VERIFY VH2O2 Indicator Tape

K172753 · STERIS Corporation · JOJ · Feb 9, 2018 · General Hospital

Device Facts

• Record ID: K172753
• Device Name: VERIFY VH2O2 Indicator Tape
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The VERIFY™ VH2O2 Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches. The tape may be used in the following sterilization cycles: Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers; Standard Cycle of the STERRAD® 100S Sterilizer; Standard and Advanced Cycles of the STERRAD® NX Sterilizer; Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

Device Story

VERIFY VH2O2 Indicator Tape is a chemical process indicator used in healthcare settings to secure wrapped surgical items and verify exposure to hydrogen peroxide sterilization. The tape consists of coated crepe paper with a chemical indicator that undergoes a color change (pink to peach/yellow) upon exposure to hydrogen peroxide vapor. It is applied by clinical staff to synthetic wraps or Tyvek pouches before sterilization. The device serves as a visual indicator to distinguish between processed and unprocessed units. It is compatible with various V-PRO and STERRAD sterilization cycles. The output is a simple color change observed by the healthcare provider, which confirms the item has been subjected to the sterilization process, aiding in inventory management and ensuring that only processed items are used in clinical procedures.

Clinical Evidence

Bench testing only. Performance was validated through simulated use testing in the V-PRO maX 2 Fast Non Lumen Cycle under both pass and fail conditions, and 18-month shelf-life stability testing. All tests met the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 chemical indicators.

Technological Characteristics

Substrate: Crepe paper. Indicator: Proprietary chemical formulation conforming to ANSI/AAMI/ISO 11140-1:2014 Type 1. Adhesive: Proprietary. Form factor: Tape. Sterilization compatibility: Vapor-phased hydrogen peroxide. Free of lead, heavy metals, and natural rubber latex.

Indications for Use

Indicated for use in healthcare facilities to secure wrapped surgical items and provide visual confirmation of exposure to hydrogen peroxide sterilization cycles (V-PRO and STERRAD systems) by changing color from pink to peach/yellow.

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 VH2O2 Indicator Tape (K160485)

Submission Summary (Full Text)

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February 9, 2018

Steris Corporation Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K172753

Trade/Device Name: VERIFY VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 9, 2017 Received: January 10, 2018

Dear Bill Brodbeck:

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 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);

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and if applicable, the electronic 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 mediation-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/CDRHLearn). 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,

# Michael J. Ryan -S

for 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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## Indications for Use

510(k) Number (if known) K172753

Device Name VERIFY VH2O2 Indicator Tape

### Indications for Use (Describe)

The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The VERIFY™ VH2O2 Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

- Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterlizers
- · Standard Cycle of the STERRAD® 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
- · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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STERIS®

Image /page/3/Picture/2 description: The image shows a blue graphic of six horizontal lines that are curved. The lines are stacked on top of each other, with the top line having the smallest curve and the bottom line having the largest curve. The lines are all the same thickness and color, and they are evenly spaced apart.

# 510(k) Summary for VERIFY™ VH2O2 Indicator Tape K172753

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

Contact: Bill Brodbeck Director, Regulatory Affairs Telephone: [phone] Fax No: [phone] E-mail: [e-mail]

Submission Date: September 11, 2017

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

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### TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFYTM VH2O2 Indicator Tape

#### Device Name 1.

| Trade Name: | VERIFY™ VH2O2 Indicator Tape |
|----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Chemical Sterilization Process Indicator |
| Classification Name: | Sterilization Process Indicator<br>(21 CFR 880.2800, JOJ) |
| Classification: | Class II |

#### Predicate Device 2.

VERIFYTM VH2O2 Indicator Tape (K160485)

### 3. Description of Device

The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.

The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.

#### Intended Use/ Indications for Use 4.

The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The VERIFY™ VH2O2 Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

- Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 . Plus, maX, 60 and maX 2 Sterilizers
- Standard Cycle of the STERRAD® 100S Sterilizer ●
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer ●
- Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

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### TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape

| Table 5.1 Indications for Use Comparison | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed | Predicate (K160485) | Comparison |
| VERIFY VH2O2 Indicator Tape | VERIFY VH2O2 Indicator Tape | |
| The VERIFYTM VH2O2 Indicator<br>Tape is intended to secure items<br>wrapped in synthetic wrap materials<br>until used and to distinguish<br>between processed and unprocessed<br>units through a color change from<br>the start color (pink) to peach,<br>yellow or lighter. The VERIFYTM<br>VH2O2 Indicator Tape is also<br>intended to be used as an external<br>process indicator when applied to<br>synthetic wrap materials and/or<br>Tyvek pouches.<br><br>The tape may be used in the<br>following sterilization cycles:<br>Non Lumen, Flexible, Lumen<br>and Fast Non Lumen Cycles of<br>the V-PRO 1, 1 Plus, maX, 60<br>and maX 2 Sterilizers Standard Cycle of the<br>STERRAD® 100S Sterilizer Standard and Advanced Cycles<br>of the STERRAD® NX<br>Sterilizer Express, Flex Scope, Duo and<br>Standard Cycles of the<br>STERRAD® 100 NX Sterilizer | The VERIFY VH2O2 Indicator Tape is<br>intended to secure items wrapped in<br>synthetic wrap materials until used and<br>to distinguish between processed and<br>unprocessed units through a color<br>change from the start color (pink) to<br>peach, yellow or lighter.<br><br>The tape may be used in the following<br>sterilization cycles:<br>Non Lumen, Flexible and Lumen<br>Cycles of the V-PRO 1, 1 Plus, maX<br>and 60 Low Temperature Sterilizers Standard Cycle of the STERRAD®<br>100S Sterilizer Standard and Advanced Cycles of the<br>STERRAD® NX Sterilizer Express,<br>Flex Scope, Duo and Standard<br>Cycles of the STERRAD® 100 NX<br>Sterilizer | The Indications for<br>Use has been<br>modified in the<br>proposed device in<br>order to include the<br>Fast Non Lumen<br>Cycle of the V-PRO<br>maX 2 device.<br><br>The proposed device<br>also includes the<br>statement that the<br>VERIFYTM VH2O2<br>Indicator Tape is<br>also intended to be<br>used as an external<br>process indicator<br>when applied to<br>synthetic wrap<br>materials and/or<br>Tyvek pouches. |

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

The VERIFY VH2O2 Indicator Tape has equivalent characteristics as compared to its predicate device. Table 5.2 compares the proposed device's design to the predicate.

| Characteristic | Proposed | Predicate | Comparison |
|----------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------|
| Substrate | Crepe Paper | Crepe Paper | Same |
| Indicator | Proprietary -<br>conforms<br>with ISO<br>11140-<br>1:2014 Type<br>1 requirements | Proprietary -<br>conforms with ISO<br>11140-1:2014 Type<br>1 requirements | Same |
| Adhesive | Proprietary | Proprietary | Testing included in this<br>submission<br>demonstrating |

### Table 5.2 Device Comparison

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| TRADITIONAL PREMARKET NOTIFICATION [510(k)] |
|---------------------------------------------------------------------------|
| VERIFY™ <span style="border: 1px solid black">VH2O2</span> Indicator Tape |

| Characteristic | Proposed | Predicate | Comparison |
|--------------------|---------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | performance (See Table<br>5.3). |
| Color Change | Pink to<br>Peach/Yellow | Pink to<br>Peach/Yellow | Same |
| Detection | hydrogen<br>peroxide dose | hydrogen peroxide<br>dose | Same |
| Shelf-life | 18 months | 18 months | Same |
| Storage Conditions | 16 - 24°C,<br>30 - 60% RH | 16 - 24°C<br>30 - 60% RH | Testing included in this<br>submission to support<br>proposed device's shelf<br>life when stored under<br>labeled conditions (See<br>Table 5.3). |

Since the VERIFY | VH2O2 Indicator Tape is identical to the predicate device, prior nonclinical testing (K160485) is referenced in this submission to support performance of the chemical indicator in accordance to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. Furthermore, since the proposed device is identical to the proposed device, testing was provided in K160485 addresses endpoint stability, light stability, biocompatibility and adhesion. To demonstrate that the CI performs appropriately according to the proposed device's expanded claims, performance was tested in the V-PRO maX 2's Fast Non Lumen Cycle with loads under simulated use conditions under pass and fail conditions. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014, endpoint color stability and tape adhesion after various times of storage within the labeled storage conditions. Table 5.3 summarizes the testing performed in the current submission.

### Table 5.3 Summary of Nonclinical Tests:

| Test | Result |
|-----------------------------------------------|--------|
| Simulated Use Testing in Fast Non Lumen Cycle | Pass |
| Stability Testing for 18 month Shelf Life | Pass |

#### 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and perform at least as well as the legally marketed predicate device K160485, Class II (21 CFR 880.2800), product code JOJ.