Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label

K192020 · STERIS Corporation · JOJ · Sep 5, 2019 · General Hospital

Device Facts

• Record ID: K192020
• Device Name: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Sep 5, 2019
• Decision: SESE
• Submission Type: Special
• 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 magenta to orange/yellow or lighter, when the device has been exposed to the: · Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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. The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the: · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology. The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow, when the SCBI has been exposed to the: · Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

Device Story

Device consists of three formats of Type 1 vaporized hydrogen peroxide (VH2O2) sterilization process indicators: a chemical indicator strip for placement inside packs, an adhesive label for pack exteriors, and an adhesive label for SCBI vials. Indicators utilize proprietary non-transferable ink printed on polypropylene or spun-bonded polyolefin substrates. Upon exposure to VH2O2 sterilization cycles, ink undergoes a visible color change from magenta to orange/yellow or lighter, providing a qualitative visual confirmation that the unit has been processed. Used in clinical settings by healthcare personnel to verify sterilization cycle exposure. Output is a visual color change; assists clinicians in distinguishing processed from unprocessed items, ensuring only sterilized items are used in patient care.

Clinical Evidence

Bench testing only. Performance verified per ANSI/AAMI/ISO 11140-1:2014 requirements for Type 1 indicators. Testing included resistometer cycle exposure (pass/fail parameters), simulated use in V-PRO and STERRAD systems, fluorescent light stability, temperature extremes (freeze/thaw), transference, adhesion stability, shelf life, and post-processing stability. All studies met pre-defined acceptance criteria.

Technological Characteristics

Type 1 process indicator per ISO 11140-1:2014. Materials: Spun-bonded polyolefin (Construction B), polypropylene (Construction C), and polypropylene with adhesive/glassine backing (Construction D). Non-transferable proprietary indicator ink. Single-use. 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 (packs or SCBI vials) in V-PRO or ASP STERRAD low-temperature sterilization 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 & VERIFY V24 Self-Contained Biological Indicator Vial Label (K183295)

Reference Devices

• VERIFY® V-PRO Chemical Indicator (K172746)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

September 5, 2019

STERIS Corporation Gregory Land Sr Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44077

### Re: K192020

Trade/Device Name: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label Regulation Number: 21 CFR 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 28, 2019 Received: August 29, 2019

Dear Gregory Land:

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.

{1}------------------------------------------------

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) 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 (QS) 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 medical devices and radiation-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,

Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K192020

Device Name Celerity HP Chemical Indicator

Indications for Use (Describe)

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, when the device has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known)

#### K192020

Device Name Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label

Indications for Use (Describe)

The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K192020

Device Name VERIFY V24 Self-Contained Biological Indicator Vial Label

Indications for Use (Describe)

The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast 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 STERRAD NX and 100NX with ALLClear Technology.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in large, bold, black font at the top of the image. Below the word STERIS is a graphic of several horizontal wavy lines in shades of blue. The STERIS logo is simple and modern.

# 510(k) Summary For Celerity™ HP Chemical Indicator

### 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 Chancery House Rayns Way Watermead Business Park System Leicester LE7 1PF United Kingdom

Contact: Gregory Land Senior Regulatory Affairs Specialist Telephone: [phone] Fax No: [phone]

[e-mail]

Submission Date: September 5, 2019

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

{6}------------------------------------------------

#### 1. Predicate Device and Reference Device

1.1 Predicate Device

| Trade Name: | Celerity™ HP Chemical Indicator & VERIFY V24<br>Self-Contained Biological Indicator Vial Label |
|--------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Chemical Indicator |
| Classification: | Class II |
| Classification Name: | Physical/chemical sterilization process indicator |
| 510(k) Submitter/Holder: | STERIS Corporation |
| 510(k) Number: | K183295 |

#### 1.2 Reference Device

| Trade Name: | VERIFY® V-PRO 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: | K172746 |

#### 2. Device Description

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 through a visible change from magenta to orange/yellow or lighter, when the device has been exposed to the:

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

The Celerity "10 HP Chemical indicator is provided in three formats:

- Version 1: Celerity™ Chemical Indicator (CI) .
- . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
- Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)

The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.

{7}------------------------------------------------

Table 1 below contains information related to the different constructions and use locations of the 3 versions of the proposed device.

Version 1, the Celerity™ HP Chemical Indicator (CI) 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 magenta to orange/vellow or lighter, when the device has been exposed to the:

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

Version 2, The Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

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

Version 3, the VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI has been exposed to the:

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

#### 2.1 Physical Description - Design, Construction, Components

The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:

- Construction C Polypropylene ●
- Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper

{8}------------------------------------------------

● Construction D - polypropylene with an adhesive and a glassine backing paper.

The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.

Note that for Constructions B and D, the glassine backing paper serves as a carrier for the label and is removed from the VERIFY® V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label prior to affixing to a surface and processing.

Table 1 Correlates the three versions of the device to the constructions of substrates.

| | Version 1:<br>Celerity™<br>Chemical Indicator | Version 2:<br>Vaporized VH2O2<br>Process Indicator<br>Adhesive Label | Version 3: VERIFY®<br>V24 Self-Contained<br>Biological Indicator<br>Vial Label |
|--------------|-----------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Construction | C | B or D | B or D |
| Use Location | Within pack | Affixed to outside of<br>pack | Affixed to outside of<br>Self-Contained<br>Biological Indicator |

### Table 1: Construction Materials and Use Locations

#### 3. Indications for Use: Indications for Use – Celerity™ HP Chemical Indicator 3.1

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 magenta to orange/yellow or lighter, when the device has been exposed to the:

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

{9}------------------------------------------------

#### Indications for Use – Celerity™ Vaporized VH2O2 Process Indicator 3.2 Adhesive Label

The Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

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

#### Indications for Use – VERIFY® V24 Self-Contained Biological Indicator 3.3 Vial Label

The VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI has been exposed to the:

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

#### 4. Technological Characteristics

The proposed and predicate devices are Type 1 single use process 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 or red to orange/vellow, respectively.

Table 2 contains a comparison of technological characteristics and specifications of the proposed Celerity™ HP Chemical Indicator to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label.

{10}------------------------------------------------

| Feature | Proposed<br>Celerity™ HP Chemical<br>Indicator<br>Constructions<br>B, C and D | K183295<br>Celerity™ HP Chemical<br>Indicator<br>Constructions B and C | Comparison |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use –<br>Celerity™ HP<br>Chemical<br>Indicator | The Celerity™ HP Chemical<br>Indicator is a Type 1 vaporized<br>hydrogen peroxide sterilization<br>process indicator. It is designed<br>to distinguish between processed<br>and unprocessed units, when<br>placed within packs to be<br>sterilized, through a visible<br>change from magenta to<br>orange/yellow or lighter, when<br>the device has been exposed to<br>the:<br>Lumen, Non Lumen, Flexible,<br>Fast Non Lumen or Fast<br>sterilization cycle of a V-PRO®<br>Low Temperature Sterilization<br>System, or<br>Standard, Advanced, Express,<br>Flex or Duo cycles of an ASP<br>STERRAD® System, including<br>those systems with ALLClear<br>Technology. | The Celerity™ HP Chemical<br>Indicator is a Type 1 vaporized<br>hydrogen peroxide sterilization<br>process indicator. It is designed<br>to distinguish between processed<br>and unprocessed units, when<br>placed within packs to be<br>sterilized, through a visible<br>change from red to<br>orange/yellow, when the device<br>has been exposed to the:<br>Lumen, Non Lumen, Flexible,<br>Fast Non Lumen or Fast<br>sterilization cycle of a V-PRO®<br>Low Temperature Sterilization<br>System, or<br>Standard, Advanced, Express,<br>Flex or Duo cycles of an ASP<br>STERRAD® System, including<br>those systems with ALLClear<br>Technology. | Similar |
| Feature | Proposed<br>Celerity™ HP Chemical<br>Indicator<br>Constructions<br>B, C and D | K183295<br>Celerity™ HP Chemical<br>Indicator<br>Constructions B and C | Comparison |
| Indications<br>for Use –<br>VERIFY®<br>V24 Self-<br>Contained<br>Biological<br>Indicator<br>Vial Label | The V24 Self-Contained<br>Biological Indicator Vial Label is<br>a Type 1 vaporized hydrogen<br>peroxide sterilization process<br>indicator. It is designed to<br>distinguish between processed<br>and unprocessed SCBIs, whilst<br>affixed to SCBI vials to be<br>sterilized, through a visible<br>change from magenta to<br>orange/yellow or lighter, when<br>the SCBI has been exposed to<br>the: Lumen, Non Lumen,<br>Flexible, Fast Non Lumen or Fast<br>sterilization cycle of a V-PRO®<br>Low Temperature Sterilization<br>System, or Standard, Advanced,<br>Express, Flex or Duo cycles of an<br>ASP STERRAD® System,<br>including those systems with<br>ALLClear Technology. | The V24 Self-Contained<br>Biological Indicator Vial Label is<br>a Type 1 vaporized hydrogen<br>peroxide sterilization process<br>indicator. It is designed to<br>distinguish between processed<br>and unprocessed SCBIs, whilst<br>affixed to SCBI vials to be<br>sterilized, through a visible<br>change from red to<br>orange/yellow, when the SCBI<br>has been exposed to the: Lumen,<br>Non Lumen, Flexible, Fast Non<br>Lumen or Fast sterilization cycle<br>of a V-PRO® Low Temperature<br>Sterilization System, or Standard,<br>Advanced, Express, Flex or Duo<br>cycles of an ASP STERRAD®<br>System, including those systems<br>with ALLClear Technology. | Similar |
| Indications<br>for Use –<br>Celerity™<br>Vaporized<br>VH2O2<br>Process<br>Indicator<br>Adhesive<br>Label | The Celerity™ Vaporized<br>VH2O2 Process Indicator<br>Adhesive Label is a Type 1<br>vaporized hydrogen peroxide<br>sterilization process indicator. It<br>is designed to distinguish<br>between processed and<br>unprocessed packs, whilst<br>affixed to packs to be sterilized,<br>through a visible change from<br>magenta to orange/yellow or<br>lighter, when the pack has been<br>exposed to the: Lumen, Non<br>Lumen, Flexible, Fast Non<br>Lumen or Fast sterilization cycle<br>of a V-PRO® Low Temperature<br>Sterilization System, or<br>Standard, Advanced, Express,<br>Flex or Duo cycles of an ASP<br>STERRAD® System, including<br>those systems with ALLClear<br>Technology. | The V24 Self-Contained<br>Biological Indicator Vial Label is<br>a Type 1 vaporized hydrogen<br>peroxide sterilization process<br>indicator. It is designed to<br>distinguish between processed<br>and unprocessed SCBIs, whilst<br>affixed to SCBI vials to be<br>sterilized, through a visible<br>change from red to<br>orange/yellow, when the SCBI<br>has been exposed to the: Lumen,<br>Non Lumen, Flexible, Fast Non<br>Lumen or Fast sterilization cycle<br>of a V-PRO® Low Temperature<br>Sterilization System, or Standard,<br>Advanced, Express, Flex or Duo<br>cycles of an ASP STERRAD®<br>System, including those systems<br>with ALLClear Technology. | Similar |
| Feature | Proposed<br>Celerity™ HP Chemical<br>Indicator<br>Constructions<br>B, C and D | K183295<br>Celerity™ HP Chemical<br>Indicator<br>Constructions B and C | Comparison |
| Device design<br>-components | Indicator Ink printed spun-bonded<br>polyolefin with an adhesive and a<br>glassine backing (Construction B)<br>polypropylene (Construction C)<br>and polypropylene substrate with<br>an adhesive supplied and a<br>backing paper (Construction D) | Indicator Ink printed onto spun-<br>bonded polyolefin with an<br>adhesive and a glassine backing<br>(Construction B) and<br>polypropylene (Construction C) | Similar |
| Indicator<br>agent | Non-transferable indicator ink of<br>proprietary formulation which<br>changes color when exposed to<br>VH2O2 | Non-transferable indicator ink of<br>proprietary formulation which<br>changes color when exposed to<br>VH2O2 | Same |
| Sterilization<br>method and<br>cycles | Vaporized Hydrogen Peroxide in<br>the V-PRO 1, V-PRO 1 Plus, V-<br>PRO maX, V-PRO 60, V-PRO<br>maX 2, V-PRO s 2 Low<br>Temperature Sterilizers and ASP<br>STERRAD 100S, NX and 100NX<br>System, including those systems<br>with ALLClear Technology. | Vaporized Hydrogen Peroxide in<br>the V-PRO 1, V-PRO 1 Plus, V-<br>PRO maX, V-PRO 60, V-PRO<br>maX 2, V-PRO s 2 Low<br>Temperature Sterilizers and ASP<br>STERRAD 100S, NX and 100NX<br>System, including those systems<br>with ALLClear Technology. | Same |
| Endpoint<br>specifications | No Endpoint Specifications<br>(Type 1 Process Indicator) | No Endpoint Specifications<br>(Type 1 Process Indicator) | Same |
| Side by side<br>testing with<br>biological<br>indicators? | No | No | Same |
| Specification | Conforms to ANSI/AAMI/ISO<br>11140-1:2014 requirements for a<br>VH2O2 Type 1 Process<br>Indicator | Conforms to ANSI/AAMI/ISO<br>11140-1:2014 requirements for a<br>VH2O2 Type 1 Process<br>Indicator | Same |

Table 2. Device Comparison to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label

{11}------------------------------------------------

{12}------------------------------------------------

## Summary

The predicate and proposed devices are identical with regards to all features except for the materials. The differences between the proposed Celerity™ HP Chemical Indicator (Version 1) and the predicate Celerity™ HP Chemical Indicator (K183295, Construction C) are limited to a change in the indicator ink. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

The differences between the proposed VERIFY V24 Self-Contained Biological Indicator Vial Label to the predicate VERIFY V24 Self-Contained Biological Indicator

{13}------------------------------------------------

Vial Label (K183295, Construction B) are limited to a change to the indicator ink and the addition of a substrate, polypropylene with an adhesive back and a glassine backing paper (Construction D). The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

Version 3 of the proposed device, the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label is similar to the predicates VERIFY V24 Self-Contained Biological Indicator Vial Label, K183295. The differences between the proposed and the predicate device are limited to a change to the indicator ink and the addition of a substrate (Construction D); the later two changes are the subject of this submission. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.

#### ട്. Performance Testing

Performance testing was conducted to verify that the proposed Celerity™ HP Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications.

Table 4 summarizes the verification activities that were performed. with their respective Report Name and result to demonstrate that the proposed Celerity™ HP Chemical Indicator is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PRO maX 2 and V-PRO s 2 Low Temperature Sterilization Systems and Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

Table 4. Verification Results Summary

{14}------------------------------------------------

| Testing | Methodology | Acceptance Criteria | Study<br>Result |
|--------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Type 1 Performance<br>Testing | ANSI/AAMI/ISO<br>11140-1:2014 | When exposed to VHP<br>Resistometer cycles at<br>the Fail parameters<br>(Test Points 2 and 3):<br>100% Celerity™ HP<br>Chemical Indicator<br>stripes must show a<br>FAIL result. | Pass |
| | | When exposed to VHP<br>Resistometer cycles at<br>the Pass condition<br>(Test Point 1):<br>Minimum 90%<br>Celerity™ HP<br>Chemical Indicator<br>stripes must show a<br>PASS result. | Pass |
| Simulated Use<br>Testing | Internal Method<br>Used | When exposed to V-<br>PRO maX Non Lumen<br>1/84 cycles with ≥50<br>lb load (Fail<br>condition): 100%<br>Celerity™ HP<br>Chemical Indicator<br>stripes must show a<br>FAIL result. | Pass |
| | | When exposed to V-<br>PRO and STERRAD<br>cycles with the worst<br>case loads: Minimum<br>90% Celerity™ HP<br>Chemical Indicator<br>stripes must show a<br>PASS result | Pass |
| Testing | Methodology | Acceptance Criteria | Study<br>Result |
| Fluorescent Light<br>Stability Testing | Internal Method<br>&<br>ANSI/AAMI/ISO<br>11140-1:2014 | Indicator start color to<br>remain unchanged<br>after exposure to<br>fluorescent lighting for<br>≥ 30 days before<br>processing. | Pass |
| | | When exposed to VHP<br>Resistometer cycles at<br>the Fail parameters<br>following exposure to<br>fluorescent lighting for<br>≥ 30 days: 100% of<br>Indicators tested must<br>show a FAIL results<br>(non-visible color<br>change or color<br>change to another<br>color except<br>orange/yellow | Pass |
| | | When exposed to VHP<br>Resistometer cycles at<br>the PASS parameters<br>following exposure to<br>fluorescent lighting for<br>≥ 30 days: Minimum<br>90% Indicators tested<br>must show a PASS<br>result (orange/yellow<br>or lighter) | Pass |
| Temperature<br>Extremes Exposure<br>(Freeze/Thaw)<br>Testing | Internal Method<br>&<br>ANSI/AAMI/ISO<br>11140-1:2014 | Indicator start color to<br>remain unchanged<br>after exposure to<br>extreme temperatures<br>before processing | Pass |
| Testing | Methodology | Acceptance Criteria | Study<br>Result |
| | | When exposed to VHP<br>Resistometer cycles at<br>the Fail parameters<br>following exposure to<br>extreme temperatures:<br>100% of Indicators<br>tested must show a<br>FAIL results (non-<br>visible color change or<br>color change to<br>another color except<br>orange/yellow | Pass |
| | | When exposed to VHP<br>Resistometer cycles at<br>the PASS parameters<br>following exposure to<br>extreme temperatures:<br>Minimum 90%<br>Indicators tested must<br>show a PASS result<br>(orange/yellow or<br>lighter) | Pass |
| Transference Testing | ANSI/AAMI/ISO<br>11140-1:2014 | Indicators placed<br>between a piece of the<br>same substrate and<br>held together with<br>tape, then processed in<br>a double V-PRO maX<br>2 Lumen cycle (no<br>load) and evaluated<br>for off-set, bleed and<br>migration. | Pass |
| Testing | Methodology | Acceptance Criteria | Study<br>Result |
| | | Samples with<br>reference and text ink<br>processed in a double<br>V-PRO maX 2 Lumen<br>cycle (no load) and<br>evaluated for<br>smearing,<br>discoloration and<br>fading | Pass |
| Adhesion Stability<br>(Vials)<br>Testing | Internal Method<br>Used | When exposed to two<br>consecutive V-PRO<br>maX 2 Lumen cycles:<br>• 0% samples<br>show bleeding of the<br>adhesive<br>• 100% must be<br>firmly affixed<br>• 0% must show<br>signs of peeling<br>• Minimum 90%<br>must show a PASS<br>result | Pass |
| Shelf Life Testing | ANSI/AAMI/ISO<br>11140-1:2014 | After the process<br>indicator has been<br>aged: Minimum of<br>90% of indicators<br>must PASS Type 1<br>PASS conditions. | Pass |
| | | After the process<br>indicator has been<br>aged: 100% of<br>indicators must FAIL<br> | Pass |
| Testing | Methodology | Acceptance Criteria | Study<br>Result |
| Post-Processing<br>Stability Testing | Internal Method<br>Used | Indicator processed<br>ink color remains<br>unchanged for a<br>minimum of 6 months<br>following exposure to<br>a PASS or FAIL cycle | Pass |

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

{18}------------------------------------------------

The results of the Celerity™ HP Chemical Indicator performance testing demonstrate that all three models of the device, Celerity™ HP Chemical Indicator (Construction C), V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (Constructions B and D), perform 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 as well as or better than the legally marketed predicate device (K183295, Class II, 21 CFR 880.2800, product code JOJ).