VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

K233654 · Steris · JOJ · Dec 8, 2023 · General Hospital

Device Facts

• Record ID: K233654
• Device Name: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
• Applicant: Steris
• Product Code: JOJ · General Hospital
• Decision Date: Dec 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle. The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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 at point of use in automated liquid chemical sterilant processing systems. Principle of operation: oxidation-based bleaching of Lissamine green B dye; color shifts from blue to beige to pink upon exposure to >1820 ppm PAA during 6-minute cycle at 45.5-60°C. Used in clinical settings by healthcare personnel operating STERIS automated processors. Provides visual confirmation of sterilant concentration; ensures cycle parameters met; aids in verifying effective sterilization process; benefits patient by confirming instrument reprocessing quality.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Polypropylene strip with printed indicator ink (Lissamine green B and Savinyl orange); clear, sterilant-permeable laminate cover. Chemical sensing via oxidation-induced dye bleaching. Dimensions/form factor: strip. Shelf-life: 2 years (6 months open bottle).

Indications for Use

Indicated for routine monitoring of peracetic acid concentration in SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems using S40 Sterilant Concentrate.

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 (K173428)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

December 8, 2023

Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060

Re: K233654

Trade/Device Name: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 14, 2023 Received: November 14, 2023

Dear Anthony Piotrkowski:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

Submission Number (if known)

K233654

Device Name

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

Indications for Use (Describe)

The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.

The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue.

## 510(k) Summary For VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

Tony Piotrkowski Contact: Director, Regulatory Affairs [phone] Telephone: Email: tony [e-mail]

Submission Date: December 7, 2023

Premarket Notification Number; K233654

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

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### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

#### 1. Device Name

| Trade Name: | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM<br>1® endo Liquid Chemical Sterilant Processing Systems |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Models: | LCC016 |
| 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 (K173428)

#### 3. Device Description

The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. 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/Indications for Use:

The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.

The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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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#### ડ. Description of Technological Characteristics

The proposed device and its predicate are physically identical. The more descriptive intended use statement will identify use of the Chemical Indicator in specific STERIS automated liquid chemical sterilant processors that use S40 Sterilant Concentrate. This includes the indicator's intended use in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.

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.

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

### Table 1. Device Comparison Table for Modified Chemical Indicator and Predicate

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### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

| Feature | Proposed VERIFY® Chemical<br>Indicator for SYSTEM 1E® and<br>SYSTEM 1® endo Liquid Chemical<br>Sterilant Processing Systems | Predicate K173428<br>VERIFY Chemical Indicator for<br>S40 Sterilant | Comparison |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------|
| Device design -<br>components | Printed indicator ink printed onto<br>polypropylene overlaid with a clear,<br>permeable laminate | Printed indicator ink printed onto<br>polypropylene overlaid with a clear,<br>permeable laminate | Identical |
| Indicator agent | Lissamine green B (active dye) and savinyl<br>orange (background dye) | Lissamine green B (active dye) and<br>savinyl orange (background dye) | Identical |
| Mechanism of<br>action | Bleaching of lissamine green B dye as a<br>result of oxidation, resulting in blue to<br>beige/pink color change. | Bleaching of lissamine green B dye as a<br>result of oxidation, resulting in blue to<br>beige/pink color change. | Identical |
| Peracetic acid<br>concentration<br>for the endpoint<br>color change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 2 years | 2 years | Identical |
| Open bottle<br>shelf life | 6 months | 6 months | Identical |

#### 6. Performance Testing

No new testing was performed for this submission. This submission revises the product's name, indications for use and, consequently, labeling to list specific liquid chemical processing systems where the CI can be used, changes that raise no new questions of safety or effectiveness.

#### 7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K173428), Class II (CFR 880.2800), product code JOJ.