VERIFY PROCESS INDICATOR FOR RELIANCE EPS

K130160 · STERIS Corporation · JOJ · Aug 16, 2013 · General Hospital

Device Facts

• Record ID: K130160
• Device Name: VERIFY PROCESS INDICATOR FOR RELIANCE EPS
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Aug 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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

Device Story

Single-use chemical indicator strip; monitors peracetic acid (PAA) dose at point of use in endoscope processing systems. Input: exposure to PAA during sterilization cycle. Transformation: chemical reaction causing color change from orange to white (colorless). Output: visual color indicator. Used in clinical settings by healthcare personnel. Provides immediate visual confirmation of effective PAA dose delivery; ensures sterilization process efficacy; aids in quality control of endoscope reprocessing.

Clinical Evidence

Bench testing only. Evaluated response to PAA doses: ≥ 11,500 mg/L PAA min (Pass/colorless) and ≤ 9000 mg/L PAA min (Fail/incomplete color change). Stability testing confirmed performance after 12 months storage and 6 months of repeated opening of containers. Endpoint color stability verified for 6 months.

Technological Characteristics

Single-use chemical indicator strip. Substrate: Polypropylene. Indicator: Ink overlaid with clear, permeable laminate. Principle: Chemical color change (orange to colorless) triggered by PAA dose. Storage: 6°C-30°C, 30-80% RH. Shelf life: 12 months.

Indications for Use

Indicated for routine monitoring of Reliance Endoscope Processing System (EPS) and Reliance Advance EPS using Reliance DG Dry Germicide to confirm effective peracetic acid dose delivery.

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

• Reliance CI Process Indicator - K063285 marketed as VERIFY Process Indicator for Reliance Endoscope Processing System

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "STERIS" in a large, bold font, with the registered trademark symbol to the right of the word. Above the word "STERIS" is the number "K130160". Below the word "STERIS" is a graphic of several horizontal lines stacked on top of each other. To the right of the word "STERIS" is the text "p1 of 4".

## 510(k) Summary For

AUG 1 6 2013

# VERIFY™ Process Indicator for Reliance TM Endoscope Processing Systems

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact:

Marcia L. Benedict Senior Director, Regulatory Affairs Telephone: [phone] Fax No:

August 7, 2013 Summary Date:

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

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K130160

p2 d 4

#### 1. Device Name

| Trade Name: | VERIFY Process Indicator for Reliance Endoscope<br>Processing Systems |
|----------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Indicator, Physical/Chemical Sterilization Process |
| Classification Name: | 21 CFR 880.2800<br>Sterilization Process Indicator |
| Device Class: | II |
| Product Code: | JOJ |

#### 2. Predicate Device

Reliance CI Process Indicator - K063285 marketed as VERIFY Process Indicator for Reliance Endoscope Processing System

#### 3. Description of Device

The VERIFY Process Indicator for Reliance Endoscope Processing Systems is a single-use chemical indicator strip with indicator ink printed on one end that monitors the peracetic acid (PAA) dose at the point of use in a Reliance EPS Endoscope Processing System or a Reliance Advance Endoscope Processing System employing Reliance DG Dry Germicide.

The process indicator shows an incomplete color change when exposed to peracetic acid at a dose of ≤ 9000 mg/L PAA min. in an Endoscope Processing Cycle. It shows a complete color change from orange to white (colorless) when exposed to peracetic acid at a dose of ≥ 11,500 mg/L PAA min. in an Endoscope Processing Cycle.

The chemical indicator performs equivalently in Reliance Endoscope Processing System (EPS) and in Reliance Advance Endoscope Processing System.

#### 4. Intended Use

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

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K130160

p3d4

#### Description of Safety and Substantial Equivalence 5.

The characteristics and technology of the proposed VERIFY Process Indicator for Reliance Endoscope Processing Systems described in this submission are physically identical to those for the predicate. This submission demonstrates that the performance of the subject indicator in the proposed Reliance Advance Endoscope Processing System is equivalent to its performance in the original Reliance Endoscope Processing System. The proposed new indication does not raise any new concerns of safety and effectiveness.

| Feature | VERIFY PI for<br>Reliance EPS<br>(proposed) | VERIFY PI for Reliance EPS<br>(STERIS predicate K063285) |
|-------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------|
| Substrate | same | Polypropylene |
| Indicator | same | Ink overlaid with clear, permeable laminate |
| Color change | same | Orange to colorless |
| Shelf life | same | 12 months |
| Storage conditions | same | 6°C (43°F) - 30°C (86°F) and 30-80% RH |
| Use and disposal | same | Single use, disposable |
| Active monitored | same | Peracetic acid (PAA) dose |
| Response to PAA dose of: | | |
| $ \u2265 $ 11,500 mg/L PAA min. | same | Colorless1: Pass |
| $ \u2264 $ 9000 mg/L PAA min. | same | Incomplete color change2: Fail<br>(not as light as Pass color) |
| none | same | Orange (Start color, unprocessed) |

#### Comparison of Technological Characteristics 6.

The Pass endpoint color is actually the absence of color, which appears dull white against the bright white 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.

#### Performance Testing 7.

Performance testing was conducted to demonstrate that the VERIFY Process Indicator for Reliance Endoscope Processing Systems is an effective monitor for the circulating peracetic acid dose provided in the Reliance Advance Endoscope Processing System employing Reliance DG Dry Germicide.

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301100 P4014

The performance of the VERIFY Process Indicator for Reliance Endoscope Processing Systems in the Reliance Advance Endoscope Processing System, as summarized below, is substantially equivalent to its performance in the predicate Reliance Endoscope Processing System.

| Test | Acceptance Criteria | Result |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Unprocessed Cl strip | Color matches the orange 'start' color block on the<br>bottle label prior to use | PASS |
| Response to PAA dose<br>≥ 11,500 mg/L PAA min | Colorless (complete change, Pass) at end of the<br>Reliance Advance Endoscope Processing Cycle | PASS |
| Response to PAA dose<br>≤ 9000 mg/L PAA min | NOT colorless (incomplete change, Fail) at end of<br>the Reliance Advance Endoscope Processing Cycle<br>using the minimum effective dose PAA, or with no<br>PAA | PASS |
| Stability | After 12 months storage in each of three test<br>environments, the product correctly indicated Pass<br>and Fail in cycles of corresponding PAA dose. | PASS |
| Opened bottle use life | Opened PI containers stored in each of three test<br>environments were re-opened repeatedly for 6<br>months and tested. The PI from the opened bottles<br>correctly indicated Pass and Fail in cycles of<br>corresponding PAA dose through 6 months. | PASS |
| Endpoint color stability | Reliance PIs processed through cycles of Pass and<br>Fail PAA dose levels, evaluated after processing<br>and read again 6 months later, each gave the same<br>outcome. The end color is stable for 6 months. | PASS |

Conclusion:

The completed nonclinical performance testing has demonstrated that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 16, 2013

STERIS Corporation Ms. Marcia L. Benedict Senior Director, Regulatory Affairs 5960 Heisley Road MENTOR OH 44060

Re: K130160

Trade/Device Name: VERIFY Process Indicator for Reliance Endoscope Processing Systems Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 29, 2013 Received: August 1, 2013

Dear Ms. Benedict:

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. 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 - Ms. Benedict

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/8 description: The image contains a logo or emblem on the left side, which is abstract and stylized. To the right of the logo, there is text that reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The text appears to be part of a letterhead or official document. The word "FOR" is located in the bottom right corner.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): K130) 60

Device Name:

VERIFY Process Indicator for Reliance Endoscope Processing Systems

Indications For Use:

The VERIFY Process Indicator for Reliance Endoscope Processing Systems is intended for routine monitoring of the Reliance Endoscope Processing System (EPS) and the Reliance Advance EPS employing Reliance DG Dry Germicide. The device 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)

ﺎ ﺇﻟﻰ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

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)

Elizabeth F. Claverie 2013.08.09 11:35:18 -04'00'

Division Sign-Off) vision of Anasthesiology, General Hospital itection Control, Dental Devices

510(k) Number. K130160

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