1E Chemical Indicatorsdemonstrated the appropriate FAIL results.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Mr. Robert F. Sullivan Senior Director STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

NOV 2 2 2010

Re: K102217

Trade/Device Name: Verify® SYSTEM 1E Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JQJ Dated: November 17, 2010 Received: November 18, 2010

Dear Mr. Sullivan:

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 reguire 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Mr.Sullivan

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/Offices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.M., 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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K↓02217

NOV 2 2 2010

Indications for Use

510(k) Number (if known):

Device Name:

Verify SYSTEM 1E Chemical Indicator

Indications For Use:

The Verify® SYSTEM IE Chemical Indicator (SYSTEM 1E Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEMIE Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate. The unprocessed Verify® SYSTEM 1E Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.

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

Over-The-Counter Use X (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)

L. Shullk

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

Page 1 of 1

510(k) Number: 4102217

Page 4-1

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).