Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

K233187 · Steris · JOJ · Oct 27, 2023 · General Hospital

Device Facts

• Record ID: K233187
• Device Name: Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
• Applicant: Steris
• Product Code: JOJ · General Hospital
• Decision Date: Oct 27, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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 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, Fast or Specialty 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.

Device Story

The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a chemical indicator used in healthcare settings to verify that sterilization packs have been exposed to a vaporized hydrogen peroxide sterilization cycle. The device consists of a proprietary indicator ink printed on a spun-bonded polyolefin substrate with an adhesive backing. When exposed to the sterilization process, the ink undergoes a visible color change from magenta to orange/yellow or lighter. This provides a visual confirmation to clinical staff that a pack has undergone the sterilization process, helping to distinguish processed from unprocessed units. The device is intended for use with specific V-PRO and ASP STERRAD sterilization systems. It does not provide information on the efficacy of the sterilization process itself, but rather serves as a process indicator.

Clinical Evidence

No clinical data. Bench testing only. Performance was demonstrated by comparing the subject device to the reference device (K231490) which uses identical materials and has been validated for the Specialty cycle. Testing confirmed the label remains adhered and exhibits the required color change in the Specialty cycle.

Technological Characteristics

Type 1 chemical process indicator. Materials: Indicator ink, spun-bonded polyolefin substrate, adhesive, glassine backing. Conforms to ANSI/AAMI/ISO 11140-1:2014. Non-transferable ink formulation. Storage: 5-25°C, away from light/moisture/oxidizing agents. No software or electronic components.

Indications for Use

Indicated for use as a Type 1 vaporized hydrogen peroxide sterilization process indicator to distinguish between processed and unprocessed packs in V-PRO Low Temperature Sterilization Systems (Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast, or Specialty cycles) and ASP STERRAD Systems (Standard, Advanced, Express, Flex, or Duo cycles).

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™ Vaporized VH2O2 Process Indicator Adhesive Label (K192020)

Reference Devices

• VERIFY V24 Self-Contained Biological Indicator (SCBI) (K231490)

Submission Summary (Full Text)

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

October 27, 2023

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

Re: K233187

Trade/Device Name: Celerity Vaporized VH202 Process Indicator Adhesive Label (PCC078) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 28, 2023 Received: September 28, 2023

Dear Anthony Piotrkowski:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Christopher K. Dugard -S

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

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

Enclosure

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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233187

Device Name

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

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 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, Fast or Specialty 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary For K233187 Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

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

Contact: Tony Piotrkowski Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Summary Date: October 17, 2023

Premarket Notification Number: K233187

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

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### K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label

#### 1. Device Name

| Trade Name: | Celerity™ Vaporized VH2O2 Process Indicator<br>Adhesive Label |
|------------------------|---------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Chemical Indicator |
| Classification Name: | Physical/chemical process indicator |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | JOJ |

#### 2. Predicate Device

Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label K192020

| Feature | Celerity™ Vaporized $VH2O2$ Process<br>Indicator Adhesive Label (Predicate<br>Device/K192020) | Celerity™ Vaporized $VH2O2$ Process<br>Indicator Adhesive Label (Modified<br>Device) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | The Celerity™ Vaporized $VH2O2$ Process<br>Indicator Adhesive Label is a Type 1<br>vaporized hydrogen peroxide sterilization<br>process indicator. It is designed to<br>distinguish between processed and<br>unprocessed units, when affixed to packs to<br>be sterilized, through a visible change from<br>magenta to orange/yellow or lighter, when<br>the pack has been exposed to the:<br>Lumen, Non Lumen, Flexible, Fast Non<br>Lumen or Fast sterilization cycle of a V-<br>PRO® Low Temperature Sterilization<br>System, or Standard, Advanced, Express, Flex or<br>Duo cycles of an ASP STERRAD®<br>System, including those systems with<br>ALLClear Technology. | The Celerity™ Vaporized $VH2O2$ Process<br>Indicator Adhesive Label is a Type 1<br>vaporized hydrogen peroxide sterilization<br>process indicator. It is designed to<br>distinguish between processed and<br>unprocessed units, when affixed to packs to<br>be sterilized, through a visible change from<br>magenta to orange/yellow or lighter, when<br>the pack has been exposed to the:<br>Lumen, Non Lumen, Flexible, Fast Non<br>Lumen, Fast or Specialty sterilization<br>cycle of a V-PRO® Low Temperature<br>Sterilization System, or Standard, Advanced, Express, Flex or<br>Duo cycles of an ASP STERRAD®<br>System, including those systems with<br>ALLClear Technology. | Added<br>indication for<br>use in the<br>Specialty<br>Cycle which is<br>the subject of<br>this<br>submission |
| Device design -<br>components | Indicator Ink printed onto spun-bonded<br>polyolefin with an adhesive and a glassine<br>backing | Indicator Ink printed onto spun-bonded<br>polyolefin with an adhesive and a glassine<br>backing | Same |
| Indicator agent | Non-transferable indicator ink of<br>proprietary formulation which changes<br>color when exposed to $VH2O2$ | Non-transferable indicator ink of<br>proprietary formulation which changes<br>color when exposed to $VH2O2$ | Same |
| Sterilization method<br>and cycles | Vaporized Hydrogen Peroxide in the V-PRO<br>1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,<br>V-PRO maX 2, V-PRO s 2 Low<br>Temperature Sterilizers and ASP STERRAD<br>100S, NX and 100NX System, including<br>those systems with ALLClear Technology. | Vaporized Hydrogen Peroxide in the V-PRO<br>1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,<br>V-PRO maX 2, V-PRO s 2 Low<br>Temperature Sterilizers and ASP STERRAD<br>100S, NX and 100NX System, including<br>those systems with ALLClear Technology. | Same |
| Endpoint<br>specifications | No Endpoint Specifications (Type 1 Process<br>Indicator) | No Endpoint Specifications (Type 1 Process<br>Indicator) | Same |
| Endpoint stability | 15 months | 15 months | Same |

### Table 1. Device Comparison Table for Modified Label and Predicate

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### K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label

| Feature | Celerity™ Vaporized VH2O2 Process<br>Indicator Adhesive Label (Predicate<br>Device/K192020) | Celerity™ Vaporized VH2O2 Process<br>Indicator Adhesive Label (Modified<br>Device) | Comparison |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Recommended<br>storage conditions | 5-25°C/41-77°F, away from direct light. Do<br>not store indicator labels near heat,<br>moisture, oxidizing agents, acids/alkalis or<br>cleaning/disinfecting agents. | 5-25°C/41-77°F, away from direct light. Do<br>not store indicator labels near heat,<br>moisture, oxidizing agents, acids/alkalis or<br>cleaning/disinfecting agents. | Same |
| 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 1<br>Process Indicator | Same |

#### 3. Reference Device

K231490 VERIFY V24 Self-Contained Biological Indicator (SCBI)

#### 4. Description of Device

The Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. 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 Fast or Specialty 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.

### న. Intended Use/Indications for Use

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 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, Fast or Specialty 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.

### 6. Summary of Nonclinical Tests

Testing was submitted as part of K231490 to demonstrate that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial and had appropriate color change in the Specialty Cycle and this testing is also applicable to the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label for the following reasons:

- The subject device has the same indicator ink as the reference vial indicator ● label of the VERIFY V24 SCBI

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- The subject device has the same substrate as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device has the same adhesive as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device is used to monitor the same cycle (Specialty) as the reference ● vial indicator label of the VERIFY V24 SCBI
- The subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen ● Cycle which has identical preconditioning and exposure phases to the Specialty Cycle.
- . The subject device is adhered to plastic of a pouch and the reference vial indicator label of the VERIFY V24 SCBI adheres to the plastic SCBI vial.

#### 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 well as the legally marketed predicate device K192020, Class II (21 CFR 880.2800), product code JOJ.