THE RELIANCE PI PROCESS INDICATOR, MODEL D5116

K043482 · STERIS Corporation · JOJ · Dec 21, 2004 · General Hospital

Device Facts

• Record ID: K043482
• Device Name: THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

Single-use chemical indicator strip; 0.2-square inch reagent pad on polystyrene handle. Monitors peracetic acid (PAA) concentration during Reliance Endoscope Processing Cycle. Principle: oxidation of triphenylmethane dye by PAA; color shifts from dark pink (START) to orange (ENDPOINT) upon exposure to effective PAA dose (≥ 11,500 mg/L PAA min). Used by healthcare providers in clinical settings to verify cycle performance. Provides visual confirmation of chemical exposure; does not measure disinfection or cleaning efficacy. Benefits: independent verification of processing cycle parameters.

Clinical Evidence

No clinical trials performed. Bench testing included kinetic studies, sensitivity (pass ≥ 11,500 mg/L PAA min; fail < 9,000 mg/L PAA min), specificity, repeatability, and stability testing. Simulated-use study processed 8 flexible endoscopes over 27 cycles, confirming correct indicator performance. In-use study confirmed correct interpretation by clinical users.

Technological Characteristics

Polystyrene strip (3.25" x 0.20") with 0.2" square reagent pad. Indicator agent: triphenylmethane dye. Mechanism: chemical oxidation. Shelf-life: 2 years unopened, 6 months opened. Standalone device; no energy source or software.

Indications for Use

Indicated for use by healthcare providers to monitor the Reliance Endoscope Processing Cycle by detecting peracetic acid levels. Not for use as an indicator of load disinfection or cleaning efficacy.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1 Processing System (K921559)

Submission Summary (Full Text)

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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 Corporation<br>5960 Heisley Road<br>Mentor Ohio 44060 USA | | |
| | Telephone: [phone] | | |
| Contact | Nancy A. Robinson<br>Director, Advanced Sterilization<br>STERIS Corporation<br>5960 Heisley Road<br>Mentor, OH 44060 USA<br><br>Tel.: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Device name | Proprietary Name:<br>Common Name:<br>Classification Name: | RelianceTM PI Process Indicator<br>Physical/Chemical Process Indicator<br>Physical/Chemical Process Indicator | |
| | The Reliance PI Process Indicator is substantially equivalent to the<br>STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1<br>Processing System (K921559) based on the following comparison: | | |
| | Property | RelianceTM PI<br>Process Indicator | STERIS PROCESS<br>Chemical Monitor<br>(K921559) |
| Legally marketed<br>devices to which<br>substantial<br>equivalence is<br>claimed | Intended use | The Reliance PI Process<br>Indicator is a single use<br>chemical indicator<br>designed to change from<br>the "START" dark pink<br>color to the "ENDPOINT"<br>orange color or lighter<br>upon exposure to an<br>effective dose of peracetic<br>acid generated from<br>Reliance DG Dry<br>Germicide during the<br>Reliance Endoscope<br>Processing Cycle. | Intended for use by<br>healthcare providers for<br>the detection of<br>peracetic acid, the<br>active ingredient of<br>STERIS 20 Sterilant,<br>during the STERIS<br>SYSTEM 1 sterilization<br>cycle. |
| | Design | 0.20" square, off-white<br>reagent pad affixed to one<br>end of a 3.25" x 0.20"<br>polystyrene strip. | 0.20" square, off-white<br>reagent pad affixed to<br>one end of a 3.25" x<br>0.20" polystyrene strip. |
| | Packaging | Fifty indicator strips per<br>screw-capped bottle with<br>desiccant. | Fifty indicator strips per<br>screw-capped bottle<br>with desiccant. |
| | Indicator agent | Triphenylmethane dye | Crystal violet |
| Legally marketed<br>devices to which<br>substantial<br>equivalence is<br>claimed, continued | Property | Reliance™ PI Process<br>Indicator | STERIS Process<br>Chemical Monitor<br>(K921559) |
| | Color change upon<br>exposure to<br>appropriate<br>concentrations of<br>peracetic acid. | Dark pink starting color to<br>orange endpoint color or<br>lighter. | Dark purple starting<br>color to pale grey or<br>lighter endpoint color |
| | Mechanism of color<br>change | Oxidation of indicator dye<br>by peracetic acid | Oxidation of indicator<br>dye by peracetic acid |
| | Cycle monitored | The Reliance Process high<br>level disinfection phase<br>consists of a 4-minute<br>generation time and a 6-<br>minute exposure to the<br>peracetic acid use dilution<br>at a temperature of<br>50 - 57°C. | The STERIS Process<br>sterilization cycle<br>consists of a 12-minute<br>exposure to the<br>peracetic acid use<br>dilution at a<br>temperature of<br>50 - 56°C. |
| | Endpoint<br>specifications | When the indicator is<br>exposed to peracetic acid<br>(PAA) at a dose ≥ 11,500<br>mg/L PAA min generated<br>from Reliance DG Dry<br>Germicide during the<br>Reliance Endoscope<br>Processing Cycle, there<br>will be a complete change<br>to endpoint color or lighter<br>in 100% of the indicator<br>strips.<br>When the indicator is<br>exposed to the minimum<br>recommended dose of<br>9000 mg/L PAA min or<br>less, there will be an<br>incomplete color change in<br>100% of the indicator<br>strips. | When the indicator is<br>exposed to production<br>lots of STERIS 20<br>Sterilant, there should<br>be a complete color<br>change to endpoint.<br>When the indicator is<br>exposed to a lowered<br>charge of the STERIS<br>20 Sterilant, there<br>should be an<br>incomplete color<br>change. |
| | Shelf-life | Based on current testing:<br>2 years unopened<br>6 months after opening | 2.5 years unopened<br>6 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 indicator<br>strip that is designed to confirm an effective dose of peracetic acid<br>(PAA), the active ingredient generated from Reliance DG Dry Germicide<br>in the Reliance Endoscope Processor's HLD cycle. | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device description | This test strip consists of a 0.2-square inch reagent-containing indicator<br>pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The<br>indicator pad contains an indicator dye with a background dye that<br>together form a dark pink color. | |
| | Upon exposure to the effective dose of PAA generated during the<br>Reliance Endoscope Processing Cycle, the indicator dye only is oxidized<br>by the Reliance DG Dry Germicide use dilution during the Reliance<br>Endoscope Processing Cycle. During the processing cycle, the indicator<br>pad color transitions through a lighter pink color until an orange<br>coloration, based on the background dye, is visible. | |
| Intended use | The Reliance PI Process Indicator is a single use chemical indicator<br>designed to change from the "START" dark pink color to the<br>"ENDPOINT" orange color or lighter upon exposure to an effective dose<br>of peracetic acid generated from Reliance DG Dry Germicide during the<br>Reliance Endoscope Processing Cycle. | |
| | The Reliance PI Process Indicator is designed to be used exclusively<br>for the independent monitoring of the Reliance Endoscope Processing<br>System. The Reliance PI Process Indicator is not an indicator of load<br>disinfection or cleaning efficacy. | |
| | The Reliance PI Process Indicator was developed and validated in<br>accordance with FDA's Guidance document: Content and Format of<br>Premarket Notification [510(k)] Submissions for Liquid Chemical<br>Sterilants/High Level Disinfectants (2000) | |
| | A summary of this testing follows: | |
| Performance<br>Testing | Kinetic Studies validated the Reliance Endoscope Processor's delivery<br>of peracetic acid in concentrations appropriate for PI performance<br>testing. Specially packaged Reliance DG Dry Germicide containers with<br>two targeted PAA generation capacities were used for the majority of<br>Reliance PI Process Indicator performance validation. | |
| | Sensitivity Studies demonstrated that the Reliance PI Process<br>Indicator develops the complete ENDPOINT color (pass) when the dose<br>of PAA is >= 11,500 mg/L PAA min, and fails to reach that color<br>(incomplete endpoint reading, not acceptable) when the PAA dose is <<br>9000 mg/L PAA min. | |
| | Specificity Testing confirmed that the two components of the Dry<br>Germicide's container cannot independently cause a color change to<br>ENDPOINT. | |
| | | |
| Performance<br>Testing, continued | Repeatability and Precision of the reaction was demonstrated over<br>numerous repeated assays using varying parameters of use. | |
| | Stability of the PI Color was confirmed when reading delays occur in<br>the closed processor or after the PI is removed from the processor. | |
| | Stability of Strips in unopened bottles was established through 24<br>months of storage under labeled storage conditions. Use-life of the<br>opened bottle was validated through 6 months after opening. Periods of<br>storage outside labeled conditions did not affect performance. | |
| | Performance of strips was validated in the Reliance Processing Cycle<br>with and without worst case washing phases, with maximum air purge<br>time and when combined with conditions of delayed PI reading. | |
| | When used during a simulated-use study of the Reliance Endoscope<br>Processing System in which eight flexible endoscopes were processed,<br>the Reliance PI Process Indicator detected the intended levels of PAA by<br>demonstrating "complete" PI readings in each of the 27 cycles. | |
| | When used during a simulated-use study of the Reliance Endoscope<br>Processing System in which three worst-case flexible endoscopes were<br>processed with a PAA dose of 9000 mg/L PAA min (minimum<br>recommended dose), the Reliance PI Process Indicator demonstrated an<br>"incomplete" PI reading in each of the 9 cycles. High level disinfection<br>was achieved for each processed device and accessory in each<br>simulated use trial. | |
| Clinical Testing | Although the Reliance Process Indicator was not of itself a subject of a<br>clinical trial, it was employed in an in-use study of the Reliance<br>Endoscope Processing System. During this in-use study, the Reliance<br>PI Process Indicator was used in each processing cycle according to the<br>instructions for use. The indicator performed as expected, and was<br>correctly 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 [phone] or [phone] 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:

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.

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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