The Reliance PI Process Indicator is a single use chemical indicator designed to change from the "START" dark pink color to the "ENDPOINT" orange color or lighter upon exposure to an effective dose of peracetic acid generated from Reliance™ DG Dry Germicide during the Reliance Endoscope Processing Cycle.

The Reliance PI Process Indicator is intended to be used exclusively for the independent monitoring of the Reliance Endoscope Processing Cycle. The Reliance PI Process Indicator is not an indicator of load disinfection or cleaning efficacy.

Device Description

The Reliance PI Process Indicator is a single use chemical indicator strip that is designed to confirm an effective dose of peracetic acid (PAA), the active ingredient generated from Reliance DG Dry Germicide in the Reliance Endoscope Processor's HLD cycle.

This test strip consists of a 0.2-square inch reagent-containing indicator pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains an indicator dye with a background dye that together form a dark pink color.

Upon exposure to the effective dose of PAA generated during the Reliance Endoscope Processing Cycle, the indicator dye only is oxidized by the Reliance DG Dry Germicide use dilution during the Reliance Endoscope Processing Cycle. During the processing cycle, the indicator pad color transitions through a lighter pink color until an orange coloration, based on the background dye, is visible.

AI/ML Overview

The Reliance™ PI Process Indicator is a chemical indicator designed to confirm an effective dose of peracetic acid (PAA) in the Reliance Endoscope Processor's High-Level Disinfection (HLD) cycle.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Endpoint Specifications)	Reported Device Performance
Complete Color Change (Pass): When exposed to PAA at a dose ≥ 11,500 mg/L PAA min generated from Reliance DG Dry Germicide during the Reliance Endoscope Processing Cycle, there will be a complete change to endpoint color (orange) or lighter in 100% of the indicator strips.	Sensitivity Studies: The Reliance PI Process Indicator develops the complete ENDPOINT color (pass) when the dose of PAA is ≥ 11,500 mg/L PAA min. Simulated-Use Study (27 cycles): Demonstrated "complete" PI readings in all 27 cycles, indicating detection of intended PAA levels.
Incomplete Color Change (Fail): When exposed to the minimum recommended dose of 9000 mg/L PAA min or less, there will be an incomplete color change in 100% of the indicator strips.	Sensitivity Studies: Fails to reach the complete ENDPOINT color (incomplete endpoint reading, not acceptable) when the PAA dose is < 9000 mg/L PAA min. Simulated-Use Study (9 cycles): Demonstrated an "incomplete" PI reading in each of the 9 cycles when processed with a PAA dose of 9000 mg/L PAA min (minimum recommended dose).
Specificity: Components of the Dry Germicide's container cannot independently cause a color change to ENDPOINT.	Specificity Testing: Confirmed that the two components of the Dry Germicide's container cannot independently cause a color change to ENDPOINT.
Repeatability and Precision: Demonstrated over numerous repeated assays using varying parameters of use.	Repeatability and Precision: Confirmed over numerous repeated assays using varying parameters of use.
Stability of PI Color: Confirmed when reading delays occur in the closed processor or after the PI is removed from the processor.	Stability of PI Color: Confirmed when reading delays occur in the closed processor or after the PI is removed from the processor.
Stability of Strips (Unopened): 2 years of storage under labeled storage conditions.	Stability of Strips in unopened bottles: Established through 24 months of storage under labeled storage conditions.
Shelf-life (Opened): 6 months after opening.	Use-life of the opened bottle: Validated through 6 months after opening.
Performance in Reliance Processing Cycle: Performance validated with and without worst-case washing phases, with maximum air purge time, and with conditions of delayed PI reading.	Performance in Reliance Processing Cycle: Validated under these varying conditions.

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

Sensitivity Studies: The exact sample size for the "Sensitivity Studies" is not explicitly stated as a number of strips but implies multiple tests to determine the PAA dose thresholds for pass/fail.
Simulated-Use Studies:
- One study involved 27 cycles using eight flexible endoscopes to detect intended PAA levels.
- Another study involved 9 cycles using three worst-case flexible endoscopes to test the minimum recommended PAA dose (9000 mg/L PAA min).
Data Provenance: Not explicitly stated, but the submission is from STERIS Corporation in Mentor, Ohio, USA, suggesting the studies were conducted within the US or under their oversight. The studies appear to be prospective as they were specifically designed and executed for device validation.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for interpreting the process indicator's color change or the PAA concentration measurements. However, it does mention "correctly interpreted by the clinical users" in an in-use study, implying clinical personnel were involved in observing the indicator results in a real-world setting, but their expert role in establishing the ground truth for validation is unclear.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1, none) for the test set. The evaluation of the indicator's color change (pass/fail) seems to be based on predefined objective criteria related to specific PAA concentrations, rather than subjective expert consensus requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of comparing human readers' performance with and without AI assistance, as this device (a chemical indicator) does not involve AI or human interpretation in the same way an imaging diagnostic device would. It's a binary "pass/fail" chemical reaction.

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

This is not applicable as the device is a physical chemical indicator, not an algorithm. Its performance is inherent to its chemical reaction to PAA, and while human observation is required to read the indicator, the "performance" described refers to the indicator's objective chemical response.

7. Type of Ground Truth Used

The ground truth used for the device's performance relies on objective chemical measurements of peracetic acid (PAA) concentrations.

"Kinetic Studies validated the Reliance Endoscope Processor's delivery of peracetic acid in concentrations appropriate for PI performance testing."
"The complete ENDPOINT color (pass) when the dose of PAA is >= 11,500 mg/L PAA min."
"Fails to reach that color (incomplete endpoint reading, not acceptable) when the PAA dose is < 9000 mg/L PAA min."
This indicates that the ground truth for "effective dose" and "minimum recommended dose" was established by precise measurements of PAA concentration (mg/L PAA min).

8. Sample Size for the Training Set

The document does not specify a separate "training set" as this is a chemical indicator, not a machine learning model. The validation tests described serve to establish its performance characteristics against defined chemical criteria.

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

As there's no "training set" in the machine learning sense, this question is not applicable. The underlying "ground truth" for the device's function (i.e., known PAA concentrations and their effect on the indicator) would have been established through controlled laboratory experiments and chemical analysis during the development and kinetic studies of the indicator itself.

Summary

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FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM KO 43439888

FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM KO 43439888
ST STERNICE ENDOSCOPE PROCESSING SYSTEM KO 4343988888888888888888888

Date	July 5, 2006
Submitter	STERIS Corporation5960 Heisley RoadMentor Ohio 44060 USA
	Telephone: 440-354-2600
Contact	Nancy A. RobinsonDirector, Advanced SterilizationSTERIS Corporation5960 Heisley RoadMentor, OH 44060 USATel.: 440-392-7742Fax: 440-392-8955E-mail: nancy_robinson@steris.com
Device name	Proprietary Name:Common Name:Classification Name:	RelianceTM PI Process IndicatorPhysical/Chemical Process IndicatorPhysical/Chemical Process Indicator
	The Reliance PI Process Indicator is substantially equivalent to theSTERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1Processing System (K921559) based on the following comparison:
	Property	RelianceTM PIProcess Indicator	STERIS PROCESSChemical Monitor(K921559)
Legally marketeddevices to whichsubstantialequivalence isclaimed	Intended use	The Reliance PI ProcessIndicator is a single usechemical indicatordesigned to change fromthe "START" dark pinkcolor to the "ENDPOINT"orange color or lighterupon exposure to aneffective dose of peraceticacid generated fromReliance DG DryGermicide during theReliance EndoscopeProcessing Cycle.	Intended for use byhealthcare providers forthe detection ofperacetic acid, theactive ingredient ofSTERIS 20 Sterilant,during the STERISSYSTEM 1 sterilizationcycle.
	Design	0.20" square, off-whitereagent pad affixed to oneend of a 3.25" x 0.20"polystyrene strip.	0.20" square, off-whitereagent pad affixed toone end of a 3.25" x0.20" polystyrene strip.
	Packaging	Fifty indicator strips perscrew-capped bottle withdesiccant.	Fifty indicator strips perscrew-capped bottlewith desiccant.
	Indicator agent	Triphenylmethane dye	Crystal violet
Legally marketeddevices to whichsubstantialequivalence isclaimed, continued	Property	Reliance™ PI ProcessIndicator	STERIS ProcessChemical Monitor(K921559)
	Color change uponexposure toappropriateconcentrations ofperacetic acid.	Dark pink starting color toorange endpoint color orlighter.	Dark purple startingcolor to pale grey orlighter endpoint color
	Mechanism of colorchange	Oxidation of indicator dyeby peracetic acid	Oxidation of indicatordye by peracetic acid
	Cycle monitored	The Reliance Process highlevel disinfection phaseconsists of a 4-minutegeneration time and a 6-minute exposure to theperacetic acid use dilutionat a temperature of50 - 57°C.	The STERIS Processsterilization cycleconsists of a 12-minuteexposure to theperacetic acid usedilution at atemperature of50 - 56°C.
	Endpointspecifications	When the indicator isexposed to peracetic acid(PAA) at a dose ≥ 11,500mg/L PAA min generatedfrom Reliance DG DryGermicide during theReliance EndoscopeProcessing Cycle, therewill be a complete changeto endpoint color or lighterin 100% of the indicatorstrips.When the indicator isexposed to the minimumrecommended dose of9000 mg/L PAA min orless, there will be anincomplete color change in100% of the indicatorstrips.	When the indicator isexposed to productionlots of STERIS 20Sterilant, there shouldbe a complete colorchange to endpoint.When the indicator isexposed to a loweredcharge of the STERIS20 Sterilant, thereshould be anincomplete colorchange.
	Shelf-life	Based on current testing:2 years unopened6 months after opening	2.5 years unopened6 months after opening

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RELIANCE™ PI PROCESS INDICATORSTRIPS : FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM 510(K) SUMMARY

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RELIANCE™ PI PROCESS INDICATORSTRIPS FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM 510(K) SUMMARY

Device description	The Reliance PI Process Indicator is a single use chemical indicatorstrip that is designed to confirm an effective dose of peracetic acid(PAA), the active ingredient generated from Reliance DG Dry Germicidein the Reliance Endoscope Processor's HLD cycle.
Device description	This test strip consists of a 0.2-square inch reagent-containing indicatorpad attached to one end of a 0.2 x 3.25-inch polystyrene handle. Theindicator pad contains an indicator dye with a background dye thattogether form a dark pink color.
	Upon exposure to the effective dose of PAA generated during theReliance Endoscope Processing Cycle, the indicator dye only is oxidizedby the Reliance DG Dry Germicide use dilution during the RelianceEndoscope Processing Cycle. During the processing cycle, the indicatorpad color transitions through a lighter pink color until an orangecoloration, based on the background dye, is visible.
Intended use	The Reliance PI Process Indicator is a single use chemical indicatordesigned to change from the "START" dark pink color to the"ENDPOINT" orange color or lighter upon exposure to an effective doseof peracetic acid generated from Reliance DG Dry Germicide during theReliance Endoscope Processing Cycle.
	The Reliance PI Process Indicator is designed to be used exclusivelyfor the independent monitoring of the Reliance Endoscope ProcessingSystem. The Reliance PI Process Indicator is not an indicator of loaddisinfection or cleaning efficacy.
	The Reliance PI Process Indicator was developed and validated inaccordance with FDA's Guidance document: Content and Format ofPremarket Notification [510(k)] Submissions for Liquid ChemicalSterilants/High Level Disinfectants (2000)
	A summary of this testing follows:
PerformanceTesting	Kinetic Studies validated the Reliance Endoscope Processor's deliveryof peracetic acid in concentrations appropriate for PI performancetesting. Specially packaged Reliance DG Dry Germicide containers withtwo targeted PAA generation capacities were used for the majority ofReliance PI Process Indicator performance validation.
	Sensitivity Studies demonstrated that the Reliance PI ProcessIndicator develops the complete ENDPOINT color (pass) when the doseof PAA is >= 11,500 mg/L PAA min, and fails to reach that color(incomplete endpoint reading, not acceptable) when the PAA dose is <9000 mg/L PAA min.
	Specificity Testing confirmed that the two components of the DryGermicide's container cannot independently cause a color change toENDPOINT.

PerformanceTesting, continued	Repeatability and Precision of the reaction was demonstrated overnumerous repeated assays using varying parameters of use.
	Stability of the PI Color was confirmed when reading delays occur inthe closed processor or after the PI is removed from the processor.
	Stability of Strips in unopened bottles was established through 24months of storage under labeled storage conditions. Use-life of theopened bottle was validated through 6 months after opening. Periods ofstorage outside labeled conditions did not affect performance.
	Performance of strips was validated in the Reliance Processing Cyclewith and without worst case washing phases, with maximum air purgetime and when combined with conditions of delayed PI reading.
	When used during a simulated-use study of the Reliance EndoscopeProcessing System in which eight flexible endoscopes were processed,the Reliance PI Process Indicator detected the intended levels of PAA bydemonstrating "complete" PI readings in each of the 27 cycles.
	When used during a simulated-use study of the Reliance EndoscopeProcessing System in which three worst-case flexible endoscopes wereprocessed with a PAA dose of 9000 mg/L PAA min (minimumrecommended dose), the Reliance PI Process Indicator demonstrated an"incomplete" PI reading in each of the 9 cycles. High level disinfectionwas achieved for each processed device and accessory in eachsimulated use trial.
Clinical Testing	Although the Reliance Process Indicator was not of itself a subject of aclinical trial, it was employed in an in-use study of the RelianceEndoscope Processing System. During this in-use study, the ReliancePI Process Indicator was used in each processing cycle according to theinstructions for use. The indicator performed as expected, and wascorrectly interpreted by the clinical users.

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RELIANCE™ PI PROCESS INDICATORSTRIPS FOR RELIANCE ENDOSCOPE PROCESSING SYSTEM 510(K) SUMMARY

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

STERIS Corporation c/o Mark A. Heller Wilmer Cutler Pickering Hale and Dorr, LLP The Willard Office Building 1455 Pennsylvania Avenue, N.W. Washington, D.C. 20004

JUL 2 1 2006

Re: K043482

Trade/Device Name: Reliance® PI Process Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Physical/Chemical Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: December 16, 2004 Received: December 17, 2004

Dear Mr. Heller:

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. Iisting 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.

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

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forth in the quality systems (OS) 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.

Miriam C. Provost

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Reliance™ P1 Process Indicator Revised July 5, 2006

Indications for Use

510(k) Number (if known): K043482

Device Name: STERIS Reliance™ PI Process Indicator

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost for DBT

、アミ代(ff) The Antesthesiology, General Hospital in Control. Dental Devices

Page 1 of 1

K043482

(Posted November 13, 2003)

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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).