VERIFY Chemical Indicator for S40 Sterilant

K173428 · STERIS Corporation · JOJ · Mar 2, 2018 · General Hospital

Device Facts

• Record ID: K173428
• Device Name: VERIFY Chemical Indicator for S40 Sterilant
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Mar 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY® Chemical Indicator for S40® Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle. The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, 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 sterilant use dilution.

Device Story

Single-use chemical indicator; polypropylene strip with indicator ink; covered by clear, sterilant-permeable laminate. Monitors peracetic acid (PAA) concentration in automated liquid chemical sterilant processing systems. Principle of operation: oxidation-based color change from blue to beige to pink upon exposure to >1820 ppm PAA for 6 minutes at 45.5-60°C. Used in clinical settings by healthcare personnel to verify sterilant concentration during automated processing cycles. Provides visual confirmation of effective sterilant concentration; ensures proper sterilization conditions for medical instruments; benefits patient by confirming device sterility.

Clinical Evidence

Bench testing only. Performance validated via comparative sensitivity/specificity, analytic specificity, blind reader studies, simulated use testing, UV stability, shelf-life (24 months), open-bottle stability (6 months), and resistance to aggressive chemicals/contaminants. All tests passed.

Technological Characteristics

Polypropylene strip with printed indicator ink; clear, sterilant-permeable laminate cover. Sensing principle: chemical oxidation resulting in colorimetric change. Dimensions/form factor: strip. Sterilization method: N/A (device is a monitor). No software or electronic components.

Indications for Use

Indicated for routine monitoring of peracetic acid concentration in automated STERIS liquid chemical sterilant processing systems using S40 Sterilant Concentrate in a controlled 6-minute cycle at 45.5-60°C.

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

• VERIFY® Chemical Indicator for SYSTEM 1E Processor (K102217)

Submission Summary (Full Text)

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May 18, 2018

STERIS Corporation Marcia Benedict Senior Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060

Re: K173428

Trade/Device Name: VERIFY Chemical Indicator for S40 Sterilant Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 31, 2018 Received: February, 2018

Dear Marcia Benedict:

This letter corrects our substantially equivalent letter of March 2, 2018.

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.

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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## Page 2 - Marcia Benedict

801); medical device 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); manufaceaning product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLeam). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tina Kiang
-S

Tina Kiang, Ph.D. Acting 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K173428

Device Name

VERIFY® Chemical Indicator for S40® Sterilant

Indications for Use (Describe)

The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.

The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, 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 sterilant use dilution.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and is above a symbol that looks like several horizontal wavy lines stacked on top of each other. The registered trademark symbol is to the right of the word STERIS.

# 510(k) Summary For VERIFY® Chemical Indicator for S40 Sterilant

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

Contact:

.

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

February 6, 2018 Submission Date:

Premarket Notification Number: K173428

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

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#### Device Name 1.

| Trade Name: | VERIFY® Chemical Indicator for S40 Sterilant |
|----------------------|---------------------------------------------------|
| Models: | N/A |
| Common Name: | Chemical Indicator. |
| Classification Name: | Physical/chemical sterilization process indicator |
| Classification | 21 CFR 880.2800 |
| Product Code | JOJ |

#### 2. Predicate Device

VERIFY® Chemical Indicator for SYSTEM 1E Processor (K102217)

#### 3. Device Description

The VERIFY® Chemical Indicator for S40 Sterilant is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end.

The subject device is physically identical to the predicate device.

The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.

#### 4. Intended Use

The VERIFY® Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of STERIS automated liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle.

The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, 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 sterilant use dilution.

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#### Description of Technological Similarities and Differences ડ.

The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical.

The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of peracetic acid greater than 1820 ppm at 45.5 - 60°C during the liquid chemical sterilant processing system's standard cycle.

The more descriptive intended use statement will enable use of the VERIFY Chemical Indicator for S40 Sterilant in STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate and provide the same specific described and validated liquid chemical sterilant exposure parameters in a controlled automated cycle.

| Feature | K173428 - Proposed<br>VERIFY® Chemical<br>Indicator for S40 Sterilant | K102217 - Predicate<br>VERIFY® Chemical<br>Indicator for SYSTEM 1E<br>Processor | Comparison |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY Chemical<br>Indicator for S40 Sterilant is a<br>peracetic acid concentration<br>indicator for routine monitoring<br>of STERIS automated liquid<br>chemical sterilant processing<br>systems that employ S40<br>Sterilant Concentrate in a<br>controlled cycle.<br>The unprocessed VERIFY<br>Chemical Indicator for S40<br>Sterilant is blue. When exposed<br>in a STERIS automated liquid<br>chemical sterilant processor to a<br>concentration of >1820 ppm<br>(mg/L) peracetic acid found in<br>the S40 use dilution during a<br>controlled 6-minute exposure at<br>45.5 - 60°C, the indicator<br>changes color from blue through<br>an intermediate beige and then to<br>the endpoint color, pink. The<br>indicator may become more pink<br>when exposed to higher<br>peracetic acid concentrations in<br>S40 sterilant use dilution. | The VERIFY SYSTEM 1E<br>Chemical Indicator (SYSTEM<br>1E Chemical Indicator) is a<br>peracetic acid concentration<br>indicator for routine monitoring<br>of the SYSTEM 1E Liquid<br>Chemical Sterilant Processing<br>System employing S40 Sterilant<br>Concentrate.<br>The unprocessed Verify<br>SYSTEM 1E Chemical Indicator<br>is blue. When exposed to a<br>concentration of >1820 ppm<br>(mg/L) peracetic acid found in<br>the S40 use dilution, the<br>indicator changes color from<br>blue through an intermediate<br>beige and then to the endpoint<br>color pink. The indicator may<br>become more pink when<br>exposed to higher peracetic acid<br>concentrations in S40 use<br>dilution. | The proposed<br>descriptive<br>wording<br>focuses on the<br>S40 sterilant<br>and the liquid<br>chemical<br>sterilization<br>cycle exposure<br>parameters<br>monitored<br>rather than on<br>a specific<br>processing<br>system name. |

# Table 1. Device Comparison Table

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## K173428/S001 STERIS Response to 12/29/17 Request for Additional Information VERIFY Chemical Indicator for S40 Sterilant

| Feature | K173428 - Proposed<br>VERIFY® Chemical<br>Indicator for S40 Sterilant | K102217 - Predicate<br>VERIFY® Chemical<br>Indicator for SYSTEM 1E<br>Processor | Comparison |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device<br>design -<br>components | Printed indicator ink printed onto<br>polypropylene overlaid with a<br>clear, permeable laminate | Printed indicator ink printed onto<br>polypropylene overlaid with a<br>clear, permeable laminate | Identical |
| Sterilization<br>method and<br>cycles | Used in a liquid chemical<br>sterilant processing system<br>employing S40 Sterilant<br>Concentrate to form a use<br>dilution concentration of ≥1820<br>ppm (mg/L) peracetic acid and<br>provide 6 minutes exposure at<br>45.5 - 60°C. | Used in a liquid chemical<br>sterilant processing system<br>employing S40 Sterilant<br>Concentrate to form a use<br>dilution concentration of ≥1820<br>ppm (mg/L) peracetic acid and<br>provide 6 minutes exposure at<br>45.5 - 60°C. | Identical |
| Mechanism<br>of action | Ink ingredients change color as a<br>result of oxidation, resulting in<br>blue to beige/pink color change. | Ink ingredients change color as a<br>result of oxidation, resulting in<br>blue to beige/pink color change. | Identical |
| Peracetic<br>acid concen-<br>tration for<br>the endpoint<br>color change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 15 months;<br>pending change to 2 years | 15 months;<br>pending change to 2 years | Identical |
| Open bottle<br>shelf life | 6 months | 6 months | Identical |

#### Description of Safety and Substantial Equivalence 6.

The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored by the strip are identical.

The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of peracetic acid greater than 1820 ppm at 45.5 - 60°C during the liquid chemical sterilant processing system's standard cycle.

#### 7. Performance Testing

The following table summarizes the non-clinical performance testing of the identical predicate device that has demonstrated that the product is safe and

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effective. This submission revises the product's name and its indications for use description, changes that raise no new questions of safety or effectiveness.

| Testing | Results |
|-----------------------------------------|---------|
| Comparative Sensitivity and Specificity | PASS |
| Color Read Time | PASS |
| Analytic Specificity | PASS |
| Blind Reader | PASS |
| Simulated Use Testing | PASS |
| UV Study | PASS |
| Shelf Life for 24 months | PASS |
| Effects of Aggressive Chemicals | PASS |
| Effects of Contaminants | PASS |
| Open Bottle Stability for 6 months | PASS |

#### 8. Conclusion

The VERIFY Chemical Indicator for S40 Sterilant has met the established performance criteria. Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K102217), Class II (CFR 880.2800), product code JOJ.