Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape

K231488 · Steris · JOJ · Aug 7, 2023 · General Hospital

Device Facts

• Record ID: K231488
• Device Name: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
• Applicant: Steris
• Product Code: JOJ · General Hospital
• Decision Date: Aug 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow or lighter, when the device has been exposed to the: Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

Device Story

Chemical indicators monitor vaporized hydrogen peroxide (VHP) sterilization cycles. Devices consist of reactive indicator ink printed on polypropylene or spun-bonded polyolefin substrates. When exposed to VHP, ink undergoes a visible color change (e.g., magenta to orange/yellow), confirming exposure to sterilization conditions. Used in clinical settings by healthcare personnel to verify that packs have undergone a sterilization cycle. Output is a visual color change; informs clinical decision-making by ensuring only processed items are used. Benefits include preventing the use of non-sterile instruments.

Clinical Evidence

Bench testing only. Simulated use testing was performed to verify the indicators' performance in the V-PRO maX 2 Sterilizer Specialty cycle. Acceptance criteria included complete color change and no reversion (or adherence for tape). All testing met acceptance criteria.

Technological Characteristics

Chemical indicators conforming to ANSI/AAMI/ISO 11140-1:2014. Materials: polypropylene or spun-bonded polyolefin with proprietary reactive indicator ink. Mechanism: chemical reaction to VHP resulting in color change. Form factors: strips, labels, or crepe paper tape. No electronic components or software.

Indications for Use

Indicated for use as a Type 1 vaporized hydrogen peroxide sterilization process indicator to distinguish between processed and unprocessed units in V-PRO Low Temperature Sterilization Systems and ASP STERRAD Systems.

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

• Celerity™ HP Chemical Indicator (K192020)
• Celerity™ HP Multivariable Chemical Indicator (K213262)
• VERIFY HPU Chemical Indicator (K172746)
• VERIFY VH2O2 Indicator Tape (K183293)

Submission Summary (Full Text)

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August 7, 2023

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060

Re: K231488

Trade/Device Name: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, QKM Dated: Mav 22, 2023 Received: May 23, 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 (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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 -2

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# STE

# 510(k) Summary For K231488 CELERITY HP Chemical Indicator (CI)

# Sponsor Facility

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

# Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

| Contact: | Anthony Piotrkowski |
|----------|------------------------------|
| | Director, Regulatory Affairs |
| | Telephone: [phone] |
| | Fax No: [phone] |
| | [e-mail] |

May 22, 2023 Submission Date:

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# STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)

### 1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

Celerity™ HP Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K192020

### 2. Device Description

The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.

### 3. Indications for Use:

The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow or lighter, when the device has been exposed to the:

- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
- · Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

### 4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.

| Feature | Proposed Celerity™ HP Chemical | Predicate: K192020 Celerity HP | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Indicator | Chemical Indicator | |
| Intended Use /<br>Indications for<br>Use | The Celerity™ HP Chemical Indicator is a<br>Type 1 vaporized hydrogen peroxide<br>sterilization process indicator. It is<br>designed to distinguish between processed<br>and unprocessed units, when placed within<br>packs to be sterilized, through a visible<br>change from red to orange/yellow, when<br>the device has been exposed to the Lumen,<br>Non Lumen, Flexible, Fast Non Lumen,<br>Fast or Specialty sterilization cycle of a V-<br>PRO® Low Temperature Sterilization | The Celerity™ HP Chemical Indicator is a<br>Type 1 vaporized hydrogen peroxide<br>sterilization process indicator. It is<br>designed to distinguish between processed<br>and unprocessed units, when placed within<br>packs to be sterilized, through a visible<br>change from red to orange/yellow, when<br>the device has been exposed to the Lumen,<br>Non Lumen, Flexible, Fast Non Lumen or<br>Fast sterilization cycle of a V-PRO® Low<br>Temperature Sterilization System, or | The Indications<br>for Use have<br>been modified<br>in the proposed<br>device in order<br>to include the<br>Specialty<br>cycles. |

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| Feature | Proposed Celerity™ HP Chemical<br>Indicator | Predicate: K192020 Celerity HP<br>Chemical Indicator | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | System, or Standard, Advanced, Express,<br>Flex Scope or Duo cycles of an ASP<br>STERRAD® System, including those<br>systems with ALLClear Technology. | Standard, Advanced, Express, Flex Scope<br>or Duo cycles of an ASP STERRAD®<br>System, including those systems with<br>ALLClear Technology. | |
| Device design –<br>Component | Indicator Ink printed onto polypropylene<br>(indicator) or self-adhesive polypropylene<br>(adhesive label/vial label). | Indicator Ink printed onto polypropylene<br>(indicator) or self-adhesive polypropylene<br>(adhesive label/vial label). | Identical |
| Indicator agent | Proprietary | Proprietary | Identical |
| Mechanism of<br>action | Proprietary | Proprietary | Identical |
| Specification | Conforms to ANSI/AAMI/ISO 11140-<br>1:2014 requirements for a VH2O2 Type 1<br>Process Indicator | Conforms to ANSI/AAMI/ISO 11140-<br>1:2014 requirements for a VH2O2 Type<br>1 Process Indicator | Identical |
| Color change | Magenta to orange/yellow or lighter<br>yellow | Magenta to orange/yellow or lighter<br>yellow | Identical |
| Endpoint stability | 15 months (all versions) | 15 months (all versions) | Identical |

# STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)

The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.

### ನ. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

# Table 5-1. Verification Results Summary

| Testing | Acceptance Criteria | Study Result |
|-----------------------|---------------------------------------|-------------------------------------------|
| Simulated Use Testing | Complete color change<br>No reversion | ● Complete color change<br>· No reversion |

The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.

### 6. 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 (K192020, Class II as per 21 CFR 880.2800, product code JOJ).

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# 510(k) Summary For K231488 CELERITY HP Multivariable Chemical Indicator (CI)

# Sponsor Facility

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

# Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: [phone] Fax No: [phone] Tony [e-mail]

May 22, 2023 Submission Date:

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### Predicate Device 1.

| Trade Name: | Celerity™ HP Chemical Indicator (renamed |
|--------------------------|---------------------------------------------------|
| | Celerity™ HP Multivariable Chemical Indicator) |
| Common/Usual Name: | Chemical Indicator |
| Classification: | Class II |
| Classification Name: | Physical/chemical Sterilization Process Indicator |
| 510(k) Submitter/Holder: | STERIS Corporation |
| 510(k) Number: | K213262 |

### 2. Device Description

The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for Specialty cycle.

### 3. Indications for Use:

The Celerity™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization ● cycle of a V-PRO Low Temperature Sterilization System, or
- Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD ● System, including those systems with ALLClear Technology.

### 4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.

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# STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Multivariable Chemical Indicator (CI)

| Table 4-1. Summary of CI Physical Description and Technological Properties | | | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Proposed: Celerity™ Multivariable HP Chemical Indicator | Predicate: Celerity™ HP Chemical Indicator K213262 | Comparison |
| Intended Use /<br>Indications for<br>Use | The Celerity™ HP Chemical Indicator is a<br>vaporized hydrogen peroxide multivariable<br>chemical indicator. It is designed for<br>routine monitoring of the following cycles:<br>• Lumen, Non Lumen, Flexible, Fast<br>Non Lumen, Fast or Specialty<br>sterilization cycle of a V-PRO® Low<br>Temperature Sterilization System, or<br>• Standard, Advanced, Express, Flex Scope<br>or Duo cycles of an ASP STERRAD®<br>System, including those systems with<br>ALLClear Technology. | The Celerity™ HP Chemical Indicator is a<br>vaporized hydrogen peroxide multivariable<br>chemical indicator. It is designed for<br>routine monitoring of the following cycles:<br>• Lumen, Non Lumen, Flexible, Fast<br>Non Lumen or Fast sterilization cycle<br>of a V-PRO® Low Temperature<br>Sterilization System, or<br>Standard, Advanced, Express, Flex or Duo<br>cycles of an ASP STERRAD® System,<br>including those systems with ALLClear<br>Technology. | The Intended<br>Use of has been<br>modified in the<br>proposed device<br>to include the<br>Specialty Cycle<br>of the V-PRO<br>maX 2. |
| Device<br>design | Proprietary Indicator Ink printed onto<br>polypropylene. | Proprietary Indicator Ink printed onto<br>polypropylene. | Identical |
| Indicator<br>agent | Proprietary | Proprietary | Identical |
| Mechanism<br>of action | Proprietary | Proprietary | Identical |
| Critical<br>parameters | 4.7 mg/L - VH2O2<br>29 second - exposure time<br>50 °C - exposure Temperature | 4.7 mg/L - VH2O2<br>29 second - exposure time<br>50 °C - exposure Temperature | Identical |
| Color change | Magenta to orange/yellow or lighter yellow | Magenta to orange/yellow or lighter yellow | Identical |
| Endpoint<br>stability | 15 months | 15 months | Identical |

| | | Table 4-1. Summary of CI Physical Description and Technological Properties | |
|--|--|----------------------------------------------------------------------------|--|
| | | | |

The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.

### న. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

# Table 5-1. Verification Results Summary

| Testing | Acceptance Criteria | Study Result |
|-----------------------|-------------------------------------------|-------------------------------------------|
| Simulated Use Testing | • Complete color change<br>• No reversion | • Complete color change<br>• No reversion |

The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.

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## 6. 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 (K213262, Class II as per 21 CFR 880.2800, product code QKM).

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Image /page/10/Picture/0 description: The image shows the STERIS logo. The word STERIS is in a bold, sans-serif font at the top of the image. Below the word STERIS is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water waves.

# 510(k) Summary For K231488 VERIFY HPU Chemical Indicator (CI)

# Sponsor Facility

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

# Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: [phone] Fax No: [phone] Tony [e-mail]

May 22, 2023 Submission Date:

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### 1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

VERIFY HPU Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K172746

### 2. Device Description

The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.

### 3. Indications for Use:

The VERIFY® HPU Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.

### 4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow.

| Feature | Proposed: VERIFY HPU<br>Chemical Indicator | Predicate: VERIFY HPU Chemical<br>Indicator (K172746) | Comparison |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY® HPU Chemical Indicator is<br>a Type 1 vaporized hydrogen peroxide<br>sterilization process indicator. It is<br>designed to distinguish between processed<br>and unprocessed units when placed within<br>packs to be sterilized to indicate, through a<br>visible change from magenta to yellow,<br>when the device has been exposed to the<br>Lumen, Non Lumen, Flexible, Fast Non<br>Lumen, or Specialty sterilization cycle of a | The VERIFY® HPU Chemical Indicator is<br>a Type 1 vaporized hydrogen peroxide<br>sterilization process indicator. It is<br>designed to distinguish between processed<br>and unprocessed units when placed within<br>packs to be sterilized to indicate, through a<br>visible change from magenta to yellow,<br>when the device has been exposed to the<br>Lumen, Non Lumen, Flexible or Fast Non | The Intended Use<br>has been modified<br>in the proposed<br>device in order to<br>include the<br>Specialty Cycle |

# Table 4-1. Comparison of the Proposed VERIFY HPU Chemical Indicator with the Predicate

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# STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY HPU Chemical Indicator (CI)

| Feature | Proposed: VERIFY HPU<br>Chemical Indicator | Predicate: VERIFY HPU Chemical<br>Indicator (K172746) | Comparison |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | V-PRO® Low Temperature Sterilization<br>System | Lumen sterilization cycle of a V-PRO®<br>Low Temperature Sterilization System | |
| Device design -<br>components | Proprietary Indicator Ink printed onto spun-<br>bonded polyolefin, (indicator) or self-<br>adhesive spun-bonded polyolefin (indicator<br>label). | Proprietary Indicator Ink printed onto spun-<br>bonded polyolefin, (indicator) or self-<br>adhesive spun-bonded polyolefin (indicator<br>label). | Identical |
| Sterilization<br>method | Vaporized Hydrogen Peroxide | Vaporized Hydrogen Peroxide | Identical |
| Endpoint<br>specifications | No Endpoint Specifications (Type 1<br>Process Indicator) | No Endpoint Specifications (Type 1<br>Process Indicator) | Identical |
| Shelf-life | 9 months (both versions) | 9 months (both versions) | Identical |

The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.

### న. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

# Table 5-1. Verification Results Summary

| Testing | Acceptance Criteria | Study Result |
|-----------------------|-------------------------------------------|-------------------------------------------|
| Simulated Use Testing | • Complete color change<br>• No reversion | • Complete color change<br>• No reversion |

The results of the performed testing demonstrate that the VERIFY HPU Chemical Indicator performs as intended.

### 6. 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 (K172746, Class II as per 21 CFR 880.2800, product code JOJ).

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# STERIS®

Image /page/13/Picture/1 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a sense of depth and movement. The logo is simple and abstract, and it could be used to represent a variety of things, such as water, waves, or sound.

# 510(k) Summary For K231488 VERIFY VH2O2 Indicator Tape

# Sponsor Facility

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

# Manufacturing Facility

Hi-Tech Products 8530 Roland Street Buena Park, CA 90621

Contact:

Anthony Piotrkowski Director, Regulatory Affairs Telephone: [phone] Fax No: [phone] Tony piotrkowski(@steris.com

Submission Date: May 22, 2023

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### 1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

VERIFY VH2O2 Indicator Tape Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K183293

### 2. Device Description

The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

### 3. Indications for Use:

The 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 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:

- . Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
- STERRAD® 100S Sterilizer (Default Cycle)
- . Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.

### 4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.

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# STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape

| Feature | Proposed: VERIFY VH2O2 Indicator Tape | Predicate: VERIFY VH2O2 Indicator<br>Tape (K183293) | Comparison |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>including<br>Sterilization<br>Method and<br>Cycles | The Indicator Tape is intended to secure items<br>wrapped in synthetic wrap materials until used<br>and to distinguish between processed and<br>unprocessed units through a color change<br>from the start color (pink) to peach, yellow or<br>lighter. The Indicator Tape is also intended to<br>be used as an external process indicator when<br>applied to synthetic wrap materials and/or<br>Tyvek pouches.<br>The tape may be used in the following<br>sterilization cycles:<br>Lumen, Non Lumen, Flexible, Fast Non<br>Lumen, Fast, and Specialty Cycles of the<br>V-PRO: 1, 1 Plus, maX, maX 2, 60, and<br>s2 Low Temperature Sterilization<br>Systems.STERRAD® 100S Sterilizer (Default<br>Cycle)Standard and Advanced Cycles of the<br>STERRAD® NX Sterilizer with or<br>without ALLClearStandard, Flex Scope, Express and DUO<br>Cycles of the STERRAD® 100NX | The Indicator Tape is intended to secure items<br>wrapped in synthetic wrap materials until used<br>and to distinguish between processed and<br>unprocessed units through a color change<br>from the start color (pink) to peach, yellow or<br>lighter. The Indicator Tape is also intended to<br>be used as an external process indicator when<br>applied to synthetic wrap materials and/or<br>Tyvek pouches.<br>The tape may be used in the following<br>sterilization cycles:<br>Lumen, Non Lumen, Fast Non Lumen,<br>Fast and Flexible Cycles of the V-PRO:<br>1, 1 Plus, maX, maX 2 and s2 Low<br>Temperature Sterilization Systems.STERRAD® 100S Sterilizer (Default<br>Cycle)Standard and Advanced Cycles of the<br>STERRAD® NX Sterilizer with or<br>without ALLClearStandard, Flex Scope, Express and DUO<br>Cycles of the STERRAD® 100NX | The Intended<br>Use of has been<br>modified to<br>include the<br>Specialty Cycle<br>of the V-PRO<br>maX 2.<br>Inclusion of the<br>V-PRO 60. The<br>Indicator Tape<br>was cleared for<br>use in the V-<br>PRO 60 in<br>K172753 but<br>was<br>inadvertently<br>left off the<br>indications in<br>K183293 |
| | Sterilizer without ALLClear | Sterilizer without ALLClear | |
| Chemical<br>Indicator<br>Agent and<br>Performance<br>Specification | The indicator agent is a vaporized hydrogen<br>peroxide reactive ink that meets the<br>requirement specified in ANSI/AAMI/ISO<br>11140-1:2014 for a Type 1 Process Indicator<br>for a vaporized hydrogen peroxide process | The indicator agent is a vaporized hydrogen<br>peroxide reactive ink that meets the<br>requirement specified in ANSI/AAMI/ISO<br>11140-1:2014 for a Type 1 Process Indicator<br>for a vaporized hydrogen peroxide process | Identical |
| End Point<br>Specification | Tape: Pink to Peach/Yellow | Tape: Pink to Peach/Yellow | Identical |
| Device<br>Design | Tape: 3/4" wide by 60 yards long crepe<br>(masking) tape which is wound around a 3"<br>core. A hydrogen peroxide reactive ink is laid<br>down on the non-adhesive surface. The ink is<br>protected from transfer to the adhesive via a<br>coating. | Tape: 3/4" wide by 60 yards long crepe<br>(masking) tape which is wound around a 3"<br>core. A hydrogen peroxide reactive ink is laid<br>down on the non-adhesive surface. The ink is<br>protected from transfer to the adhesive via a<br>coating. | Identical |
| Shelf Life | 24 months | 24 months | Identical |
| Performance<br>Limitations<br>(taken from<br>instructions<br>for use) | Do not overlap the tape onto itself as this may<br>prevent the underlying layer from being<br>appropriately exposed to hydrogen peroxide<br>resulting in a failed indicator response. | Do not overlap the tape onto itself as this may<br>prevent the underlying layer from being<br>exposed to hydrogen peroxide resulting in a<br>failed indicator response. | Identical |

# Table 4.1 Comparison of the Proposed VERIFY | VH2O2 Indicator Tape with the Predicate

The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.

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# STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape

### ട്. Performance Testing

Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.

Table 5-8. Verification Results Summary

| Testing | Acceptance Criteria | Study Result |
|-----------------------|---------------------------------------------------------|-----------------------------------------------------------|
| Simulated Use Testing | • Complete color change<br>• Remain adhered after cycle | • Complete color change<br>• Remained adhered after cycle |

The results of the performed testing demonstrate that the VERIFY [VH2O2 Indicator Tape performs as intended.

### 6. 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 (K183293, Class II as per 21 CFR 880.2800, product code JOJ).