The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.

Device Description

The Reliance CI is a single-use chemical indicator with indicator ink printed on one end that was developed to monitor the peracetic acid (PAA) dose at the point of use in a Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.

AI/ML Overview

The document provides a 510(k) summary for the Reliance™ CI Process Indicator, a chemical indicator for monitoring peracetic acid dose in endoscope processing systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance (Reliance™ CI)
Color Change (Pass)	Colorless (white) at ≥11,500 mg/L PAA min.	Changes from orange to white (colorless) at ≥11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.
Color Change (Fail)	Incomplete color change (any shade of orange or other than reference pass color) at ≤ 9,000 mg/L PAA min.	Shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.
Unprocessed State	Orange	Orange

2. Sample size used for the test set and the data provenance

The document indicates that "Performance testing was conducted to demonstrate that the Reliance CI is an effective monitor for the circulating peracetic acid dose." However, it does not specify the sample size used for this performance testing.

Regarding data provenance, the testing was conducted in the context of the device's development by Albert Browne Ltd., a subsidiary of STERIS Corporation, which is based in the United Kingdom. The exact location of the testing facility is not explicitly stated, but it would presumably be within the company's research and development arm. The testing described is inherent to the development and validation of the device, making it prospective in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" for chemical indicators like this is typically established by controlled laboratory conditions where the concentration of the active chemical (peracetic acid in this case) is precisely known and measured by analytical methods, rather than by human expert consensus or pathology. The assessment of color change is likely objective based on defined reference colors.

4. Adjudication method for the test set

This information is not provided. Given that the "ground truth" for a chemical indicator's color change is typically based on objective chemical concentrations and predefined color references, a formal adjudication method by experts (like 2+1, 3+1) is usually not applicable in the same way it would be for image-based diagnostic devices. The assessment is likely based on comparing the indicator's color to a standard color chart or reference after exposure to known concentrations.

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

Not applicable. This device is a chemical indicator, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Not applicable. This device is a physical chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction and visible color change, which is then interpreted by a human user (by observing the color). There is no "algorithm only" performance separate from its physical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the Reliance™ CI Process Indicator is based on precisely measured and controlled concentrations of peracetic acid (PAA) dose (specifically, 9,000 mg/L PAA min. and 11,500 mg/L PAA min.) within the specified Reliance™ EPS Endoscope Processing System. The efficacy of the indicator is determined by its ability to accurately reflect these known chemical concentrations through its defined color change.

8. The sample size for the training set

Not applicable. This document describes a chemical indicator, not a machine learning or AI-based device that requires a training set. The performance is based on chemical and physical properties, not trained algorithms.

9. How the ground truth for the training set was established

Not applicable. As stated above, this is not an AI/machine learning device, so there is no "training set" or establishment of ground truth for such a set.

Summary

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K063285

JAN 1 2 2007

APPENDIX F

510(k) Summary for Reliance™ CI Process Indicator

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510(k) Summary for Reliance™ CI Process Indicator

1. SUBMITTER NAME AND ADDRESS

Richard Bancroft Albert Browne Ltd., a Subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Contact:	Richard Bancroft
Telephone number:	44 116 276 8636

2. DEVICE NAME

Proprietary Name:	Reliance™ CI Process Indicator
Common/Usual Name:	Chemical indicator
Classification Name:	Physical/chemical sterilization process indicator

3. PREDICATE DEVICE

Reliance™ PI Process Indicator (K043482) .

4. INTENDED USE

5. DEVICE DESCRIPTION

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DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.

TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics of the proposed Reliance CI described in this submission are similar to the predicate Reliance™ PI Process Indicator. Both the Reliance CI and the Reliance™ PI Process Indicator are non-sterile, disposable polymeric strips with indicator ink that changes color in a Reliance™ EPS Endoscope Processing System cycle employing Reliance™ DG Dry Germicide. A table that compares the technological characteristics of the proposed and predicate devices is provided on the following page.

PERFORMANCE TESTING 7.

Performance testing was conducted to demonstrate that the Reliance CI is an effective monitor for the circulating peracetic acid dose of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide.

Characteristics	Reliance™ CI Process Indicator(proposed)	Reliance™ PI Process Indicator(STERIS Corporation, K043482)
Material – Indicator	printed indicator ink overlaid with aclear, permeable laminate	Cellulose paper pad impregnatedwith reagents
Material – Indicator Substrate	polypropylene	polystyrene
Disposable	yes	yes
Active Component Monitored	peracetic acid dose	peracetic acid dose
Color Change	orange to white	purple to pale grey or lighter
Response to Peracetic Acid Dose
Colorless1	≥11,500 mg/L PAA min.	≥11,500 mg/L PAA min.
Incomplete color change2	≤ 9000 mg/L PAA min	≤ 9000 mg/L PAA min.
Orange	Unprocessed	Unprocessed

Comparison of Technological Characteristics

The endpoint color is actually the absence of color, which appears white (the color of the strip on which the indicator ink is printed)

2 Any shade of orange or any color other than the reference pass color

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Service Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

JAN 1 2 2007

Re: K063285

Trade/Device Name: Reliance™ CI Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: December 22, 2006 Received: December 26, 2006

Dear Dr. Nolte:

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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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Chiv Lin, Ph.D.

Chiu Lin. Ph.D. 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): KOG 32-85

Device Name: Reliance™ CI Process Indicator

Indications For Use:

The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Cremiciden The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula M. Murphy, M.D.

richar, Caneral H a. Donial Davi

Page 1 of_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).